Breast Cancer

The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that progressed on at least one line of endocrine therapy.

The agency also approved the Guardant360 CDx assay as a companion diagnostic to identify breast cancer patients who meet the treatment requirements, according to the agency’s press release announcing the approval.

The novel oral selective estrogen receptor degrader was approved based on the phase 3 EMERALD trial, which included 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer, about half of whom had ESR1 mutations. Patients had progressed on one or two prior lines of endocrine therapy, including one containing a CDK4/6 inhibitor. Participants could also have had one prior line of chemotherapy in the advanced or metastatic setting.

Participants were randomized 1:1 to either elacestrant 345 mg orally once daily or investigator’s choice of endocrine therapy, which included fulvestrant or an aromatase inhibitor.

In the 228 patients (48%) with ESR1 mutations, median progression-free survival (PFS) was 3.8 months with elacestrant versus 1.9 months in the fulvestrant or aromatase inhibitor arm (hazard ratio, 0.55; P = .0005). Investigators observed no statistically significant PFS difference between the treatment arms in patients who didn’t have the mutation.
 

Fair comparison?

In June, experts raised concerns about the adequacy of the “standard of care” control arm in EMERALD, particularly that single agents were used at a time when combination therapy is becoming more common.

“The expression ‘standard of care’ is applied generously, as the control arm is restricted” to single agents and no combinations, which “may have led to a substandard” comparison group, Timothée Olivier, MD, Geneva University Hospital, and Vinay Prasad, MD, MPH, University of California, San Francisco, said in an editorial quoted in the piece.

EMERALD investigators acknowledged that there were issues with the control group, noting that in the “United States and Europe, combination therapy with fulvestrant” – instead of single agents – “is increasingly being used as the second-line [standard of care] treatment.”

However, the goal of the study “was to compare a novel endocrine therapy vs. currently available endocrine therapies,” not combination regimens, the investigators said.

Also, “the benefit of elacestrant over fulvestrant and AIs [aromatase inhibitors] in our monotherapy trial ... suggests that incorporating elacestrant as the preferred endocrine therapy backbone in future earlier-line combination studies is a promising strategy.”
 

Lipid monitoring necessary

The most common adverse events with elacestrant, occurring in 10% or more of patients, are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia, according to labeling.

Labeling warns that elacestrant “may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.”

The recommended elacestrant dose is the trial dose, 345 mg orally with food once daily until disease progression or unacceptable toxicity.

A version of this article first appeared on Medscape.com.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

Poly-(ADP-ribose) polymerase (PARP) inhibitors have emerged as essential therapeutic agents in patients with germline BRCA1/2-mutated BC. A BRCA-like phenotype is displayed by a large subset of patients with germline BRCA1/2-wildtype BC who present with homologous recombination deficiency (HRD). The randomized phase 2 S1416 trial (Rodler et al) evaluated the efficacy of cisplatin combined with the PARP inhibitor veliparib in three cohorts of metastatic BC: mutated germline BRCA1/2, BRCA-like, and non-BRCA–like. A total of 335 patients with metastatic or recurrent triple-negative BC (TNBC) or germline BRCA1/2-mutated metastatic BC were randomly assigned (1:1) to receive cisplatin plus either veliparib or a matching placebo. The findings showed that the addition of veliparib to cisplatin significantly improved progression-free survival (PFS) in patients with BRCA-like metastatic TNBC compared with placebo (5.9 vs 4.2 months; HR 0.57; log-rank P = .01), but not in mutated germline BRCA1/2 (6.2 vs 6.4 months; P = .54) and non-BRCA–like (4.0 vs 3.0 months; P = .57) groups. No new toxicity signals were observed. These findings suggest BRCA-like TNBC might show sensitivity to PARP inhibitors and therefore these agents should be explored further in this cohort.

A recent update from the combined analysis of the SOFT and TEXT studies comparing outcomes in 4690 premenopausal women with estrogen/progesterone receptor–positive early BC (Pagani et al) showed that exemestane plus ovarian function suppression (OFS) led to a greater reduction in recurrence risk compared with tamoxifen plus OFS in premenopausal women. After a median follow-up of 13 years, results showed a 4.6% absolute improvement in 12-year disease-free survival (HR 0.79; P < .001) and a 1.8% absolute improvement in disease recurrence-free interval (HR 0.83; P = .03) with exemestane plus OFS compared with tamoxifen plus OFS. These treatment effects on recurrence began to attenuate over time, being strongest in the first 5 years with no further improvement after 10 or more years. No improvement in overall survival (OS) was noted with exemestane vs tamoxifen, although both arms had excellent survival outcomes (90.1% vs 89.1%; HR 0.93; 95% CI 0.78-1.11). It is important to note that there was a 3.3% absolute improvement in 12-year OS with exemestane plus OFS among patients with HER2-negative tumors who received chemotherapy. This OS benefit was also noted amongst patients with high-risk clinicopathologic characteristics (<35 years and those with > 2 cm or grade 3 tumors), ranging from 4.0% to 5.5% absolute improvement. In conclusion, sustained recurrence risk reductions were noted with adjuvant exemestane plus OFS compared with tamoxifen plus OFS, with the most clinically meaningful survival benefit noted for patients with higher risk tumors. Proper selection of patients who are most likely to benefit from exemestane over tamoxifen is vital to maximize the survival benefit while minimizing the burden of treatment intensification.

Findings from a retrospective study including 221 women with BC who received preoperative neoadjuvant chemotherapy (NAC) showed that the presence of metabolic syndrome (MetS) worsened survival outcomes and increased disease recurrence risk (Zhou et al). Patients were divided into MetS and non-MetS groups according to National Cholesterol Education Program Adult Treatment Panel III criteria to investigate the association between MetS and clinicopathologic characteristics, pathologic complete response (pCR), and long-term survival. The MetS group had a significantly lower likelihood of achieving pCR after NAC compared with the non-MetS group (odds ratio [OR] 0.316; P = .028), with the risk for death (OR 2.587; P = .004) and disease recurrence (OR 2.228; P = .007) being significantly higher in patients with vs without MetS. In a multivariate analysis, MetS (P = 0.028) and hormone receptors status were independent predictors of pCR after NAC in BC. These findings emphasize the importance of timely intervention of metabolic syndrome to improve outcomes in patients with BC.

