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Patritumab deruxtecan shows promise for breast cancer patients
according to data presented from Abstract 1240 at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Patritumab deruxtecan (HER3-DXd) has previously demonstrated an acceptable safety profile and antitumor activity in phase I studies involving heavily pretreated patients with metastatic breast cancer and various levels of HER3 protein expression, said Mafalda Oliveira, MD, of the Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology in Barcelona.
Antibody-drug conjugates (ADCs) are a combination of a monoclonal antibody chemically linked to a drug, as defined by the National Cancer Institute. ADCs work by binding to receptors or proteins and selectively delivering cytotoxic drugs to the site of a tumor.
Dr. Oliveira presented results from part B the of SOLTI TOT-HER3 trial, a window-of-opportunity trial that evaluated the effect of a single dose of HER3-Dxd in patients with treatment-naive HR+/HER2– early breast cancer.
In such trials, patients receive one or more new compounds between the time of cancer diagnosis and standard treatment. Biological and clinical activity from part A of the SOLTI TOT-HER3 trial were presented at last year’s ESMO Breast Cancer Congress, Dr. Oliveira said.
In the current study, Dr. Oliveira and colleagues recruited 37 women with HR+/HER2– early breast cancer, including 20 who were hormone receptor–positive and 17 who had triple negative breast cancer (TNBC). The age of the participants ranged from 30 to 81 years, with a median age of 51 years; 54% were premenopausal. The mean tumor size was 21 mm, with a range of 10-81 mm.
Distinct from part A of the SOLTI TOT-HER3 trial, part B included a subset of patients with TNBC to assess preliminary efficacy in this subtype, Dr. Oliveira noted.
All patients in part B received a single dose of 5.6 mg/kg of HER3-DXd. The primary outcome was the variation in the tumor cellularity and tumor-infiltrating lymphocyte (CelTIL) score at baseline and after 21 days via breast ultrasound.
At day 21, the total CelTIL score increased by a significant mean difference of 9.4 points after a single dose; the mean differences for TNBC and HR+/HER2– patients, were 17.9 points and 2.2 points, respectively, Dr. Oliveira said. The overall response rate was 32% (35% in TNBC patients and 30% in HR+/HER2– patients) and was significantly associated with the absolute change in CelTIL (area under the curve = 0.693; P = .049).
In a subtype analysis, a statistically significant change in CelTIL was observed between paired samples overall (P = .046) and in TNBC (P = .016), but not in HR+ (P = .793).
Baseline levels of ERBB3 (also known as human epidermal growth factor receptor type 3, or HER3) were not associated with changes in CelTIL or in overall response rate.
HER3-DXd induced high expression of immune-related genes (such as PD1, CD8, and CD19), and suppressed proliferation-related genes, she said.
A total of 31 patients (84%) reported any adverse events. Of these, the most common were nausea, fatigue, alopecia, diarrhea, constipation, and vomiting, and one patient experienced grade 3 treatment-related nausea. No interstitial lung disease events were reported during the study, and the incidence of hematological and hepatic toxicity was lower with the lower dose in part B, compared with the 6.5 mg/kg dose used in part A, Dr. Oliveira noted.
To further validate the findings of the current study and assess the activity of HER3-DXd in early breast cancer, Dr. Oliveira and colleagues are conducting a neoadjuvant phase II trial known as SOLTI-2103 VALENTINE. In this study, they are testing six cycles of HER3-DXd at a 5.6 mg/kg dose in HR+/HER2– breast cancer patients, she said.
During a question-and-answer session, Dr. Oliveira was asked whether CelTIL is the best endpoint for assessing HER3-DXd. Finding the best endpoint is always a challenge when conducting window-of-opportunity trials, she said. The CelTIL score has been correlated with pathologic complete response (pCR), as well as with disease-free survival and overall survival, she added.
ICARUS-BREAST01
In a presentation of Abstract 1890 during the same session, Barbari Pistilli, MD, of Gustave Roussy Cancer Center, Villejuif, France, shared data from a phase II study known as ICARUS-BREAST.
The study population included women with unresectable locally advanced breast cancer (ABC) who had undergone a median of two previous systemic therapies. In the current study, the patients underwent a median of eight cycles of HER3-DXd. The dosage was 5.6 mg/kg every 3 weeks until disease progression or unacceptable toxicity.
The primary outcome was overall response and disease progression after 3 months. Dr. Pistilli, who is also a coauthor of the research, provided data from 56 evaluable patients.
After 3 months, 16 patients (28.6%) showed a partial response, 30 patients showed stable disease (54%), and 10 (18%) showed disease progression. “No patients had a complete response,” Dr. Pistilli noted.
As for the safety profile, all patients reported at least one treatment-emergent event of any grade, but less than half (48.2%) were grade 3 or higher, and 12.5% led to treatment discontinuation. Fatigue and nausea were the most frequently reported adverse events overall, and occurred in 89.3% and 76.8% of patients, respectively. All grade and grade 3 or higher neutropenia occurred in four patients and six patients, respectively; all grade and grade 3 or higher thrombocytopenia occurred in four patients and two patients, respectively, Dr. Pistilli said.
Data on circulating tumor cells (CTCs) were available for 31 patients, and the researchers reviewed CTC counts after the first HER3-DXd cycle.
“We found that the median number of CTCs decreased by one to two cell cycles of HER3-DXd,” said Dr. Pistilli. She and her coauthors found no substantial impact of the treatment on HER3 negative CTC counts, and “more importantly, no increase of HER3 negative CTC counts at disease progression,” Dr. Pistilli continued.
In addition, patients with higher HER+ CTC counts at baseline or a greater decrease in HER3+ CTC counts after one cycle of HER3-DXd were more likely to have an early treatment response, but this association was not statistically significant.
Looking ahead, further analysis will be performed to evaluate the association between HER3+ CTC counts and dynamics and the main outcomes of overall response rate and progression-free survival to determine the potential of HER3+ CTC counts to identify patients who can benefit from HER3-DXd, said Dr. Pistilli. The ICARUS-BREAST01 study is ongoing, and further efficacy and biomarker analysis will be presented, she added.
In the question-and-answer session, Dr. Pistilli was asked why she chose CTC as a measure.
Dr. Pistilli responded that she and her coauthors wanted to understand whether CTC could serve as a biomarker to help in patient selection.
Also, when asked about which genes might be upregulated and downregulated in responders vs. nonresponders, she noted that some genes related to DNA repair were involved in patients who were responders, but more research is needed.
Early results merit further exploration
Although patritumab deruxtecan is early in development, “there is a clear signal to expand,” based on preliminary research, said Rebecca A. Dent, MD, who served as discussant for the two studies.
“There is no clear role for a specific subtype in both protein and gene expression,” noted Dr. Dent, who is a professor at Duke NUS Medical School, a collaboration between Duke University, Durham, N.C., and the National University of Singapore.
In the SOLTI TOT-HER3 trial, the small numbers make teasing out correlations a challenge, said Dr. Dent. However, changes were observed after just one cycle of the drug, and the upregulation of immune signature genes was reassuring, she said.
“A single dose of HER3-DXd induced an overall response of approximately 30% independently of hormone receptor status,” she emphasized, and the lower incidence of hematological and hepatic toxicity with the lower dose is good news as well. The findings were limited by the small sample size, but the results support moving forward with clinical development of HER3-DXd, she said.
The ICARUS-BREAST01 study researchers tried to show whether they could identify potential markers of early treatment response, and they examined CTCs and gene alterations, said Dr. Dent. “I think it is reassuring that despite these patients being heavily pretreated, HER-DXd seems to be active regardless of most frequent breast cancer genomic alterations,” she noted. Remaining questions include the need for more data on primary resistance.
“We are able to get these patients to respond, but what makes patients resistant to ADCs is just as important,” she said. “We see exciting data across all these subtypes,”
In Dr. Dent’s opinion, future research should focus on triple negative breast cancer, an opinion supported by the stronger response in this subset of patients in the SOLTI TOT-HER3 trial. “I think you need to bring triple negative to the table,” she said.
The SOLTI TOT-HER3 study was funded by Daiichi Sankyo. Dr. Oliveira disclosed relationships with companies including AstraZeneca, Ayala Pharmaceuticals, Boehringer-Ingelheim, Genentech, Gilead, GSK, Novartis, Roche, Seagen, Zenith Epigenetics, Daiichi Sankyo, iTEOS, MSD, Pierre-Fabre, Relay Therapeutics, and Eisai. ICARUS-BREAST01 was sponsored by the Gustave Roussy Cancer Center and supported by Daiichi Sankyo. Dr. Pistilli disclosed relationships with multiple companies including Daiichi-Sankyo, AstraZeneca, Gilead, Seagen, MSD, Novartis, Lilly, and Pierre Fabre. Dr. Dent disclosed financial relationships with companies including AstraZeneca, Roche, Eisai, Lilly, MSD, Novartis, and Pfizer.
according to data presented from Abstract 1240 at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Patritumab deruxtecan (HER3-DXd) has previously demonstrated an acceptable safety profile and antitumor activity in phase I studies involving heavily pretreated patients with metastatic breast cancer and various levels of HER3 protein expression, said Mafalda Oliveira, MD, of the Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology in Barcelona.
Antibody-drug conjugates (ADCs) are a combination of a monoclonal antibody chemically linked to a drug, as defined by the National Cancer Institute. ADCs work by binding to receptors or proteins and selectively delivering cytotoxic drugs to the site of a tumor.
Dr. Oliveira presented results from part B the of SOLTI TOT-HER3 trial, a window-of-opportunity trial that evaluated the effect of a single dose of HER3-Dxd in patients with treatment-naive HR+/HER2– early breast cancer.
In such trials, patients receive one or more new compounds between the time of cancer diagnosis and standard treatment. Biological and clinical activity from part A of the SOLTI TOT-HER3 trial were presented at last year’s ESMO Breast Cancer Congress, Dr. Oliveira said.
In the current study, Dr. Oliveira and colleagues recruited 37 women with HR+/HER2– early breast cancer, including 20 who were hormone receptor–positive and 17 who had triple negative breast cancer (TNBC). The age of the participants ranged from 30 to 81 years, with a median age of 51 years; 54% were premenopausal. The mean tumor size was 21 mm, with a range of 10-81 mm.
Distinct from part A of the SOLTI TOT-HER3 trial, part B included a subset of patients with TNBC to assess preliminary efficacy in this subtype, Dr. Oliveira noted.
All patients in part B received a single dose of 5.6 mg/kg of HER3-DXd. The primary outcome was the variation in the tumor cellularity and tumor-infiltrating lymphocyte (CelTIL) score at baseline and after 21 days via breast ultrasound.
At day 21, the total CelTIL score increased by a significant mean difference of 9.4 points after a single dose; the mean differences for TNBC and HR+/HER2– patients, were 17.9 points and 2.2 points, respectively, Dr. Oliveira said. The overall response rate was 32% (35% in TNBC patients and 30% in HR+/HER2– patients) and was significantly associated with the absolute change in CelTIL (area under the curve = 0.693; P = .049).
