Breast Cancer

A new study finds that mortality is significantly higher among patients with advanced solid tumors who are admitted to the hospital for chemotherapy treatment.

The findings – released in a poster session at the annual meeting of the American Society of Clinical Oncology – found that patients with solid tumors were more likely to be treated for nonurgent indications, not be referred to palliative care, and die within 60 days, compared with patients with hematologic malignancies.

Decisions about inpatient chemotherapy should not be uniform and instead should be based on a case-by-case basis, said Natalie Berger, MD, a hematologist-oncologist at Mount Sinai Hospital,, New York, and the study’s lead author.

Inpatient chemotherapy can be appropriate in certain situations, such as when chemotherapy must be given in the hospital and when it must be administered quickly after a patient presents with cancer symptoms and needs relief, she said.

However, “sometimes patients are admitted due to infection, side effects of chemotherapy or cancer, or for reasons unrelated to their cancer, and chemotherapy may be administered when it is not appropriate. It is also overutilized at the end of life which can lead to more aggressive end-of-life care rather than focusing on quality of life and supportive care,” Dr. Berger said.

The study is based on a retrospective chart review of 880 patients admitted to Mount Sinai Hospital between January 2016 and December 2017 to receive chemotherapy.

They found that the type of tumor was used to determine the urgency of an in-hospital stay for chemotherapy (odds ratio, 0.42; 95% CI, 0.25-0.72; P = .001). Patients with solid tumors or older patients or patients with a functional impairment score (Karnofsky Performance Scale) of 50% were less likely to respond to chemotherapy. There was also a decrease in quality of life among these patients, but only 46% of patients with solid tumors and 15% of patients with hematologic malignancies met with a palliative care professional.

One-third (34%) of patients with solid tumors didn’t have urgent indications, 43% of patients had no response to inpatient chemotherapy, and 20% died within 60 days, compared with patients with hematologic malignancies (19%, 19%, and 9%, respectively).

“There are many reasons why this [high mortality rate in patients with solid tumors] may be happening. Solid tumor patients are more often admitted at a later stage of their cancer when they are sicker, and they were also less likely to have a response to inpatient chemotherapy. Older patients and patients with a poor performance status were also less likely to respond to chemotherapy. This indicates that these patients were sicker, and chemotherapy use may not have been appropriate and palliative care may be underutilized,” she said.

Dr. Berger and colleagues have created a standardized protocol to assess “the appropriateness” of inpatient chemotherapy, improve quality of life, and reduce chemotherapy and health care utilization at the end of life. The protocol has been implemented as a pilot program at Mount Sinai Hospital, Dr. Berger said.

“Any inpatient chemotherapy case that meets standard accepted criteria for required inpatient administration are auto-approved through the electronic survey. For cases outside of standard criteria, further information must be inputted to determine appropriateness of inpatient treatment and are then scored electronically and reviewed by committee physicians and pharmacists,” she said.

Gabriel A. Brooks, MD, MPH, an oncologist with Dartmouth Hitchcock Medical Center, Lebanon, N.H., who was not affiliated with the study, said that inpatient chemotherapy treatment is under scrutiny elsewhere as well.

“There has been recognition that patients who are otherwise sick enough to require hospital admission are often too sick to benefit from chemotherapy,” although there are exceptions. “There is certainly a movement to limit inpatient chemotherapy to situations where it is most likely to be beneficial. Some of this is driven by cost pressures. For instance, Medicare pays for inpatient hospitalizations using the DRG [diagnosis-related group] system. Hospitals cannot charge a la carte for treatments given in the hospital. Instead, they are reimbursed at a fixed rate based on the hospital diagnoses. This will often lead to poor reimbursement of high-cost cancer treatments.”

Dr. Brooks said the study offers insight into who’s getting inpatient chemotherapy. However, “what I can’t tell from this poster is how often the solid tumor patients are getting first-line chemotherapy [as] these patients may be presenting late or may have a potentially treatable cancer with a narrow closing window for treatment versus later-line chemotherapy.”

He also noted that patient and family wishes are missing from the research. “This is critical. Patients and families should be informed that inpatient chemotherapy may not provide the benefit they are hoping for, especially for patients with solid tumors starting later lines of therapy. Patients should be informed that there are alternatives to inpatient chemotherapy, such as hospice referral or waiting for possible outpatient treatment – if their condition improves. But when a patient wants to try inpatient chemotherapy and their doctor wants to offer it, then it is likely a reasonable thing to try.”

Going forward, he said, “qualitative study is needed to better understand when and why inpatient chemotherapy is used. There are likely some clear good uses and some clear bad uses of inpatient chemotherapy. Can outpatient regimens be substituted for the regimens where patients are directly admitted? Or, can outpatient protocols be devised for these regimens? Are there specific situations where inpatient chemotherapy is the right thing (leukemia, esophageal cancer with worsening dysphagia, etc.)?”

No study funding was received.

A new study finds that mortality is significantly higher among patients with advanced solid tumors who are admitted to the hospital for chemotherapy treatment.

The findings – released in a poster session at the annual meeting of the American Society of Clinical Oncology – found that patients with solid tumors were more likely to be treated for nonurgent indications, not be referred to palliative care, and die within 60 days, compared with patients with hematologic malignancies.

Decisions about inpatient chemotherapy should not be uniform and instead should be based on a case-by-case basis, said Natalie Berger, MD, a hematologist-oncologist at Mount Sinai Hospital,, New York, and the study’s lead author.

Inpatient chemotherapy can be appropriate in certain situations, such as when chemotherapy must be given in the hospital and when it must be administered quickly after a patient presents with cancer symptoms and needs relief, she said.

However, “sometimes patients are admitted due to infection, side effects of chemotherapy or cancer, or for reasons unrelated to their cancer, and chemotherapy may be administered when it is not appropriate. It is also overutilized at the end of life which can lead to more aggressive end-of-life care rather than focusing on quality of life and supportive care,” Dr. Berger said.

The study is based on a retrospective chart review of 880 patients admitted to Mount Sinai Hospital between January 2016 and December 2017 to receive chemotherapy.

They found that the type of tumor was used to determine the urgency of an in-hospital stay for chemotherapy (odds ratio, 0.42; 95% CI, 0.25-0.72; P = .001). Patients with solid tumors or older patients or patients with a functional impairment score (Karnofsky Performance Scale) of 50% were less likely to respond to chemotherapy. There was also a decrease in quality of life among these patients, but only 46% of patients with solid tumors and 15% of patients with hematologic malignancies met with a palliative care professional.

One-third (34%) of patients with solid tumors didn’t have urgent indications, 43% of patients had no response to inpatient chemotherapy, and 20% died within 60 days, compared with patients with hematologic malignancies (19%, 19%, and 9%, respectively).

“There are many reasons why this [high mortality rate in patients with solid tumors] may be happening. Solid tumor patients are more often admitted at a later stage of their cancer when they are sicker, and they were also less likely to have a response to inpatient chemotherapy. Older patients and patients with a poor performance status were also less likely to respond to chemotherapy. This indicates that these patients were sicker, and chemotherapy use may not have been appropriate and palliative care may be underutilized,” she said.