Despite improvements in access to health coverage under the Affordable Care Act (ACA), racial disparities in breast cancer mortality rates persist and the underuse of advanced breast imaging may be one culprit, experts say.
 

In a recent position statement, researchers highlighted the disproportionally high breast cancer mortality rates among Black women in Louisiana – a state that has one of the highest breast cancer mortality rates in the nation. In 2019, the breast cancer mortality rate among Black women in Louisiana was 29.3 per 100,000 women compared with the national rate of 19.4 per 100,000.

Although Louisiana has made strides in improving access to breast cancer screening in recent years, the use of advanced imaging – specifically breast MRI – remains underused in this high-risk population. A major barrier to wider use of breast MRI has been cost, and ACA expansion led to higher, not lower, out-of-pocket costs for this screening modality.

“Breast MRI is a powerful imaging tool for early detection and for screening women at high risk for breast cancer,” wrote the researchers, led by Brooke L. Morrell, MD, of Louisiana State University Health and Sciences Center, New Orleans.

However, greater access to health care has not necessarily translated to increased breast MRI screening or improved survival among Black women. Even years after the adoption of the ACA, “Black women in Louisiana continue to die of breast cancer at rates significantly greater than the national average,” the authors wrote.

The position statement was published in Cancer.

Breast MRI is known to provide the highest rate of breast cancer detection among commonly used imaging options, with a sensitivity ranging from 81% to 100%. That’s about twice as high as the sensitivity range for mammography after factoring in breast density.

“This is of particular importance when we consider the risk‐based screening of younger populations, in which dense breasts are more prevalent,” the authors explained.

For Black women in particular, studies show nearly a quarter (23%) who develop breast cancer are diagnosed under the age of 50, compared with 16% of White women. Black women are also more likely to develop more aggressive, premenopausal breast cancers, including triple-negative breast cancer, that are more easily detected on MRI.

“Adding supplemental screening breast MRI to annual mammography in higher risk women has been shown to detect up to 18 additional cancers out of 1,000 patients,” Dr. Morrell said. And “many of these cancers are detected much earlier than with mammography alone.”

Still, with ACA expansion, out-of-pocket costs for breast MRI actually increased. This increase likely occurred, in part, because the financial protections outlined in the ACA’s Women’s Preventive Services Guidelines covered mammograms but not breast MRI.

More specifically, under the ACA, Medicaid and most private health insurance plans are required to provide coverage for mammograms at no cost to the patient. The percentage of health plans providing zero cost sharing for mammograms increased under the ACA from 81.9% to 96.8%, but the corresponding rates of zero cost sharing for breast MRI screening went in the opposite direction – from 43.1% in 2009 to only 26.2% in 2017, a 2022 study found.

This study also highlighted geographic variations in zero cost sharing and out-of-pocket costs for screening breast MRI, with a higher financial burden observed for women living in the South. In addition, studies have demonstrated that race and socioeconomic factors, including education and income, play a role in the underuse of screening, including breast MRI.

These factors all likely contribute to screening breast MRI remaining inaccessible to many women, Dr. Morrell and colleagues said.

The authors also outlined three key action items that could help address barriers to MRI breast screening, which include reducing the high cost of breast MRI, lobbying to include breast MRI in ACA protections, and addressing knowledge gaps among patients and clinicians to better identify women who might benefit from breast MRI.

On the financial front, the team explained that a central driver for high costs is the scan time for breast MRI, which could be substantially reduced from 30 to 5 minutes, using an abbreviated protocol.

“Widespread use of low‐cost breast abbreviated MRI screening could remove the cost barrier of adding breast MRI screening to ACA coverage,” without compromising diagnostic accuracy, the authors noted.

Further efforts should focus on overcoming cultural barriers, including fear and mistrust of the health care system among Black women. Outreach efforts could include public campaigns or town hall and church gatherings that enlist patient navigators, advocates, or community members.

“Our visibility in the community builds trust and affords us the opportunity to share knowledge that may empower women to be their own health advocates,” the authors wrote.

In terms of the feasibility of revising ACA policies to improve breast MRI access and affordability, Dr. Morrell pointed to improvements made in colon cancer screening.

“Studies have demonstrated that after ACA policy changes lowering out-of-pocket cost for colonoscopies, screening colonoscopy rates significantly increased among men, predominantly in socioeconomically disadvantaged population,” she noted. “Similarly, we should investigate how to this can be applied to screening breast MRI.”

A version of this article first appeared on Medscape.com.

Despite improvements in access to health coverage under the Affordable Care Act (ACA), racial disparities in breast cancer mortality rates persist and the underuse of advanced breast imaging may be one culprit, experts say.
 

In a recent position statement, researchers highlighted the disproportionally high breast cancer mortality rates among Black women in Louisiana – a state that has one of the highest breast cancer mortality rates in the nation. In 2019, the breast cancer mortality rate among Black women in Louisiana was 29.3 per 100,000 women compared with the national rate of 19.4 per 100,000.

Although Louisiana has made strides in improving access to breast cancer screening in recent years, the use of advanced imaging – specifically breast MRI – remains underused in this high-risk population. A major barrier to wider use of breast MRI has been cost, and ACA expansion led to higher, not lower, out-of-pocket costs for this screening modality.

“Breast MRI is a powerful imaging tool for early detection and for screening women at high risk for breast cancer,” wrote the researchers, led by Brooke L. Morrell, MD, of Louisiana State University Health and Sciences Center, New Orleans.

However, greater access to health care has not necessarily translated to increased breast MRI screening or improved survival among Black women. Even years after the adoption of the ACA, “Black women in Louisiana continue to die of breast cancer at rates significantly greater than the national average,” the authors wrote.

The position statement was published in Cancer.

Breast MRI is known to provide the highest rate of breast cancer detection among commonly used imaging options, with a sensitivity ranging from 81% to 100%. That’s about twice as high as the sensitivity range for mammography after factoring in breast density.

“This is of particular importance when we consider the risk‐based screening of younger populations, in which dense breasts are more prevalent,” the authors explained.

For Black women in particular, studies show nearly a quarter (23%) who develop breast cancer are diagnosed under the age of 50, compared with 16% of White women. Black women are also more likely to develop more aggressive, premenopausal breast cancers, including triple-negative breast cancer, that are more easily detected on MRI.