In a subtype analysis, a statistically significant change in CelTIL was observed between paired samples overall (P = .046) and in TNBC (P = .016), but not in HR+ (P = .793).
Baseline levels of ERBB3 (also known as human epidermal growth factor receptor type 3, or HER3) were not associated with changes in CelTIL or in overall response rate.
HER3-DXd induced high expression of immune-related genes (such as PD1, CD8, and CD19), and suppressed proliferation-related genes, she said.
A total of 31 patients (84%) reported any adverse events. Of these, the most common were nausea, fatigue, alopecia, diarrhea, constipation, and vomiting, and one patient experienced grade 3 treatment-related nausea. No interstitial lung disease events were reported during the study, and the incidence of hematological and hepatic toxicity was lower with the lower dose in part B, compared with the 6.5 mg/kg dose used in part A, Dr. Oliveira noted.
To further validate the findings of the current study and assess the activity of HER3-DXd in early breast cancer, Dr. Oliveira and colleagues are conducting a neoadjuvant phase II trial known as SOLTI-2103 VALENTINE. In this study, they are testing six cycles of HER3-DXd at a 5.6 mg/kg dose in HR+/HER2– breast cancer patients, she said.
During a question-and-answer session, Dr. Oliveira was asked whether CelTIL is the best endpoint for assessing HER3-DXd. Finding the best endpoint is always a challenge when conducting window-of-opportunity trials, she said. The CelTIL score has been correlated with pathologic complete response (pCR), as well as with disease-free survival and overall survival, she added.
ICARUS-BREAST01
In a presentation of Abstract 1890 during the same session, Barbari Pistilli, MD, of Gustave Roussy Cancer Center, Villejuif, France, shared data from a phase II study known as ICARUS-BREAST.
The study population included women with unresectable locally advanced breast cancer (ABC) who had undergone a median of two previous systemic therapies. In the current study, the patients underwent a median of eight cycles of HER3-DXd. The dosage was 5.6 mg/kg every 3 weeks until disease progression or unacceptable toxicity.
The primary outcome was overall response and disease progression after 3 months. Dr. Pistilli, who is also a coauthor of the research, provided data from 56 evaluable patients.
After 3 months, 16 patients (28.6%) showed a partial response, 30 patients showed stable disease (54%), and 10 (18%) showed disease progression. “No patients had a complete response,” Dr. Pistilli noted.
As for the safety profile, all patients reported at least one treatment-emergent event of any grade, but less than half (48.2%) were grade 3 or higher, and 12.5% led to treatment discontinuation. Fatigue and nausea were the most frequently reported adverse events overall, and occurred in 89.3% and 76.8% of patients, respectively. All grade and grade 3 or higher neutropenia occurred in four patients and six patients, respectively; all grade and grade 3 or higher thrombocytopenia occurred in four patients and two patients, respectively, Dr. Pistilli said.
Data on circulating tumor cells (CTCs) were available for 31 patients, and the researchers reviewed CTC counts after the first HER3-DXd cycle.
“We found that the median number of CTCs decreased by one to two cell cycles of HER3-DXd,” said Dr. Pistilli. She and her coauthors found no substantial impact of the treatment on HER3 negative CTC counts, and “more importantly, no increase of HER3 negative CTC counts at disease progression,” Dr. Pistilli continued.
In addition, patients with higher HER+ CTC counts at baseline or a greater decrease in HER3+ CTC counts after one cycle of HER3-DXd were more likely to have an early treatment response, but this association was not statistically significant.
Looking ahead, further analysis will be performed to evaluate the association between HER3+ CTC counts and dynamics and the main outcomes of overall response rate and progression-free survival to determine the potential of HER3+ CTC counts to identify patients who can benefit from HER3-DXd, said Dr. Pistilli. The ICARUS-BREAST01 study is ongoing, and further efficacy and biomarker analysis will be presented, she added.
In the question-and-answer session, Dr. Pistilli was asked why she chose CTC as a measure.
Dr. Pistilli responded that she and her coauthors wanted to understand whether CTC could serve as a biomarker to help in patient selection.
Also, when asked about which genes might be upregulated and downregulated in responders vs. nonresponders, she noted that some genes related to DNA repair were involved in patients who were responders, but more research is needed.
Early results merit further exploration
Although patritumab deruxtecan is early in development, “there is a clear signal to expand,” based on preliminary research, said Rebecca A. Dent, MD, who served as discussant for the two studies.
“There is no clear role for a specific subtype in both protein and gene expression,” noted Dr. Dent, who is a professor at Duke NUS Medical School, a collaboration between Duke University, Durham, N.C., and the National University of Singapore.
In the SOLTI TOT-HER3 trial, the small numbers make teasing out correlations a challenge, said Dr. Dent. However, changes were observed after just one cycle of the drug, and the upregulation of immune signature genes was reassuring, she said.
“A single dose of HER3-DXd induced an overall response of approximately 30% independently of hormone receptor status,” she emphasized, and the lower incidence of hematological and hepatic toxicity with the lower dose is good news as well. The findings were limited by the small sample size, but the results support moving forward with clinical development of HER3-DXd, she said.
The ICARUS-BREAST01 study researchers tried to show whether they could identify potential markers of early treatment response, and they examined CTCs and gene alterations, said Dr. Dent. “I think it is reassuring that despite these patients being heavily pretreated, HER-DXd seems to be active regardless of most frequent breast cancer genomic alterations,” she noted. Remaining questions include the need for more data on primary resistance.
“We are able to get these patients to respond, but what makes patients resistant to ADCs is just as important,” she said. “We see exciting data across all these subtypes,”
In Dr. Dent’s opinion, future research should focus on triple negative breast cancer, an opinion supported by the stronger response in this subset of patients in the SOLTI TOT-HER3 trial. “I think you need to bring triple negative to the table,” she said.
The SOLTI TOT-HER3 study was funded by Daiichi Sankyo. Dr. Oliveira disclosed relationships with companies including AstraZeneca, Ayala Pharmaceuticals, Boehringer-Ingelheim, Genentech, Gilead, GSK, Novartis, Roche, Seagen, Zenith Epigenetics, Daiichi Sankyo, iTEOS, MSD, Pierre-Fabre, Relay Therapeutics, and Eisai. ICARUS-BREAST01 was sponsored by the Gustave Roussy Cancer Center and supported by Daiichi Sankyo. Dr. Pistilli disclosed relationships with multiple companies including Daiichi-Sankyo, AstraZeneca, Gilead, Seagen, MSD, Novartis, Lilly, and Pierre Fabre. Dr. Dent disclosed financial relationships with companies including AstraZeneca, Roche, Eisai, Lilly, MSD, Novartis, and Pfizer.
according to data presented from Abstract 1240 at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
Patritumab deruxtecan (HER3-DXd) has previously demonstrated an acceptable safety profile and antitumor activity in phase I studies involving heavily pretreated patients with metastatic breast cancer and various levels of HER3 protein expression, said Mafalda Oliveira, MD, of the Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology in Barcelona.
Antibody-drug conjugates (ADCs) are a combination of a monoclonal antibody chemically linked to a drug, as defined by the National Cancer Institute. ADCs work by binding to receptors or proteins and selectively delivering cytotoxic drugs to the site of a tumor.
Dr. Oliveira presented results from part B the of SOLTI TOT-HER3 trial, a window-of-opportunity trial that evaluated the effect of a single dose of HER3-Dxd in patients with treatment-naive HR+/HER2– early breast cancer.
In such trials, patients receive one or more new compounds between the time of cancer diagnosis and standard treatment. Biological and clinical activity from part A of the SOLTI TOT-HER3 trial were presented at last year’s ESMO Breast Cancer Congress, Dr. Oliveira said.
In the current study, Dr. Oliveira and colleagues recruited 37 women with HR+/HER2– early breast cancer, including 20 who were hormone receptor–positive and 17 who had triple negative breast cancer (TNBC). The age of the participants ranged from 30 to 81 years, with a median age of 51 years; 54% were premenopausal. The mean tumor size was 21 mm, with a range of 10-81 mm.
Distinct from part A of the SOLTI TOT-HER3 trial, part B included a subset of patients with TNBC to assess preliminary efficacy in this subtype, Dr. Oliveira noted.
All patients in part B received a single dose of 5.6 mg/kg of HER3-DXd. The primary outcome was the variation in the tumor cellularity and tumor-infiltrating lymphocyte (CelTIL) score at baseline and after 21 days via breast ultrasound.
At day 21, the total CelTIL score increased by a significant mean difference of 9.4 points after a single dose; the mean differences for TNBC and HR+/HER2– patients, were 17.9 points and 2.2 points, respectively, Dr. Oliveira said. The overall response rate was 32% (35% in TNBC patients and 30% in HR+/HER2– patients) and was significantly associated with the absolute change in CelTIL (area under the curve = 0.693; P = .049).
In a subtype analysis, a statistically significant change in CelTIL was observed between paired samples overall (P = .046) and in TNBC (P = .016), but not in HR+ (P = .793).
Baseline levels of ERBB3 (also known as human epidermal growth factor receptor type 3, or HER3) were not associated with changes in CelTIL or in overall response rate.
HER3-DXd induced high expression of immune-related genes (such as PD1, CD8, and CD19), and suppressed proliferation-related genes, she said.
A total of 31 patients (84%) reported any adverse events. Of these, the most common were nausea, fatigue, alopecia, diarrhea, constipation, and vomiting, and one patient experienced grade 3 treatment-related nausea. No interstitial lung disease events were reported during the study, and the incidence of hematological and hepatic toxicity was lower with the lower dose in part B, compared with the 6.5 mg/kg dose used in part A, Dr. Oliveira noted.
To further validate the findings of the current study and assess the activity of HER3-DXd in early breast cancer, Dr. Oliveira and colleagues are conducting a neoadjuvant phase II trial known as SOLTI-2103 VALENTINE. In this study, they are testing six cycles of HER3-DXd at a 5.6 mg/kg dose in HR+/HER2– breast cancer patients, she said.
During a question-and-answer session, Dr. Oliveira was asked whether CelTIL is the best endpoint for assessing HER3-DXd. Finding the best endpoint is always a challenge when conducting window-of-opportunity trials, she said. The CelTIL score has been correlated with pathologic complete response (pCR), as well as with disease-free survival and overall survival, she added.
ICARUS-BREAST01
In a presentation of Abstract 1890 during the same session, Barbari Pistilli, MD, of Gustave Roussy Cancer Center, Villejuif, France, shared data from a phase II study known as ICARUS-BREAST.
The study population included women with unresectable locally advanced breast cancer (ABC) who had undergone a median of two previous systemic therapies. In the current study, the patients underwent a median of eight cycles of HER3-DXd. The dosage was 5.6 mg/kg every 3 weeks until disease progression or unacceptable toxicity.
