Breast Cancer

Short-term fasting during chemotherapy enhances health-related quality of life in patients with early breast cancer, with no untoward effects, according to late-breaking research presented on day 1 of the annual meeting of the European Society for Medical Oncology.

“Strikingly,” fasting also appeared to prevent fatigue, something patients with breast cancer struggle with, Daniela A. Koppold, MD, Charité University Medicine Berlin, noted in her oral presentation.

The study adds to other evidence suggesting that fasting around chemotherapy cycles may reduce toxicity and adverse effects associated with chemotherapy.

The invited discussant, Jann Arends, MD, with Freiburg (Germany) University Medical Center, said that the findings fit “very well” with previous observations. “Short-term fasting in subjects not at risk for malnutrition is feasible, well tolerated, and appears to improve several parameters of quality of life,” Dr. Arends said.
 

Promising supportive therapy

The randomized controlled trial assessed the feasibility and impact of short-term fasting on health-related quality of life, compared with a plant-based, low-sugar diet (active comparator) in 106 women with early breast cancer.

The chemotherapy regimens in the trial included four cycles of doxorubicin or epirubicin, followed by taxane therapy. The interventions for both groups occurred about 2 days before chemotherapy plus 24 hours after each cycle ended (about 60-72 hours total).

For the fasting group, this meant about 200 kcal/day through vegetable juices and vegetable broths. In between chemotherapy sessions, both groups were advised to eat a more vegetarian-focused diet, but that was not mandatory.

Health-related quality of life assessments occurred at baseline and after each chemotherapy session (cycle four at day 7) as well as after 4 and 6 months.

The investigators assessed health-related quality of life using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) that measured the domains of physical, social/familial, emotional, and functional well-being.

At baseline, the two groups had similar FACT-G scores (fasting, 82.9 vs. plant diet, 81.9; P = .523). By day 7, the short-term–fasting group had a significantly better FACT-G score, compared with the plant-based–diet group (fasting, 78.3 vs. plant, 69.5; P = .021).

Although the two groups “started out from the same point, the fasting group had an incremental effect, which quite startled us,” Dr. Koppold told the audience. “Over the course of the chemotherapies, [fasting] had additive effects” and by cycle four of chemotherapy, the difference became statistically and clinically significant, indicating “much better” quality of life in the short-term–fasting group.

What was “even more striking,” said Dr. Koppold, was the impact fasting had on the secondary outcome of fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue).

“Short-term fasting not only had a protective effect on fatigue, compared to the control group, but the short-term–fasting group didn’t develop any clinically visible fatigue,” Dr. Koppold said. “They were in a normal range by cycle four while the control group developed fatigue as we would have expected.”

Importantly, she noted, fasting had no significant impact on weight. The study excluded women who were underweight or had a history of eating disorder or relevant psychopathology.

Summing up, Dr. Koppold said that short-term fasting represents a “promising” supportive therapy during breast cancer chemotherapy to enhance quality of life.

Commenting on the study, Rebecca Guterman, a registered dietitian at Perlmutter Cancer Center at NYU Langone Health, New York, said that it’s well known that a healthy diet plays “a key role during anticancer treatments.” Dietary changes can, for instance, help alleviate common chemotherapy side effects such as loss of appetite, nausea, fatigue, or diarrhea, she said.

These new findings support fasting for 60-72 hours around chemotherapy for some patients with breast cancer who may experience more rapid recovery and better quality of life, said Ms. Guterman.

However, she noted, the results should not be applied to patient populations outside of breast cancer or treatment regimens outside this study. And, she noted, “how the patient feels during the 60-72 hour fast also has to be considered.”

An individual’s “nutritional status must be considered. If a patient has poor appetite and loses weight between treatments, fasting should not be done before next treatment,” Ms. Guterman said.

The study was funded by a private sponsor (G. Müller, Munich, Germany) and a grant from the Günter and Regine KelmFoundation (Zurich). Dr. Koppold is a member of the steering board of ÄGHE e.V. (German-speaking Medical Association for Fasting and Nutrition); cofounder of the Academy for Integrative Fasting GbR; and consults for a mobile app on intermittent fasting (Fastic) as well as a company producing plant-based supplements (EVERYYIN). Dr. Arends has disclosed relationships with Baxter. Ms. Guterman has no relevant disclosures.

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

Short-term fasting during chemotherapy enhances health-related quality of life in patients with early breast cancer, with no untoward effects, according to late-breaking research presented on day 1 of the annual meeting of the European Society for Medical Oncology.

“Strikingly,” fasting also appeared to prevent fatigue, something patients with breast cancer struggle with, Daniela A. Koppold, MD, Charité University Medicine Berlin, noted in her oral presentation.

The study adds to other evidence suggesting that fasting around chemotherapy cycles may reduce toxicity and adverse effects associated with chemotherapy.

The invited discussant, Jann Arends, MD, with Freiburg (Germany) University Medical Center, said that the findings fit “very well” with previous observations. “Short-term fasting in subjects not at risk for malnutrition is feasible, well tolerated, and appears to improve several parameters of quality of life,” Dr. Arends said.
 

Promising supportive therapy

The randomized controlled trial assessed the feasibility and impact of short-term fasting on health-related quality of life, compared with a plant-based, low-sugar diet (active comparator) in 106 women with early breast cancer.

The chemotherapy regimens in the trial included four cycles of doxorubicin or epirubicin, followed by taxane therapy. The interventions for both groups occurred about 2 days before chemotherapy plus 24 hours after each cycle ended (about 60-72 hours total).

For the fasting group, this meant about 200 kcal/day through vegetable juices and vegetable broths. In between chemotherapy sessions, both groups were advised to eat a more vegetarian-focused diet, but that was not mandatory.

Health-related quality of life assessments occurred at baseline and after each chemotherapy session (cycle four at day 7) as well as after 4 and 6 months.

The investigators assessed health-related quality of life using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) that measured the domains of physical, social/familial, emotional, and functional well-being.

At baseline, the two groups had similar FACT-G scores (fasting, 82.9 vs. plant diet, 81.9; P = .523). By day 7, the short-term–fasting group had a significantly better FACT-G score, compared with the plant-based–diet group (fasting, 78.3 vs. plant, 69.5; P = .021).

Although the two groups “started out from the same point, the fasting group had an incremental effect, which quite startled us,” Dr. Koppold told the audience. “Over the course of the chemotherapies, [fasting] had additive effects” and by cycle four of chemotherapy, the difference became statistically and clinically significant, indicating “much better” quality of life in the short-term–fasting group.

What was “even more striking,” said Dr. Koppold, was the impact fasting had on the secondary outcome of fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue).

“Short-term fasting not only had a protective effect on fatigue, compared to the control group, but the short-term–fasting group didn’t develop any clinically visible fatigue,” Dr. Koppold said. “They were in a normal range by cycle four while the control group developed fatigue as we would have expected.”

Importantly, she noted, fasting had no significant impact on weight. The study excluded women who were underweight or had a history of eating disorder or relevant psychopathology.

Summing up, Dr. Koppold said that short-term fasting represents a “promising” supportive therapy during breast cancer chemotherapy to enhance quality of life.