“Adding supplemental screening breast MRI to annual mammography in higher risk women has been shown to detect up to 18 additional cancers out of 1,000 patients,” Dr. Morrell said. And “many of these cancers are detected much earlier than with mammography alone.”

Still, with ACA expansion, out-of-pocket costs for breast MRI actually increased. This increase likely occurred, in part, because the financial protections outlined in the ACA’s Women’s Preventive Services Guidelines covered mammograms but not breast MRI.

More specifically, under the ACA, Medicaid and most private health insurance plans are required to provide coverage for mammograms at no cost to the patient. The percentage of health plans providing zero cost sharing for mammograms increased under the ACA from 81.9% to 96.8%, but the corresponding rates of zero cost sharing for breast MRI screening went in the opposite direction – from 43.1% in 2009 to only 26.2% in 2017, a 2022 study found.

This study also highlighted geographic variations in zero cost sharing and out-of-pocket costs for screening breast MRI, with a higher financial burden observed for women living in the South. In addition, studies have demonstrated that race and socioeconomic factors, including education and income, play a role in the underuse of screening, including breast MRI.

These factors all likely contribute to screening breast MRI remaining inaccessible to many women, Dr. Morrell and colleagues said.

The authors also outlined three key action items that could help address barriers to MRI breast screening, which include reducing the high cost of breast MRI, lobbying to include breast MRI in ACA protections, and addressing knowledge gaps among patients and clinicians to better identify women who might benefit from breast MRI.

On the financial front, the team explained that a central driver for high costs is the scan time for breast MRI, which could be substantially reduced from 30 to 5 minutes, using an abbreviated protocol.

“Widespread use of low‐cost breast abbreviated MRI screening could remove the cost barrier of adding breast MRI screening to ACA coverage,” without compromising diagnostic accuracy, the authors noted.

Further efforts should focus on overcoming cultural barriers, including fear and mistrust of the health care system among Black women. Outreach efforts could include public campaigns or town hall and church gatherings that enlist patient navigators, advocates, or community members.

“Our visibility in the community builds trust and affords us the opportunity to share knowledge that may empower women to be their own health advocates,” the authors wrote.

In terms of the feasibility of revising ACA policies to improve breast MRI access and affordability, Dr. Morrell pointed to improvements made in colon cancer screening.

“Studies have demonstrated that after ACA policy changes lowering out-of-pocket cost for colonoscopies, screening colonoscopy rates significantly increased among men, predominantly in socioeconomically disadvantaged population,” she noted. “Similarly, we should investigate how to this can be applied to screening breast MRI.”

A version of this article first appeared on Medscape.com.

Despite improvements in access to health coverage under the Affordable Care Act (ACA), racial disparities in breast cancer mortality rates persist and the underuse of advanced breast imaging may be one culprit, experts say.
 

In a recent position statement, researchers highlighted the disproportionally high breast cancer mortality rates among Black women in Louisiana – a state that has one of the highest breast cancer mortality rates in the nation. In 2019, the breast cancer mortality rate among Black women in Louisiana was 29.3 per 100,000 women compared with the national rate of 19.4 per 100,000.

Although Louisiana has made strides in improving access to breast cancer screening in recent years, the use of advanced imaging – specifically breast MRI – remains underused in this high-risk population. A major barrier to wider use of breast MRI has been cost, and ACA expansion led to higher, not lower, out-of-pocket costs for this screening modality.

“Breast MRI is a powerful imaging tool for early detection and for screening women at high risk for breast cancer,” wrote the researchers, led by Brooke L. Morrell, MD, of Louisiana State University Health and Sciences Center, New Orleans.

However, greater access to health care has not necessarily translated to increased breast MRI screening or improved survival among Black women. Even years after the adoption of the ACA, “Black women in Louisiana continue to die of breast cancer at rates significantly greater than the national average,” the authors wrote.

The position statement was published in Cancer.

Breast MRI is known to provide the highest rate of breast cancer detection among commonly used imaging options, with a sensitivity ranging from 81% to 100%. That’s about twice as high as the sensitivity range for mammography after factoring in breast density.

“This is of particular importance when we consider the risk‐based screening of younger populations, in which dense breasts are more prevalent,” the authors explained.

For Black women in particular, studies show nearly a quarter (23%) who develop breast cancer are diagnosed under the age of 50, compared with 16% of White women. Black women are also more likely to develop more aggressive, premenopausal breast cancers, including triple-negative breast cancer, that are more easily detected on MRI.

“Adding supplemental screening breast MRI to annual mammography in higher risk women has been shown to detect up to 18 additional cancers out of 1,000 patients,” Dr. Morrell said. And “many of these cancers are detected much earlier than with mammography alone.”

Still, with ACA expansion, out-of-pocket costs for breast MRI actually increased. This increase likely occurred, in part, because the financial protections outlined in the ACA’s Women’s Preventive Services Guidelines covered mammograms but not breast MRI.

More specifically, under the ACA, Medicaid and most private health insurance plans are required to provide coverage for mammograms at no cost to the patient. The percentage of health plans providing zero cost sharing for mammograms increased under the ACA from 81.9% to 96.8%, but the corresponding rates of zero cost sharing for breast MRI screening went in the opposite direction – from 43.1% in 2009 to only 26.2% in 2017, a 2022 study found.

This study also highlighted geographic variations in zero cost sharing and out-of-pocket costs for screening breast MRI, with a higher financial burden observed for women living in the South. In addition, studies have demonstrated that race and socioeconomic factors, including education and income, play a role in the underuse of screening, including breast MRI.

These factors all likely contribute to screening breast MRI remaining inaccessible to many women, Dr. Morrell and colleagues said.

The authors also outlined three key action items that could help address barriers to MRI breast screening, which include reducing the high cost of breast MRI, lobbying to include breast MRI in ACA protections, and addressing knowledge gaps among patients and clinicians to better identify women who might benefit from breast MRI.

On the financial front, the team explained that a central driver for high costs is the scan time for breast MRI, which could be substantially reduced from 30 to 5 minutes, using an abbreviated protocol.

“Widespread use of low‐cost breast abbreviated MRI screening could remove the cost barrier of adding breast MRI screening to ACA coverage,” without compromising diagnostic accuracy, the authors noted.