The primary outcome was overall response and disease progression after 3 months. Dr. Pistilli, who is also a coauthor of the research, provided data from 56 evaluable patients.
After 3 months, 16 patients (28.6%) showed a partial response, 30 patients showed stable disease (54%), and 10 (18%) showed disease progression. “No patients had a complete response,” Dr. Pistilli noted.
As for the safety profile, all patients reported at least one treatment-emergent event of any grade, but less than half (48.2%) were grade 3 or higher, and 12.5% led to treatment discontinuation. Fatigue and nausea were the most frequently reported adverse events overall, and occurred in 89.3% and 76.8% of patients, respectively. All grade and grade 3 or higher neutropenia occurred in four patients and six patients, respectively; all grade and grade 3 or higher thrombocytopenia occurred in four patients and two patients, respectively, Dr. Pistilli said.
Data on circulating tumor cells (CTCs) were available for 31 patients, and the researchers reviewed CTC counts after the first HER3-DXd cycle.
“We found that the median number of CTCs decreased by one to two cell cycles of HER3-DXd,” said Dr. Pistilli. She and her coauthors found no substantial impact of the treatment on HER3 negative CTC counts, and “more importantly, no increase of HER3 negative CTC counts at disease progression,” Dr. Pistilli continued.
In addition, patients with higher HER+ CTC counts at baseline or a greater decrease in HER3+ CTC counts after one cycle of HER3-DXd were more likely to have an early treatment response, but this association was not statistically significant.
Looking ahead, further analysis will be performed to evaluate the association between HER3+ CTC counts and dynamics and the main outcomes of overall response rate and progression-free survival to determine the potential of HER3+ CTC counts to identify patients who can benefit from HER3-DXd, said Dr. Pistilli. The ICARUS-BREAST01 study is ongoing, and further efficacy and biomarker analysis will be presented, she added.
In the question-and-answer session, Dr. Pistilli was asked why she chose CTC as a measure.
Dr. Pistilli responded that she and her coauthors wanted to understand whether CTC could serve as a biomarker to help in patient selection.
Also, when asked about which genes might be upregulated and downregulated in responders vs. nonresponders, she noted that some genes related to DNA repair were involved in patients who were responders, but more research is needed.
Early results merit further exploration
Although patritumab deruxtecan is early in development, “there is a clear signal to expand,” based on preliminary research, said Rebecca A. Dent, MD, who served as discussant for the two studies.
“There is no clear role for a specific subtype in both protein and gene expression,” noted Dr. Dent, who is a professor at Duke NUS Medical School, a collaboration between Duke University, Durham, N.C., and the National University of Singapore.
In the SOLTI TOT-HER3 trial, the small numbers make teasing out correlations a challenge, said Dr. Dent. However, changes were observed after just one cycle of the drug, and the upregulation of immune signature genes was reassuring, she said.
“A single dose of HER3-DXd induced an overall response of approximately 30% independently of hormone receptor status,” she emphasized, and the lower incidence of hematological and hepatic toxicity with the lower dose is good news as well. The findings were limited by the small sample size, but the results support moving forward with clinical development of HER3-DXd, she said.
The ICARUS-BREAST01 study researchers tried to show whether they could identify potential markers of early treatment response, and they examined CTCs and gene alterations, said Dr. Dent. “I think it is reassuring that despite these patients being heavily pretreated, HER-DXd seems to be active regardless of most frequent breast cancer genomic alterations,” she noted. Remaining questions include the need for more data on primary resistance.
“We are able to get these patients to respond, but what makes patients resistant to ADCs is just as important,” she said. “We see exciting data across all these subtypes,”
In Dr. Dent’s opinion, future research should focus on triple negative breast cancer, an opinion supported by the stronger response in this subset of patients in the SOLTI TOT-HER3 trial. “I think you need to bring triple negative to the table,” she said.
The SOLTI TOT-HER3 study was funded by Daiichi Sankyo. Dr. Oliveira disclosed relationships with companies including AstraZeneca, Ayala Pharmaceuticals, Boehringer-Ingelheim, Genentech, Gilead, GSK, Novartis, Roche, Seagen, Zenith Epigenetics, Daiichi Sankyo, iTEOS, MSD, Pierre-Fabre, Relay Therapeutics, and Eisai. ICARUS-BREAST01 was sponsored by the Gustave Roussy Cancer Center and supported by Daiichi Sankyo. Dr. Pistilli disclosed relationships with multiple companies including Daiichi-Sankyo, AstraZeneca, Gilead, Seagen, MSD, Novartis, Lilly, and Pierre Fabre. Dr. Dent disclosed financial relationships with companies including AstraZeneca, Roche, Eisai, Lilly, MSD, Novartis, and Pfizer.
FROM ESMO BREAST CANCER 2023
T-DXd for HER2-low BC: Analysis confirms adverse effects
Interstitial lung disease (ILD) also remains a concern, and it’s not clear if retreatment after resolution is warranted.
In general, however, “T-DXd demonstrates a manageable safety profile consistent with prior reports. Results from this safety analysis continued to support its use as a new standard of care in patients with HER2-low metastatic breast cancer,” said report lead author Hope Rugo, MD, of the University of California, San Francisco, during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
T-DXd, an antibody-drug conjugate, received FDA approval in August 2022 for patients with HER2-low disease. The drug has been touted as “practice changing” and a “new standard of care.”
However, physicians have noted that the benefits of the drug come at the cost of significant adverse effects, including some that can cause hospitalization. There’s special concern about high-grade interstitial lung disease/pneumonitis, and an FDA boxed warning cautions clinicians about this possible side effect.
For the new analysis, researchers presented additional safety data from the industry-funded DESTINY-Breast04 trial, whose results was published in July 2022 in the New England Journal of Medicine. That study randomized 373 patients to T-DXd and 184 to physician’s choice of treatment. It found that, “among all patients, the median progression-free survival was 9.9 months in the trastuzumab deruxtecan group and 5.1 months in the physician’s choice group (hazard ratio for disease progression or death, 0.50; P < .001), and overall survival was 23.4 months and 16.8 months, respectively (hazard ratio for death, 0.64; P = .001).”
Exposure-adjusted incidence rates for any-grade treatment-emergent adverse events were lower for T-DXd versus physician’s choice of treatment (1.30 vs. 2.66). However, nausea and vomiting events were more than twice as common in patients who took T-DXd versus the physician’s choice (79.5% vs. 35.5%).
A total of 50.9% of patients in the T-DXd arm received antiemetic prophylaxis versus 37.2% in the physician’s choice arm. A single patient discontinued T-DXd treatment because of vomiting, and a single patient discontinued treatment because of nausea. No patients in the physician choice group discontinued treatment because of nausea or vomiting.
Neutropenia and febrile neutropenia were less frequent in the T-DXd arm versus physician’s choice (12.9% vs. 18.0% and 0.3% vs. 2.9%, respectively.)
ILD occurred in 45 patients (12.1%) of those in the T-DXd arm versus 1 (0.6%) in the physician choice arm. Ten patients of the patients in the T-DXd arm had not recovered by the data cutoff point.
Six patients with ILD were retreated following resolution; one discontinued because of an adverse event, two discontinued because of progressive disease, and three remained on the drug. “Given that there was only a small number of patients who were retreated with T-DXd, it’s difficult to make clinically meaningful conclusions on the effect of retreatment following grade IDL events that have resolved,” Dr. Rugo said.
In the big picture, “ILD pneumonitis remains an important identified risk and an adverse event of interest associated with T-DXd,” Dr. Rugo said. “It’s important that we adhere to management guidelines and updated toxicity management guidelines.”
In a discussion, Dr. Rugo said she prescribes three antiemetic drugs to help patients tolerate T-DXd therapy: “It makes a big difference. Anecdotally, it really has improved management of nausea. Start more and back down [as symptoms fade].”
Gustavo Werutsky, MD, PhD, of Moinhos de Vento Hospital, Porto Alegre, Brazil, the discussant for the presentation, also emphasized the importance of prevention and said he prescribes two or three prophylactic drugs. “In the beginning, we didn’t know these events were so important. A big part of the message is that patients from the beginning need to have a good prophylaxis for the nausea and vomiting.”
The researchers also presented a related report at the conference, an analysis of patient-reported outcomes from DESTINY-Breast02, a randomized phase 3 study of T-DXd (n = 406) versus physician’s choice of treatment (n = 202) in patients with HER2-positive metastatic breast cancer who were resistant/refractory to trastuzumab emtansine.
The analysis, led by Tanja Fehm, MD, of University Hospital Düsseldorf (Germany), found that the median time to definitive deterioration was longer with T-DXd versus the other arm per the EORTC QLQ-C30 global health status/quality of life score (14.1 vs. 5.9 months; HR, 0.56; 95% confidence interval, 0.44-0.71).
The studies were funded by Daiichi Sankyo and AstraZeneca, which make T-DXd. Dr. Hugo discloses relationships with Puma, NAPO, Blueprint, Scorpion Therapeutics, Merck, AstraZeneca, Gilead, Astellas, Daiichi Sankyo, F. Hoffmann–La Roche/Genentech, GlaxoSmithKline, Lilly, Novartis, OBI, Pfizer, Pionyr, Sermonix, Taiho Oncology, and Veru. Multiple other authors of both studies have various disclosures.
Interstitial lung disease (ILD) also remains a concern, and it’s not clear if retreatment after resolution is warranted.
In general, however, “T-DXd demonstrates a manageable safety profile consistent with prior reports. Results from this safety analysis continued to support its use as a new standard of care in patients with HER2-low metastatic breast cancer,” said report lead author Hope Rugo, MD, of the University of California, San Francisco, during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
T-DXd, an antibody-drug conjugate, received FDA approval in August 2022 for patients with HER2-low disease. The drug has been touted as “practice changing” and a “new standard of care.”
However, physicians have noted that the benefits of the drug come at the cost of significant adverse effects, including some that can cause hospitalization. There’s special concern about high-grade interstitial lung disease/pneumonitis, and an FDA boxed warning cautions clinicians about this possible side effect.
For the new analysis, researchers presented additional safety data from the industry-funded DESTINY-Breast04 trial, whose results was published in July 2022 in the New England Journal of Medicine. That study randomized 373 patients to T-DXd and 184 to physician’s choice of treatment. It found that, “among all patients, the median progression-free survival was 9.9 months in the trastuzumab deruxtecan group and 5.1 months in the physician’s choice group (hazard ratio for disease progression or death, 0.50; P < .001), and overall survival was 23.4 months and 16.8 months, respectively (hazard ratio for death, 0.64; P = .001).”
Exposure-adjusted incidence rates for any-grade treatment-emergent adverse events were lower for T-DXd versus physician’s choice of treatment (1.30 vs. 2.66). However, nausea and vomiting events were more than twice as common in patients who took T-DXd versus the physician’s choice (79.5% vs. 35.5%).