Dr. Berger and colleagues have created a standardized protocol to assess “the appropriateness” of inpatient chemotherapy, improve quality of life, and reduce chemotherapy and health care utilization at the end of life. The protocol has been implemented as a pilot program at Mount Sinai Hospital, Dr. Berger said.

“Any inpatient chemotherapy case that meets standard accepted criteria for required inpatient administration are auto-approved through the electronic survey. For cases outside of standard criteria, further information must be inputted to determine appropriateness of inpatient treatment and are then scored electronically and reviewed by committee physicians and pharmacists,” she said.

Gabriel A. Brooks, MD, MPH, an oncologist with Dartmouth Hitchcock Medical Center, Lebanon, N.H., who was not affiliated with the study, said that inpatient chemotherapy treatment is under scrutiny elsewhere as well.

“There has been recognition that patients who are otherwise sick enough to require hospital admission are often too sick to benefit from chemotherapy,” although there are exceptions. “There is certainly a movement to limit inpatient chemotherapy to situations where it is most likely to be beneficial. Some of this is driven by cost pressures. For instance, Medicare pays for inpatient hospitalizations using the DRG [diagnosis-related group] system. Hospitals cannot charge a la carte for treatments given in the hospital. Instead, they are reimbursed at a fixed rate based on the hospital diagnoses. This will often lead to poor reimbursement of high-cost cancer treatments.”

Dr. Brooks said the study offers insight into who’s getting inpatient chemotherapy. However, “what I can’t tell from this poster is how often the solid tumor patients are getting first-line chemotherapy [as] these patients may be presenting late or may have a potentially treatable cancer with a narrow closing window for treatment versus later-line chemotherapy.”

He also noted that patient and family wishes are missing from the research. “This is critical. Patients and families should be informed that inpatient chemotherapy may not provide the benefit they are hoping for, especially for patients with solid tumors starting later lines of therapy. Patients should be informed that there are alternatives to inpatient chemotherapy, such as hospice referral or waiting for possible outpatient treatment – if their condition improves. But when a patient wants to try inpatient chemotherapy and their doctor wants to offer it, then it is likely a reasonable thing to try.”

Going forward, he said, “qualitative study is needed to better understand when and why inpatient chemotherapy is used. There are likely some clear good uses and some clear bad uses of inpatient chemotherapy. Can outpatient regimens be substituted for the regimens where patients are directly admitted? Or, can outpatient protocols be devised for these regimens? Are there specific situations where inpatient chemotherapy is the right thing (leukemia, esophageal cancer with worsening dysphagia, etc.)?”

No study funding was received.

A new study finds that mortality is significantly higher among patients with advanced solid tumors who are admitted to the hospital for chemotherapy treatment.

The findings – released in a poster session at the annual meeting of the American Society of Clinical Oncology – found that patients with solid tumors were more likely to be treated for nonurgent indications, not be referred to palliative care, and die within 60 days, compared with patients with hematologic malignancies.

Decisions about inpatient chemotherapy should not be uniform and instead should be based on a case-by-case basis, said Natalie Berger, MD, a hematologist-oncologist at Mount Sinai Hospital,, New York, and the study’s lead author.

Inpatient chemotherapy can be appropriate in certain situations, such as when chemotherapy must be given in the hospital and when it must be administered quickly after a patient presents with cancer symptoms and needs relief, she said.

However, “sometimes patients are admitted due to infection, side effects of chemotherapy or cancer, or for reasons unrelated to their cancer, and chemotherapy may be administered when it is not appropriate. It is also overutilized at the end of life which can lead to more aggressive end-of-life care rather than focusing on quality of life and supportive care,” Dr. Berger said.

The study is based on a retrospective chart review of 880 patients admitted to Mount Sinai Hospital between January 2016 and December 2017 to receive chemotherapy.

They found that the type of tumor was used to determine the urgency of an in-hospital stay for chemotherapy (odds ratio, 0.42; 95% CI, 0.25-0.72; P = .001). Patients with solid tumors or older patients or patients with a functional impairment score (Karnofsky Performance Scale) of 50% were less likely to respond to chemotherapy. There was also a decrease in quality of life among these patients, but only 46% of patients with solid tumors and 15% of patients with hematologic malignancies met with a palliative care professional.

One-third (34%) of patients with solid tumors didn’t have urgent indications, 43% of patients had no response to inpatient chemotherapy, and 20% died within 60 days, compared with patients with hematologic malignancies (19%, 19%, and 9%, respectively).

“There are many reasons why this [high mortality rate in patients with solid tumors] may be happening. Solid tumor patients are more often admitted at a later stage of their cancer when they are sicker, and they were also less likely to have a response to inpatient chemotherapy. Older patients and patients with a poor performance status were also less likely to respond to chemotherapy. This indicates that these patients were sicker, and chemotherapy use may not have been appropriate and palliative care may be underutilized,” she said.

Dr. Berger and colleagues have created a standardized protocol to assess “the appropriateness” of inpatient chemotherapy, improve quality of life, and reduce chemotherapy and health care utilization at the end of life. The protocol has been implemented as a pilot program at Mount Sinai Hospital, Dr. Berger said.

“Any inpatient chemotherapy case that meets standard accepted criteria for required inpatient administration are auto-approved through the electronic survey. For cases outside of standard criteria, further information must be inputted to determine appropriateness of inpatient treatment and are then scored electronically and reviewed by committee physicians and pharmacists,” she said.

Gabriel A. Brooks, MD, MPH, an oncologist with Dartmouth Hitchcock Medical Center, Lebanon, N.H., who was not affiliated with the study, said that inpatient chemotherapy treatment is under scrutiny elsewhere as well.

“There has been recognition that patients who are otherwise sick enough to require hospital admission are often too sick to benefit from chemotherapy,” although there are exceptions. “There is certainly a movement to limit inpatient chemotherapy to situations where it is most likely to be beneficial. Some of this is driven by cost pressures. For instance, Medicare pays for inpatient hospitalizations using the DRG [diagnosis-related group] system. Hospitals cannot charge a la carte for treatments given in the hospital. Instead, they are reimbursed at a fixed rate based on the hospital diagnoses. This will often lead to poor reimbursement of high-cost cancer treatments.”

Dr. Brooks said the study offers insight into who’s getting inpatient chemotherapy. However, “what I can’t tell from this poster is how often the solid tumor patients are getting first-line chemotherapy [as] these patients may be presenting late or may have a potentially treatable cancer with a narrow closing window for treatment versus later-line chemotherapy.”

He also noted that patient and family wishes are missing from the research. “This is critical. Patients and families should be informed that inpatient chemotherapy may not provide the benefit they are hoping for, especially for patients with solid tumors starting later lines of therapy. Patients should be informed that there are alternatives to inpatient chemotherapy, such as hospice referral or waiting for possible outpatient treatment – if their condition improves. But when a patient wants to try inpatient chemotherapy and their doctor wants to offer it, then it is likely a reasonable thing to try.”

Going forward, he said, “qualitative study is needed to better understand when and why inpatient chemotherapy is used. There are likely some clear good uses and some clear bad uses of inpatient chemotherapy. Can outpatient regimens be substituted for the regimens where patients are directly admitted? Or, can outpatient protocols be devised for these regimens? Are there specific situations where inpatient chemotherapy is the right thing (leukemia, esophageal cancer with worsening dysphagia, etc.)?”