Further efforts should focus on overcoming cultural barriers, including fear and mistrust of the health care system among Black women. Outreach efforts could include public campaigns or town hall and church gatherings that enlist patient navigators, advocates, or community members.

“Our visibility in the community builds trust and affords us the opportunity to share knowledge that may empower women to be their own health advocates,” the authors wrote.

In terms of the feasibility of revising ACA policies to improve breast MRI access and affordability, Dr. Morrell pointed to improvements made in colon cancer screening.

“Studies have demonstrated that after ACA policy changes lowering out-of-pocket cost for colonoscopies, screening colonoscopy rates significantly increased among men, predominantly in socioeconomically disadvantaged population,” she noted. “Similarly, we should investigate how to this can be applied to screening breast MRI.”

A version of this article first appeared on Medscape.com.

The elevated risk for recurrence in young women with HR+ early breast cancer highlights the importance of aggressive endocrine therapy in the majority of patients in this population. Examples of approaches to maximize endocrine therapy benefit include the addition of ovarian suppression to either tamoxifen or an aromatase inhibitor (AI) as well as an extended duration of adjuvant endocrine therapy.^4,5 Among 3047 premenopausal women included in SOFT study, at 12 years follow-up, the addition of ovarian function suppression (OFS) to tamoxifen significantly improved disease-free survival (DFS) compared with tamoxifen alone (hazard ratio 0.82; P = .03) with a more pronounced DFS benefit with exemestane plus OFS compared with tamoxifen (hazard ratio 0.69) (Francis et al). In the HER2- subgroup, those who received prior chemotherapy had 12-year OFS rates of 78.8% with tamoxifen, 81.1% with tamoxifen plus OFS and 84.4% with exemestane plus OFS. Furthermore, in the HER2- subgroup, women younger than 35 years had absolute improvements in 12-year OS of 9.1% with tamoxifen plus OFS and 16.5% with exemestane plus OFS compared with tamoxifen. These updated results provide further support for OFS added to tamoxifen or an AI (with more benefit seen with an AI) in the treatment of HR+ early breast cancer in young women who are at high risk for recurrence. Longer follow-up will be important to better define the treatment effect considering recurrence patterns for this subtype of breast cancer.

Various guidelines recommend the use of adjuvant bisphosphonates for postmenopausal patients with early breast cancer on the basis of disease-free and bone metastasis-free survival benefits.⁶ A regimen of zolendronic acid every 6 months for 3 years is commonly used in clinical practice. A substudy of ABCSG-12, including 725 premenopausal patients with HR+ early breast cancer on ovarian suppression randomly assigned to receive tamoxifen or anastrozole with or without zolendronic acid every 6 months, investigated the effect of shorter duration of bisphosphonate therapy on breast cancer outcomes (Beltran-Bless et al). After a median follow-up of 96 months, there was no statistically significant difference in DFS (hazard ratio 0.88; log-rank P = .642) or OS (stratified hazard ratio 1.16; log-rank P = .796) between patients who received ≤6 or ≥7 infusions. Rates of adverse events were increased in the patients who received ≥7 or ≤6 infusions (arthralgia, 20.1% vs 12.4%; nausea, 12.8% vs 7.3%; bone pain, 41.6% vs 34.9%). Modifications to adjuvant breast cancer regimens that can provide more ease for patients with less toxicity while maintaining efficacy are greatly desired to simultaneously support quality of life and disease outcomes.

Additional References

1. Swain SM, Baselga J, Kim SB, et al; for the CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372:724-734. Doi: 10.1056/NEJMoa1413513
2. Miles D, Ciruelos E, Schneeweiss A, et al; for the PERUSE investigators. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication. Ann Oncol. 2021;32:1245-1255. Doi: 10.1016/j.annonc.2021.06.024
3. Hua X, Bi X-W, Zhao J-L, et al; for the South China Breast Cancer Group (SCBCG). Trastuzumab plus endocrine therapy or chemotherapy as first-line treatment for patients with hormone receptor-positive and HER2-positive metastatic breast cancer (SYSUCC-002). Clin Cancer Res. 2022;28:637-645. Doi: 10.1158/1078-0432.CCR-21-3435
4. Kim H-A, Lee JW, Nam SJ, et al; for the Korean Breast Cancer Study Group. Adding ovarian suppression to tamoxifen for premenopausal breast Cancer: a randomized phase III trial. J Clin Oncol. 2020;38:434-443. Doi: 10.1200/JCO.19.00126
5. Davies C, Pan H, Godwin J, et al; for the Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805-816. Doi: 10.1016/S0140-6736(12)61963-1
6. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Adjuvant bisphosphonate treatment in early breast cancer: meta-analyses of individual patient data from randomised trials. Lancet. 2015;386:1353-1361. Doi: 10.1016/S0140-6736(15)60908-4

The elevated risk for recurrence in young women with HR+ early breast cancer highlights the importance of aggressive endocrine therapy in the majority of patients in this population. Examples of approaches to maximize endocrine therapy benefit include the addition of ovarian suppression to either tamoxifen or an aromatase inhibitor (AI) as well as an extended duration of adjuvant endocrine therapy.^4,5 Among 3047 premenopausal women included in SOFT study, at 12 years follow-up, the addition of ovarian function suppression (OFS) to tamoxifen significantly improved disease-free survival (DFS) compared with tamoxifen alone (hazard ratio 0.82; P = .03) with a more pronounced DFS benefit with exemestane plus OFS compared with tamoxifen (hazard ratio 0.69) (Francis et al). In the HER2- subgroup, those who received prior chemotherapy had 12-year OFS rates of 78.8% with tamoxifen, 81.1% with tamoxifen plus OFS and 84.4% with exemestane plus OFS. Furthermore, in the HER2- subgroup, women younger than 35 years had absolute improvements in 12-year OS of 9.1% with tamoxifen plus OFS and 16.5% with exemestane plus OFS compared with tamoxifen. These updated results provide further support for OFS added to tamoxifen or an AI (with more benefit seen with an AI) in the treatment of HR+ early breast cancer in young women who are at high risk for recurrence. Longer follow-up will be important to better define the treatment effect considering recurrence patterns for this subtype of breast cancer.