A total of 50.9% of patients in the T-DXd arm received antiemetic prophylaxis versus 37.2% in the physician’s choice arm. A single patient discontinued T-DXd treatment because of vomiting, and a single patient discontinued treatment because of nausea. No patients in the physician choice group discontinued treatment because of nausea or vomiting.
Neutropenia and febrile neutropenia were less frequent in the T-DXd arm versus physician’s choice (12.9% vs. 18.0% and 0.3% vs. 2.9%, respectively.)
ILD occurred in 45 patients (12.1%) of those in the T-DXd arm versus 1 (0.6%) in the physician choice arm. Ten patients of the patients in the T-DXd arm had not recovered by the data cutoff point.
Six patients with ILD were retreated following resolution; one discontinued because of an adverse event, two discontinued because of progressive disease, and three remained on the drug. “Given that there was only a small number of patients who were retreated with T-DXd, it’s difficult to make clinically meaningful conclusions on the effect of retreatment following grade IDL events that have resolved,” Dr. Rugo said.
In the big picture, “ILD pneumonitis remains an important identified risk and an adverse event of interest associated with T-DXd,” Dr. Rugo said. “It’s important that we adhere to management guidelines and updated toxicity management guidelines.”
In a discussion, Dr. Rugo said she prescribes three antiemetic drugs to help patients tolerate T-DXd therapy: “It makes a big difference. Anecdotally, it really has improved management of nausea. Start more and back down [as symptoms fade].”
Gustavo Werutsky, MD, PhD, of Moinhos de Vento Hospital, Porto Alegre, Brazil, the discussant for the presentation, also emphasized the importance of prevention and said he prescribes two or three prophylactic drugs. “In the beginning, we didn’t know these events were so important. A big part of the message is that patients from the beginning need to have a good prophylaxis for the nausea and vomiting.”
The researchers also presented a related report at the conference, an analysis of patient-reported outcomes from DESTINY-Breast02, a randomized phase 3 study of T-DXd (n = 406) versus physician’s choice of treatment (n = 202) in patients with HER2-positive metastatic breast cancer who were resistant/refractory to trastuzumab emtansine.
The analysis, led by Tanja Fehm, MD, of University Hospital Düsseldorf (Germany), found that the median time to definitive deterioration was longer with T-DXd versus the other arm per the EORTC QLQ-C30 global health status/quality of life score (14.1 vs. 5.9 months; HR, 0.56; 95% confidence interval, 0.44-0.71).
The studies were funded by Daiichi Sankyo and AstraZeneca, which make T-DXd. Dr. Hugo discloses relationships with Puma, NAPO, Blueprint, Scorpion Therapeutics, Merck, AstraZeneca, Gilead, Astellas, Daiichi Sankyo, F. Hoffmann–La Roche/Genentech, GlaxoSmithKline, Lilly, Novartis, OBI, Pfizer, Pionyr, Sermonix, Taiho Oncology, and Veru. Multiple other authors of both studies have various disclosures.
Interstitial lung disease (ILD) also remains a concern, and it’s not clear if retreatment after resolution is warranted.
In general, however, “T-DXd demonstrates a manageable safety profile consistent with prior reports. Results from this safety analysis continued to support its use as a new standard of care in patients with HER2-low metastatic breast cancer,” said report lead author Hope Rugo, MD, of the University of California, San Francisco, during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.
T-DXd, an antibody-drug conjugate, received FDA approval in August 2022 for patients with HER2-low disease. The drug has been touted as “practice changing” and a “new standard of care.”
However, physicians have noted that the benefits of the drug come at the cost of significant adverse effects, including some that can cause hospitalization. There’s special concern about high-grade interstitial lung disease/pneumonitis, and an FDA boxed warning cautions clinicians about this possible side effect.
For the new analysis, researchers presented additional safety data from the industry-funded DESTINY-Breast04 trial, whose results was published in July 2022 in the New England Journal of Medicine. That study randomized 373 patients to T-DXd and 184 to physician’s choice of treatment. It found that, “among all patients, the median progression-free survival was 9.9 months in the trastuzumab deruxtecan group and 5.1 months in the physician’s choice group (hazard ratio for disease progression or death, 0.50; P < .001), and overall survival was 23.4 months and 16.8 months, respectively (hazard ratio for death, 0.64; P = .001).”
Exposure-adjusted incidence rates for any-grade treatment-emergent adverse events were lower for T-DXd versus physician’s choice of treatment (1.30 vs. 2.66). However, nausea and vomiting events were more than twice as common in patients who took T-DXd versus the physician’s choice (79.5% vs. 35.5%).
A total of 50.9% of patients in the T-DXd arm received antiemetic prophylaxis versus 37.2% in the physician’s choice arm. A single patient discontinued T-DXd treatment because of vomiting, and a single patient discontinued treatment because of nausea. No patients in the physician choice group discontinued treatment because of nausea or vomiting.
Neutropenia and febrile neutropenia were less frequent in the T-DXd arm versus physician’s choice (12.9% vs. 18.0% and 0.3% vs. 2.9%, respectively.)
ILD occurred in 45 patients (12.1%) of those in the T-DXd arm versus 1 (0.6%) in the physician choice arm. Ten patients of the patients in the T-DXd arm had not recovered by the data cutoff point.
Six patients with ILD were retreated following resolution; one discontinued because of an adverse event, two discontinued because of progressive disease, and three remained on the drug. “Given that there was only a small number of patients who were retreated with T-DXd, it’s difficult to make clinically meaningful conclusions on the effect of retreatment following grade IDL events that have resolved,” Dr. Rugo said.
In the big picture, “ILD pneumonitis remains an important identified risk and an adverse event of interest associated with T-DXd,” Dr. Rugo said. “It’s important that we adhere to management guidelines and updated toxicity management guidelines.”
In a discussion, Dr. Rugo said she prescribes three antiemetic drugs to help patients tolerate T-DXd therapy: “It makes a big difference. Anecdotally, it really has improved management of nausea. Start more and back down [as symptoms fade].”
Gustavo Werutsky, MD, PhD, of Moinhos de Vento Hospital, Porto Alegre, Brazil, the discussant for the presentation, also emphasized the importance of prevention and said he prescribes two or three prophylactic drugs. “In the beginning, we didn’t know these events were so important. A big part of the message is that patients from the beginning need to have a good prophylaxis for the nausea and vomiting.”
The researchers also presented a related report at the conference, an analysis of patient-reported outcomes from DESTINY-Breast02, a randomized phase 3 study of T-DXd (n = 406) versus physician’s choice of treatment (n = 202) in patients with HER2-positive metastatic breast cancer who were resistant/refractory to trastuzumab emtansine.
The analysis, led by Tanja Fehm, MD, of University Hospital Düsseldorf (Germany), found that the median time to definitive deterioration was longer with T-DXd versus the other arm per the EORTC QLQ-C30 global health status/quality of life score (14.1 vs. 5.9 months; HR, 0.56; 95% confidence interval, 0.44-0.71).
The studies were funded by Daiichi Sankyo and AstraZeneca, which make T-DXd. Dr. Hugo discloses relationships with Puma, NAPO, Blueprint, Scorpion Therapeutics, Merck, AstraZeneca, Gilead, Astellas, Daiichi Sankyo, F. Hoffmann–La Roche/Genentech, GlaxoSmithKline, Lilly, Novartis, OBI, Pfizer, Pionyr, Sermonix, Taiho Oncology, and Veru. Multiple other authors of both studies have various disclosures.
FROM ESMO BREAST CANCER 2023
BMI has greater impact on survival in younger breast cancer patients
new data suggest.
Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.
Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.
The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.
Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), or obese (30 kg/m2 or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.
DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).
“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.
In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.
The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.
In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.
When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
Data draw attention to quality of life and lifestyle factors
The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.
Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.
Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.
“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.
The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.
new data suggest.
Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.
Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.
The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.
Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), or obese (30 kg/m2 or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.
DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).
“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.
In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.
The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.
In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.
When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
Data draw attention to quality of life and lifestyle factors
The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.
Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.
Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.
“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.
The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.
new data suggest.
Obesity is a well-known risk factor for breast cancer in postmenopausal women and has been associated with adverse prognosis, said Senna W.M. Lammers, MD, of Maastricht (the Netherlands) University during a presentation at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. In addition, some studies suggest that patients with higher body mass index (BMI) experience reduced benefits from endocrine therapy, she said.
Dr. Lammers and colleagues conducted a study to determine the prognostic and predictive effect of BMI on disease-free survival in postmenopausal women with hormone receptor–positive (HR+) breast cancer who were treated with extended endocrine therapy.
The study population included participants in the randomized, phase III DATA trial, which evaluated the use of 6 years vs. 3 years of anastrozole in postmenopausal women with HR+ breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen therapy.
Patients were categorized based on BMI as having normal weight (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), or obese (30 kg/m2 or higher). The primary outcome was disease-free survival (DFS); the median follow-up period was 13.1 years.
DFS for patients with normal weight, overweight, and obesity was 66.2%, 59.5%, and 52.4%, with a P value of less than .001 for the trend, Dr. Lammers said. “These results were confirmed in multivariable analysis,” she said. Overall, patients with overweight and obesity had a worse DFS when compared with patients with normal weight (hazard ratio, 1.16; P = .10, for patients with overweight and HR, 1.26; P = .03 for patients with obesity).
“Next, we aimed to determine whether the prognostic effect of BMI differed by age,” Dr. Lammers said.
In women younger than 60 years, overweight and obesity were significantly associated with worse DFS (HR, 1.29; P = .05 and HR 1.83, P less than .001, respectively). However, this effect was not observed in women aged 60 years and older.
The researchers also examined the treatment effect of extended anastrozole on adapted DFS by weight, and found no significant differences among patients with normal weight, overweight, and obesity (HR, 1.00; HR, 0.74; and HR, 0.97, respectively), said Dr. Lammers.
In the question and answer session, Dr. Lammers was asked about possible explanations for the difference in DFS by age. Potential explanations include possible survival bias “as only the healthier [patients with obesity] survive to old age,” she said. Other potential explanations are biological, such as the potentially higher levels of bone density in older [patients with obesity], she said.
When asked about additional clinical implications, Dr. Lammers emphasized the importance of maintaining a healthy BMI for breast cancer patients of all ages. Other research areas might involve the use of lifestyle interventions, although these are challenging to implement, she noted.
Data draw attention to quality of life and lifestyle factors
The need to “look at drug development with new eyes” is particularly important when reviewing patient-reported outcomes, said Otto Metzger, MD, of the Dana Farber Cancer Institute, Boston, who served as the discussant for the session.
Dr. Metzger brought up the association between age and the effect of BMI on DFS, specifically.
Based on data from multiple studies and meta-analyses, “I do believe that obesity does play a role in prognosis,” he said, but the question is how long will researchers continue to simply record data without acting to add lifestyle interventions while also trying to develop new drugs, he said. Although convincing patients to make lifestyle changes remains a challenge, patients are often more motivated to make such changes after a cancer diagnosis, Dr. Metzger noted.