Commenting on the study, Rebecca Guterman, a registered dietitian at Perlmutter Cancer Center at NYU Langone Health, New York, said that it’s well known that a healthy diet plays “a key role during anticancer treatments.” Dietary changes can, for instance, help alleviate common chemotherapy side effects such as loss of appetite, nausea, fatigue, or diarrhea, she said.

These new findings support fasting for 60-72 hours around chemotherapy for some patients with breast cancer who may experience more rapid recovery and better quality of life, said Ms. Guterman.

However, she noted, the results should not be applied to patient populations outside of breast cancer or treatment regimens outside this study. And, she noted, “how the patient feels during the 60-72 hour fast also has to be considered.”

An individual’s “nutritional status must be considered. If a patient has poor appetite and loses weight between treatments, fasting should not be done before next treatment,” Ms. Guterman said.

The study was funded by a private sponsor (G. Müller, Munich, Germany) and a grant from the Günter and Regine KelmFoundation (Zurich). Dr. Koppold is a member of the steering board of ÄGHE e.V. (German-speaking Medical Association for Fasting and Nutrition); cofounder of the Academy for Integrative Fasting GbR; and consults for a mobile app on intermittent fasting (Fastic) as well as a company producing plant-based supplements (EVERYYIN). Dr. Arends has disclosed relationships with Baxter. Ms. Guterman has no relevant disclosures.

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

Short-term fasting during chemotherapy enhances health-related quality of life in patients with early breast cancer, with no untoward effects, according to late-breaking research presented on day 1 of the annual meeting of the European Society for Medical Oncology.

“Strikingly,” fasting also appeared to prevent fatigue, something patients with breast cancer struggle with, Daniela A. Koppold, MD, Charité University Medicine Berlin, noted in her oral presentation.

The study adds to other evidence suggesting that fasting around chemotherapy cycles may reduce toxicity and adverse effects associated with chemotherapy.

The invited discussant, Jann Arends, MD, with Freiburg (Germany) University Medical Center, said that the findings fit “very well” with previous observations. “Short-term fasting in subjects not at risk for malnutrition is feasible, well tolerated, and appears to improve several parameters of quality of life,” Dr. Arends said.
 

Promising supportive therapy

The randomized controlled trial assessed the feasibility and impact of short-term fasting on health-related quality of life, compared with a plant-based, low-sugar diet (active comparator) in 106 women with early breast cancer.

The chemotherapy regimens in the trial included four cycles of doxorubicin or epirubicin, followed by taxane therapy. The interventions for both groups occurred about 2 days before chemotherapy plus 24 hours after each cycle ended (about 60-72 hours total).

For the fasting group, this meant about 200 kcal/day through vegetable juices and vegetable broths. In between chemotherapy sessions, both groups were advised to eat a more vegetarian-focused diet, but that was not mandatory.

Health-related quality of life assessments occurred at baseline and after each chemotherapy session (cycle four at day 7) as well as after 4 and 6 months.

The investigators assessed health-related quality of life using the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) that measured the domains of physical, social/familial, emotional, and functional well-being.

At baseline, the two groups had similar FACT-G scores (fasting, 82.9 vs. plant diet, 81.9; P = .523). By day 7, the short-term–fasting group had a significantly better FACT-G score, compared with the plant-based–diet group (fasting, 78.3 vs. plant, 69.5; P = .021).

Although the two groups “started out from the same point, the fasting group had an incremental effect, which quite startled us,” Dr. Koppold told the audience. “Over the course of the chemotherapies, [fasting] had additive effects” and by cycle four of chemotherapy, the difference became statistically and clinically significant, indicating “much better” quality of life in the short-term–fasting group.

What was “even more striking,” said Dr. Koppold, was the impact fasting had on the secondary outcome of fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue).

“Short-term fasting not only had a protective effect on fatigue, compared to the control group, but the short-term–fasting group didn’t develop any clinically visible fatigue,” Dr. Koppold said. “They were in a normal range by cycle four while the control group developed fatigue as we would have expected.”

Importantly, she noted, fasting had no significant impact on weight. The study excluded women who were underweight or had a history of eating disorder or relevant psychopathology.

Summing up, Dr. Koppold said that short-term fasting represents a “promising” supportive therapy during breast cancer chemotherapy to enhance quality of life.

Commenting on the study, Rebecca Guterman, a registered dietitian at Perlmutter Cancer Center at NYU Langone Health, New York, said that it’s well known that a healthy diet plays “a key role during anticancer treatments.” Dietary changes can, for instance, help alleviate common chemotherapy side effects such as loss of appetite, nausea, fatigue, or diarrhea, she said.

These new findings support fasting for 60-72 hours around chemotherapy for some patients with breast cancer who may experience more rapid recovery and better quality of life, said Ms. Guterman.

However, she noted, the results should not be applied to patient populations outside of breast cancer or treatment regimens outside this study. And, she noted, “how the patient feels during the 60-72 hour fast also has to be considered.”

An individual’s “nutritional status must be considered. If a patient has poor appetite and loses weight between treatments, fasting should not be done before next treatment,” Ms. Guterman said.

The study was funded by a private sponsor (G. Müller, Munich, Germany) and a grant from the Günter and Regine KelmFoundation (Zurich). Dr. Koppold is a member of the steering board of ÄGHE e.V. (German-speaking Medical Association for Fasting and Nutrition); cofounder of the Academy for Integrative Fasting GbR; and consults for a mobile app on intermittent fasting (Fastic) as well as a company producing plant-based supplements (EVERYYIN). Dr. Arends has disclosed relationships with Baxter. Ms. Guterman has no relevant disclosures.

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

MADRID – Five years on, the addition of the CDK4/6 inhibitor abemaciclib (Verzenio) to endocrine therapy for women with high-risk hormone receptor–positive, HER2-negative (HR+/HER2–) early breast cancer continues to show modest but clinically significant benefits, compared with endocrine therapy alone.

Results of a planned 5-year efficacy analysis of the monarchE trial showed that at a median follow-up of 4.5 years, the abemaciclib/endocrine therapy combination was associated with a 7.6% absolute improvement in invasive disease–free survival (IDFS) and 6.7% edge in distant relapse–free survival (DRFS), compared with endocrine therapy alone, reported Nadia Harbeck, MD, from the Breast Center at Ludwig Maximilians University Hospital in Munich.

“The data are consistent with a carryover effect and further support the addition of adjuvant abemaciclib to endocrine therapy for patients with hormone receptor–positive, HER2-negative, node-positive high-risk early breast cancer,” she said at the 2023 European Society for Medical Oncology Congress.
 

High recurrence risk

Although HR+/HER2– breast cancer, the most common subtype of breast cancer, is generally associated with better outcomes than other subtypes, patients with node-positive early disease are at high risk for early recurrence and need treatment intensification, Dr. Harbeck said.

The monarchE trial included two cohorts: a primary cohort consisting of patients deemed at high risk based on clinical pathological features such as the number of involved axillary nodes, grade 3 disease, and tumors 5 cm or larger, and a second cohort of patients with lower disease grade and smaller tumors but with high levels of the proliferation marker Ki-67.

A total of 5,637 patients were randomized to receive either 2 years of abemaciclib 150 mg twice daily plus endocrine therapy, or endocrine therapy alone, followed by 3-8 years of additional endocrine as clinically indicated in each study arm.