Various guidelines recommend the use of adjuvant bisphosphonates for postmenopausal patients with early breast cancer on the basis of disease-free and bone metastasis-free survival benefits.⁶ A regimen of zolendronic acid every 6 months for 3 years is commonly used in clinical practice. A substudy of ABCSG-12, including 725 premenopausal patients with HR+ early breast cancer on ovarian suppression randomly assigned to receive tamoxifen or anastrozole with or without zolendronic acid every 6 months, investigated the effect of shorter duration of bisphosphonate therapy on breast cancer outcomes (Beltran-Bless et al). After a median follow-up of 96 months, there was no statistically significant difference in DFS (hazard ratio 0.88; log-rank P = .642) or OS (stratified hazard ratio 1.16; log-rank P = .796) between patients who received ≤6 or ≥7 infusions. Rates of adverse events were increased in the patients who received ≥7 or ≤6 infusions (arthralgia, 20.1% vs 12.4%; nausea, 12.8% vs 7.3%; bone pain, 41.6% vs 34.9%). Modifications to adjuvant breast cancer regimens that can provide more ease for patients with less toxicity while maintaining efficacy are greatly desired to simultaneously support quality of life and disease outcomes.

Additional References

1. Swain SM, Baselga J, Kim SB, et al; for the CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372:724-734. Doi: 10.1056/NEJMoa1413513
2. Miles D, Ciruelos E, Schneeweiss A, et al; for the PERUSE investigators. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication. Ann Oncol. 2021;32:1245-1255. Doi: 10.1016/j.annonc.2021.06.024
3. Hua X, Bi X-W, Zhao J-L, et al; for the South China Breast Cancer Group (SCBCG). Trastuzumab plus endocrine therapy or chemotherapy as first-line treatment for patients with hormone receptor-positive and HER2-positive metastatic breast cancer (SYSUCC-002). Clin Cancer Res. 2022;28:637-645. Doi: 10.1158/1078-0432.CCR-21-3435
4. Kim H-A, Lee JW, Nam SJ, et al; for the Korean Breast Cancer Study Group. Adding ovarian suppression to tamoxifen for premenopausal breast Cancer: a randomized phase III trial. J Clin Oncol. 2020;38:434-443. Doi: 10.1200/JCO.19.00126
5. Davies C, Pan H, Godwin J, et al; for the Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805-816. Doi: 10.1016/S0140-6736(12)61963-1
6. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Adjuvant bisphosphonate treatment in early breast cancer: meta-analyses of individual patient data from randomised trials. Lancet. 2015;386:1353-1361. Doi: 10.1016/S0140-6736(15)60908-4

The elevated risk for recurrence in young women with HR+ early breast cancer highlights the importance of aggressive endocrine therapy in the majority of patients in this population. Examples of approaches to maximize endocrine therapy benefit include the addition of ovarian suppression to either tamoxifen or an aromatase inhibitor (AI) as well as an extended duration of adjuvant endocrine therapy.^4,5 Among 3047 premenopausal women included in SOFT study, at 12 years follow-up, the addition of ovarian function suppression (OFS) to tamoxifen significantly improved disease-free survival (DFS) compared with tamoxifen alone (hazard ratio 0.82; P = .03) with a more pronounced DFS benefit with exemestane plus OFS compared with tamoxifen (hazard ratio 0.69) (Francis et al). In the HER2- subgroup, those who received prior chemotherapy had 12-year OFS rates of 78.8% with tamoxifen, 81.1% with tamoxifen plus OFS and 84.4% with exemestane plus OFS. Furthermore, in the HER2- subgroup, women younger than 35 years had absolute improvements in 12-year OS of 9.1% with tamoxifen plus OFS and 16.5% with exemestane plus OFS compared with tamoxifen. These updated results provide further support for OFS added to tamoxifen or an AI (with more benefit seen with an AI) in the treatment of HR+ early breast cancer in young women who are at high risk for recurrence. Longer follow-up will be important to better define the treatment effect considering recurrence patterns for this subtype of breast cancer.

Various guidelines recommend the use of adjuvant bisphosphonates for postmenopausal patients with early breast cancer on the basis of disease-free and bone metastasis-free survival benefits.⁶ A regimen of zolendronic acid every 6 months for 3 years is commonly used in clinical practice. A substudy of ABCSG-12, including 725 premenopausal patients with HR+ early breast cancer on ovarian suppression randomly assigned to receive tamoxifen or anastrozole with or without zolendronic acid every 6 months, investigated the effect of shorter duration of bisphosphonate therapy on breast cancer outcomes (Beltran-Bless et al). After a median follow-up of 96 months, there was no statistically significant difference in DFS (hazard ratio 0.88; log-rank P = .642) or OS (stratified hazard ratio 1.16; log-rank P = .796) between patients who received ≤6 or ≥7 infusions. Rates of adverse events were increased in the patients who received ≥7 or ≤6 infusions (arthralgia, 20.1% vs 12.4%; nausea, 12.8% vs 7.3%; bone pain, 41.6% vs 34.9%). Modifications to adjuvant breast cancer regimens that can provide more ease for patients with less toxicity while maintaining efficacy are greatly desired to simultaneously support quality of life and disease outcomes.

Additional References

1. Swain SM, Baselga J, Kim SB, et al; for the CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372:724-734. Doi: 10.1056/NEJMoa1413513
2. Miles D, Ciruelos E, Schneeweiss A, et al; for the PERUSE investigators. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication. Ann Oncol. 2021;32:1245-1255. Doi: 10.1016/j.annonc.2021.06.024
3. Hua X, Bi X-W, Zhao J-L, et al; for the South China Breast Cancer Group (SCBCG). Trastuzumab plus endocrine therapy or chemotherapy as first-line treatment for patients with hormone receptor-positive and HER2-positive metastatic breast cancer (SYSUCC-002). Clin Cancer Res. 2022;28:637-645. Doi: 10.1158/1078-0432.CCR-21-3435
4. Kim H-A, Lee JW, Nam SJ, et al; for the Korean Breast Cancer Study Group. Adding ovarian suppression to tamoxifen for premenopausal breast Cancer: a randomized phase III trial. J Clin Oncol. 2020;38:434-443. Doi: 10.1200/JCO.19.00126
5. Davies C, Pan H, Godwin J, et al; for the Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381:805-816. Doi: 10.1016/S0140-6736(12)61963-1
6. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Adjuvant bisphosphonate treatment in early breast cancer: meta-analyses of individual patient data from randomised trials. Lancet. 2015;386:1353-1361. Doi: 10.1016/S0140-6736(15)60908-4

Key clinical point: The presence of metabolic syndromes (MetS) worsened survival outcomes and increased disease recurrence risk in patients with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The MetS group had a significantly lower likelihood of achieving pathological complete response than the non-MetS group (odds ratio [OR] 0.316; P  =  .028), with the risk for death (OR 2.587; P  =  .004) and disease recurrence (OR 2.228; P  =  .007) being significantly higher in patients with vs without MetS.