“I am a firm believer in the use of digital therapeutics in the context of clinical trials,” said Dr. Metzger. Digital technology offers great potential to educate patients on [adverse effects] and also to improve treatment adherence and quality of life, he concluded.
The study was supported by AstraZeneca, and Dr. Lammers disclosed financial relationships with AstraZeneca and Eli Lilly. Dr. Metzger disclosed receiving research funding to his institution from Pfizer, Genentech/Roche, and Sanofi, and serving as an adviser/consultant to AstraZeneca, Merck, Oncoclinicas, Resilience, and Roche.
FROM ESMO BREAST CANCER 2023
Number of cancer survivors with functional limitations doubled in 20 years
Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.
Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.
The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.
For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
Patients surveyed on function
Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.
Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
Not just a result of living longer
Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.
“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.
Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.
Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.
“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
Quality of life beyond survivorship
Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.
“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.
The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.
There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”
Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.
“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.
A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.
Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.
Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.
The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.
For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
Patients surveyed on function
Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.
Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
Not just a result of living longer
Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.
“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.
Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.
Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.
“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
Quality of life beyond survivorship
Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.
“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.
The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.
There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”
Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.
“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.
A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.
Vishal Patel, BS, a student at the Dell Medical School at The University of Texas at Austin, and colleagues identified 51,258 cancer survivors from the National Health Interview Survey, representing a weighted population of approximately 178.8 million from 1999 to 2018.
Most survivors were women (60.2%) and were at least 65 years old (55.4%). In 1999, 3.6 million weighted survivors reported functional limitation. In 2018, the number increased to 8.2 million, a 2.25-fold increase.
The number of survivors who reported no limitations also increased, but not by as much. That group grew 1.34-fold during the study period.
For context, “the 70% prevalence of functional limitation among survivors in 2018 is nearly twice that of the general population,” the authors wrote.
Patients surveyed on function
Functional limitation was defined as “self-reported difficulty performing any of 12 routine physical or social activities without assistance.” Examples of the activities included difficulty sitting for more than 2 hours, difficulty participating in social activities or difficulty pushing or pulling an object the size of a living room chair.
Over the 2 decades analyzed, the adjusted prevalence of functional limitation was highest among survivors of pancreatic cancer (80.3%) and lung cancer (76.5%). Prevalence was lowest for survivors of melanoma (62.2%), breast (61.8%) and prostate (59.5%) cancers.
Not just a result of living longer
Mr. Patel told this publication that one assumption people might make when they read these results is that people are just living longer with cancer and losing functional ability accordingly.
“But, in fact, we found that the youngest [– those less than 65 years–] actually contributed to this trend more than the oldest people, which means it’s not just [happening], because people are getting older,” he said.
Hispanic and Black individuals had disproportionately higher increases in functional limitation; percentage point increases over the 2 decades were 19.5 for Black people, 25.1 for Hispanic people and 12.5 for White people. There may be a couple of reasons for that, Mr. Patel noted.
Those who are Black or Hispanic tend to have less access to cancer survivorship care for reasons including insurance status and historic health care inequities, he noted.
“The other potential reason is that they have had less access to cancer care historically. And if, 20 years ago Black and Hispanic individuals didn’t have access to some chemotherapies, and now they do, maybe it’s the increased access to care that’s causing these functional limitations. Because chemotherapy can sometimes be very toxic. It may be sort of a catch-up toxicity,” he said.
Quality of life beyond survivorship
Mr. Patel said the results seem to call for building on improved survival rates by tracking and improving function.
“It’s good to celebrate that there are more survivors. But now that we can keep people alive longer, maybe we can shift gears to improving their quality of life,” he said.
The more-than-doubling of functional limitations over 2 decades “is a very sobering trend,” he noted, while pointing out that the functional limitations applied to 8 million people in the United States – people whose needs are not being met.
There’s no sign of the trend stopping, he continued. “We saw no downward trend, only an upward trend.”
Increasingly, including functionality as an endpoint in cancer trials, in addition to improvements in mortality, is one place to start, he added.
“Our findings suggest an urgent need for care teams to understand and address function, for researchers to evaluate function as a core outcome in trials, and for health systems and policy makers to reimagine survivorship care, recognizing the burden of cancer and its treatment on physical, psychosocial, and cognitive function,” the authors wrote in their paper. Limitations of the study include the potential for recall bias, lack of cancer staging or treatment information, and the subjective perception of function.
A coauthor reported personal fees from Astellas, AstraZeneca, AAA, Blue Earth, Janssen, Lantheus, Myovant, Myriad Genetics, Novartis, Telix, and Sanofi, as well as grants from Pfizer and Bayer during the conduct of the study. No other disclosures were reported.
FROM JAMA ONCOLOGY
New USPSTF draft suggests mammography start at 40, not 50
The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.
The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.
The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.
In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”
Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.
“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.
The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.
When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.
“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
Insurance access
Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.
But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit.
Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.
Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
Uncertainties persist
The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.
The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).
The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.
The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.
“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.
The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.
One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.
“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.
The task force will accept comments from the public on this draft update through June 5.
A version of this article first appeared on Medscape.com.
The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.
The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.
The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.
In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”
Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.
“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.
The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.
When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.
“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
Insurance access
Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.
But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit.
Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.
Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
Uncertainties persist
The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.
The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).
The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.
The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.
“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.
The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.
One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.
“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.
The task force will accept comments from the public on this draft update through June 5.
A version of this article first appeared on Medscape.com.
The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.
The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.
The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.
In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”
Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.
“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.
The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.
When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.
“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
Insurance access
Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.
But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit.
Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.
Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
Uncertainties persist
The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.
The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).
The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.
The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.
“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.
The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.
One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.
“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.
The task force will accept comments from the public on this draft update through June 5.
A version of this article first appeared on Medscape.com.
Familial cancer risk complex, not limited to same site
The researchers found, for instance, that children of breast cancer patients had a 27% higher risk of any discordant early-onset cancer, and patients’ siblings had a 7.6-fold higher risk of early pancreatic cancer. The analysis also indicated that children of patients’ siblings had a significantly increased risk of testicular and ovarian cancers.
“The findings suggest that the familial risk extends to discordant early-onset cancers, including ovarian, testicular, and pancreatic cancers, as well as beyond first-degree relatives,” the researchers, led by Janne M. Pitkäniemi, PhD, Finnish Cancer Registry, Institute for Statistical and Epidemiological Cancer Research, Helsinki, say. “Our findings are interesting but raise some questions about unknown [genetic] and environmental mechanisms that need to be further studied.”
Erin F. Cobain, MD, who was not involved in the research, said the findings are “not very surprising to me.”
Dr. Cobain said that at her institution, she has seen “many, many cases” of family members of early-onset breast cancer patients with discordant cancers “where we are unable to find a clear genetic cause.”
Not being able to find an identifiable cause for the clustering of early-onset cancers can be “very frustrating” for patients and their families, said Dr. Cobain, a medical oncologist at the University of Michigan Health, Ann Arbor.
The study was published online in the International Journal of Cancer.
Family members of patients with early-onset breast cancer are at elevated risk for early-onset breast cancer. However, it is “unclear whether the familial risk is limited to early-onset cancer of the same site,” the authors explained.
To investigate, the researchers studied data from the Finnish Cancer Registry and the Finnish Population System, which included 54,753 relatives from 5,562 families of females diagnosed with early-onset breast cancer, defined as probands. A proband was the first member of the family diagnosed with female breast cancer at age 40 years or younger in Finland between January 1970 and December 31, 2012. Cancers were considered familial if they occurred in a family with a previously diagnosed proband and were deemed early onset if diagnosed before age 41.
The researchers found that only 5.5% of probands’ families had a family member with a discordant early-onset cancer. The most common diagnoses were testicular cancer (0.6% of families) and cancer of the thyroid gland (also 0.6%), followed by melanoma (0.5%).
Overall, the risk of any nonbreast early-onset cancer among first-degree relatives of probands was comparable with the risk in the general population (standardized incidence ratio, 0.99; 95% confidence interval, 0.84-1.16).
However, the risk was elevated for certain family members and certain cancers.
Specifically, the children of probands had an increased risk for any discordant cancer (SIR, 1.27; 95% CI, 1.05-1.55).
The siblings of probands had an elevated risk for early-onset pancreatic cancer (SIR, 7.61) but not overall for any discordant cancer (SIR, 0.93; 95% CI, 0.68-1.25).
And siblings’ children faced an elevated risk for testicular (SIR, 1.74) and ovarian (SIR, 2.69) cancer, though not of any discordant cancer (SIR, 1.16; 95% CI, 0.97-1.37).
The researchers also found that the fathers (SIR, 0.43), mothers (SIR, 0.48), and spouses (SIR, 0.58) of probands appeared to have a decreased risk of any discordant early-onset cancer.
A potential limitation to the study was that the authors could not identify individuals with hereditary cancer syndromes or concerning gene mutations, such as BRCA carriers, because “registry data do not include comprehensive information on the gene mutation carriage status.” But the authors note that the number of BRCA carriers is likely low because of the low number of ovarian cancers observed in first-degree relatives of probands.
Dr. Cobain noted as well that the current study is potentially limited by its “very homogeneous” cohort.
But, overall, the findings indicate that familial risk is often “a much more complicated problem, mathematically and statistically,” than were there a single genetic culprit, Dr. Cobain said. One possibility is that some shared environmental exposure may be increasing the cancer risk among members of the same family.
“Genetic diversity is so vast and understanding how the interplay of multiple genes can influence an individual’s cancer risk is so much more complicated than a single BRCA1 mutation that clearly influences your breast cancer risk,” she added. However, “we’re starting to get there.”
The study was funded by the Cancer Foundation Finland and Academy of Finland. The authors and Dr. Cobain had no relevant financial relationships to declare.
A version of this article originally appeared on Medscape.com.
The researchers found, for instance, that children of breast cancer patients had a 27% higher risk of any discordant early-onset cancer, and patients’ siblings had a 7.6-fold higher risk of early pancreatic cancer. The analysis also indicated that children of patients’ siblings had a significantly increased risk of testicular and ovarian cancers.
“The findings suggest that the familial risk extends to discordant early-onset cancers, including ovarian, testicular, and pancreatic cancers, as well as beyond first-degree relatives,” the researchers, led by Janne M. Pitkäniemi, PhD, Finnish Cancer Registry, Institute for Statistical and Epidemiological Cancer Research, Helsinki, say. “Our findings are interesting but raise some questions about unknown [genetic] and environmental mechanisms that need to be further studied.”
Erin F. Cobain, MD, who was not involved in the research, said the findings are “not very surprising to me.”
Dr. Cobain said that at her institution, she has seen “many, many cases” of family members of early-onset breast cancer patients with discordant cancers “where we are unable to find a clear genetic cause.”
Not being able to find an identifiable cause for the clustering of early-onset cancers can be “very frustrating” for patients and their families, said Dr. Cobain, a medical oncologist at the University of Michigan Health, Ann Arbor.