An earlier preplanned interim analysis of the phase 3 trial of more than 5,600 patients was presented at the ESMO Virtual Congress 2020, and simultaneously published in the Journal of Clinical Oncology.

As that analysis showed, at a median follow-up of 15.5 months abemaciclib plus endocrine therapy was associated with a 25% relative risk reduction in the primary endpoint of IDFS vs. endocrine therapy alone.

At the time, the findings were hailed as practice-changing and, once approved for high-risk HR+/HER2-negative early breast cancer, as the new standard of care.

In the current analysis, Dr. Harbeck and colleagues looked at 5-year outcomes from a prespecified analysis, with a data cutoff of July 3, 2023.

All patients originally assigned to abemaciclib are now off the drug, and more than 80% have been followed for a minimum of 2 year since completing therapy with the CDK4/6 inhibitor.
 

Results

At 5 years there were cumulative totals of 407 IDFS events in the combination arm, compared with 585 in the endocrine therapy alone arm, a difference that translated into a hazard ratio of 0.68 favoring abemaciclib (P < .001).

The IDFS benefit with the combination was consistent across most subgroups, including older patients, perimenopausal and postmenopausal patients, those who had received prior neoadjuvant or adjuvant chemotherapy, all tumor sizes, number of positive lymph nodes, less favorable tumor stage or grade, and order of endocrine therapy (tamoxifen or aromatase inhibitor as first drug).

As noted before, DRFS, a secondary endpoint, also favored abemaciclib, with 345 events occurring over 5 years in the combination arm, compared with 501 in the endocrine therapy arm alone. This translated into a HR with the combination of 0.68 (P < .001).

There were fewer deaths in the abemaciclib arm (208 vs. 234), but this difference was not statistically significant.

The proportions of patients with treatment-emergent adverse events and serious adverse events (SAEs) were higher in the combination arm than in the endocrine therapy alone arm in all previous analyses of the trial data.

In the current analysis, “I would say it’s reassuring to see that the SAEs reported in the follow-up period, after the study treatment had been completed, are quite similar between the endocrine therapy alone arm and the abemaciclib plus endocrine therapy arm,” Dr. Harbeck said.
 

Changing road map

Invited discussant Kevin Kalinsky, MD, MS, from the Winship Cancer Institute at Emory University, Atlanta, commented that CDK4/6 inhibitors “have changed the road map for treating hormone receptor–positive, HER2-negative disease.”

To put the monarchE results in context, he compared them with those of the NATALEE trial, in which patients were randomized to endocrine therapy with or without the CDK4/6 inhibitor ribociclib (Kisqali). That combination was previously shown to provide a significant survival advantage for women with metastatic breast cancer.

In NATALEE, which included both high-risk and intermediate-risk patients with early breast cancer, the absolute difference in 3-year IDFS rates between the combination group and endocrine monotherapy groups was 3.3%.

To determine the ultimate value of combining a CDK4/6 inhibitor with endocrine therapy in early breast cancer, longer follow-up of both trials will be necessary, Dr. Kalinsky said.

“The reason that follow-up is critical for both of these studies is that for this subtype of breast cancer, based upon data including from the Early Breast Cancer Trialists Group, we can see approximately 50% of recurrences after the first 5 years, and we think of cytotoxic chemotherapy as benefiting patients within those first 5 years. And while we think of CDK4/6 inhibitors as being cytostatic drugs, we are seeing a carryover effect in which 2 years of abemaciclib is improving outcome at the 5-year landmark,” he said.

Questions that still need to be answered include the optimal duration of CDK4/6 inhibitor therapy, whether adjuvant therapy should be resumed when there are signs of renewed proliferation, and whether there would be a benefit to restarting CDK4/6 inhibitors when metastasis occurs.

The monarchE trial was sponsored by Eli Lilly and Co. Dr. Harbeck disclosed research funding and speaker’s bureau activity for Lilly and others, and a consulting or advisory role with Gilead, Roche, Sanofi, Sandoz, and Seagen. Dr. Kalinsky disclosed a consulting or advisory role with multiple companies, not including Lilly.

MADRID – Five years on, the addition of the CDK4/6 inhibitor abemaciclib (Verzenio) to endocrine therapy for women with high-risk hormone receptor–positive, HER2-negative (HR+/HER2–) early breast cancer continues to show modest but clinically significant benefits, compared with endocrine therapy alone.

Results of a planned 5-year efficacy analysis of the monarchE trial showed that at a median follow-up of 4.5 years, the abemaciclib/endocrine therapy combination was associated with a 7.6% absolute improvement in invasive disease–free survival (IDFS) and 6.7% edge in distant relapse–free survival (DRFS), compared with endocrine therapy alone, reported Nadia Harbeck, MD, from the Breast Center at Ludwig Maximilians University Hospital in Munich.

“The data are consistent with a carryover effect and further support the addition of adjuvant abemaciclib to endocrine therapy for patients with hormone receptor–positive, HER2-negative, node-positive high-risk early breast cancer,” she said at the 2023 European Society for Medical Oncology Congress.
 

High recurrence risk

Although HR+/HER2– breast cancer, the most common subtype of breast cancer, is generally associated with better outcomes than other subtypes, patients with node-positive early disease are at high risk for early recurrence and need treatment intensification, Dr. Harbeck said.

The monarchE trial included two cohorts: a primary cohort consisting of patients deemed at high risk based on clinical pathological features such as the number of involved axillary nodes, grade 3 disease, and tumors 5 cm or larger, and a second cohort of patients with lower disease grade and smaller tumors but with high levels of the proliferation marker Ki-67.

A total of 5,637 patients were randomized to receive either 2 years of abemaciclib 150 mg twice daily plus endocrine therapy, or endocrine therapy alone, followed by 3-8 years of additional endocrine as clinically indicated in each study arm.

An earlier preplanned interim analysis of the phase 3 trial of more than 5,600 patients was presented at the ESMO Virtual Congress 2020, and simultaneously published in the Journal of Clinical Oncology.

As that analysis showed, at a median follow-up of 15.5 months abemaciclib plus endocrine therapy was associated with a 25% relative risk reduction in the primary endpoint of IDFS vs. endocrine therapy alone.

At the time, the findings were hailed as practice-changing and, once approved for high-risk HR+/HER2-negative early breast cancer, as the new standard of care.

In the current analysis, Dr. Harbeck and colleagues looked at 5-year outcomes from a prespecified analysis, with a data cutoff of July 3, 2023.

All patients originally assigned to abemaciclib are now off the drug, and more than 80% have been followed for a minimum of 2 year since completing therapy with the CDK4/6 inhibitor.
 

Results

At 5 years there were cumulative totals of 407 IDFS events in the combination arm, compared with 585 in the endocrine therapy alone arm, a difference that translated into a hazard ratio of 0.68 favoring abemaciclib (P < .001).

The IDFS benefit with the combination was consistent across most subgroups, including older patients, perimenopausal and postmenopausal patients, those who had received prior neoadjuvant or adjuvant chemotherapy, all tumor sizes, number of positive lymph nodes, less favorable tumor stage or grade, and order of endocrine therapy (tamoxifen or aromatase inhibitor as first drug).

As noted before, DRFS, a secondary endpoint, also favored abemaciclib, with 345 events occurring over 5 years in the combination arm, compared with 501 in the endocrine therapy arm alone. This translated into a HR with the combination of 0.68 (P < .001).

There were fewer deaths in the abemaciclib arm (208 vs. 234), but this difference was not statistically significant.

The proportions of patients with treatment-emergent adverse events and serious adverse events (SAEs) were higher in the combination arm than in the endocrine therapy alone arm in all previous analyses of the trial data.

In the current analysis, “I would say it’s reassuring to see that the SAEs reported in the follow-up period, after the study treatment had been completed, are quite similar between the endocrine therapy alone arm and the abemaciclib plus endocrine therapy arm,” Dr. Harbeck said.
 

Changing road map

Invited discussant Kevin Kalinsky, MD, MS, from the Winship Cancer Institute at Emory University, Atlanta, commented that CDK4/6 inhibitors “have changed the road map for treating hormone receptor–positive, HER2-negative disease.”

To put the monarchE results in context, he compared them with those of the NATALEE trial, in which patients were randomized to endocrine therapy with or without the CDK4/6 inhibitor ribociclib (Kisqali). That combination was previously shown to provide a significant survival advantage for women with metastatic breast cancer.

In NATALEE, which included both high-risk and intermediate-risk patients with early breast cancer, the absolute difference in 3-year IDFS rates between the combination group and endocrine monotherapy groups was 3.3%.

To determine the ultimate value of combining a CDK4/6 inhibitor with endocrine therapy in early breast cancer, longer follow-up of both trials will be necessary, Dr. Kalinsky said.

“The reason that follow-up is critical for both of these studies is that for this subtype of breast cancer, based upon data including from the Early Breast Cancer Trialists Group, we can see approximately 50% of recurrences after the first 5 years, and we think of cytotoxic chemotherapy as benefiting patients within those first 5 years. And while we think of CDK4/6 inhibitors as being cytostatic drugs, we are seeing a carryover effect in which 2 years of abemaciclib is improving outcome at the 5-year landmark,” he said.

Questions that still need to be answered include the optimal duration of CDK4/6 inhibitor therapy, whether adjuvant therapy should be resumed when there are signs of renewed proliferation, and whether there would be a benefit to restarting CDK4/6 inhibitors when metastasis occurs.

The monarchE trial was sponsored by Eli Lilly and Co. Dr. Harbeck disclosed research funding and speaker’s bureau activity for Lilly and others, and a consulting or advisory role with Gilead, Roche, Sanofi, Sandoz, and Seagen. Dr. Kalinsky disclosed a consulting or advisory role with multiple companies, not including Lilly.

MADRID – Five years on, the addition of the CDK4/6 inhibitor abemaciclib (Verzenio) to endocrine therapy for women with high-risk hormone receptor–positive, HER2-negative (HR+/HER2–) early breast cancer continues to show modest but clinically significant benefits, compared with endocrine therapy alone.

Results of a planned 5-year efficacy analysis of the monarchE trial showed that at a median follow-up of 4.5 years, the abemaciclib/endocrine therapy combination was associated with a 7.6% absolute improvement in invasive disease–free survival (IDFS) and 6.7% edge in distant relapse–free survival (DRFS), compared with endocrine therapy alone, reported Nadia Harbeck, MD, from the Breast Center at Ludwig Maximilians University Hospital in Munich.

“The data are consistent with a carryover effect and further support the addition of adjuvant abemaciclib to endocrine therapy for patients with hormone receptor–positive, HER2-negative, node-positive high-risk early breast cancer,” she said at the 2023 European Society for Medical Oncology Congress.
 

High recurrence risk

Although HR+/HER2– breast cancer, the most common subtype of breast cancer, is generally associated with better outcomes than other subtypes, patients with node-positive early disease are at high risk for early recurrence and need treatment intensification, Dr. Harbeck said.

The monarchE trial included two cohorts: a primary cohort consisting of patients deemed at high risk based on clinical pathological features such as the number of involved axillary nodes, grade 3 disease, and tumors 5 cm or larger, and a second cohort of patients with lower disease grade and smaller tumors but with high levels of the proliferation marker Ki-67.

A total of 5,637 patients were randomized to receive either 2 years of abemaciclib 150 mg twice daily plus endocrine therapy, or endocrine therapy alone, followed by 3-8 years of additional endocrine as clinically indicated in each study arm.

An earlier preplanned interim analysis of the phase 3 trial of more than 5,600 patients was presented at the ESMO Virtual Congress 2020, and simultaneously published in the Journal of Clinical Oncology.

As that analysis showed, at a median follow-up of 15.5 months abemaciclib plus endocrine therapy was associated with a 25% relative risk reduction in the primary endpoint of IDFS vs. endocrine therapy alone.

At the time, the findings were hailed as practice-changing and, once approved for high-risk HR+/HER2-negative early breast cancer, as the new standard of care.

In the current analysis, Dr. Harbeck and colleagues looked at 5-year outcomes from a prespecified analysis, with a data cutoff of July 3, 2023.

All patients originally assigned to abemaciclib are now off the drug, and more than 80% have been followed for a minimum of 2 year since completing therapy with the CDK4/6 inhibitor.
 

Results

At 5 years there were cumulative totals of 407 IDFS events in the combination arm, compared with 585 in the endocrine therapy alone arm, a difference that translated into a hazard ratio of 0.68 favoring abemaciclib (P < .001).

The IDFS benefit with the combination was consistent across most subgroups, including older patients, perimenopausal and postmenopausal patients, those who had received prior neoadjuvant or adjuvant chemotherapy, all tumor sizes, number of positive lymph nodes, less favorable tumor stage or grade, and order of endocrine therapy (tamoxifen or aromatase inhibitor as first drug).

As noted before, DRFS, a secondary endpoint, also favored abemaciclib, with 345 events occurring over 5 years in the combination arm, compared with 501 in the endocrine therapy arm alone. This translated into a HR with the combination of 0.68 (P < .001).

There were fewer deaths in the abemaciclib arm (208 vs. 234), but this difference was not statistically significant.

The proportions of patients with treatment-emergent adverse events and serious adverse events (SAEs) were higher in the combination arm than in the endocrine therapy alone arm in all previous analyses of the trial data.

In the current analysis, “I would say it’s reassuring to see that the SAEs reported in the follow-up period, after the study treatment had been completed, are quite similar between the endocrine therapy alone arm and the abemaciclib plus endocrine therapy arm,” Dr. Harbeck said.
 

Changing road map

Invited discussant Kevin Kalinsky, MD, MS, from the Winship Cancer Institute at Emory University, Atlanta, commented that CDK4/6 inhibitors “have changed the road map for treating hormone receptor–positive, HER2-negative disease.”

To put the monarchE results in context, he compared them with those of the NATALEE trial, in which patients were randomized to endocrine therapy with or without the CDK4/6 inhibitor ribociclib (Kisqali). That combination was previously shown to provide a significant survival advantage for women with metastatic breast cancer.

In NATALEE, which included both high-risk and intermediate-risk patients with early breast cancer, the absolute difference in 3-year IDFS rates between the combination group and endocrine monotherapy groups was 3.3%.

To determine the ultimate value of combining a CDK4/6 inhibitor with endocrine therapy in early breast cancer, longer follow-up of both trials will be necessary, Dr. Kalinsky said.