No study funding was received.

CHICAGO – The American Society of Clinical Oncology recently wrapped its annual meeting in Chicago. Many of us attended virtually, or in person, and were wowed by some of the abstracts and their implications for our patients – some practice changing. Here, I highlight some presentations that stood out to me.

A first-line treatment for metastatic colorectal cancer

The plenary session did not disappoint. In abstract LBA1, investigators presented first-line treatment for patients with metastatic colorectal cancer who were randomized to receive mFOLFOX6 with either bevacizumab or panitumumab in RAS wild-type positive patients. This was the phase 3 PARADIGM trial.

The primary outcome for this study was overall survival. It included 823 patients who were randomized 1:1 with a subset analysis of whether the primary tumor was on the left or right side of the colon. At 61 months follow-up, the median overall survival results for left-sided colon cancer was 38 months versus 34 months. It was statistically significant favoring the panitumumab arm. It improved the curable resection rate for patients with left-sided tumors from 11% in the bevacizumab arm to 18% in the panitumumab arm. Interestingly, patients randomized with right-sided tumors showed no difference in overall survival. The investigator, Takayuki Yoshino, MD, PhD, National Cancer Center Hospital East, Kashiwa, Japan, said the study findings support the use of mFOLFOX6 with panitumumab in left-sided RAS wild type as first-line therapy in metastatic colorectal patients. 
 

A possible new standard of care in breast cancer

Shanu Modi, MD, of Memorial Sloan Kettering Cancer Center, New York, received a standing ovation and deserved it. In the phase 3 clinical trial DESTINY-Breast04 (abstract LBA3), she demonstrated that trastuzumab deruxtecan (T-DXd) for patients with metastatic breast cancer who were HER2 low (IHC 1+ or 2+ ISH-), led to a statistically significant and clinically meaningful benefit in both progression free survival and overall survival. In this trial, patients were randomized 2:1 to receive trastuzumab deruxtecan or physician’s choice of chemotherapy. All patients had at least one to two lines of chemotherapy before entering the trial. Hormone-positive patients were allowed if they had already received and failed, or progressed on hormone therapy. 

Previously, most patients were treated either with eribulin with some receiving capecitabine, gemcitabine or taxane, or hormone therapy if hormone positive.

The progression-free survival was 10.1 versus 5.4 months in hormone-positive patients, and in all patients (hormone receptor positive or negative), there was a likewise improvement of 9.9 versus 5.1 months progression free survival.

Overall survival was equally impressive. In the hormone receptor–positive patients, the hazard ratio was 0.64 with a 23.9 versus 17.5 month survival. If all patients were included, the HR was again 0.64 with 23.4 versus 16.8 month survival. Even the triple-negative breast cancer patients had a HR of 0.48 with 18.2 versus 8.3 months survival. Adverse events were quite tolerable with some nausea, some decreased white count, and only an interstitial lung disease of grade 2 or less in 12%. 

Trastuzumab deruxtecan is a targeted treatment which, in addition to striking its target, also targets other tumor cells that are part of the cancer. The results of this study may lead to a new standard of care of this patient population.

The study by Dr. Modi and colleagues was simultaneously published in the New England Journal of Medicine.
 

Improving outcomes in multiple myeloma

In abstract LBA4, Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, Boston, asks if autologous stem cell transplant (ASCT) can improve outcomes after induction with an RVD regimen (lenalidomide, bortezomib, and dexamethasone) and lenalidomide (Revlimid) maintenance for newly diagnosed patients with multiple myeloma in the DETERMINATION study.

The take home here was quite interesting. In fact, there is no difference in overall survival if patients get this standard RVD/lenalidomide maintenance induction with or without ASCT. However, the progression free survival was better with ASCT: 46 versus 67 months (improvement of 21 months). However, there were some caveats. There was toxicity and change in quality of life for a while in those patients receiving ASCT as would be expected. Furthermore, the study only allowed 65 years old or younger and ASCT may not be wise for older patients. The discussant made a strong point that African Americans tend to have higher risk disease with different mutations and might also be better served by have ASCT later.

The conclusion was that, given all the new therapies in myeloma for second line and beyond, ASCT should be a discussion with each new patient and not an automatic decision.

This study was simultaneously published in the New England Journal of Medicine.
 

Adagrasib promising for pretreated patients with NSCLC with KRAS mutation

In patients with advanced or metastatic non–small cell lung cancer (NSCLC), adagrasib was found to be well tolerated and “demonstrates promising efficacy” for patients with the KRAS G12C mutation (KRYSTAL-1, abstract 9002). This was a phase 2 registration trial of 116 patients who were treated with 600 mg of adagrasib twice orally. Patients all had previous chemotherapy or immunotherapy or both. The overall response rate was a surprisingly good 43% (complete response and partial response). Disease control was an incredible 80% if stable disease was included. The duration of response was 8.5 months, progression-free survival was 6.5 months, and overall survival was 12.6 months. Furthermore, 33% of those with brain metastases had a complete response or partial response.

The take-home message is that, since 15% of NSCLC metastatic patients are KRAS mutant G12C, we should be watching for such patients in our biomarker analysis. While we have sotorasib – approved by the Food and Drug Administration for NSCLC – the results of this study suggests we may have another new molecule in the same class.
 

Neoadjuvant chemotherapy with immunotherapy for NSCLC

It may be time to consider neoadjuvant chemotherapy with immunotherapy, such as nivolumab, for patients with NSCLC in order to achieve the best response possible.

In NADIM II, investigators led by Mariano Provencio-Pulla, MD, of the Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, confirmed the superiority of chemotherapy with immunotherapy for patients with resectable stage IIIA NSCLC. NADIM included patients with resectable stage IIIA/B NSCLC who were randomized 2:1 to receive carboplatin taxol neoadjuvant therapy with or without nivolumab before and after surgery. The pathological complete response rates overall were 36% versus 7%, favoring the nivolumab arm, but even higher pCR rates occurred in patients with PD-L1 over 50%.

In closing, always check MMR, KRAS, BRAF, and HER2. For wild-type left-sided mCRC, consider FOLFOX or FOLFIRI with an anti-EGFR. For KRAS mutant or right-sided colon tumor, consider FOLFOX or FOLFIRI with bevacizumab, followed by maintenance 5FU or capecitabine, with or without bevacizumab.

CHICAGO – The American Society of Clinical Oncology recently wrapped its annual meeting in Chicago. Many of us attended virtually, or in person, and were wowed by some of the abstracts and their implications for our patients – some practice changing. Here, I highlight some presentations that stood out to me.

A first-line treatment for metastatic colorectal cancer

The plenary session did not disappoint. In abstract LBA1, investigators presented first-line treatment for patients with metastatic colorectal cancer who were randomized to receive mFOLFOX6 with either bevacizumab or panitumumab in RAS wild-type positive patients. This was the phase 3 PARADIGM trial.

The primary outcome for this study was overall survival. It included 823 patients who were randomized 1:1 with a subset analysis of whether the primary tumor was on the left or right side of the colon. At 61 months follow-up, the median overall survival results for left-sided colon cancer was 38 months versus 34 months. It was statistically significant favoring the panitumumab arm. It improved the curable resection rate for patients with left-sided tumors from 11% in the bevacizumab arm to 18% in the panitumumab arm. Interestingly, patients randomized with right-sided tumors showed no difference in overall survival. The investigator, Takayuki Yoshino, MD, PhD, National Cancer Center Hospital East, Kashiwa, Japan, said the study findings support the use of mFOLFOX6 with panitumumab in left-sided RAS wild type as first-line therapy in metastatic colorectal patients. 
 

A possible new standard of care in breast cancer

Shanu Modi, MD, of Memorial Sloan Kettering Cancer Center, New York, received a standing ovation and deserved it. In the phase 3 clinical trial DESTINY-Breast04 (abstract LBA3), she demonstrated that trastuzumab deruxtecan (T-DXd) for patients with metastatic breast cancer who were HER2 low (IHC 1+ or 2+ ISH-), led to a statistically significant and clinically meaningful benefit in both progression free survival and overall survival. In this trial, patients were randomized 2:1 to receive trastuzumab deruxtecan or physician’s choice of chemotherapy. All patients had at least one to two lines of chemotherapy before entering the trial. Hormone-positive patients were allowed if they had already received and failed, or progressed on hormone therapy. 

Previously, most patients were treated either with eribulin with some receiving capecitabine, gemcitabine or taxane, or hormone therapy if hormone positive.

The progression-free survival was 10.1 versus 5.4 months in hormone-positive patients, and in all patients (hormone receptor positive or negative), there was a likewise improvement of 9.9 versus 5.1 months progression free survival.

Overall survival was equally impressive. In the hormone receptor–positive patients, the hazard ratio was 0.64 with a 23.9 versus 17.5 month survival. If all patients were included, the HR was again 0.64 with 23.4 versus 16.8 month survival. Even the triple-negative breast cancer patients had a HR of 0.48 with 18.2 versus 8.3 months survival. Adverse events were quite tolerable with some nausea, some decreased white count, and only an interstitial lung disease of grade 2 or less in 12%. 

Trastuzumab deruxtecan is a targeted treatment which, in addition to striking its target, also targets other tumor cells that are part of the cancer. The results of this study may lead to a new standard of care of this patient population.

The study by Dr. Modi and colleagues was simultaneously published in the New England Journal of Medicine.
 

Improving outcomes in multiple myeloma

In abstract LBA4, Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, Boston, asks if autologous stem cell transplant (ASCT) can improve outcomes after induction with an RVD regimen (lenalidomide, bortezomib, and dexamethasone) and lenalidomide (Revlimid) maintenance for newly diagnosed patients with multiple myeloma in the DETERMINATION study.

The take home here was quite interesting. In fact, there is no difference in overall survival if patients get this standard RVD/lenalidomide maintenance induction with or without ASCT. However, the progression free survival was better with ASCT: 46 versus 67 months (improvement of 21 months). However, there were some caveats. There was toxicity and change in quality of life for a while in those patients receiving ASCT as would be expected. Furthermore, the study only allowed 65 years old or younger and ASCT may not be wise for older patients. The discussant made a strong point that African Americans tend to have higher risk disease with different mutations and might also be better served by have ASCT later.

The conclusion was that, given all the new therapies in myeloma for second line and beyond, ASCT should be a discussion with each new patient and not an automatic decision.

This study was simultaneously published in the New England Journal of Medicine.
 

Adagrasib promising for pretreated patients with NSCLC with KRAS mutation

In patients with advanced or metastatic non–small cell lung cancer (NSCLC), adagrasib was found to be well tolerated and “demonstrates promising efficacy” for patients with the KRAS G12C mutation (KRYSTAL-1, abstract 9002). This was a phase 2 registration trial of 116 patients who were treated with 600 mg of adagrasib twice orally. Patients all had previous chemotherapy or immunotherapy or both. The overall response rate was a surprisingly good 43% (complete response and partial response). Disease control was an incredible 80% if stable disease was included. The duration of response was 8.5 months, progression-free survival was 6.5 months, and overall survival was 12.6 months. Furthermore, 33% of those with brain metastases had a complete response or partial response.

The take-home message is that, since 15% of NSCLC metastatic patients are KRAS mutant G12C, we should be watching for such patients in our biomarker analysis. While we have sotorasib – approved by the Food and Drug Administration for NSCLC – the results of this study suggests we may have another new molecule in the same class.
 

Neoadjuvant chemotherapy with immunotherapy for NSCLC

It may be time to consider neoadjuvant chemotherapy with immunotherapy, such as nivolumab, for patients with NSCLC in order to achieve the best response possible.

In NADIM II, investigators led by Mariano Provencio-Pulla, MD, of the Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, confirmed the superiority of chemotherapy with immunotherapy for patients with resectable stage IIIA NSCLC. NADIM included patients with resectable stage IIIA/B NSCLC who were randomized 2:1 to receive carboplatin taxol neoadjuvant therapy with or without nivolumab before and after surgery. The pathological complete response rates overall were 36% versus 7%, favoring the nivolumab arm, but even higher pCR rates occurred in patients with PD-L1 over 50%.

In closing, always check MMR, KRAS, BRAF, and HER2. For wild-type left-sided mCRC, consider FOLFOX or FOLFIRI with an anti-EGFR. For KRAS mutant or right-sided colon tumor, consider FOLFOX or FOLFIRI with bevacizumab, followed by maintenance 5FU or capecitabine, with or without bevacizumab.

CHICAGO – The American Society of Clinical Oncology recently wrapped its annual meeting in Chicago. Many of us attended virtually, or in person, and were wowed by some of the abstracts and their implications for our patients – some practice changing. Here, I highlight some presentations that stood out to me.

A first-line treatment for metastatic colorectal cancer

The plenary session did not disappoint. In abstract LBA1, investigators presented first-line treatment for patients with metastatic colorectal cancer who were randomized to receive mFOLFOX6 with either bevacizumab or panitumumab in RAS wild-type positive patients. This was the phase 3 PARADIGM trial.

The primary outcome for this study was overall survival. It included 823 patients who were randomized 1:1 with a subset analysis of whether the primary tumor was on the left or right side of the colon. At 61 months follow-up, the median overall survival results for left-sided colon cancer was 38 months versus 34 months. It was statistically significant favoring the panitumumab arm. It improved the curable resection rate for patients with left-sided tumors from 11% in the bevacizumab arm to 18% in the panitumumab arm. Interestingly, patients randomized with right-sided tumors showed no difference in overall survival. The investigator, Takayuki Yoshino, MD, PhD, National Cancer Center Hospital East, Kashiwa, Japan, said the study findings support the use of mFOLFOX6 with panitumumab in left-sided RAS wild type as first-line therapy in metastatic colorectal patients. 
 

A possible new standard of care in breast cancer

Shanu Modi, MD, of Memorial Sloan Kettering Cancer Center, New York, received a standing ovation and deserved it. In the phase 3 clinical trial DESTINY-Breast04 (abstract LBA3), she demonstrated that trastuzumab deruxtecan (T-DXd) for patients with metastatic breast cancer who were HER2 low (IHC 1+ or 2+ ISH-), led to a statistically significant and clinically meaningful benefit in both progression free survival and overall survival. In this trial, patients were randomized 2:1 to receive trastuzumab deruxtecan or physician’s choice of chemotherapy. All patients had at least one to two lines of chemotherapy before entering the trial. Hormone-positive patients were allowed if they had already received and failed, or progressed on hormone therapy. 

Previously, most patients were treated either with eribulin with some receiving capecitabine, gemcitabine or taxane, or hormone therapy if hormone positive.

The progression-free survival was 10.1 versus 5.4 months in hormone-positive patients, and in all patients (hormone receptor positive or negative), there was a likewise improvement of 9.9 versus 5.1 months progression free survival.

Overall survival was equally impressive. In the hormone receptor–positive patients, the hazard ratio was 0.64 with a 23.9 versus 17.5 month survival. If all patients were included, the HR was again 0.64 with 23.4 versus 16.8 month survival. Even the triple-negative breast cancer patients had a HR of 0.48 with 18.2 versus 8.3 months survival. Adverse events were quite tolerable with some nausea, some decreased white count, and only an interstitial lung disease of grade 2 or less in 12%. 

Trastuzumab deruxtecan is a targeted treatment which, in addition to striking its target, also targets other tumor cells that are part of the cancer. The results of this study may lead to a new standard of care of this patient population.

The study by Dr. Modi and colleagues was simultaneously published in the New England Journal of Medicine.
 

Improving outcomes in multiple myeloma

In abstract LBA4, Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, Boston, asks if autologous stem cell transplant (ASCT) can improve outcomes after induction with an RVD regimen (lenalidomide, bortezomib, and dexamethasone) and lenalidomide (Revlimid) maintenance for newly diagnosed patients with multiple myeloma in the DETERMINATION study.

The take home here was quite interesting. In fact, there is no difference in overall survival if patients get this standard RVD/lenalidomide maintenance induction with or without ASCT. However, the progression free survival was better with ASCT: 46 versus 67 months (improvement of 21 months). However, there were some caveats. There was toxicity and change in quality of life for a while in those patients receiving ASCT as would be expected. Furthermore, the study only allowed 65 years old or younger and ASCT may not be wise for older patients. The discussant made a strong point that African Americans tend to have higher risk disease with different mutations and might also be better served by have ASCT later.

The conclusion was that, given all the new therapies in myeloma for second line and beyond, ASCT should be a discussion with each new patient and not an automatic decision.

This study was simultaneously published in the New England Journal of Medicine.
 

Adagrasib promising for pretreated patients with NSCLC with KRAS mutation

In patients with advanced or metastatic non–small cell lung cancer (NSCLC), adagrasib was found to be well tolerated and “demonstrates promising efficacy” for patients with the KRAS G12C mutation (KRYSTAL-1, abstract 9002). This was a phase 2 registration trial of 116 patients who were treated with 600 mg of adagrasib twice orally. Patients all had previous chemotherapy or immunotherapy or both. The overall response rate was a surprisingly good 43% (complete response and partial response). Disease control was an incredible 80% if stable disease was included. The duration of response was 8.5 months, progression-free survival was 6.5 months, and overall survival was 12.6 months. Furthermore, 33% of those with brain metastases had a complete response or partial response.

The take-home message is that, since 15% of NSCLC metastatic patients are KRAS mutant G12C, we should be watching for such patients in our biomarker analysis. While we have sotorasib – approved by the Food and Drug Administration for NSCLC – the results of this study suggests we may have another new molecule in the same class.
 

Neoadjuvant chemotherapy with immunotherapy for NSCLC

It may be time to consider neoadjuvant chemotherapy with immunotherapy, such as nivolumab, for patients with NSCLC in order to achieve the best response possible.

In NADIM II, investigators led by Mariano Provencio-Pulla, MD, of the Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, confirmed the superiority of chemotherapy with immunotherapy for patients with resectable stage IIIA NSCLC. NADIM included patients with resectable stage IIIA/B NSCLC who were randomized 2:1 to receive carboplatin taxol neoadjuvant therapy with or without nivolumab before and after surgery. The pathological complete response rates overall were 36% versus 7%, favoring the nivolumab arm, but even higher pCR rates occurred in patients with PD-L1 over 50%.

In closing, always check MMR, KRAS, BRAF, and HER2. For wild-type left-sided mCRC, consider FOLFOX or FOLFIRI with an anti-EGFR. For KRAS mutant or right-sided colon tumor, consider FOLFOX or FOLFIRI with bevacizumab, followed by maintenance 5FU or capecitabine, with or without bevacizumab.

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

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

Key clinical point: In estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) neoadjuvant chemotherapy (NAC) should be considered to enable axillary conservation in patients aged <50 years with Ki67 ≥20%.

Major finding: Both Ki67 ≥20% (adjusted odds ratio [aOR] 2.60; P = .04) and age <50 years (aOR 2.44; P = .01) were significant independent predictors of nodal pathological complete response (pCR). Younger patients (<50 years) had a higher nodal pCR when Ki67 index was ≥20% vs. <20% (35.8% vs. 14.3%; P = .02), whereas older patients (≥50 years) had an extremely low nodal pCR when Ki67 was <20% vs. ≥20% (2.6% vs. 21%; P = .008).

Study details: This study included 315 patients with node-positive, stage I-III, ER+/HER2− BC who were treated with NAC followed by surgery.

Disclosures: This work was partly supported by the National Institutes of Health Mayo Clinic Breast SPORE grant. Dr. Goetz and Dr. Boughey declared having research collaboration and receiving grants, funding, personal fees, or consulting fees from several sources.

Source: Boughey JC et al. Neoadjuvant chemotherapy and nodal response rates in luminal breast cancer: effects of age and tumor Ki67. Ann Surg Oncol. 2022 (May 15). Doi: 10.1245/s10434-022-11871-z

Key clinical point: In estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) neoadjuvant chemotherapy (NAC) should be considered to enable axillary conservation in patients aged <50 years with Ki67 ≥20%.

Major finding: Both Ki67 ≥20% (adjusted odds ratio [aOR] 2.60; P = .04) and age <50 years (aOR 2.44; P = .01) were significant independent predictors of nodal pathological complete response (pCR). Younger patients (<50 years) had a higher nodal pCR when Ki67 index was ≥20% vs. <20% (35.8% vs. 14.3%; P = .02), whereas older patients (≥50 years) had an extremely low nodal pCR when Ki67 was <20% vs. ≥20% (2.6% vs. 21%; P = .008).

Study details: This study included 315 patients with node-positive, stage I-III, ER+/HER2− BC who were treated with NAC followed by surgery.

Disclosures: This work was partly supported by the National Institutes of Health Mayo Clinic Breast SPORE grant. Dr. Goetz and Dr. Boughey declared having research collaboration and receiving grants, funding, personal fees, or consulting fees from several sources.

Source: Boughey JC et al. Neoadjuvant chemotherapy and nodal response rates in luminal breast cancer: effects of age and tumor Ki67. Ann Surg Oncol. 2022 (May 15). Doi: 10.1245/s10434-022-11871-z

Key clinical point: In estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) neoadjuvant chemotherapy (NAC) should be considered to enable axillary conservation in patients aged <50 years with Ki67 ≥20%.

Major finding: Both Ki67 ≥20% (adjusted odds ratio [aOR] 2.60; P = .04) and age <50 years (aOR 2.44; P = .01) were significant independent predictors of nodal pathological complete response (pCR). Younger patients (<50 years) had a higher nodal pCR when Ki67 index was ≥20% vs. <20% (35.8% vs. 14.3%; P = .02), whereas older patients (≥50 years) had an extremely low nodal pCR when Ki67 was <20% vs. ≥20% (2.6% vs. 21%; P = .008).

Study details: This study included 315 patients with node-positive, stage I-III, ER+/HER2− BC who were treated with NAC followed by surgery.

Disclosures: This work was partly supported by the National Institutes of Health Mayo Clinic Breast SPORE grant. Dr. Goetz and Dr. Boughey declared having research collaboration and receiving grants, funding, personal fees, or consulting fees from several sources.

Source: Boughey JC et al. Neoadjuvant chemotherapy and nodal response rates in luminal breast cancer: effects of age and tumor Ki67. Ann Surg Oncol. 2022 (May 15). Doi: 10.1245/s10434-022-11871-z

Key clinical point: Patients with breast cancer (BC) treated with standard chemotherapy during pregnancy show comparable prognosis to young nonpregnant patients with BC, supporting chemotherapy initiation in pregnant women with BC as indicated.

Major finding: Median follow-up was 66.3 months. Disease-free survival (hazard ratio [HR] 1.024; P = .830) and overall survival (HR 1.082; P = .592) were not significantly different between pregnant and nonpregnant patients receiving chemotherapy.

Study details: Findings are from a large cohort study including 2081 nonpregnant women aged <45 years and 662 pregnant women, all of whom were diagnosed with stage I-III BC and received standard chemotherapy.

Disclosures: This study was funded by German Breast Group and other sources. Some authors declared receiving grants, honoraria, personal fees, or speaking fees from several sources.

Source: Amant F et al. Outcome of breast cancer patients treated with chemotherapy during pregnancy compared with non-pregnant controls. Eur J Cancer. 2022;170:54-63 (May 17). Doi: 10.1016/j.ejca.2022.04.014

Key clinical point: Patients with breast cancer (BC) treated with standard chemotherapy during pregnancy show comparable prognosis to young nonpregnant patients with BC, supporting chemotherapy initiation in pregnant women with BC as indicated.

Major finding: Median follow-up was 66.3 months. Disease-free survival (hazard ratio [HR] 1.024; P = .830) and overall survival (HR 1.082; P = .592) were not significantly different between pregnant and nonpregnant patients receiving chemotherapy.

Study details: Findings are from a large cohort study including 2081 nonpregnant women aged <45 years and 662 pregnant women, all of whom were diagnosed with stage I-III BC and received standard chemotherapy.

Disclosures: This study was funded by German Breast Group and other sources. Some authors declared receiving grants, honoraria, personal fees, or speaking fees from several sources.

Source: Amant F et al. Outcome of breast cancer patients treated with chemotherapy during pregnancy compared with non-pregnant controls. Eur J Cancer. 2022;170:54-63 (May 17). Doi: 10.1016/j.ejca.2022.04.014

Key clinical point: Patients with breast cancer (BC) treated with standard chemotherapy during pregnancy show comparable prognosis to young nonpregnant patients with BC, supporting chemotherapy initiation in pregnant women with BC as indicated.

Major finding: Median follow-up was 66.3 months. Disease-free survival (hazard ratio [HR] 1.024; P = .830) and overall survival (HR 1.082; P = .592) were not significantly different between pregnant and nonpregnant patients receiving chemotherapy.

Study details: Findings are from a large cohort study including 2081 nonpregnant women aged <45 years and 662 pregnant women, all of whom were diagnosed with stage I-III BC and received standard chemotherapy.

Disclosures: This study was funded by German Breast Group and other sources. Some authors declared receiving grants, honoraria, personal fees, or speaking fees from several sources.

Source: Amant F et al. Outcome of breast cancer patients treated with chemotherapy during pregnancy compared with non-pregnant controls. Eur J Cancer. 2022;170:54-63 (May 17). Doi: 10.1016/j.ejca.2022.04.014

Key clinical point: Male-origin infertility was associated with an increased risk for breast cancer (BC) in men.

Major finding: Risk for BC was significantly higher in men diagnosed with infertility (odds ratio [OR] 2.03; P = .01), those diagnosed with infertility or low sperm count (OR 2.17; P = .004), and those who had not fathered any children (OR 1.50; P < .001).

Study details: Findings are from a case-control study including 1998 men diagnosed with in situ or invasive BC at <80 years of age and 1597 matched male controls.

Disclosures: This study was supported by Breast Cancer Now, formerly Breakthrough Breast Cancer, and the John Tridgell family. The authors declared no conflicts of interest.

Source: Swerdlow AJ et al. Infertility and risk of breast cancer in men: a national case–control study in England and Wales. Breast Cancer Res. 2022;24:29 (May 17). Doi: 10.1186/s13058-022-01517-z

Key clinical point: Male-origin infertility was associated with an increased risk for breast cancer (BC) in men.

Major finding: Risk for BC was significantly higher in men diagnosed with infertility (odds ratio [OR] 2.03; P = .01), those diagnosed with infertility or low sperm count (OR 2.17; P = .004), and those who had not fathered any children (OR 1.50; P < .001).

Study details: Findings are from a case-control study including 1998 men diagnosed with in situ or invasive BC at <80 years of age and 1597 matched male controls.

Disclosures: This study was supported by Breast Cancer Now, formerly Breakthrough Breast Cancer, and the John Tridgell family. The authors declared no conflicts of interest.

Source: Swerdlow AJ et al. Infertility and risk of breast cancer in men: a national case–control study in England and Wales. Breast Cancer Res. 2022;24:29 (May 17). Doi: 10.1186/s13058-022-01517-z

Key clinical point: Male-origin infertility was associated with an increased risk for breast cancer (BC) in men.

Major finding: Risk for BC was significantly higher in men diagnosed with infertility (odds ratio [OR] 2.03; P = .01), those diagnosed with infertility or low sperm count (OR 2.17; P = .004), and those who had not fathered any children (OR 1.50; P < .001).

Study details: Findings are from a case-control study including 1998 men diagnosed with in situ or invasive BC at <80 years of age and 1597 matched male controls.

Disclosures: This study was supported by Breast Cancer Now, formerly Breakthrough Breast Cancer, and the John Tridgell family. The authors declared no conflicts of interest.

Source: Swerdlow AJ et al. Infertility and risk of breast cancer in men: a national case–control study in England and Wales. Breast Cancer Res. 2022;24:29 (May 17). Doi: 10.1186/s13058-022-01517-z

Key clinical point: Patients who received adjuvant radiotherapy for breast cancer (BC) experienced a significant reduction in radiation-induced dermatitis (RID) incidence and severity after the prophylactic use of epigallocatechin-3-gallate (EGCG) solution.

Major finding: Incidence rates of grade ≥2 RID (50.5% vs. 72.2%; P = .008), the mean RID index of patients (5.22 vs. 6.21; P < .001), and RID-related symptoms, such as pain (P = .03), burning sensation (P = .001), itching (P < .001), and tenderness (P = .002), were significantly lower in the EGCG vs. placebo group. No severe EGCG solution/placebo-related adverse events were observed.

Study details: Findings are from a double-blind, phase 2 study including 165 women with histologically confirmed BC who received postoperative radiotherapy and were randomly assigned to receive EGCG solution or placebo.

Disclosures: Z Zhou, J Yu, and H Zhao received funding from the National Natural Science Foundation of China, Jinan Science and Technology Plan Project, and other sources. The authors declared no conflicts of interest.

Source: Zhao H et al. Efficacy of epigallocatechin-3-gallate in preventing dermatitis in patients with breast cancer receiving postoperative radiotherapy: A double-blind, placebo-controlled, phase 2 randomized clinical trial. JAMA Dermatol. 2022 (Jun 1). Doi: 10.1001/jamadermatol.2022.1736

Key clinical point: Patients who received adjuvant radiotherapy for breast cancer (BC) experienced a significant reduction in radiation-induced dermatitis (RID) incidence and severity after the prophylactic use of epigallocatechin-3-gallate (EGCG) solution.

Major finding: Incidence rates of grade ≥2 RID (50.5% vs. 72.2%; P = .008), the mean RID index of patients (5.22 vs. 6.21; P < .001), and RID-related symptoms, such as pain (P = .03), burning sensation (P = .001), itching (P < .001), and tenderness (P = .002), were significantly lower in the EGCG vs. placebo group. No severe EGCG solution/placebo-related adverse events were observed.

Study details: Findings are from a double-blind, phase 2 study including 165 women with histologically confirmed BC who received postoperative radiotherapy and were randomly assigned to receive EGCG solution or placebo.

Disclosures: Z Zhou, J Yu, and H Zhao received funding from the National Natural Science Foundation of China, Jinan Science and Technology Plan Project, and other sources. The authors declared no conflicts of interest.

Source: Zhao H et al. Efficacy of epigallocatechin-3-gallate in preventing dermatitis in patients with breast cancer receiving postoperative radiotherapy: A double-blind, placebo-controlled, phase 2 randomized clinical trial. JAMA Dermatol. 2022 (Jun 1). Doi: 10.1001/jamadermatol.2022.1736

Key clinical point: Patients who received adjuvant radiotherapy for breast cancer (BC) experienced a significant reduction in radiation-induced dermatitis (RID) incidence and severity after the prophylactic use of epigallocatechin-3-gallate (EGCG) solution.

Major finding: Incidence rates of grade ≥2 RID (50.5% vs. 72.2%; P = .008), the mean RID index of patients (5.22 vs. 6.21; P < .001), and RID-related symptoms, such as pain (P = .03), burning sensation (P = .001), itching (P < .001), and tenderness (P = .002), were significantly lower in the EGCG vs. placebo group. No severe EGCG solution/placebo-related adverse events were observed.

Study details: Findings are from a double-blind, phase 2 study including 165 women with histologically confirmed BC who received postoperative radiotherapy and were randomly assigned to receive EGCG solution or placebo.

Disclosures: Z Zhou, J Yu, and H Zhao received funding from the National Natural Science Foundation of China, Jinan Science and Technology Plan Project, and other sources. The authors declared no conflicts of interest.

Source: Zhao H et al. Efficacy of epigallocatechin-3-gallate in preventing dermatitis in patients with breast cancer receiving postoperative radiotherapy: A double-blind, placebo-controlled, phase 2 randomized clinical trial. JAMA Dermatol. 2022 (Jun 1). Doi: 10.1001/jamadermatol.2022.1736

Key clinical point: Etirinotecan pegol failed to prolong survival compared with chemotherapy in patients with metastatic breast cancer (BC) and stable pretreated brain metastases (BM).

Major finding: The median overall survival (hazard ratio [HR] 0.90; P = .60) and median progression-free survival for non-central nervous system (CNS; HR 0.72; P = .18) or CNS (HR 0.59; P = .07) metastases were similar in the etirinotecan pegol and chemotherapy groups, with overall safety profiles of the two treatments being largely comparable.

Study details: Findings are from the phase 3 ATTAIN study including 178 patients with metastatic BC and a history of stable pretreated BM who were randomly assigned to receive etirinotecan pegol or chemotherapy.

Disclosures: This study was funded by Nektar Therapeutics. Dr. Hoch and Dr. Tagliaferri declared being employees of Nektar Therapeutics, and the other authors reported ties with several sources, including Nektar Therapeutics.

Source: Tripathy D et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: Final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022 (May 12). Doi: 10.1001/jamaoncol.2022.0514

Key clinical point: Etirinotecan pegol failed to prolong survival compared with chemotherapy in patients with metastatic breast cancer (BC) and stable pretreated brain metastases (BM).

Major finding: The median overall survival (hazard ratio [HR] 0.90; P = .60) and median progression-free survival for non-central nervous system (CNS; HR 0.72; P = .18) or CNS (HR 0.59; P = .07) metastases were similar in the etirinotecan pegol and chemotherapy groups, with overall safety profiles of the two treatments being largely comparable.

Study details: Findings are from the phase 3 ATTAIN study including 178 patients with metastatic BC and a history of stable pretreated BM who were randomly assigned to receive etirinotecan pegol or chemotherapy.

Disclosures: This study was funded by Nektar Therapeutics. Dr. Hoch and Dr. Tagliaferri declared being employees of Nektar Therapeutics, and the other authors reported ties with several sources, including Nektar Therapeutics.

Source: Tripathy D et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: Final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022 (May 12). Doi: 10.1001/jamaoncol.2022.0514

Key clinical point: Etirinotecan pegol failed to prolong survival compared with chemotherapy in patients with metastatic breast cancer (BC) and stable pretreated brain metastases (BM).

Major finding: The median overall survival (hazard ratio [HR] 0.90; P = .60) and median progression-free survival for non-central nervous system (CNS; HR 0.72; P = .18) or CNS (HR 0.59; P = .07) metastases were similar in the etirinotecan pegol and chemotherapy groups, with overall safety profiles of the two treatments being largely comparable.

Study details: Findings are from the phase 3 ATTAIN study including 178 patients with metastatic BC and a history of stable pretreated BM who were randomly assigned to receive etirinotecan pegol or chemotherapy.

Disclosures: This study was funded by Nektar Therapeutics. Dr. Hoch and Dr. Tagliaferri declared being employees of Nektar Therapeutics, and the other authors reported ties with several sources, including Nektar Therapeutics.

Source: Tripathy D et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: Final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022 (May 12). Doi: 10.1001/jamaoncol.2022.0514

Key clinical point: Adjuvant breast intensity-modulated radiotherapy (IMRT) in the prone vs. supine position was less toxic in women with large breast size and early-stage breast cancer (BC) who underwent breast-conserving surgery (BCS).

Major finding: IMRT in the supine vs. prone position was significantly associated with higher rates of desquamation anywhere in the breast and grade 3 desquamation in the overall cohort (odds ratio [OR] 1.78; P = .002, and OR 2.09; P < .001, respectively) and among women receiving extended fractionation (OR 1.92 and OR 2.76, respectively; both P < .001). The quality of life outcomes were similar between both treatment arms.

Study details: This phase 3 study included 357 women with large breast size and early-stage BC who underwent BCS and were randomly assigned to receive adjuvant IMRT in the supine or prone position.

Disclosures: This study was supported by Canadian Cancer Society. Dr. Rakovitch declared receiving grants and personal fees from some sources, and Dr. Pignol declared being employed by Accuray Inc.

Source: Vesprini D et al. Effect of supine vs prone breast radiotherapy on acute toxic effects of the skin among women with large breast size: A randomized clinical trial. JAMA Oncol. 2022 (May 26). Doi: 10.1001/jamaoncol.2022.1479

Key clinical point: Adjuvant breast intensity-modulated radiotherapy (IMRT) in the prone vs. supine position was less toxic in women with large breast size and early-stage breast cancer (BC) who underwent breast-conserving surgery (BCS).

Major finding: IMRT in the supine vs. prone position was significantly associated with higher rates of desquamation anywhere in the breast and grade 3 desquamation in the overall cohort (odds ratio [OR] 1.78; P = .002, and OR 2.09; P < .001, respectively) and among women receiving extended fractionation (OR 1.92 and OR 2.76, respectively; both P < .001). The quality of life outcomes were similar between both treatment arms.

Study details: This phase 3 study included 357 women with large breast size and early-stage BC who underwent BCS and were randomly assigned to receive adjuvant IMRT in the supine or prone position.

Disclosures: This study was supported by Canadian Cancer Society. Dr. Rakovitch declared receiving grants and personal fees from some sources, and Dr. Pignol declared being employed by Accuray Inc.

Source: Vesprini D et al. Effect of supine vs prone breast radiotherapy on acute toxic effects of the skin among women with large breast size: A randomized clinical trial. JAMA Oncol. 2022 (May 26). Doi: 10.1001/jamaoncol.2022.1479

Key clinical point: Adjuvant breast intensity-modulated radiotherapy (IMRT) in the prone vs. supine position was less toxic in women with large breast size and early-stage breast cancer (BC) who underwent breast-conserving surgery (BCS).

Major finding: IMRT in the supine vs. prone position was significantly associated with higher rates of desquamation anywhere in the breast and grade 3 desquamation in the overall cohort (odds ratio [OR] 1.78; P = .002, and OR 2.09; P < .001, respectively) and among women receiving extended fractionation (OR 1.92 and OR 2.76, respectively; both P < .001). The quality of life outcomes were similar between both treatment arms.

Study details: This phase 3 study included 357 women with large breast size and early-stage BC who underwent BCS and were randomly assigned to receive adjuvant IMRT in the supine or prone position.

Disclosures: This study was supported by Canadian Cancer Society. Dr. Rakovitch declared receiving grants and personal fees from some sources, and Dr. Pignol declared being employed by Accuray Inc.

Source: Vesprini D et al. Effect of supine vs prone breast radiotherapy on acute toxic effects of the skin among women with large breast size: A randomized clinical trial. JAMA Oncol. 2022 (May 26). Doi: 10.1001/jamaoncol.2022.1479

Key clinical point: Elacestrant significantly improved progression-free survival (PFS) compared with standard-of-care (SOC) endocrine monotherapy in previously treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) with a manageable safety.

Major finding: Elacestrant vs. SOC prolonged PFS in the overall cohort (hazard ratio [HR] 0.70; P = .002) and in patients with estrogen receptor 1 mutation (HR 0.55; P = .0005). Grade 3/4 adverse events occurred in 27.0% vs. 20.5% of patients receiving elacestrant vs. SOC therapy, respectively.

Study details: Findings are from the phase 3 EMERALD study including 477 patients with ER+/HER2− metastatic BC who progressed after the first- or second-line treatment with endocrine therapy + cyclin-dependent kinase 4/6 inhibitor and ≤1 rounds of chemotherapy treatment and were randomly assigned to receive elacestrant or SOC endocrine monotherapy.

Disclosures: This study was sponsored by Radius Health, Inc. The authors declared owning stock options or patents, receiving research funding, travel, accommodation expenses, or honoraria from, or serving as consultants, advisors, and in speakers’ bureaus for several sources, including Radius Health.

Source: Bidard FC et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Results from the randomized phase III EMERALD Trial. J Clin Oncol. 2022 (May 18). Doi: 10.1200/JCO.22.00338

Key clinical point: Elacestrant significantly improved progression-free survival (PFS) compared with standard-of-care (SOC) endocrine monotherapy in previously treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) with a manageable safety.

Major finding: Elacestrant vs. SOC prolonged PFS in the overall cohort (hazard ratio [HR] 0.70; P = .002) and in patients with estrogen receptor 1 mutation (HR 0.55; P = .0005). Grade 3/4 adverse events occurred in 27.0% vs. 20.5% of patients receiving elacestrant vs. SOC therapy, respectively.

Study details: Findings are from the phase 3 EMERALD study including 477 patients with ER+/HER2− metastatic BC who progressed after the first- or second-line treatment with endocrine therapy + cyclin-dependent kinase 4/6 inhibitor and ≤1 rounds of chemotherapy treatment and were randomly assigned to receive elacestrant or SOC endocrine monotherapy.

Disclosures: This study was sponsored by Radius Health, Inc. The authors declared owning stock options or patents, receiving research funding, travel, accommodation expenses, or honoraria from, or serving as consultants, advisors, and in speakers’ bureaus for several sources, including Radius Health.

Source: Bidard FC et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Results from the randomized phase III EMERALD Trial. J Clin Oncol. 2022 (May 18). Doi: 10.1200/JCO.22.00338

Key clinical point: Elacestrant significantly improved progression-free survival (PFS) compared with standard-of-care (SOC) endocrine monotherapy in previously treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) with a manageable safety.

Major finding: Elacestrant vs. SOC prolonged PFS in the overall cohort (hazard ratio [HR] 0.70; P = .002) and in patients with estrogen receptor 1 mutation (HR 0.55; P = .0005). Grade 3/4 adverse events occurred in 27.0% vs. 20.5% of patients receiving elacestrant vs. SOC therapy, respectively.

Study details: Findings are from the phase 3 EMERALD study including 477 patients with ER+/HER2− metastatic BC who progressed after the first- or second-line treatment with endocrine therapy + cyclin-dependent kinase 4/6 inhibitor and ≤1 rounds of chemotherapy treatment and were randomly assigned to receive elacestrant or SOC endocrine monotherapy.

Disclosures: This study was sponsored by Radius Health, Inc. The authors declared owning stock options or patents, receiving research funding, travel, accommodation expenses, or honoraria from, or serving as consultants, advisors, and in speakers’ bureaus for several sources, including Radius Health.

Source: Bidard FC et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Results from the randomized phase III EMERALD Trial. J Clin Oncol. 2022 (May 18). Doi: 10.1200/JCO.22.00338