The study was published online in the International Journal of Cancer.
Family members of patients with early-onset breast cancer are at elevated risk for early-onset breast cancer. However, it is “unclear whether the familial risk is limited to early-onset cancer of the same site,” the authors explained.
To investigate, the researchers studied data from the Finnish Cancer Registry and the Finnish Population System, which included 54,753 relatives from 5,562 families of females diagnosed with early-onset breast cancer, defined as probands. A proband was the first member of the family diagnosed with female breast cancer at age 40 years or younger in Finland between January 1970 and December 31, 2012. Cancers were considered familial if they occurred in a family with a previously diagnosed proband and were deemed early onset if diagnosed before age 41.
The researchers found that only 5.5% of probands’ families had a family member with a discordant early-onset cancer. The most common diagnoses were testicular cancer (0.6% of families) and cancer of the thyroid gland (also 0.6%), followed by melanoma (0.5%).
Overall, the risk of any nonbreast early-onset cancer among first-degree relatives of probands was comparable with the risk in the general population (standardized incidence ratio, 0.99; 95% confidence interval, 0.84-1.16).
However, the risk was elevated for certain family members and certain cancers.
Specifically, the children of probands had an increased risk for any discordant cancer (SIR, 1.27; 95% CI, 1.05-1.55).
The siblings of probands had an elevated risk for early-onset pancreatic cancer (SIR, 7.61) but not overall for any discordant cancer (SIR, 0.93; 95% CI, 0.68-1.25).
And siblings’ children faced an elevated risk for testicular (SIR, 1.74) and ovarian (SIR, 2.69) cancer, though not of any discordant cancer (SIR, 1.16; 95% CI, 0.97-1.37).
The researchers also found that the fathers (SIR, 0.43), mothers (SIR, 0.48), and spouses (SIR, 0.58) of probands appeared to have a decreased risk of any discordant early-onset cancer.
A potential limitation to the study was that the authors could not identify individuals with hereditary cancer syndromes or concerning gene mutations, such as BRCA carriers, because “registry data do not include comprehensive information on the gene mutation carriage status.” But the authors note that the number of BRCA carriers is likely low because of the low number of ovarian cancers observed in first-degree relatives of probands.
Dr. Cobain noted as well that the current study is potentially limited by its “very homogeneous” cohort.
But, overall, the findings indicate that familial risk is often “a much more complicated problem, mathematically and statistically,” than were there a single genetic culprit, Dr. Cobain said. One possibility is that some shared environmental exposure may be increasing the cancer risk among members of the same family.
“Genetic diversity is so vast and understanding how the interplay of multiple genes can influence an individual’s cancer risk is so much more complicated than a single BRCA1 mutation that clearly influences your breast cancer risk,” she added. However, “we’re starting to get there.”
The study was funded by the Cancer Foundation Finland and Academy of Finland. The authors and Dr. Cobain had no relevant financial relationships to declare.
A version of this article originally appeared on Medscape.com.
The researchers found, for instance, that children of breast cancer patients had a 27% higher risk of any discordant early-onset cancer, and patients’ siblings had a 7.6-fold higher risk of early pancreatic cancer. The analysis also indicated that children of patients’ siblings had a significantly increased risk of testicular and ovarian cancers.
“The findings suggest that the familial risk extends to discordant early-onset cancers, including ovarian, testicular, and pancreatic cancers, as well as beyond first-degree relatives,” the researchers, led by Janne M. Pitkäniemi, PhD, Finnish Cancer Registry, Institute for Statistical and Epidemiological Cancer Research, Helsinki, say. “Our findings are interesting but raise some questions about unknown [genetic] and environmental mechanisms that need to be further studied.”
Erin F. Cobain, MD, who was not involved in the research, said the findings are “not very surprising to me.”
Dr. Cobain said that at her institution, she has seen “many, many cases” of family members of early-onset breast cancer patients with discordant cancers “where we are unable to find a clear genetic cause.”
Not being able to find an identifiable cause for the clustering of early-onset cancers can be “very frustrating” for patients and their families, said Dr. Cobain, a medical oncologist at the University of Michigan Health, Ann Arbor.
The study was published online in the International Journal of Cancer.
Family members of patients with early-onset breast cancer are at elevated risk for early-onset breast cancer. However, it is “unclear whether the familial risk is limited to early-onset cancer of the same site,” the authors explained.
To investigate, the researchers studied data from the Finnish Cancer Registry and the Finnish Population System, which included 54,753 relatives from 5,562 families of females diagnosed with early-onset breast cancer, defined as probands. A proband was the first member of the family diagnosed with female breast cancer at age 40 years or younger in Finland between January 1970 and December 31, 2012. Cancers were considered familial if they occurred in a family with a previously diagnosed proband and were deemed early onset if diagnosed before age 41.
The researchers found that only 5.5% of probands’ families had a family member with a discordant early-onset cancer. The most common diagnoses were testicular cancer (0.6% of families) and cancer of the thyroid gland (also 0.6%), followed by melanoma (0.5%).
Overall, the risk of any nonbreast early-onset cancer among first-degree relatives of probands was comparable with the risk in the general population (standardized incidence ratio, 0.99; 95% confidence interval, 0.84-1.16).
However, the risk was elevated for certain family members and certain cancers.
Specifically, the children of probands had an increased risk for any discordant cancer (SIR, 1.27; 95% CI, 1.05-1.55).
The siblings of probands had an elevated risk for early-onset pancreatic cancer (SIR, 7.61) but not overall for any discordant cancer (SIR, 0.93; 95% CI, 0.68-1.25).
And siblings’ children faced an elevated risk for testicular (SIR, 1.74) and ovarian (SIR, 2.69) cancer, though not of any discordant cancer (SIR, 1.16; 95% CI, 0.97-1.37).
The researchers also found that the fathers (SIR, 0.43), mothers (SIR, 0.48), and spouses (SIR, 0.58) of probands appeared to have a decreased risk of any discordant early-onset cancer.
A potential limitation to the study was that the authors could not identify individuals with hereditary cancer syndromes or concerning gene mutations, such as BRCA carriers, because “registry data do not include comprehensive information on the gene mutation carriage status.” But the authors note that the number of BRCA carriers is likely low because of the low number of ovarian cancers observed in first-degree relatives of probands.
Dr. Cobain noted as well that the current study is potentially limited by its “very homogeneous” cohort.
But, overall, the findings indicate that familial risk is often “a much more complicated problem, mathematically and statistically,” than were there a single genetic culprit, Dr. Cobain said. One possibility is that some shared environmental exposure may be increasing the cancer risk among members of the same family.
“Genetic diversity is so vast and understanding how the interplay of multiple genes can influence an individual’s cancer risk is so much more complicated than a single BRCA1 mutation that clearly influences your breast cancer risk,” she added. However, “we’re starting to get there.”
The study was funded by the Cancer Foundation Finland and Academy of Finland. The authors and Dr. Cobain had no relevant financial relationships to declare.
A version of this article originally appeared on Medscape.com.
FROM INTERNATIONAL JOURNAL OF CANCER
Pausing endocrine therapy to attempt pregnancy is safe
The results provide the “strongest evidence to date on the short-term safety of this choice,” Sharon Giordano, MD, MPH, with University of Texas M.D. Anderson Cancer Center, Houston, wrote in an editorial accompanying the study.
“Physicians should now incorporate these positive data into their shared decision-making process with patients,” Dr. Giordano said.
The POSITIVE trial findings were published online in The New England Journal of Medicine.
Before the analysis, the risks associated with taking a break from endocrine therapy among young women with hormone receptor (HR)–positive breast cancer remained unclear.
In the current trial, Ann Partridge, MD, MPH, and colleagues sought prospective data on the safety associated with taking a temporary break from therapy to attempt pregnancy.
The single-group trial enrolled more than 500 premenopausal women who had received 18-30 months of endocrine therapy for mostly stage I or II HR-positive breast cancer. After a 3-month washout, the women were given 2 years to conceive, deliver, and breastfeed, if desired, before resuming treatment. Breast cancer events – the primary outcome – were defined as local, regional, or distant recurrence of invasive breast cancer or new contralateral invasive breast cancer.
The results, initially reported at San Antonio Breast Cancer Symposium (SABCS) 2022, showed that a temporary interruption of therapy to attempt pregnancy did not appear to lead to worse breast cancer outcomes.
Among 497 women who were followed for pregnancy status, 368 (74%) had at least one pregnancy, and 317 (64%) had at least one live birth.
After a median follow-up of 3.4 years, 44 women had had a breast cancer event – a result that was close to, but did not exceed, the safety threshold of 46 breast cancer events.
The 3-year incidence of breast cancer events was 8.9% (95% confidence interval [CI], 6.3-11.6) in the treatment-interruption group compared with 9.2% (95% CI, 7.6-10.8) among historical controls, which included women who would have met the entry criteria for the trial.
“These results suggest that although endocrine therapy for a period of 5-10 years substantially improves disease outcomes in patients with hormone receptor–positive early breast cancer, a temporary interruption of therapy to attempt pregnancy does not appear to have an appreciable negative short-term effect,” wrote Dr. Partridge, vice chair of medical oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, Boston, and colleagues.
The authors cautioned, however, that the median follow-up was only 3.4 years and that 10-year follow-up data will be “critical” to confirm the safety of interruption of adjuvant endocrine therapy.
Dr. Giordano agreed, noting that “recurrences of breast cancer are reported to occur at a steady rate for up to 20 years after diagnosis among patients with hormone receptor–positive disease; the protocol-specified 10-year follow-up data will be essential to establish longer-term safety.”
The study was supported by the International Breast Cancer Study Group and by the Alliance for Clinical Trials in Oncology in North America in collaboration with the Breast International Group (BIG). Disclosures for authors and editorial writer are available at NEJM.org.
A version of this article first appeared on Medscape.com.
The results provide the “strongest evidence to date on the short-term safety of this choice,” Sharon Giordano, MD, MPH, with University of Texas M.D. Anderson Cancer Center, Houston, wrote in an editorial accompanying the study.
“Physicians should now incorporate these positive data into their shared decision-making process with patients,” Dr. Giordano said.
The POSITIVE trial findings were published online in The New England Journal of Medicine.
Before the analysis, the risks associated with taking a break from endocrine therapy among young women with hormone receptor (HR)–positive breast cancer remained unclear.
In the current trial, Ann Partridge, MD, MPH, and colleagues sought prospective data on the safety associated with taking a temporary break from therapy to attempt pregnancy.
The single-group trial enrolled more than 500 premenopausal women who had received 18-30 months of endocrine therapy for mostly stage I or II HR-positive breast cancer. After a 3-month washout, the women were given 2 years to conceive, deliver, and breastfeed, if desired, before resuming treatment. Breast cancer events – the primary outcome – were defined as local, regional, or distant recurrence of invasive breast cancer or new contralateral invasive breast cancer.