Study details: Findings are from a retrospective study including 221 women with BC who received preoperative NAC, of which 22.2% of patients were included in the MetS group.

Disclosures: This study was supported by the Beijing Medical Award Foundation. The authors declared no conflicts of interest.

Source: Zhou Z et al. Metabolic syndrome is a risk factor for breast cancer patients receiving neoadjuvant chemotherapy: A case-control study. Front Oncol. 2023;12:1080054 (Jan 4). Doi: 10.3389/fonc.2022.1080054

Key clinical point: The presence of metabolic syndromes (MetS) worsened survival outcomes and increased disease recurrence risk in patients with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The MetS group had a significantly lower likelihood of achieving pathological complete response than the non-MetS group (odds ratio [OR] 0.316; P  =  .028), with the risk for death (OR 2.587; P  =  .004) and disease recurrence (OR 2.228; P  =  .007) being significantly higher in patients with vs without MetS.

Study details: Findings are from a retrospective study including 221 women with BC who received preoperative NAC, of which 22.2% of patients were included in the MetS group.

Disclosures: This study was supported by the Beijing Medical Award Foundation. The authors declared no conflicts of interest.

Source: Zhou Z et al. Metabolic syndrome is a risk factor for breast cancer patients receiving neoadjuvant chemotherapy: A case-control study. Front Oncol. 2023;12:1080054 (Jan 4). Doi: 10.3389/fonc.2022.1080054

Key clinical point: The presence of metabolic syndromes (MetS) worsened survival outcomes and increased disease recurrence risk in patients with breast cancer (BC) who received neoadjuvant chemotherapy (NAC).

Major finding: The MetS group had a significantly lower likelihood of achieving pathological complete response than the non-MetS group (odds ratio [OR] 0.316; P  =  .028), with the risk for death (OR 2.587; P  =  .004) and disease recurrence (OR 2.228; P  =  .007) being significantly higher in patients with vs without MetS.

Study details: Findings are from a retrospective study including 221 women with BC who received preoperative NAC, of which 22.2% of patients were included in the MetS group.

Disclosures: This study was supported by the Beijing Medical Award Foundation. The authors declared no conflicts of interest.

Source: Zhou Z et al. Metabolic syndrome is a risk factor for breast cancer patients receiving neoadjuvant chemotherapy: A case-control study. Front Oncol. 2023;12:1080054 (Jan 4). Doi: 10.3389/fonc.2022.1080054

Key clinical point: Recent phase 2 trials have recommended a 2-weekly schedule of pegylated liposomal doxorubicin (PLD) in patients with heavily treated metastatic breast cancer (BC); however, it failed to demonstrate any advantage in terms of efficacy or safety over the registered 4-weekly regimen of PLD.

Major finding: The median progression-free survival was 3.0 and 3.4 months in the 2-weekly and 4-weekly PLD schedule groups, respectively, with a weighted hazard ratio of 1.12 (P  =  .54). The rate of adverse events also appeared comparable between both the groups.

Study details: Findings are from a retrospective study including 191 heavily pretreated patients with metastatic BC who received a 2-weekly (n = 95) or the registered 4-weekly (n = 96) schedule of PLD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Bischoff H et al. A propensity score-weighted study comparing a two- versus four-weekly pegylated liposomal doxorubicin regimen in metastatic breast cancer. Breast Cancer Res Treat. 2022 (Dec 23). Doi: 10.1007/s10549-022-06844-5

Key clinical point: Recent phase 2 trials have recommended a 2-weekly schedule of pegylated liposomal doxorubicin (PLD) in patients with heavily treated metastatic breast cancer (BC); however, it failed to demonstrate any advantage in terms of efficacy or safety over the registered 4-weekly regimen of PLD.

Major finding: The median progression-free survival was 3.0 and 3.4 months in the 2-weekly and 4-weekly PLD schedule groups, respectively, with a weighted hazard ratio of 1.12 (P  =  .54). The rate of adverse events also appeared comparable between both the groups.

Study details: Findings are from a retrospective study including 191 heavily pretreated patients with metastatic BC who received a 2-weekly (n = 95) or the registered 4-weekly (n = 96) schedule of PLD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Bischoff H et al. A propensity score-weighted study comparing a two- versus four-weekly pegylated liposomal doxorubicin regimen in metastatic breast cancer. Breast Cancer Res Treat. 2022 (Dec 23). Doi: 10.1007/s10549-022-06844-5

Key clinical point: Recent phase 2 trials have recommended a 2-weekly schedule of pegylated liposomal doxorubicin (PLD) in patients with heavily treated metastatic breast cancer (BC); however, it failed to demonstrate any advantage in terms of efficacy or safety over the registered 4-weekly regimen of PLD.

Major finding: The median progression-free survival was 3.0 and 3.4 months in the 2-weekly and 4-weekly PLD schedule groups, respectively, with a weighted hazard ratio of 1.12 (P  =  .54). The rate of adverse events also appeared comparable between both the groups.

Study details: Findings are from a retrospective study including 191 heavily pretreated patients with metastatic BC who received a 2-weekly (n = 95) or the registered 4-weekly (n = 96) schedule of PLD.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Bischoff H et al. A propensity score-weighted study comparing a two- versus four-weekly pegylated liposomal doxorubicin regimen in metastatic breast cancer. Breast Cancer Res Treat. 2022 (Dec 23). Doi: 10.1007/s10549-022-06844-5

Key clinical point: Autologous fat grafting (AFG) in the second stage of a 2-stage prosthetic breast reconstruction was linked to a higher risk for breast cancer (BC) recurrence when performed within a year after mastectomy.

Major finding: Patients who did vs did not undergo AFG within 1 year after the primary operation had a significantly increased risk for disease recurrence (hazard ratio 5.701; 95% CI 1.164-27.927). However, delaying the fat grafting beyond 12 months after mastectomy did not affect survival outcomes.

Study details: Findings are from a retrospective cohort study including 267 patients with unilateral invasive BC who underwent total mastectomy and immediate tissue-expander-based reconstruction, of which 203 patients underwent the second-stage operation within 12 months of mastectomy and 64 patients underwent the operation after 12 months of mastectomy.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Lee KT et al. Association of fat graft with breast cancer recurrence in implant-based reconstruction: Does the timing matter? Ann Surg Oncol. 2022;30(2):1087-1097 (Dec 10). Doi: 10.1245/s10434-022-12389-0

Key clinical point: Autologous fat grafting (AFG) in the second stage of a 2-stage prosthetic breast reconstruction was linked to a higher risk for breast cancer (BC) recurrence when performed within a year after mastectomy.

Major finding: Patients who did vs did not undergo AFG within 1 year after the primary operation had a significantly increased risk for disease recurrence (hazard ratio 5.701; 95% CI 1.164-27.927). However, delaying the fat grafting beyond 12 months after mastectomy did not affect survival outcomes.

Study details: Findings are from a retrospective cohort study including 267 patients with unilateral invasive BC who underwent total mastectomy and immediate tissue-expander-based reconstruction, of which 203 patients underwent the second-stage operation within 12 months of mastectomy and 64 patients underwent the operation after 12 months of mastectomy.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Lee KT et al. Association of fat graft with breast cancer recurrence in implant-based reconstruction: Does the timing matter? Ann Surg Oncol. 2022;30(2):1087-1097 (Dec 10). Doi: 10.1245/s10434-022-12389-0

Key clinical point: Autologous fat grafting (AFG) in the second stage of a 2-stage prosthetic breast reconstruction was linked to a higher risk for breast cancer (BC) recurrence when performed within a year after mastectomy.

Major finding: Patients who did vs did not undergo AFG within 1 year after the primary operation had a significantly increased risk for disease recurrence (hazard ratio 5.701; 95% CI 1.164-27.927). However, delaying the fat grafting beyond 12 months after mastectomy did not affect survival outcomes.

Study details: Findings are from a retrospective cohort study including 267 patients with unilateral invasive BC who underwent total mastectomy and immediate tissue-expander-based reconstruction, of which 203 patients underwent the second-stage operation within 12 months of mastectomy and 64 patients underwent the operation after 12 months of mastectomy.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Lee KT et al. Association of fat graft with breast cancer recurrence in implant-based reconstruction: Does the timing matter? Ann Surg Oncol. 2022;30(2):1087-1097 (Dec 10). Doi: 10.1245/s10434-022-12389-0

Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), adding capecitabine to classic anthracycline/taxane-based adjuvant chemotherapy improved overall survival (OS) and carboplatin/paclitaxel was the most effective regimen for improving disease-free survival (DFS).

Major finding: Adjuvant chemotherapy with anthracyclines/taxanes plus capecitabine vs anthracyclines significantly improved OS outcomes (hazard ratio [HR] 0.56; 95% CI 0.36-0.87; probability for ranking the first 29%), whereas carboplatin/paclitaxel vs anthracyclines was the best regimen for improving DFS outcomes (HR 0.51; 95% CI 0.30-0.86; probability for ranking the first 41%).

Study details: Findings are from a network meta-analysis of 27 randomized phase 3 trials that compared adjuvant chemotherapy regimens in patients with resected, stage I-III TNBC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Petrelli F et al. Adjuvant chemotherapy for resected triple negative breast cancer patients: A network meta-analysis. Breast. 2022;67:8-13 (Dec 15). Doi: 10.1016/j.breast.2022.12.004

Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), adding capecitabine to classic anthracycline/taxane-based adjuvant chemotherapy improved overall survival (OS) and carboplatin/paclitaxel was the most effective regimen for improving disease-free survival (DFS).

Major finding: Adjuvant chemotherapy with anthracyclines/taxanes plus capecitabine vs anthracyclines significantly improved OS outcomes (hazard ratio [HR] 0.56; 95% CI 0.36-0.87; probability for ranking the first 29%), whereas carboplatin/paclitaxel vs anthracyclines was the best regimen for improving DFS outcomes (HR 0.51; 95% CI 0.30-0.86; probability for ranking the first 41%).

Study details: Findings are from a network meta-analysis of 27 randomized phase 3 trials that compared adjuvant chemotherapy regimens in patients with resected, stage I-III TNBC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Petrelli F et al. Adjuvant chemotherapy for resected triple negative breast cancer patients: A network meta-analysis. Breast. 2022;67:8-13 (Dec 15). Doi: 10.1016/j.breast.2022.12.004

Key clinical point: In patients with early-stage triple-negative breast cancer (TNBC), adding capecitabine to classic anthracycline/taxane-based adjuvant chemotherapy improved overall survival (OS) and carboplatin/paclitaxel was the most effective regimen for improving disease-free survival (DFS).

Major finding: Adjuvant chemotherapy with anthracyclines/taxanes plus capecitabine vs anthracyclines significantly improved OS outcomes (hazard ratio [HR] 0.56; 95% CI 0.36-0.87; probability for ranking the first 29%), whereas carboplatin/paclitaxel vs anthracyclines was the best regimen for improving DFS outcomes (HR 0.51; 95% CI 0.30-0.86; probability for ranking the first 41%).

Study details: Findings are from a network meta-analysis of 27 randomized phase 3 trials that compared adjuvant chemotherapy regimens in patients with resected, stage I-III TNBC.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Petrelli F et al. Adjuvant chemotherapy for resected triple negative breast cancer patients: A network meta-analysis. Breast. 2022;67:8-13 (Dec 15). Doi: 10.1016/j.breast.2022.12.004

Key clinical point: Treatment with adjuvant chemotherapy significantly improved overall survival (OS) outcomes in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−), T1abN0 breast cancer (BC).

Major finding: After a median follow-up of 7.7 years, a significant improvement was observed in OS with vs without chemotherapy in the overall cohort of patients with T1abN0 BC (hazard ratio 0.35; P  =  .02), along with both subgroups of patients with T1a (log-rank P  =  .001) and T1b (P  =  .001) BC.

Study details: Findings are from a nationwide, retrospective cohort study including 296 patients with ER− /HER2−, T1abN0 BC, of which 79.4% of patients received adjuvant chemotherapy.

Disclosures: This study was supported by the Danish Cancer Society, Denmark, and other sources. Some authors declared receiving personal fees, speaker honorarium, or research grants from various sources.

Source: Hassing CMS et al. Adjuvant chemotherapy in patients with ER-negative/HER2-negative, T1abN0 breast cancer: A nationwide study. Breast Cancer Res Treat. 2022 (Dec 28). Doi: 10.1007/s10549-022-06839-2

Key clinical point: Treatment with adjuvant chemotherapy significantly improved overall survival (OS) outcomes in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−), T1abN0 breast cancer (BC).

Major finding: After a median follow-up of 7.7 years, a significant improvement was observed in OS with vs without chemotherapy in the overall cohort of patients with T1abN0 BC (hazard ratio 0.35; P  =  .02), along with both subgroups of patients with T1a (log-rank P  =  .001) and T1b (P  =  .001) BC.

Study details: Findings are from a nationwide, retrospective cohort study including 296 patients with ER− /HER2−, T1abN0 BC, of which 79.4% of patients received adjuvant chemotherapy.

Disclosures: This study was supported by the Danish Cancer Society, Denmark, and other sources. Some authors declared receiving personal fees, speaker honorarium, or research grants from various sources.

Source: Hassing CMS et al. Adjuvant chemotherapy in patients with ER-negative/HER2-negative, T1abN0 breast cancer: A nationwide study. Breast Cancer Res Treat. 2022 (Dec 28). Doi: 10.1007/s10549-022-06839-2

Key clinical point: Treatment with adjuvant chemotherapy significantly improved overall survival (OS) outcomes in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−), T1abN0 breast cancer (BC).

Major finding: After a median follow-up of 7.7 years, a significant improvement was observed in OS with vs without chemotherapy in the overall cohort of patients with T1abN0 BC (hazard ratio 0.35; P  =  .02), along with both subgroups of patients with T1a (log-rank P  =  .001) and T1b (P  =  .001) BC.

Study details: Findings are from a nationwide, retrospective cohort study including 296 patients with ER− /HER2−, T1abN0 BC, of which 79.4% of patients received adjuvant chemotherapy.

Disclosures: This study was supported by the Danish Cancer Society, Denmark, and other sources. Some authors declared receiving personal fees, speaker honorarium, or research grants from various sources.

Source: Hassing CMS et al. Adjuvant chemotherapy in patients with ER-negative/HER2-negative, T1abN0 breast cancer: A nationwide study. Breast Cancer Res Treat. 2022 (Dec 28). Doi: 10.1007/s10549-022-06839-2

Key clinical point: In patients with advanced human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) breast cancer (BC) treated with trastuzumab emtansine, the pre-established levels of ERBB2 mRNA expression according to the HER2DX standardized assay served as an important prognostic biomarker in predicting survival outcomes.

Major finding: High, medium, and low levels of ERBB2 mRNA expression were associated with overall response rates of 56%, 29%, and 0%, respectively, with high ERBB2 mRNA expression being associated with both better progression-free survival (P < .001) and overall survival (P  =  .007) outcomes.

Study details: Findings are from a study including 87 patients with HER2+ advanced BC who received treatment with trastuzumab emtansine.

Disclosures: This study was funded by Hospital Clinic, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, University of Padova, Italy, and other sources. The authors declared serving as consultants; receiving advisory, lecture, or consulting fees; or having other ties with several sources.

Source: Brasó-Maristany F et al. HER2DX ERBB2 mRNA expression in advanced HER2-positive breast cancer treated with T-DM1. J Natl Cancer Inst. 2022 (Dec 28). Doi: 10.1093/jnci/djac227

Key clinical point: In patients with advanced human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) breast cancer (BC) treated with trastuzumab emtansine, the pre-established levels of ERBB2 mRNA expression according to the HER2DX standardized assay served as an important prognostic biomarker in predicting survival outcomes.

Major finding: High, medium, and low levels of ERBB2 mRNA expression were associated with overall response rates of 56%, 29%, and 0%, respectively, with high ERBB2 mRNA expression being associated with both better progression-free survival (P < .001) and overall survival (P  =  .007) outcomes.

Study details: Findings are from a study including 87 patients with HER2+ advanced BC who received treatment with trastuzumab emtansine.

Disclosures: This study was funded by Hospital Clinic, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, University of Padova, Italy, and other sources. The authors declared serving as consultants; receiving advisory, lecture, or consulting fees; or having other ties with several sources.

Source: Brasó-Maristany F et al. HER2DX ERBB2 mRNA expression in advanced HER2-positive breast cancer treated with T-DM1. J Natl Cancer Inst. 2022 (Dec 28). Doi: 10.1093/jnci/djac227

Key clinical point: In patients with advanced human epidermal growth factor receptor 2-positive (HER2+ or ERBB2+) breast cancer (BC) treated with trastuzumab emtansine, the pre-established levels of ERBB2 mRNA expression according to the HER2DX standardized assay served as an important prognostic biomarker in predicting survival outcomes.

Major finding: High, medium, and low levels of ERBB2 mRNA expression were associated with overall response rates of 56%, 29%, and 0%, respectively, with high ERBB2 mRNA expression being associated with both better progression-free survival (P < .001) and overall survival (P  =  .007) outcomes.

Study details: Findings are from a study including 87 patients with HER2+ advanced BC who received treatment with trastuzumab emtansine.

Disclosures: This study was funded by Hospital Clinic, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, University of Padova, Italy, and other sources. The authors declared serving as consultants; receiving advisory, lecture, or consulting fees; or having other ties with several sources.

Source: Brasó-Maristany F et al. HER2DX ERBB2 mRNA expression in advanced HER2-positive breast cancer treated with T-DM1. J Natl Cancer Inst. 2022 (Dec 28). Doi: 10.1093/jnci/djac227