“The reason that follow-up is critical for both of these studies is that for this subtype of breast cancer, based upon data including from the Early Breast Cancer Trialists Group, we can see approximately 50% of recurrences after the first 5 years, and we think of cytotoxic chemotherapy as benefiting patients within those first 5 years. And while we think of CDK4/6 inhibitors as being cytostatic drugs, we are seeing a carryover effect in which 2 years of abemaciclib is improving outcome at the 5-year landmark,” he said.

Questions that still need to be answered include the optimal duration of CDK4/6 inhibitor therapy, whether adjuvant therapy should be resumed when there are signs of renewed proliferation, and whether there would be a benefit to restarting CDK4/6 inhibitors when metastasis occurs.

The monarchE trial was sponsored by Eli Lilly and Co. Dr. Harbeck disclosed research funding and speaker’s bureau activity for Lilly and others, and a consulting or advisory role with Gilead, Roche, Sanofi, Sandoz, and Seagen. Dr. Kalinsky disclosed a consulting or advisory role with multiple companies, not including Lilly.

The Food and Drug Administration is considering banning chemicals used in hair straightening products that have been linked to cancer.

The proposal specifies that formaldehyde would be banned, as well as other chemicals that release formaldehyde, such as methylene glycol. Using hair smoothing products containing formaldehyde and formaldehyde-releasing chemicals “is linked to short-term adverse health effects, such as sensitization reactions and breathing problems, and long-term adverse health effects, including an increased risk of certain cancers,” the proposal states.

One study published last year showed that repeated use of hair straightening products, also called relaxers, could more than double the risk of uterine cancer. Although that study didn’t find that the uterine cancer risk varied based on a person’s race, the researchers noted that women who are Black are among the most likely to use the products and tend to start using them at younger ages, compared with people of other races and ethnicities.

Hair straightening products have also been linked to elevated risks of hormone-sensitive cancers, such as breast cancer and ovarian cancer.

Rep. Ayanna Pressley (D-Mass.) and Rep. Shontel Brown (D-Ohio) applauded the proposed rule in a statement issued jointly on Oct. 6. “The FDA’s proposal to ban these harmful chemicals in hair straighteners and relaxers is a win for public health – especially the health of Black women who are disproportionately put at risk by these products as a result of systemic racism and anti–Black hair sentiment,” Rep. Pressley said The two congresswomen wrote a letter to the FDA earlier this year requesting the topic be investigated.

“Regardless of how we wear our hair, we should be allowed to show up in the world without putting our health at risk. I applaud the FDA for being responsive to our calls and advancing a rule that will help prevent manufacturers from making a profit at the expense of our health,” Rep. Pressley said in the statement. “The administration should finalize this rule without delay.”



A version of this article appeared on WebMD.com

The Food and Drug Administration is considering banning chemicals used in hair straightening products that have been linked to cancer.

The proposal specifies that formaldehyde would be banned, as well as other chemicals that release formaldehyde, such as methylene glycol. Using hair smoothing products containing formaldehyde and formaldehyde-releasing chemicals “is linked to short-term adverse health effects, such as sensitization reactions and breathing problems, and long-term adverse health effects, including an increased risk of certain cancers,” the proposal states.

One study published last year showed that repeated use of hair straightening products, also called relaxers, could more than double the risk of uterine cancer. Although that study didn’t find that the uterine cancer risk varied based on a person’s race, the researchers noted that women who are Black are among the most likely to use the products and tend to start using them at younger ages, compared with people of other races and ethnicities.

Hair straightening products have also been linked to elevated risks of hormone-sensitive cancers, such as breast cancer and ovarian cancer.

Rep. Ayanna Pressley (D-Mass.) and Rep. Shontel Brown (D-Ohio) applauded the proposed rule in a statement issued jointly on Oct. 6. “The FDA’s proposal to ban these harmful chemicals in hair straighteners and relaxers is a win for public health – especially the health of Black women who are disproportionately put at risk by these products as a result of systemic racism and anti–Black hair sentiment,” Rep. Pressley said The two congresswomen wrote a letter to the FDA earlier this year requesting the topic be investigated.

“Regardless of how we wear our hair, we should be allowed to show up in the world without putting our health at risk. I applaud the FDA for being responsive to our calls and advancing a rule that will help prevent manufacturers from making a profit at the expense of our health,” Rep. Pressley said in the statement. “The administration should finalize this rule without delay.”



A version of this article appeared on WebMD.com

The Food and Drug Administration is considering banning chemicals used in hair straightening products that have been linked to cancer.

The proposal specifies that formaldehyde would be banned, as well as other chemicals that release formaldehyde, such as methylene glycol. Using hair smoothing products containing formaldehyde and formaldehyde-releasing chemicals “is linked to short-term adverse health effects, such as sensitization reactions and breathing problems, and long-term adverse health effects, including an increased risk of certain cancers,” the proposal states.

One study published last year showed that repeated use of hair straightening products, also called relaxers, could more than double the risk of uterine cancer. Although that study didn’t find that the uterine cancer risk varied based on a person’s race, the researchers noted that women who are Black are among the most likely to use the products and tend to start using them at younger ages, compared with people of other races and ethnicities.

Hair straightening products have also been linked to elevated risks of hormone-sensitive cancers, such as breast cancer and ovarian cancer.

Rep. Ayanna Pressley (D-Mass.) and Rep. Shontel Brown (D-Ohio) applauded the proposed rule in a statement issued jointly on Oct. 6. “The FDA’s proposal to ban these harmful chemicals in hair straighteners and relaxers is a win for public health – especially the health of Black women who are disproportionately put at risk by these products as a result of systemic racism and anti–Black hair sentiment,” Rep. Pressley said The two congresswomen wrote a letter to the FDA earlier this year requesting the topic be investigated.

“Regardless of how we wear our hair, we should be allowed to show up in the world without putting our health at risk. I applaud the FDA for being responsive to our calls and advancing a rule that will help prevent manufacturers from making a profit at the expense of our health,” Rep. Pressley said in the statement. “The administration should finalize this rule without delay.”



A version of this article appeared on WebMD.com

Key clinical point: The prognosis for patients with breast cancer (BC) who develop contralateral axillary lymph node metastasis (CAM) is similar to that for patients developing oligometastatic disease (OM) but is considerably worse than that for patients developing locoregional recurrence (LRR).

Major finding: The overall survival (OS) and progression-free survival (PFS) outcomes in patients with CAM were similar to those in patients with OM (P = .07 and P = .97, respectively) but were significantly worse than those in patients with LRR (hazard ratio [HR] 0.47, P = .0097; and HR 0.39, P < .0001).

Study details: Findings are from a single-center retrospective study including 299 patients with BC, of whom 29, 180, and 90 patients developed CAM, OM, and LRR respectively.

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

Source: Zhao Q et al. Contralateral axillary lymph node metastasis in breast cancer: An oligometastatic-like disease. Breast. 2023 (Oct 7). doi: 10.1016/j.breast.2023.103589

Key clinical point: The prognosis for patients with breast cancer (BC) who develop contralateral axillary lymph node metastasis (CAM) is similar to that for patients developing oligometastatic disease (OM) but is considerably worse than that for patients developing locoregional recurrence (LRR).

Major finding: The overall survival (OS) and progression-free survival (PFS) outcomes in patients with CAM were similar to those in patients with OM (P = .07 and P = .97, respectively) but were significantly worse than those in patients with LRR (hazard ratio [HR] 0.47, P = .0097; and HR 0.39, P < .0001).

Study details: Findings are from a single-center retrospective study including 299 patients with BC, of whom 29, 180, and 90 patients developed CAM, OM, and LRR respectively.

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

Source: Zhao Q et al. Contralateral axillary lymph node metastasis in breast cancer: An oligometastatic-like disease. Breast. 2023 (Oct 7). doi: 10.1016/j.breast.2023.103589

Key clinical point: The prognosis for patients with breast cancer (BC) who develop contralateral axillary lymph node metastasis (CAM) is similar to that for patients developing oligometastatic disease (OM) but is considerably worse than that for patients developing locoregional recurrence (LRR).

Major finding: The overall survival (OS) and progression-free survival (PFS) outcomes in patients with CAM were similar to those in patients with OM (P = .07 and P = .97, respectively) but were significantly worse than those in patients with LRR (hazard ratio [HR] 0.47, P = .0097; and HR 0.39, P < .0001).

Study details: Findings are from a single-center retrospective study including 299 patients with BC, of whom 29, 180, and 90 patients developed CAM, OM, and LRR respectively.

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

Source: Zhao Q et al. Contralateral axillary lymph node metastasis in breast cancer: An oligometastatic-like disease. Breast. 2023 (Oct 7). doi: 10.1016/j.breast.2023.103589

Key clinical point: The combination of oral metronomic capecitabine and pyrotinib showed acceptable efficacy and tolerable safety in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC).

Major finding: Patients receiving metronomic capecitabine + pyrotinib had an objective response rate of 34.7% and a clinical benefit rate of 81.6%, with 4.1% and 30.6% of patients achieving complete and partial responses, respectively, which lasted for ≥ 24 weeks. The most common grade 3 adverse events were hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%).

Study details: Findings are from a prospective, single-arm phase 2 trial including 49 patients with HER2+ metastatic BC who received 500 mg oral metronomic capecitabine 3 times per day and 400 mg pyrotinib per day.

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

Source: He M, Liu J, et al. Safety and efficacy study of oral metronomic capecitabine combined with pyrotinib in HER2-positive metastatic breast cancer: A phase II trial. Breast. 2023;72:105381 (Sep 19). doi: 10.1016/j.breast.2023.103581

Key clinical point: The combination of oral metronomic capecitabine and pyrotinib showed acceptable efficacy and tolerable safety in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC).

Major finding: Patients receiving metronomic capecitabine + pyrotinib had an objective response rate of 34.7% and a clinical benefit rate of 81.6%, with 4.1% and 30.6% of patients achieving complete and partial responses, respectively, which lasted for ≥ 24 weeks. The most common grade 3 adverse events were hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%).

Study details: Findings are from a prospective, single-arm phase 2 trial including 49 patients with HER2+ metastatic BC who received 500 mg oral metronomic capecitabine 3 times per day and 400 mg pyrotinib per day.

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

Source: He M, Liu J, et al. Safety and efficacy study of oral metronomic capecitabine combined with pyrotinib in HER2-positive metastatic breast cancer: A phase II trial. Breast. 2023;72:105381 (Sep 19). doi: 10.1016/j.breast.2023.103581

Key clinical point: The combination of oral metronomic capecitabine and pyrotinib showed acceptable efficacy and tolerable safety in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC).

Major finding: Patients receiving metronomic capecitabine + pyrotinib had an objective response rate of 34.7% and a clinical benefit rate of 81.6%, with 4.1% and 30.6% of patients achieving complete and partial responses, respectively, which lasted for ≥ 24 weeks. The most common grade 3 adverse events were hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%).

Study details: Findings are from a prospective, single-arm phase 2 trial including 49 patients with HER2+ metastatic BC who received 500 mg oral metronomic capecitabine 3 times per day and 400 mg pyrotinib per day.

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

Source: He M, Liu J, et al. Safety and efficacy study of oral metronomic capecitabine combined with pyrotinib in HER2-positive metastatic breast cancer: A phase II trial. Breast. 2023;72:105381 (Sep 19). doi: 10.1016/j.breast.2023.103581

Key clinical point: First-line therapy with palbociclib plus an aromatase inhibitor (AI) vs only AI improved survival outcomes in elderly patients (age ≥75 years) with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).

Major finding: Patients receiving palbociclib + AI combination therapy vs only AI had a significantly improved overall survival (hazard ratio 0.66; P = .0007), real-world progression-free survival (hazard ratio 0.72; P = .0021) and prolonged time to receiving chemotherapy (hazard ratio 0.69; P = .0014).

Study details: This sub-analysis of the retrospective observational P-REALITY X cohort study included 961 patients with HR+/HER2− metastatic BC who were age ≥ 75 years and received either palbociclib + AI (32.6%) or only AI (67.4%) as first-line therapy.

Disclosures: This study was funded by Pfizer. Four authors declared being employees and stockholders of Pfizer. The other authors declared receiving research grants, consulting or advisory fees, honoraria, or sponsorship for research from Pfizer and other sources.

Source: Brufsky A et al. Real-world treatment patterns and effectiveness of palbociclib plus an aromatase inhibitor in patients with metastatic breast cancer aged 75 years or older. Front Oncol. 2023;13:1237751 (Sep 28). doi: 10.3389/fonc.2023.1237751

Key clinical point: First-line therapy with palbociclib plus an aromatase inhibitor (AI) vs only AI improved survival outcomes in elderly patients (age ≥75 years) with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).

Major finding: Patients receiving palbociclib + AI combination therapy vs only AI had a significantly improved overall survival (hazard ratio 0.66; P = .0007), real-world progression-free survival (hazard ratio 0.72; P = .0021) and prolonged time to receiving chemotherapy (hazard ratio 0.69; P = .0014).

Study details: This sub-analysis of the retrospective observational P-REALITY X cohort study included 961 patients with HR+/HER2− metastatic BC who were age ≥ 75 years and received either palbociclib + AI (32.6%) or only AI (67.4%) as first-line therapy.

Disclosures: This study was funded by Pfizer. Four authors declared being employees and stockholders of Pfizer. The other authors declared receiving research grants, consulting or advisory fees, honoraria, or sponsorship for research from Pfizer and other sources.

Source: Brufsky A et al. Real-world treatment patterns and effectiveness of palbociclib plus an aromatase inhibitor in patients with metastatic breast cancer aged 75 years or older. Front Oncol. 2023;13:1237751 (Sep 28). doi: 10.3389/fonc.2023.1237751

Key clinical point: First-line therapy with palbociclib plus an aromatase inhibitor (AI) vs only AI improved survival outcomes in elderly patients (age ≥75 years) with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC).

Major finding: Patients receiving palbociclib + AI combination therapy vs only AI had a significantly improved overall survival (hazard ratio 0.66; P = .0007), real-world progression-free survival (hazard ratio 0.72; P = .0021) and prolonged time to receiving chemotherapy (hazard ratio 0.69; P = .0014).

Study details: This sub-analysis of the retrospective observational P-REALITY X cohort study included 961 patients with HR+/HER2− metastatic BC who were age ≥ 75 years and received either palbociclib + AI (32.6%) or only AI (67.4%) as first-line therapy.

Disclosures: This study was funded by Pfizer. Four authors declared being employees and stockholders of Pfizer. The other authors declared receiving research grants, consulting or advisory fees, honoraria, or sponsorship for research from Pfizer and other sources.

Source: Brufsky A et al. Real-world treatment patterns and effectiveness of palbociclib plus an aromatase inhibitor in patients with metastatic breast cancer aged 75 years or older. Front Oncol. 2023;13:1237751 (Sep 28). doi: 10.3389/fonc.2023.1237751

Key clinical point: Receptor profiles and the presence of extracranial visceral metastases were significant predictors of prognosis in patients with metastatic breast cancer (BC) who had brain metastases and underwent stereotactic radiosurgery (SRS).

Major finding: The median overall survival (OS) was 14.8 months for the entire cohort. OS outcomes worsened in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−) BC (hazard ratio [HR] 2.00; 95% CI 1.09-3.67) but were better in those with ER+/HER2+ BC (HR 0.43; 95% CI 0.19-0.96). The presence of extracranial visceral metastases (HR 2.90; 95% CI 1.53-5.50) was also associated with poor survival outcomes.

Study details: Findings are from a retrospective analysis of a cohort including 149 patients with metastatic breast cancer and brain metastases underwent received SRS.

Disclosures: This study was supported by Lundbeck Foundation, Copenhagen. The authors declared no conflicts of interest.

Source: Depner JF et al. Treating brain metastases in metastatic breast cancer: Outcomes after stereotactic radiosurgery examined in a retrospective, single-center cohort analysis. Acta Oncol. 2023 (Sep 26). doi: 10.1080/0284186X.2023.2260942

Key clinical point: Receptor profiles and the presence of extracranial visceral metastases were significant predictors of prognosis in patients with metastatic breast cancer (BC) who had brain metastases and underwent stereotactic radiosurgery (SRS).

Major finding: The median overall survival (OS) was 14.8 months for the entire cohort. OS outcomes worsened in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−) BC (hazard ratio [HR] 2.00; 95% CI 1.09-3.67) but were better in those with ER+/HER2+ BC (HR 0.43; 95% CI 0.19-0.96). The presence of extracranial visceral metastases (HR 2.90; 95% CI 1.53-5.50) was also associated with poor survival outcomes.

Study details: Findings are from a retrospective analysis of a cohort including 149 patients with metastatic breast cancer and brain metastases underwent received SRS.

Disclosures: This study was supported by Lundbeck Foundation, Copenhagen. The authors declared no conflicts of interest.

Source: Depner JF et al. Treating brain metastases in metastatic breast cancer: Outcomes after stereotactic radiosurgery examined in a retrospective, single-center cohort analysis. Acta Oncol. 2023 (Sep 26). doi: 10.1080/0284186X.2023.2260942

Key clinical point: Receptor profiles and the presence of extracranial visceral metastases were significant predictors of prognosis in patients with metastatic breast cancer (BC) who had brain metastases and underwent stereotactic radiosurgery (SRS).

Major finding: The median overall survival (OS) was 14.8 months for the entire cohort. OS outcomes worsened in patients with estrogen receptor-negative (ER−)/human epidermal growth factor receptor 2-negative (HER2−) BC (hazard ratio [HR] 2.00; 95% CI 1.09-3.67) but were better in those with ER+/HER2+ BC (HR 0.43; 95% CI 0.19-0.96). The presence of extracranial visceral metastases (HR 2.90; 95% CI 1.53-5.50) was also associated with poor survival outcomes.

Study details: Findings are from a retrospective analysis of a cohort including 149 patients with metastatic breast cancer and brain metastases underwent received SRS.

Disclosures: This study was supported by Lundbeck Foundation, Copenhagen. The authors declared no conflicts of interest.

Source: Depner JF et al. Treating brain metastases in metastatic breast cancer: Outcomes after stereotactic radiosurgery examined in a retrospective, single-center cohort analysis. Acta Oncol. 2023 (Sep 26). doi: 10.1080/0284186X.2023.2260942

Key clinical point: Surgical removal of the primary tumor failed to prolong survival and may not be necessary in patients with de novo metastatic breast cancer (BC).

Major finding: In women with de novo metastatic BC, primary breast tumor surgery vs no surgery improved the local progression-free survival outcomes (hazard ratio [HR] 0.37; 95% CI 0.19-0.74) but not the overall survival (HR 0.93; 95% CI 0.76-1.14).

Study details: Findings are from a meta-analysis of five randomized controlled trials including 1381 patients with de novo metastatic BC, of whom 49.6% underwent primary breast tumor surgery.

Disclosures: This study did not receive any specific funding. Three authors declared having advisory roles, serving as consultants, or receiving speaker fees, consulting fees, or unrelated research grants from various sources.

Source: Villacampa G et al. Impact of primary breast surgery on overall survival of patients with de novo metastatic breast cancer: A systematic review and meta-analysis. Oncologist. 2023 (Sep 12). doi: 10.1093/oncolo/oyad266

Key clinical point: Surgical removal of the primary tumor failed to prolong survival and may not be necessary in patients with de novo metastatic breast cancer (BC).

Major finding: In women with de novo metastatic BC, primary breast tumor surgery vs no surgery improved the local progression-free survival outcomes (hazard ratio [HR] 0.37; 95% CI 0.19-0.74) but not the overall survival (HR 0.93; 95% CI 0.76-1.14).

Study details: Findings are from a meta-analysis of five randomized controlled trials including 1381 patients with de novo metastatic BC, of whom 49.6% underwent primary breast tumor surgery.

Disclosures: This study did not receive any specific funding. Three authors declared having advisory roles, serving as consultants, or receiving speaker fees, consulting fees, or unrelated research grants from various sources.

Source: Villacampa G et al. Impact of primary breast surgery on overall survival of patients with de novo metastatic breast cancer: A systematic review and meta-analysis. Oncologist. 2023 (Sep 12). doi: 10.1093/oncolo/oyad266

Key clinical point: Surgical removal of the primary tumor failed to prolong survival and may not be necessary in patients with de novo metastatic breast cancer (BC).

Major finding: In women with de novo metastatic BC, primary breast tumor surgery vs no surgery improved the local progression-free survival outcomes (hazard ratio [HR] 0.37; 95% CI 0.19-0.74) but not the overall survival (HR 0.93; 95% CI 0.76-1.14).

Study details: Findings are from a meta-analysis of five randomized controlled trials including 1381 patients with de novo metastatic BC, of whom 49.6% underwent primary breast tumor surgery.

Disclosures: This study did not receive any specific funding. Three authors declared having advisory roles, serving as consultants, or receiving speaker fees, consulting fees, or unrelated research grants from various sources.

Source: Villacampa G et al. Impact of primary breast surgery on overall survival of patients with de novo metastatic breast cancer: A systematic review and meta-analysis. Oncologist. 2023 (Sep 12). doi: 10.1093/oncolo/oyad266

Key clinical point: Patritumab deruxtecan (HER3-DXd) showed meaningful clinical efficacy and a manageable safety profile across breast cancer (BC) subtypes in heavily pretreated patients with human epidermal growth factor receptor 3 (HER3)-expressing metastatic BC.

Major finding: The objective response rate was 30.1% (95% CI 21.8%-39.4%) in hormone receptor-positive/HER2-negative BC, 22.6% (95% CI 12.3%-36.2%) in triple-negative BC, and 42.9% (95% CI 17.1%-71.1%) in HER2-positive BC. Although 71.4% of patients reported grade ≥3 treatment-emergent adverse events (TEAE), the overall rate of treatment discontinuation due to TEAE was low (9.9%).

Study details: Findings are from a phase I/II trial including 182 heavily pretreated patients with HER3-expressing advanced BC who received HER3-DXd.

Disclosures: This trial was sponsored by Daiichi Sankyo Co., Ltd. Nine authors declared being employees of or holding stocks and other ownership interests in Daiichi Sankyo. The other authors declared ties with various sources, including Daiichi Sankyo.

Source: Krop IE et al. Patritumab deruxtecan (HER3-DXd), a human epidermal growth factor receptor 3-directed antibody-drug conjugate, in patients with previously treated human epidermal growth factor receptor 3-expressing metastatic breast cancer: A multicenter, phase I/II trial. J Clin Oncol. 2023 (Oct 6). doi: 10.1200/JCO.23.00882

Key clinical point: Patritumab deruxtecan (HER3-DXd) showed meaningful clinical efficacy and a manageable safety profile across breast cancer (BC) subtypes in heavily pretreated patients with human epidermal growth factor receptor 3 (HER3)-expressing metastatic BC.

Major finding: The objective response rate was 30.1% (95% CI 21.8%-39.4%) in hormone receptor-positive/HER2-negative BC, 22.6% (95% CI 12.3%-36.2%) in triple-negative BC, and 42.9% (95% CI 17.1%-71.1%) in HER2-positive BC. Although 71.4% of patients reported grade ≥3 treatment-emergent adverse events (TEAE), the overall rate of treatment discontinuation due to TEAE was low (9.9%).

Study details: Findings are from a phase I/II trial including 182 heavily pretreated patients with HER3-expressing advanced BC who received HER3-DXd.

Disclosures: This trial was sponsored by Daiichi Sankyo Co., Ltd. Nine authors declared being employees of or holding stocks and other ownership interests in Daiichi Sankyo. The other authors declared ties with various sources, including Daiichi Sankyo.

Source: Krop IE et al. Patritumab deruxtecan (HER3-DXd), a human epidermal growth factor receptor 3-directed antibody-drug conjugate, in patients with previously treated human epidermal growth factor receptor 3-expressing metastatic breast cancer: A multicenter, phase I/II trial. J Clin Oncol. 2023 (Oct 6). doi: 10.1200/JCO.23.00882

Key clinical point: Patritumab deruxtecan (HER3-DXd) showed meaningful clinical efficacy and a manageable safety profile across breast cancer (BC) subtypes in heavily pretreated patients with human epidermal growth factor receptor 3 (HER3)-expressing metastatic BC.

Major finding: The objective response rate was 30.1% (95% CI 21.8%-39.4%) in hormone receptor-positive/HER2-negative BC, 22.6% (95% CI 12.3%-36.2%) in triple-negative BC, and 42.9% (95% CI 17.1%-71.1%) in HER2-positive BC. Although 71.4% of patients reported grade ≥3 treatment-emergent adverse events (TEAE), the overall rate of treatment discontinuation due to TEAE was low (9.9%).

Study details: Findings are from a phase I/II trial including 182 heavily pretreated patients with HER3-expressing advanced BC who received HER3-DXd.

Disclosures: This trial was sponsored by Daiichi Sankyo Co., Ltd. Nine authors declared being employees of or holding stocks and other ownership interests in Daiichi Sankyo. The other authors declared ties with various sources, including Daiichi Sankyo.

Source: Krop IE et al. Patritumab deruxtecan (HER3-DXd), a human epidermal growth factor receptor 3-directed antibody-drug conjugate, in patients with previously treated human epidermal growth factor receptor 3-expressing metastatic breast cancer: A multicenter, phase I/II trial. J Clin Oncol. 2023 (Oct 6). doi: 10.1200/JCO.23.00882

Key clinical point: Neoadjuvant chemotherapy (NAC) may increase the odds of a pathological complete response (pCR) in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) and BRCA1 mutation vs in those with sporadic BC.

Major finding: The rate of achieving a pCR was significantly higher in BRCA1/2 and BRCA1 mutation carriers vs non-carriers (16% and 38%, respectively, vs 7.8%; P < .001), with BRCA1 mutation carrier vs non-carrier status being associated with higher odds of achieving a pCR (odds ratio 6.31; P = .002).

Study details: Findings are from a retrospective study including 522 patients with HR+/HER2− BC who received NAC, of whom 21 and 38 patients had BRCA1 and BRCA2 mutations, respectively.

Disclosures: This study was partly supported by a  US National Institutes of Health/National Cancer Institute Cancer Center Support grant. The authors declared no conflicts of interest.

Source: Myers SP et al. Mutational status is associated with a higher rate of pathologic complete response after neoadjuvant chemotherapy in hormone receptor-positive breast cancer. Ann Surg Oncol. 2023 (Oct 5). doi: 10.1245/s10434-023-14319-0

Key clinical point: Neoadjuvant chemotherapy (NAC) may increase the odds of a pathological complete response (pCR) in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) and BRCA1 mutation vs in those with sporadic BC.

Major finding: The rate of achieving a pCR was significantly higher in BRCA1/2 and BRCA1 mutation carriers vs non-carriers (16% and 38%, respectively, vs 7.8%; P < .001), with BRCA1 mutation carrier vs non-carrier status being associated with higher odds of achieving a pCR (odds ratio 6.31; P = .002).

Study details: Findings are from a retrospective study including 522 patients with HR+/HER2− BC who received NAC, of whom 21 and 38 patients had BRCA1 and BRCA2 mutations, respectively.

Disclosures: This study was partly supported by a  US National Institutes of Health/National Cancer Institute Cancer Center Support grant. The authors declared no conflicts of interest.

Source: Myers SP et al. Mutational status is associated with a higher rate of pathologic complete response after neoadjuvant chemotherapy in hormone receptor-positive breast cancer. Ann Surg Oncol. 2023 (Oct 5). doi: 10.1245/s10434-023-14319-0

Key clinical point: Neoadjuvant chemotherapy (NAC) may increase the odds of a pathological complete response (pCR) in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) and BRCA1 mutation vs in those with sporadic BC.

Major finding: The rate of achieving a pCR was significantly higher in BRCA1/2 and BRCA1 mutation carriers vs non-carriers (16% and 38%, respectively, vs 7.8%; P < .001), with BRCA1 mutation carrier vs non-carrier status being associated with higher odds of achieving a pCR (odds ratio 6.31; P = .002).

Study details: Findings are from a retrospective study including 522 patients with HR+/HER2− BC who received NAC, of whom 21 and 38 patients had BRCA1 and BRCA2 mutations, respectively.

Disclosures: This study was partly supported by a  US National Institutes of Health/National Cancer Institute Cancer Center Support grant. The authors declared no conflicts of interest.

Source: Myers SP et al. Mutational status is associated with a higher rate of pathologic complete response after neoadjuvant chemotherapy in hormone receptor-positive breast cancer. Ann Surg Oncol. 2023 (Oct 5). doi: 10.1245/s10434-023-14319-0