The results, initially reported at San Antonio Breast Cancer Symposium (SABCS) 2022, showed that a temporary interruption of therapy to attempt pregnancy did not appear to lead to worse breast cancer outcomes.
Among 497 women who were followed for pregnancy status, 368 (74%) had at least one pregnancy, and 317 (64%) had at least one live birth.
After a median follow-up of 3.4 years, 44 women had had a breast cancer event – a result that was close to, but did not exceed, the safety threshold of 46 breast cancer events.
The 3-year incidence of breast cancer events was 8.9% (95% confidence interval [CI], 6.3-11.6) in the treatment-interruption group compared with 9.2% (95% CI, 7.6-10.8) among historical controls, which included women who would have met the entry criteria for the trial.
“These results suggest that although endocrine therapy for a period of 5-10 years substantially improves disease outcomes in patients with hormone receptor–positive early breast cancer, a temporary interruption of therapy to attempt pregnancy does not appear to have an appreciable negative short-term effect,” wrote Dr. Partridge, vice chair of medical oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, Boston, and colleagues.
The authors cautioned, however, that the median follow-up was only 3.4 years and that 10-year follow-up data will be “critical” to confirm the safety of interruption of adjuvant endocrine therapy.
Dr. Giordano agreed, noting that “recurrences of breast cancer are reported to occur at a steady rate for up to 20 years after diagnosis among patients with hormone receptor–positive disease; the protocol-specified 10-year follow-up data will be essential to establish longer-term safety.”
The study was supported by the International Breast Cancer Study Group and by the Alliance for Clinical Trials in Oncology in North America in collaboration with the Breast International Group (BIG). Disclosures for authors and editorial writer are available at NEJM.org.
A version of this article first appeared on Medscape.com.
The results provide the “strongest evidence to date on the short-term safety of this choice,” Sharon Giordano, MD, MPH, with University of Texas M.D. Anderson Cancer Center, Houston, wrote in an editorial accompanying the study.
“Physicians should now incorporate these positive data into their shared decision-making process with patients,” Dr. Giordano said.
The POSITIVE trial findings were published online in The New England Journal of Medicine.
Before the analysis, the risks associated with taking a break from endocrine therapy among young women with hormone receptor (HR)–positive breast cancer remained unclear.
In the current trial, Ann Partridge, MD, MPH, and colleagues sought prospective data on the safety associated with taking a temporary break from therapy to attempt pregnancy.
The single-group trial enrolled more than 500 premenopausal women who had received 18-30 months of endocrine therapy for mostly stage I or II HR-positive breast cancer. After a 3-month washout, the women were given 2 years to conceive, deliver, and breastfeed, if desired, before resuming treatment. Breast cancer events – the primary outcome – were defined as local, regional, or distant recurrence of invasive breast cancer or new contralateral invasive breast cancer.
The results, initially reported at San Antonio Breast Cancer Symposium (SABCS) 2022, showed that a temporary interruption of therapy to attempt pregnancy did not appear to lead to worse breast cancer outcomes.
Among 497 women who were followed for pregnancy status, 368 (74%) had at least one pregnancy, and 317 (64%) had at least one live birth.
After a median follow-up of 3.4 years, 44 women had had a breast cancer event – a result that was close to, but did not exceed, the safety threshold of 46 breast cancer events.
The 3-year incidence of breast cancer events was 8.9% (95% confidence interval [CI], 6.3-11.6) in the treatment-interruption group compared with 9.2% (95% CI, 7.6-10.8) among historical controls, which included women who would have met the entry criteria for the trial.
“These results suggest that although endocrine therapy for a period of 5-10 years substantially improves disease outcomes in patients with hormone receptor–positive early breast cancer, a temporary interruption of therapy to attempt pregnancy does not appear to have an appreciable negative short-term effect,” wrote Dr. Partridge, vice chair of medical oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School, Boston, and colleagues.
The authors cautioned, however, that the median follow-up was only 3.4 years and that 10-year follow-up data will be “critical” to confirm the safety of interruption of adjuvant endocrine therapy.
Dr. Giordano agreed, noting that “recurrences of breast cancer are reported to occur at a steady rate for up to 20 years after diagnosis among patients with hormone receptor–positive disease; the protocol-specified 10-year follow-up data will be essential to establish longer-term safety.”
The study was supported by the International Breast Cancer Study Group and by the Alliance for Clinical Trials in Oncology in North America in collaboration with the Breast International Group (BIG). Disclosures for authors and editorial writer are available at NEJM.org.
A version of this article first appeared on Medscape.com.
FROM NEJM
Preop MRI does not reduce positive margins in breast surgery
BOSTON – a new study concludes.
The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.
“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”
The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.
In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.
Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.
“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”
Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”
This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.
MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.
However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”
“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
Study details
Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.
She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.
Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).
These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.
The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.
In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).
Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).
However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.
It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.
This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”
The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – a new study concludes.
The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.
“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”
The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.
In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.
Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.
“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”
Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”
This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.
MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.
However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”
“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
Study details
Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.
She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.
Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).
These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.
The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.
In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).
Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).
However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.
It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.
This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”
The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – a new study concludes.
The current results suggest that MRI is “not useful to achieve this goal and not a productive use of health care resources,” said senior author Marissa Howard-McNatt, MD, director of the Breast Care Center, Wake Forest University, Winston-Salem, N.C.
“Researchers continue to look for better ways to assess margin status while the patient is still on the operating table,” she said, as a re-operation “can be traumatic.”
The study was presented at the annual meeting of the American Society of Breast Surgeons and was highlighted in a press briefing.
In the study, more than 630 patients with early stage breast cancer were randomly assigned to partial mastectomy with or without cavity shaving of the tumor margins, of whom 193 underwent MRI before their operation.
Although there was a difference in the rate of positive surgical margins before cavity shaving between patients who did and did not undergo MRI, the difference did not reach statistical significance.
“MRI exams are costly and potentially stressful for patients,” Dr. Howard-McNatt commented in a press statement. “The thought is that they will help physicians achieve negative margins during the initial surgery. However, our study shows this is simply not the case.”
Approached for comment, Mediget Teshome, MD, MPH, said, “In my practice, I primarily utilize MRI preoperatively to evaluate the extent of disease in cases where the information is not clear from mammogram and ultrasound.”
This may be when there is “discordance between the size of the malignancy or concern for chest wall or muscle involvement,” Dr. Teshome said in an interview.
MRI is also useful when there may be occult disease, such as in patients “with high suspicion for extensive intraductal component not evident on mammography and those who present with axillary metastasis and unknown breast primary,” as well as in high-risk patients with a genetic predisposition for breast cancer, she explained.
However, Dr. Teshome, an associate professor in the department of breast surgical oncology at the University of Texas MD Anderson Cancer Center, Houston, stressed that, “as with any test, it is important that preoperative MRI is performed with the specific intent to inform clinical decision-making in a meaningful way.”
“While it can provide a benefit in selected cases given its high sensitivity, MRI is associated with false positives and can also contribute to increased patient anxiety and additional procedures,” she cautioned.
Study details
Lumpectomy has become “a mainstay of breast cancer management, with safe and reliable outcomes as compared to mastectomy,” said Dr. Howard-McNatt, but it is associated with a higher rate of positive margins, of up to 27%.
She underlined that “re-excision surgery can contribute to greater morbidity, patient anxiety, poor cosmetic outcomes, and health care system overload,” and the desire to reduce re-operations has led to “much attention” being paid to preoperative imaging.
Their study set out to investigate the value of preoperative MRI in this regard, and for this they analyzed data on 631 women who had participated in two prior randomized trials (SHAVE1 and SHAVE2).
These women were randomly assigned to standard partial mastectomy with or without resection of cavity shave margins, with preoperative MRI performed prior to randomization in both trials at the surgeon’s discretion.
The median tumor size was 1.3 cm. An extensive intraductal component was identified in 32.8% of patients, 26.1% had palpable tumors, and 7% had invasive lobular histology. Neoadjuvant chemotherapy was administered in 6.5% of patients.
In all, 193 individuals underwent MRI. These women were less likely to have a positive surgical margin before resection of cavity shave margins, at 31.1% vs. 38.8% in those who did not have MRI, although the difference was not statistically significant (P = .073).
Multivariate analysis taking into account patient age, race, receipt of neoadjuvant chemotherapy, the presence of an extensive intraductal component, as well as histologic subtype and tumor size, revealed that MRI was not associated with a higher rate of negative surgical margins (P = .110).
However, it was shown that both tumor size (P = .040) and age (P = .032) were predictive of margin status.
It was notable that MRI use was associated with younger patient age, at a median of 63 years vs. 66 years, and smaller tumor size, at a median of 2.0 cm vs. 2.1 cm.
This latter finding “may be attributable to an inaccurate initial assessment of the extent of the actual tumor size for a variety of reasons,” Dr. Howard-McNatt commented. “For example, tumors may be discontinuous or have satellite lesions which may touch the edge of a specimen.”
The study was funded in part by the David and Katie Burke Fund for Breast Cancer Research, the Connecticut Breast Health Initiative, the Troy Cancer Program, Cleveland Clinic Akron General Operations, the Cleveland Clinic Akron General Foundation, the Lineberger Comprehensive Cancer Center, the Watson Clinic Center for Research, and LifeCycle. The study authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASBRS 2023
Mammography after breast cancer: No benefit for older patients?
BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities.
In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.
“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.
“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.
“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”
The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.
Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.
She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”
The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.
Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”
She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.
Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.
“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.
“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
Study details
To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.
The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.
Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).
Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.
Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.
The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.
The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.
Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.
Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.
The team found that it was common for women across all the groups to undergo mammography.
Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.
Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.
No funding for the study was declared. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities.
In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.
“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.
“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.
“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”
The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.
Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.
She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”
The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.
Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”
She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.
Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.
“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.
“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
Study details
To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.
The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.
Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).
Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.
Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.
The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.
The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.
Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.
Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.
The team found that it was common for women across all the groups to undergo mammography.
Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.
Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.
No funding for the study was declared. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – Older women who have had breast cancer frequently undergo annual surveillance mammography, even if there is only a small risk of their developing a second cancer or if they have other mortality risks associated with age and comorbidities.
In a study that included almost 45,000 women who were aged 67 years or older when they were diagnosed with breast cancer, investigators found that patients commonly underwent annual mammographies.
“Even 10 years after their initial diagnosis ... about 40% of them were still getting surveillance mammography well into their 80s and 90s,” noted lead investigator Elizabeth Berger, MD, assistant professor of breast surgical oncology, Yale University, New Haven, Conn.
“Ongoing surveillance mammography in these patients may lead to overdiagnosis and overtreatment of cancers that potentially would not harm patients if left untreated,” Dr. Berger said.
“A positive or false positive finding may unnecessarily erode patient quality of life and incur costs to the patient and health care system without benefit,” she said. She added: “If an elderly woman is in poor health and has significant competing mortality risks compared to breast cancer, annual mammography may not be necessary.”
The research was presented at the annual meeting of the American Society of Breast Surgeons (ASBrS). The study was highlighted in a preview press briefing.
Speaking at the press briefing, Dr. Berger said that the “risks and benefits of surveillance mammography, including its downstream effects, should be considered by both patients and their doctors together to create a shared decision plan.” She acknowledged that the idea of skipping mammograms may be a sensitive one for patients.
She also shared what she described as “exciting news”: “We have just recently received funding from our geriatric group here at Yale to start to evaluate the potential benefits and harms of these surveillance mammographies.”
The aim is to evaluate false positive rates and the potential for overdiagnosis and overtreatment, “so stay tuned,” she added.
Approached for comment, Mediget Teshome, MD, MPH, said it was “not surprising to see the high rates of surveillance mammography, especially in the short term after treatment.”
She said in an interview that the results suggest that it “may be being overused,” given the low rates of second primary breast cancer and the “competing health concerns” of these women.
Overuse can, on the other hand, “definitely be a complex issue,” said Dr. Teshome, associate professor, department of breast surgical oncology, University of Texas MD Anderson Cancer Center, Houston.
“The goal of mammography screening is to identify breast cancer at an early stage,” she explained. She noted that because of the “competing mortality risk from other challenging and life-threatening health problems,” early-stage breast cancer “may not contribute significantly” to the overall mortality risk.
“In general, in this patient population, consideration should be given to stratifying based on an individual patient’s risk of breast cancer recurrence or new breast cancer, estimated life expectancy, as well as shared decision-making with the patient based on their goals of care.”
Study details
To examine the use of surveillance mammography and the risk of subsequent cancers among older women, Dr. Berger and her team used data from the Surveillance, Epidemiology, and End Results (SEER) registry to identify women aged 67 years or older who were diagnosed with a first nonmetastatic beast cancer between 2003 and 2007.
The patients were followed beginning 1 year after diagnosis until the occurrence of a second primary breast cancer, death, or the end of follow-up in 2017.
Data on 44,475 women were analyzed. Of those patients, 30% were older than 80 years. The majority (74%) of breast cancers were of stage I or II, and 72% were hormone receptor–positive (HR+).
Comorbid conditions were common; 55% of women had at least one, and 16% had three or more.
Life expectancy, determined on the basis of age, sex, and comorbidities, was estimated at less than 5 years for 26% of women. For 36% of patients, life expectancy was 6-10 years, and for 38%, it was longer than 10 years.
The cumulative incidence of developing a second primary breast cancer varied by life expectancy and the tumor’s molecular subtype.
The incidence was 3.7% among women with a life expectancy of less than 5 years, 4.9% among those expected to live 6-10 years, and 7.6% among those predicted to live more than 10 years.
Among women with a life expectancy of less than 5 years, the cumulative incidence of a second primary tumor was 4.0% among those with triple-negative breast cancer, vs. 3.0% among those with HR+ breast cancer.
Among patients whose life expectancy was more than 10 years, the cumulative incidence of a second primary tumor was 9.2% among women with triple-negative disease, vs. 7.0% among those with HR+ cancers.
The team found that it was common for women across all the groups to undergo mammography.
Among women with a life expectancy of 6-10 years, 82% underwent at least one mammogram, and 65% underwent five mammograms. Even among women with a life expectancy of less than 1 year, 51% underwent at least one mammogram within 12 months of death.
Among women with a life expectancy of less than 5 years, 68% of women had received a mammogram 1 year after treatment; 53% underwent three mammograms within 3 years after treatment.
No funding for the study was declared. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ASBRS 2023
SCC from breast implants: Negligible risk, study finds
Findings from a large cohort study suggest the incidence of SCC is negligible. The analysis found one case of SCC among nearly 57,000 women who had undergone breast implant reconstruction over 421,227 person-years of follow-up.
The authors also confirmed the known risk of breast implant–associated anaplastic large-cell lymphoma (ALCL), identifying five cases in the population, which was considered a “significantly elevated” risk.
Although patients with breast cancer who are eligible for mastectomy should be counseled on the risks for cancer after implant reconstruction, patients “should not be dissuaded from pursuing implant-based reconstruction because of the risk of SCC,” lead author Connor J. Kinslow, MD, of Columbia University, New York, and colleagues concluded.
SCC cases associated with breast implants are distinct from breast implant–associated ALCL, the authors noted, explaining that this lymphoma “is the subject of a boxed warning on all saline- and silicone gel–filled breast implants since 2020.”
The results were published in a research letter in JAMA Surgery.
Last September, a safety communication from the FDA highlighted reports of SCC and other lymphomas associated with breast implants. The FDA said it was aware of fewer than 20 cases of SCC.
Following the safety communication, Dr. Kinslow and colleagues assessed SCC risk among 56,785 women who underwent cancer-directed mastectomy with implant reconstruction for breast tumors.
Women in the cohort were diagnosed between 2000 and 2018 and included in the Surveillance, Epidemiology, and End Results (SEER) 17 database. Patients had a median age of 51 years; most (84%) where White, 8.1% were Black, 7.4% were Asian or Pacific Islander, 0.4% were American Indian/Alaska Native, and race was unknown in 0.4%.
Across 421,227 person-years of follow-up, the team identified one case of SCC, corresponding to an incidence rate of 2.37 per million person-years vs. an expected incidence of 1.02 per million person-years in the general population. Although the 2.33 standardized incidence ratio (SIR) “appeared elevated vs. the general population,” it was “not significant given the low incidence” (95% confidence interval, 0.06-13.0).
The team also identified five cases of breast implant–associated ALCL. That corresponded to an incidence rate of 11.9 per million person-years compared with an expected incidence of 0.29 per million person-years – for a significantly elevated SIR of 40.9. The authors also noted more than 1,000 reported cases of breast implant–associated ALCL previous as well as a robust association with implants.
Regarding SCC, “whether the observed elevated risk is associated with the implants is difficult to interpret because it is based on only one case and wide [confidence intervals],” the authors said. But, overall, “we found that the incidence rate of SCC was extraordinarily low and of minimal public health concern.”
A version of this article first appeared on Medscape.com.
Findings from a large cohort study suggest the incidence of SCC is negligible. The analysis found one case of SCC among nearly 57,000 women who had undergone breast implant reconstruction over 421,227 person-years of follow-up.
The authors also confirmed the known risk of breast implant–associated anaplastic large-cell lymphoma (ALCL), identifying five cases in the population, which was considered a “significantly elevated” risk.
Although patients with breast cancer who are eligible for mastectomy should be counseled on the risks for cancer after implant reconstruction, patients “should not be dissuaded from pursuing implant-based reconstruction because of the risk of SCC,” lead author Connor J. Kinslow, MD, of Columbia University, New York, and colleagues concluded.
SCC cases associated with breast implants are distinct from breast implant–associated ALCL, the authors noted, explaining that this lymphoma “is the subject of a boxed warning on all saline- and silicone gel–filled breast implants since 2020.”
The results were published in a research letter in JAMA Surgery.
Last September, a safety communication from the FDA highlighted reports of SCC and other lymphomas associated with breast implants. The FDA said it was aware of fewer than 20 cases of SCC.
Following the safety communication, Dr. Kinslow and colleagues assessed SCC risk among 56,785 women who underwent cancer-directed mastectomy with implant reconstruction for breast tumors.
Women in the cohort were diagnosed between 2000 and 2018 and included in the Surveillance, Epidemiology, and End Results (SEER) 17 database. Patients had a median age of 51 years; most (84%) where White, 8.1% were Black, 7.4% were Asian or Pacific Islander, 0.4% were American Indian/Alaska Native, and race was unknown in 0.4%.
Across 421,227 person-years of follow-up, the team identified one case of SCC, corresponding to an incidence rate of 2.37 per million person-years vs. an expected incidence of 1.02 per million person-years in the general population. Although the 2.33 standardized incidence ratio (SIR) “appeared elevated vs. the general population,” it was “not significant given the low incidence” (95% confidence interval, 0.06-13.0).
The team also identified five cases of breast implant–associated ALCL. That corresponded to an incidence rate of 11.9 per million person-years compared with an expected incidence of 0.29 per million person-years – for a significantly elevated SIR of 40.9. The authors also noted more than 1,000 reported cases of breast implant–associated ALCL previous as well as a robust association with implants.
Regarding SCC, “whether the observed elevated risk is associated with the implants is difficult to interpret because it is based on only one case and wide [confidence intervals],” the authors said. But, overall, “we found that the incidence rate of SCC was extraordinarily low and of minimal public health concern.”
A version of this article first appeared on Medscape.com.
Findings from a large cohort study suggest the incidence of SCC is negligible. The analysis found one case of SCC among nearly 57,000 women who had undergone breast implant reconstruction over 421,227 person-years of follow-up.
The authors also confirmed the known risk of breast implant–associated anaplastic large-cell lymphoma (ALCL), identifying five cases in the population, which was considered a “significantly elevated” risk.
Although patients with breast cancer who are eligible for mastectomy should be counseled on the risks for cancer after implant reconstruction, patients “should not be dissuaded from pursuing implant-based reconstruction because of the risk of SCC,” lead author Connor J. Kinslow, MD, of Columbia University, New York, and colleagues concluded.
SCC cases associated with breast implants are distinct from breast implant–associated ALCL, the authors noted, explaining that this lymphoma “is the subject of a boxed warning on all saline- and silicone gel–filled breast implants since 2020.”
The results were published in a research letter in JAMA Surgery.
Last September, a safety communication from the FDA highlighted reports of SCC and other lymphomas associated with breast implants. The FDA said it was aware of fewer than 20 cases of SCC.
Following the safety communication, Dr. Kinslow and colleagues assessed SCC risk among 56,785 women who underwent cancer-directed mastectomy with implant reconstruction for breast tumors.
Women in the cohort were diagnosed between 2000 and 2018 and included in the Surveillance, Epidemiology, and End Results (SEER) 17 database. Patients had a median age of 51 years; most (84%) where White, 8.1% were Black, 7.4% were Asian or Pacific Islander, 0.4% were American Indian/Alaska Native, and race was unknown in 0.4%.
Across 421,227 person-years of follow-up, the team identified one case of SCC, corresponding to an incidence rate of 2.37 per million person-years vs. an expected incidence of 1.02 per million person-years in the general population. Although the 2.33 standardized incidence ratio (SIR) “appeared elevated vs. the general population,” it was “not significant given the low incidence” (95% confidence interval, 0.06-13.0).
The team also identified five cases of breast implant–associated ALCL. That corresponded to an incidence rate of 11.9 per million person-years compared with an expected incidence of 0.29 per million person-years – for a significantly elevated SIR of 40.9. The authors also noted more than 1,000 reported cases of breast implant–associated ALCL previous as well as a robust association with implants.
Regarding SCC, “whether the observed elevated risk is associated with the implants is difficult to interpret because it is based on only one case and wide [confidence intervals],” the authors said. But, overall, “we found that the incidence rate of SCC was extraordinarily low and of minimal public health concern.”
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY