Breast Cancer

Breast cancer treatments have made great strides in recent years with significant reductions in overall mortality. However, the incidence of breast cancer has increased just slightly in recent years after a dip in the early 2000s.

“The good news is that mortality is decreasing, but it still remains high. We still have a long way to go to tackle this problem of breast cancer incidence as well as the number of deaths,” said Angela DeMichele, MD, co-leader of the breast cancer research program at the University of Pennsylvania’s Abramson Cancer Center. She participated in a session on obstacles in breast cancer treatment held in December at the San Antonio Breast Cancer Symposium. She joined other oncologists in outlining key challenges that need to be addressed to improve breast cancer diagnosis and treatment.

They highlighted six obstacles: The need for more prevention/early detection strategies; the underutilization of artificial intelligence; underuse of precision oncology such as targeted therapies; the need for innovation in clinical trials; a widening gap in cancer disparities; and the need to align incentives and funding for research collaboration, training, and retention.

Since 2012, the Food and Drug Administration has approved 20 new therapeutics to treat breast cancer. Nadia Harbeck, MD, PhD, director of the breast center at LMU University Hospital, Munich, said that the development of new therapies has in a way become a victim of its own success. Therapies and survival have improved, making it harder to compare novel therapies to the standard of care and prove a benefit. Treatment guidelines are changing so quickly that clinical trials are sometimes obsolete by the time they are published because of changes to the standard of care. That places a need on more real-world evidence that can be designed to be useful in the clinic, and AI can help here. “We need to convince regulators to act upon cleverly planned real world evidence analysis. You can randomize them, you can use registries, and you should also be able to change labels because of [new] data,” Dr. Harbeck said.

There are many risk factors that drive breast cancer, and it is very heterogeneous, said Christine Ambrosone, PhD, chair of the department of cancer prevention and control at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y. She called for identifying patients who are at risk for a poor prognosis, such as patients with hormone receptor–negative breast cancer, high-grade, and triple-negative breast cancer. Otherwise there is a risk of overtreatment of low-risk tumors, which could potentially be identified with new tools in precision oncology such as liquid biopsy tests, also known as multicancer early detection tests. These tests can detect cancers long before they become symptomatic. The first such test was launched this year and many more are in clinical trials.

Regina Barzilay, PhD, professor and expert in the use of artificial intelligence in health at the Massachusetts Institute of Technology, pointed out that machine learning is used in many fields, but hardly at all in breast cancer. It could be applied to data on biomarkers and other factors collected from retrospective analyses and clinical trials. She added that machine learning is often applied to biochemistry and single cell analysis of other tumor types, but rarely in breast cancer. “It is severely underutilized,” Dr. Barzilay said. One challenge is that researchers are not necessarily familiar with the techniques of machine learning and AI. Another issue is that breast cancer data are not easy to share and may not be readily available to AI researchers. “An investment in interchangeable data is crucially important,” she said.

Artificial intelligence could assist in identifying and modeling factors that contribute to cancer risk by teasing apart complicated relationships, such as the association between pregnancy, breastfeeding, and breast cancer risk. Pregnancy reduces the risk of hormone receptor–positive disease, but increases the risk of hormone receptor–negative disease.

Another key challenge is the underuse of “omics” technologies, which measure large scale patterns in biological characteristics such as gene variation or protein expression. That has roots in the history of breast cancer being considered as a separate entity from other solid tumors such as lung or pancreatic cancer. Fabrice André, MD, PhD, an oncologist with Gustave Roussy Cancer Center, France, emphasized that breast cancer shouldn’t be considered an entity when it’s metastatic. Instead, tumors should be defined by molecular characteristics they share. He anticipates a personalized medicine future where academic and industry groups collaborate to create an individualized therapy for patients based on genetic factors.
 

Access to therapies for all patients

Novel and effective therapies can make a difference only if patients have access to them, and a key obstacle to improving breast cancer care is racism and inequities in health care. “We have to acknowledge that there is racism in medicine. I think once we acknowledge that, then we can look at things in our practices that we need to change. We can think very broadly and look at things that perhaps disadvantage one population over another,” said Lori Pierce, MD, a radiation oncologist with the University of Michigan, Ann Arbor.

Dr. Pierce also emphasized the need to recruit more underrepresented groups to participate in clinical trials. For example, of six breast cancer clinical trials – for margetuximab (Margenza), sacituzumab govitecan (Trodelvy), tucatinib (Tukysa), trastuzumab deruxtecan (Enhertu), alpelisib (Piqray), and talazoparib (Talzenna), only a small percentage included Black, Asian, and Hispanic women. For trastuzumab deruxtecan, which is widely recognized as a best-in-class HER2-targeting antibody drug conjugate, 51% were White, 42% Asian, 6% Hispanic, and 3% Black. For sacituzumab govitecan, a blockbuster drug for triple-negative breast cancer (TNBC), an aggressive subtype of breast cancer that disproportionately affects Black women, only 7% of women enrolled in clinical trials were Black. In clinical trials for margetuximab, approved to treat HER2-positive breast cancer, 80% of participants were White, 5% Black, 6% Asian, and 9% Hispanic.

There is a perception that minorities may be unwilling to participate in clinical trials, but that’s not true, according to Patty Spears, a research manager of the Patient Advocates for Research Council at the University of North Carolina. “We know that there are data that clearly show that patients will go on clinical trials at the same rate, whether they’re Black, White, Asian, or whatever. You have to be able to have them in your system and ask them to go on trial,” she said.

Another panelist told a personal anecdote to illustrate the point. Matthew Ellis, MD, PhD, recalled that he spent 13 years at Washington University in St. Louis, serving one of the more segregated cities in the United States. The city hospital closed, and Washington University and the Siteman Cancer Center signed a contract to treat the underserved population that was suddenly without a source of care. “Subsequent to that, we over-accrued relative to the population of African American patients. What that taught me is it’s nothing to do with the lack of willingness of African Americans to participate in clinical trials. Quite the opposite. It’s the question of access to clinical trials, access to great care, and not creating health care systems that segregate patients into places where they’re not getting access,” he said.

Breast cancer treatments have made great strides in recent years with significant reductions in overall mortality. However, the incidence of breast cancer has increased just slightly in recent years after a dip in the early 2000s.

“The good news is that mortality is decreasing, but it still remains high. We still have a long way to go to tackle this problem of breast cancer incidence as well as the number of deaths,” said Angela DeMichele, MD, co-leader of the breast cancer research program at the University of Pennsylvania’s Abramson Cancer Center. She participated in a session on obstacles in breast cancer treatment held in December at the San Antonio Breast Cancer Symposium. She joined other oncologists in outlining key challenges that need to be addressed to improve breast cancer diagnosis and treatment.

They highlighted six obstacles: The need for more prevention/early detection strategies; the underutilization of artificial intelligence; underuse of precision oncology such as targeted therapies; the need for innovation in clinical trials; a widening gap in cancer disparities; and the need to align incentives and funding for research collaboration, training, and retention.

Since 2012, the Food and Drug Administration has approved 20 new therapeutics to treat breast cancer. Nadia Harbeck, MD, PhD, director of the breast center at LMU University Hospital, Munich, said that the development of new therapies has in a way become a victim of its own success. Therapies and survival have improved, making it harder to compare novel therapies to the standard of care and prove a benefit. Treatment guidelines are changing so quickly that clinical trials are sometimes obsolete by the time they are published because of changes to the standard of care. That places a need on more real-world evidence that can be designed to be useful in the clinic, and AI can help here. “We need to convince regulators to act upon cleverly planned real world evidence analysis. You can randomize them, you can use registries, and you should also be able to change labels because of [new] data,” Dr. Harbeck said.

There are many risk factors that drive breast cancer, and it is very heterogeneous, said Christine Ambrosone, PhD, chair of the department of cancer prevention and control at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y. She called for identifying patients who are at risk for a poor prognosis, such as patients with hormone receptor–negative breast cancer, high-grade, and triple-negative breast cancer. Otherwise there is a risk of overtreatment of low-risk tumors, which could potentially be identified with new tools in precision oncology such as liquid biopsy tests, also known as multicancer early detection tests. These tests can detect cancers long before they become symptomatic. The first such test was launched this year and many more are in clinical trials.

Regina Barzilay, PhD, professor and expert in the use of artificial intelligence in health at the Massachusetts Institute of Technology, pointed out that machine learning is used in many fields, but hardly at all in breast cancer. It could be applied to data on biomarkers and other factors collected from retrospective analyses and clinical trials. She added that machine learning is often applied to biochemistry and single cell analysis of other tumor types, but rarely in breast cancer. “It is severely underutilized,” Dr. Barzilay said. One challenge is that researchers are not necessarily familiar with the techniques of machine learning and AI. Another issue is that breast cancer data are not easy to share and may not be readily available to AI researchers. “An investment in interchangeable data is crucially important,” she said.

Artificial intelligence could assist in identifying and modeling factors that contribute to cancer risk by teasing apart complicated relationships, such as the association between pregnancy, breastfeeding, and breast cancer risk. Pregnancy reduces the risk of hormone receptor–positive disease, but increases the risk of hormone receptor–negative disease.

Another key challenge is the underuse of “omics” technologies, which measure large scale patterns in biological characteristics such as gene variation or protein expression. That has roots in the history of breast cancer being considered as a separate entity from other solid tumors such as lung or pancreatic cancer. Fabrice André, MD, PhD, an oncologist with Gustave Roussy Cancer Center, France, emphasized that breast cancer shouldn’t be considered an entity when it’s metastatic. Instead, tumors should be defined by molecular characteristics they share. He anticipates a personalized medicine future where academic and industry groups collaborate to create an individualized therapy for patients based on genetic factors.
 

Access to therapies for all patients

Novel and effective therapies can make a difference only if patients have access to them, and a key obstacle to improving breast cancer care is racism and inequities in health care. “We have to acknowledge that there is racism in medicine. I think once we acknowledge that, then we can look at things in our practices that we need to change. We can think very broadly and look at things that perhaps disadvantage one population over another,” said Lori Pierce, MD, a radiation oncologist with the University of Michigan, Ann Arbor.

Dr. Pierce also emphasized the need to recruit more underrepresented groups to participate in clinical trials. For example, of six breast cancer clinical trials – for margetuximab (Margenza), sacituzumab govitecan (Trodelvy), tucatinib (Tukysa), trastuzumab deruxtecan (Enhertu), alpelisib (Piqray), and talazoparib (Talzenna), only a small percentage included Black, Asian, and Hispanic women. For trastuzumab deruxtecan, which is widely recognized as a best-in-class HER2-targeting antibody drug conjugate, 51% were White, 42% Asian, 6% Hispanic, and 3% Black. For sacituzumab govitecan, a blockbuster drug for triple-negative breast cancer (TNBC), an aggressive subtype of breast cancer that disproportionately affects Black women, only 7% of women enrolled in clinical trials were Black. In clinical trials for margetuximab, approved to treat HER2-positive breast cancer, 80% of participants were White, 5% Black, 6% Asian, and 9% Hispanic.

There is a perception that minorities may be unwilling to participate in clinical trials, but that’s not true, according to Patty Spears, a research manager of the Patient Advocates for Research Council at the University of North Carolina. “We know that there are data that clearly show that patients will go on clinical trials at the same rate, whether they’re Black, White, Asian, or whatever. You have to be able to have them in your system and ask them to go on trial,” she said.

Another panelist told a personal anecdote to illustrate the point. Matthew Ellis, MD, PhD, recalled that he spent 13 years at Washington University in St. Louis, serving one of the more segregated cities in the United States. The city hospital closed, and Washington University and the Siteman Cancer Center signed a contract to treat the underserved population that was suddenly without a source of care. “Subsequent to that, we over-accrued relative to the population of African American patients. What that taught me is it’s nothing to do with the lack of willingness of African Americans to participate in clinical trials. Quite the opposite. It’s the question of access to clinical trials, access to great care, and not creating health care systems that segregate patients into places where they’re not getting access,” he said.

Breast cancer treatments have made great strides in recent years with significant reductions in overall mortality. However, the incidence of breast cancer has increased just slightly in recent years after a dip in the early 2000s.

“The good news is that mortality is decreasing, but it still remains high. We still have a long way to go to tackle this problem of breast cancer incidence as well as the number of deaths,” said Angela DeMichele, MD, co-leader of the breast cancer research program at the University of Pennsylvania’s Abramson Cancer Center. She participated in a session on obstacles in breast cancer treatment held in December at the San Antonio Breast Cancer Symposium. She joined other oncologists in outlining key challenges that need to be addressed to improve breast cancer diagnosis and treatment.

They highlighted six obstacles: The need for more prevention/early detection strategies; the underutilization of artificial intelligence; underuse of precision oncology such as targeted therapies; the need for innovation in clinical trials; a widening gap in cancer disparities; and the need to align incentives and funding for research collaboration, training, and retention.

Since 2012, the Food and Drug Administration has approved 20 new therapeutics to treat breast cancer. Nadia Harbeck, MD, PhD, director of the breast center at LMU University Hospital, Munich, said that the development of new therapies has in a way become a victim of its own success. Therapies and survival have improved, making it harder to compare novel therapies to the standard of care and prove a benefit. Treatment guidelines are changing so quickly that clinical trials are sometimes obsolete by the time they are published because of changes to the standard of care. That places a need on more real-world evidence that can be designed to be useful in the clinic, and AI can help here. “We need to convince regulators to act upon cleverly planned real world evidence analysis. You can randomize them, you can use registries, and you should also be able to change labels because of [new] data,” Dr. Harbeck said.

There are many risk factors that drive breast cancer, and it is very heterogeneous, said Christine Ambrosone, PhD, chair of the department of cancer prevention and control at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y. She called for identifying patients who are at risk for a poor prognosis, such as patients with hormone receptor–negative breast cancer, high-grade, and triple-negative breast cancer. Otherwise there is a risk of overtreatment of low-risk tumors, which could potentially be identified with new tools in precision oncology such as liquid biopsy tests, also known as multicancer early detection tests. These tests can detect cancers long before they become symptomatic. The first such test was launched this year and many more are in clinical trials.

Regina Barzilay, PhD, professor and expert in the use of artificial intelligence in health at the Massachusetts Institute of Technology, pointed out that machine learning is used in many fields, but hardly at all in breast cancer. It could be applied to data on biomarkers and other factors collected from retrospective analyses and clinical trials. She added that machine learning is often applied to biochemistry and single cell analysis of other tumor types, but rarely in breast cancer. “It is severely underutilized,” Dr. Barzilay said. One challenge is that researchers are not necessarily familiar with the techniques of machine learning and AI. Another issue is that breast cancer data are not easy to share and may not be readily available to AI researchers. “An investment in interchangeable data is crucially important,” she said.

Artificial intelligence could assist in identifying and modeling factors that contribute to cancer risk by teasing apart complicated relationships, such as the association between pregnancy, breastfeeding, and breast cancer risk. Pregnancy reduces the risk of hormone receptor–positive disease, but increases the risk of hormone receptor–negative disease.

Another key challenge is the underuse of “omics” technologies, which measure large scale patterns in biological characteristics such as gene variation or protein expression. That has roots in the history of breast cancer being considered as a separate entity from other solid tumors such as lung or pancreatic cancer. Fabrice André, MD, PhD, an oncologist with Gustave Roussy Cancer Center, France, emphasized that breast cancer shouldn’t be considered an entity when it’s metastatic. Instead, tumors should be defined by molecular characteristics they share. He anticipates a personalized medicine future where academic and industry groups collaborate to create an individualized therapy for patients based on genetic factors.
 

Access to therapies for all patients

Novel and effective therapies can make a difference only if patients have access to them, and a key obstacle to improving breast cancer care is racism and inequities in health care. “We have to acknowledge that there is racism in medicine. I think once we acknowledge that, then we can look at things in our practices that we need to change. We can think very broadly and look at things that perhaps disadvantage one population over another,” said Lori Pierce, MD, a radiation oncologist with the University of Michigan, Ann Arbor.

Dr. Pierce also emphasized the need to recruit more underrepresented groups to participate in clinical trials. For example, of six breast cancer clinical trials – for margetuximab (Margenza), sacituzumab govitecan (Trodelvy), tucatinib (Tukysa), trastuzumab deruxtecan (Enhertu), alpelisib (Piqray), and talazoparib (Talzenna), only a small percentage included Black, Asian, and Hispanic women. For trastuzumab deruxtecan, which is widely recognized as a best-in-class HER2-targeting antibody drug conjugate, 51% were White, 42% Asian, 6% Hispanic, and 3% Black. For sacituzumab govitecan, a blockbuster drug for triple-negative breast cancer (TNBC), an aggressive subtype of breast cancer that disproportionately affects Black women, only 7% of women enrolled in clinical trials were Black. In clinical trials for margetuximab, approved to treat HER2-positive breast cancer, 80% of participants were White, 5% Black, 6% Asian, and 9% Hispanic.

There is a perception that minorities may be unwilling to participate in clinical trials, but that’s not true, according to Patty Spears, a research manager of the Patient Advocates for Research Council at the University of North Carolina. “We know that there are data that clearly show that patients will go on clinical trials at the same rate, whether they’re Black, White, Asian, or whatever. You have to be able to have them in your system and ask them to go on trial,” she said.

Another panelist told a personal anecdote to illustrate the point. Matthew Ellis, MD, PhD, recalled that he spent 13 years at Washington University in St. Louis, serving one of the more segregated cities in the United States. The city hospital closed, and Washington University and the Siteman Cancer Center signed a contract to treat the underserved population that was suddenly without a source of care. “Subsequent to that, we over-accrued relative to the population of African American patients. What that taught me is it’s nothing to do with the lack of willingness of African Americans to participate in clinical trials. Quite the opposite. It’s the question of access to clinical trials, access to great care, and not creating health care systems that segregate patients into places where they’re not getting access,” he said.

The risk for disease recurrence, and specifically distant relapse, for women with high-risk early breast cancer highlights the need for novel therapies in this population.^2,3 The phase 3 randomized monarchE trial investigated the role of the CDK4/6 inhibitor abemaciclib combined with endocrine therapy vs standard endocrine therapy alone in 5637 patients with high-risk (≥ 4 positive axillary nodes or 1-3 positive nodes and either grade 3 tumor, tumor size ≥ 5 cm or Ki-67 ≥ 20%) hormone receptor–positive/HER2-negative early breast cancer. At a median follow-up of 42 months, the median invasive disease-free survival (iDFS) benefit was sustained with abemaciclib + endocrine therapy vs endocrine therapy alone (HR 0.664; nominal P < .0001); the absolute 4-year iDFS benefit was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group). Furthermore, this effect appeared to deepen over time, as the previous absolute iDFS differences were 2.8% (2 years) and 4.8% (3 years). Abemaciclib was associated with a higher rate of grade 3 or higher adverse events (49.9% vs 16.9%), the most common being neutropenia, leukopenia, and diarrhea (Johnston et al). Although adjuvant palbociclib trials (PALLAS⁴ and PENELOPE-B⁵) did not meet their primary endpoint, longer follow-up of monarchE and results from NATALEE with ribociclib are anxiously awaited to further define the role of CDK4/6 inhibitors in this space.

Aromatase inhibitors (AI) are an integral component of treatment for hormone receptor–positive breast cancer for many women. However, joint pain and stiffness associated with these agents can affect compliance. Various management strategies, including trials of alternative AI or endocrine therapies and pharmacologic (duloxetine) and non-pharmacologic (acupuncture,⁶ exercise) modalities, have been investigated. A randomized trial including 226 women with early-stage breast cancer receiving AI therapy with baseline joint pain (Brief Pain Inventory Worst Pain [BPI-WP] item score of ≥ 3) evaluated whether true acupuncture (TA) provided a sustained reduction in pain symptoms compared with sham acupuncture (SA) or waiting-list control (WC). Acupuncture protocols consisted of 6 weeks of intervention (2 sessions per week) followed by 1 session per week for another 6 weeks. At 52 weeks, mean BPI-WP scores were 1.08 points lower in the TA group compared with the SA group (P = .01) and were 0.99 points lower in the TA group compared with the WC group (P = .03) (Hershman et al). These data support consideration of acupuncture as a mechanism to help maintain patients on aromatase inhibitors, particularly for patients who wish to avoid or have not received benefit from pharmacologic therapy.

Additional References

1. Puglisi F, Gerratana L, Lambertini M, et al. Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer. NPJ Breast Cancer. 2021;7:82. Doi: 10.1038/s41523-021-00286-w
2. Salvo EM, Ramirez AO, Cueto J, et al. Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis. Breast. 2021;57:5-17. Doi: 10.1016/j.breast.2021.02.009
3. Sheffield KM, Peachey JR, Method M, et al. A real-world US study of recurrence risks using combined clinicopathological features in HR-positive, HER2-negative early breast cancer. Future Oncol.2022;18:2667-2682. Doi: 10.2217/fon-2022-0310
4. Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212-222. Doi: Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-The Penelope-B trial. J Clin Oncol. 2021;39(14):1518-1530. Doi: Liu X, Lu J, Wang G, et al. Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer: A systematic review and meta-analysis. Integr Cancer Ther. 2021;20:1534735420980811. Doi: 10.1177/1534735420980811

The risk for disease recurrence, and specifically distant relapse, for women with high-risk early breast cancer highlights the need for novel therapies in this population.^2,3 The phase 3 randomized monarchE trial investigated the role of the CDK4/6 inhibitor abemaciclib combined with endocrine therapy vs standard endocrine therapy alone in 5637 patients with high-risk (≥ 4 positive axillary nodes or 1-3 positive nodes and either grade 3 tumor, tumor size ≥ 5 cm or Ki-67 ≥ 20%) hormone receptor–positive/HER2-negative early breast cancer. At a median follow-up of 42 months, the median invasive disease-free survival (iDFS) benefit was sustained with abemaciclib + endocrine therapy vs endocrine therapy alone (HR 0.664; nominal P < .0001); the absolute 4-year iDFS benefit was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group). Furthermore, this effect appeared to deepen over time, as the previous absolute iDFS differences were 2.8% (2 years) and 4.8% (3 years). Abemaciclib was associated with a higher rate of grade 3 or higher adverse events (49.9% vs 16.9%), the most common being neutropenia, leukopenia, and diarrhea (Johnston et al). Although adjuvant palbociclib trials (PALLAS⁴ and PENELOPE-B⁵) did not meet their primary endpoint, longer follow-up of monarchE and results from NATALEE with ribociclib are anxiously awaited to further define the role of CDK4/6 inhibitors in this space.

Aromatase inhibitors (AI) are an integral component of treatment for hormone receptor–positive breast cancer for many women. However, joint pain and stiffness associated with these agents can affect compliance. Various management strategies, including trials of alternative AI or endocrine therapies and pharmacologic (duloxetine) and non-pharmacologic (acupuncture,⁶ exercise) modalities, have been investigated. A randomized trial including 226 women with early-stage breast cancer receiving AI therapy with baseline joint pain (Brief Pain Inventory Worst Pain [BPI-WP] item score of ≥ 3) evaluated whether true acupuncture (TA) provided a sustained reduction in pain symptoms compared with sham acupuncture (SA) or waiting-list control (WC). Acupuncture protocols consisted of 6 weeks of intervention (2 sessions per week) followed by 1 session per week for another 6 weeks. At 52 weeks, mean BPI-WP scores were 1.08 points lower in the TA group compared with the SA group (P = .01) and were 0.99 points lower in the TA group compared with the WC group (P = .03) (Hershman et al). These data support consideration of acupuncture as a mechanism to help maintain patients on aromatase inhibitors, particularly for patients who wish to avoid or have not received benefit from pharmacologic therapy.

Additional References

1. Puglisi F, Gerratana L, Lambertini M, et al. Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer. NPJ Breast Cancer. 2021;7:82. Doi: 10.1038/s41523-021-00286-w
2. Salvo EM, Ramirez AO, Cueto J, et al. Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis. Breast. 2021;57:5-17. Doi: 10.1016/j.breast.2021.02.009
3. Sheffield KM, Peachey JR, Method M, et al. A real-world US study of recurrence risks using combined clinicopathological features in HR-positive, HER2-negative early breast cancer. Future Oncol.2022;18:2667-2682. Doi: 10.2217/fon-2022-0310
4. Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212-222. Doi: Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-The Penelope-B trial. J Clin Oncol. 2021;39(14):1518-1530. Doi: Liu X, Lu J, Wang G, et al. Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer: A systematic review and meta-analysis. Integr Cancer Ther. 2021;20:1534735420980811. Doi: 10.1177/1534735420980811

The risk for disease recurrence, and specifically distant relapse, for women with high-risk early breast cancer highlights the need for novel therapies in this population.^2,3 The phase 3 randomized monarchE trial investigated the role of the CDK4/6 inhibitor abemaciclib combined with endocrine therapy vs standard endocrine therapy alone in 5637 patients with high-risk (≥ 4 positive axillary nodes or 1-3 positive nodes and either grade 3 tumor, tumor size ≥ 5 cm or Ki-67 ≥ 20%) hormone receptor–positive/HER2-negative early breast cancer. At a median follow-up of 42 months, the median invasive disease-free survival (iDFS) benefit was sustained with abemaciclib + endocrine therapy vs endocrine therapy alone (HR 0.664; nominal P < .0001); the absolute 4-year iDFS benefit was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group). Furthermore, this effect appeared to deepen over time, as the previous absolute iDFS differences were 2.8% (2 years) and 4.8% (3 years). Abemaciclib was associated with a higher rate of grade 3 or higher adverse events (49.9% vs 16.9%), the most common being neutropenia, leukopenia, and diarrhea (Johnston et al). Although adjuvant palbociclib trials (PALLAS⁴ and PENELOPE-B⁵) did not meet their primary endpoint, longer follow-up of monarchE and results from NATALEE with ribociclib are anxiously awaited to further define the role of CDK4/6 inhibitors in this space.

Aromatase inhibitors (AI) are an integral component of treatment for hormone receptor–positive breast cancer for many women. However, joint pain and stiffness associated with these agents can affect compliance. Various management strategies, including trials of alternative AI or endocrine therapies and pharmacologic (duloxetine) and non-pharmacologic (acupuncture,⁶ exercise) modalities, have been investigated. A randomized trial including 226 women with early-stage breast cancer receiving AI therapy with baseline joint pain (Brief Pain Inventory Worst Pain [BPI-WP] item score of ≥ 3) evaluated whether true acupuncture (TA) provided a sustained reduction in pain symptoms compared with sham acupuncture (SA) or waiting-list control (WC). Acupuncture protocols consisted of 6 weeks of intervention (2 sessions per week) followed by 1 session per week for another 6 weeks. At 52 weeks, mean BPI-WP scores were 1.08 points lower in the TA group compared with the SA group (P = .01) and were 0.99 points lower in the TA group compared with the WC group (P = .03) (Hershman et al). These data support consideration of acupuncture as a mechanism to help maintain patients on aromatase inhibitors, particularly for patients who wish to avoid or have not received benefit from pharmacologic therapy.

Additional References

1. Puglisi F, Gerratana L, Lambertini M, et al. Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer. NPJ Breast Cancer. 2021;7:82. Doi: 10.1038/s41523-021-00286-w
2. Salvo EM, Ramirez AO, Cueto J, et al. Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis. Breast. 2021;57:5-17. Doi: 10.1016/j.breast.2021.02.009
3. Sheffield KM, Peachey JR, Method M, et al. A real-world US study of recurrence risks using combined clinicopathological features in HR-positive, HER2-negative early breast cancer. Future Oncol.2022;18:2667-2682. Doi: 10.2217/fon-2022-0310
4. Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212-222. Doi: Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-The Penelope-B trial. J Clin Oncol. 2021;39(14):1518-1530. Doi: Liu X, Lu J, Wang G, et al. Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer: A systematic review and meta-analysis. Integr Cancer Ther. 2021;20:1534735420980811. Doi: 10.1177/1534735420980811

Key clinical point: Chronic exposure to heavy metals was not associated with an increased risk for breast cancer (BC) among never smokers in the general population.

Major finding: Serum levels of cobalt were inversely associated with the risk for BC (odds ratio 0.33; P = .033), with no association being observed between the risk for BC and exposure to other heavy metals.

Study details: Findings are from a prospective cohort study including 150 women with BC and without a smoking history and 150 matched control women without BC and smoking history.

Disclosures: This study was supported by the Tuscany Region, “Bando Ricerca Salute 2018.” The authors declared no conflicts of interest.

Source: Caini S et al. Serum heavy metals and breast cancer risk: A case-control study nested in the Florence cohort of the EPIC (European Prospective Investigation into Cancer and nutrition) study. Sci Total Environ. 2022;160568 (Dec 1). Doi: 10.1016/j.scitotenv.2022.160568

Key clinical point: Chronic exposure to heavy metals was not associated with an increased risk for breast cancer (BC) among never smokers in the general population.

Major finding: Serum levels of cobalt were inversely associated with the risk for BC (odds ratio 0.33; P = .033), with no association being observed between the risk for BC and exposure to other heavy metals.

Study details: Findings are from a prospective cohort study including 150 women with BC and without a smoking history and 150 matched control women without BC and smoking history.

Disclosures: This study was supported by the Tuscany Region, “Bando Ricerca Salute 2018.” The authors declared no conflicts of interest.

Source: Caini S et al. Serum heavy metals and breast cancer risk: A case-control study nested in the Florence cohort of the EPIC (European Prospective Investigation into Cancer and nutrition) study. Sci Total Environ. 2022;160568 (Dec 1). Doi: 10.1016/j.scitotenv.2022.160568

Key clinical point: Chronic exposure to heavy metals was not associated with an increased risk for breast cancer (BC) among never smokers in the general population.

Major finding: Serum levels of cobalt were inversely associated with the risk for BC (odds ratio 0.33; P = .033), with no association being observed between the risk for BC and exposure to other heavy metals.

Study details: Findings are from a prospective cohort study including 150 women with BC and without a smoking history and 150 matched control women without BC and smoking history.

Disclosures: This study was supported by the Tuscany Region, “Bando Ricerca Salute 2018.” The authors declared no conflicts of interest.

Source: Caini S et al. Serum heavy metals and breast cancer risk: A case-control study nested in the Florence cohort of the EPIC (European Prospective Investigation into Cancer and nutrition) study. Sci Total Environ. 2022;160568 (Dec 1). Doi: 10.1016/j.scitotenv.2022.160568

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) who had an isolated brain metastasis as their first metastatic event reported worse survival outcomes than those with concurrent progressive or stable/responding extracranial disease (ECD).

Major finding: Patients with isolated brain relapse or no evidence of ECD (28.4 months; P = .0028) reported worse overall survival from metastatic diagnosis to death than patients with concurrent progressive ECD (48.8 months) or stable/responding disease (71.5 months).

Study details: Findings are from a retrospective analysis including 126 patients with HER2+ BC, brain metastasis, and known ECD status.

Disclosures: This study was funded by the Duke University Department of Medicine and other sources. Some authors declared receiving royalties or serving as consultants at various sources.

Source: Noteware L et al. Brain metastasis as the first and only metastatic relapse site portends worse survival in patients with advanced HER2 + breast cancer. Breast Cancer Res Treat. 2022 (Nov 20). Doi: 10.1007/s10549-022-06799-7

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) who had an isolated brain metastasis as their first metastatic event reported worse survival outcomes than those with concurrent progressive or stable/responding extracranial disease (ECD).

Major finding: Patients with isolated brain relapse or no evidence of ECD (28.4 months; P = .0028) reported worse overall survival from metastatic diagnosis to death than patients with concurrent progressive ECD (48.8 months) or stable/responding disease (71.5 months).

Study details: Findings are from a retrospective analysis including 126 patients with HER2+ BC, brain metastasis, and known ECD status.

Disclosures: This study was funded by the Duke University Department of Medicine and other sources. Some authors declared receiving royalties or serving as consultants at various sources.

Source: Noteware L et al. Brain metastasis as the first and only metastatic relapse site portends worse survival in patients with advanced HER2 + breast cancer. Breast Cancer Res Treat. 2022 (Nov 20). Doi: 10.1007/s10549-022-06799-7

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) who had an isolated brain metastasis as their first metastatic event reported worse survival outcomes than those with concurrent progressive or stable/responding extracranial disease (ECD).

Major finding: Patients with isolated brain relapse or no evidence of ECD (28.4 months; P = .0028) reported worse overall survival from metastatic diagnosis to death than patients with concurrent progressive ECD (48.8 months) or stable/responding disease (71.5 months).

Study details: Findings are from a retrospective analysis including 126 patients with HER2+ BC, brain metastasis, and known ECD status.

Disclosures: This study was funded by the Duke University Department of Medicine and other sources. Some authors declared receiving royalties or serving as consultants at various sources.

Source: Noteware L et al. Brain metastasis as the first and only metastatic relapse site portends worse survival in patients with advanced HER2 + breast cancer. Breast Cancer Res Treat. 2022 (Nov 20). Doi: 10.1007/s10549-022-06799-7

Key clinical point: Breast conserving surgery (BCS) plus radiotherapy (RT) demonstrated superior survival outcomes compared to mastectomy in patients with ductal carcinoma in situ with microinvasion (DCIS-MI).

Major finding: Overall survival (hazard ratio [HR] 0.676; P < .001) and breast cancer-specific survival (HR 0.565; P = .017) were significantly improved in the BCS+RT vs mastectomy group.

Study details: This study analyzed the data of 5432 patients with DCIS-MI from the Surveillance, Epidemiology, and End Results (SEER) database, of which 52.17% of patients had received BCS+RT.

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

Source: Xia LY et al. Survival outcomes after breast-conserving surgery plus radiotherapy compared with mastectomy in breast ductal carcinoma in situ with microinvasion. Sci Rep. 2022;12:20132 (Nov 22). Doi: 10.1038/s41598-022-24630-7

Key clinical point: Breast conserving surgery (BCS) plus radiotherapy (RT) demonstrated superior survival outcomes compared to mastectomy in patients with ductal carcinoma in situ with microinvasion (DCIS-MI).

Major finding: Overall survival (hazard ratio [HR] 0.676; P < .001) and breast cancer-specific survival (HR 0.565; P = .017) were significantly improved in the BCS+RT vs mastectomy group.

Study details: This study analyzed the data of 5432 patients with DCIS-MI from the Surveillance, Epidemiology, and End Results (SEER) database, of which 52.17% of patients had received BCS+RT.

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

Source: Xia LY et al. Survival outcomes after breast-conserving surgery plus radiotherapy compared with mastectomy in breast ductal carcinoma in situ with microinvasion. Sci Rep. 2022;12:20132 (Nov 22). Doi: 10.1038/s41598-022-24630-7

Key clinical point: Breast conserving surgery (BCS) plus radiotherapy (RT) demonstrated superior survival outcomes compared to mastectomy in patients with ductal carcinoma in situ with microinvasion (DCIS-MI).

Major finding: Overall survival (hazard ratio [HR] 0.676; P < .001) and breast cancer-specific survival (HR 0.565; P = .017) were significantly improved in the BCS+RT vs mastectomy group.

Study details: This study analyzed the data of 5432 patients with DCIS-MI from the Surveillance, Epidemiology, and End Results (SEER) database, of which 52.17% of patients had received BCS+RT.

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

Source: Xia LY et al. Survival outcomes after breast-conserving surgery plus radiotherapy compared with mastectomy in breast ductal carcinoma in situ with microinvasion. Sci Rep. 2022;12:20132 (Nov 22). Doi: 10.1038/s41598-022-24630-7

Key clinical point: Palbociclib plus endocrine therapy (ET) improved progression-free survival (PFS) across all subgroups of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (BC).

Major finding: Median PFS was longer in patients receiving palbociclib+letrozole vs placebo+letrozole (hazard ratio [HR] 0.56; 95% CI 0.46-0.69) or palbociclib+fulvestrant vs placebo+fulvestrant (HR 0.50; 95% CI 0.40-0.62), with similar outcomes observed in subgroups of patients reporting a disease-free interval of ≤12 months, visceral disease, or ET resistance.

Study details: Findings are from a post hoc analysis of two phase 3 trials including women with HR+/HER2− advanced BC who were randomly assigned to receive letrozole with palbociclib or placebo (n = 666; PALOMA-2) or fulvestrant with palbociclib or placebo (n = 521; PALOMA-3).

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and stockholders of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Rugo HS et al. Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3. Breast. 2022;66:324-331 (Nov 15). Doi: 10.1016/j.breast.2022.11.005

Key clinical point: Palbociclib plus endocrine therapy (ET) improved progression-free survival (PFS) across all subgroups of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (BC).

Major finding: Median PFS was longer in patients receiving palbociclib+letrozole vs placebo+letrozole (hazard ratio [HR] 0.56; 95% CI 0.46-0.69) or palbociclib+fulvestrant vs placebo+fulvestrant (HR 0.50; 95% CI 0.40-0.62), with similar outcomes observed in subgroups of patients reporting a disease-free interval of ≤12 months, visceral disease, or ET resistance.

Study details: Findings are from a post hoc analysis of two phase 3 trials including women with HR+/HER2− advanced BC who were randomly assigned to receive letrozole with palbociclib or placebo (n = 666; PALOMA-2) or fulvestrant with palbociclib or placebo (n = 521; PALOMA-3).

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and stockholders of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Rugo HS et al. Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3. Breast. 2022;66:324-331 (Nov 15). Doi: 10.1016/j.breast.2022.11.005

Key clinical point: Palbociclib plus endocrine therapy (ET) improved progression-free survival (PFS) across all subgroups of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (BC).

Major finding: Median PFS was longer in patients receiving palbociclib+letrozole vs placebo+letrozole (hazard ratio [HR] 0.56; 95% CI 0.46-0.69) or palbociclib+fulvestrant vs placebo+fulvestrant (HR 0.50; 95% CI 0.40-0.62), with similar outcomes observed in subgroups of patients reporting a disease-free interval of ≤12 months, visceral disease, or ET resistance.

Study details: Findings are from a post hoc analysis of two phase 3 trials including women with HR+/HER2− advanced BC who were randomly assigned to receive letrozole with palbociclib or placebo (n = 666; PALOMA-2) or fulvestrant with palbociclib or placebo (n = 521; PALOMA-3).

Disclosures: This study was funded by Pfizer Inc. Four authors declared being employees and stockholders of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Rugo HS et al. Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3. Breast. 2022;66:324-331 (Nov 15). Doi: 10.1016/j.breast.2022.11.005

Key clinical point: Q-122, a novel nonhormonal oral treatment, significantly improved vasomotor symptoms and was well-tolerated in women with breast cancer (BC) who received oral adjuvant endocrine therapy (ET).

Major finding: After 28 days, Q-122 led to a significantly higher improvement in the mean Vasomotor Symptom Severity Score of moderate and severe hot flushes and night sweats than placebo (−39% vs −26%; P = .018). Q-122 was well tolerated, and most adverse events were mild-to-moderate in severity.

Study details: Findings are from a multicenter, phase 2 study including 131 women with BC who were receiving oral adjuvant ET and were randomly assigned to receive 100 mg oral Q-122 or identical placebo, twice daily for 28 days.

Disclosures: This study was funded by QUE Oncology. The authors declared delivering lectures or receiving honoraria, grant funding, or personal fees from several sources. Two authors declared being current or former employees of QUE Oncology.

Source: Vrselja A et al. Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: A phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2022;400(10364):1704-1711 (Nov 12). Doi: 10.1016/S0140-6736(22)01977-8

Key clinical point: Q-122, a novel nonhormonal oral treatment, significantly improved vasomotor symptoms and was well-tolerated in women with breast cancer (BC) who received oral adjuvant endocrine therapy (ET).

Major finding: After 28 days, Q-122 led to a significantly higher improvement in the mean Vasomotor Symptom Severity Score of moderate and severe hot flushes and night sweats than placebo (−39% vs −26%; P = .018). Q-122 was well tolerated, and most adverse events were mild-to-moderate in severity.

Study details: Findings are from a multicenter, phase 2 study including 131 women with BC who were receiving oral adjuvant ET and were randomly assigned to receive 100 mg oral Q-122 or identical placebo, twice daily for 28 days.

Disclosures: This study was funded by QUE Oncology. The authors declared delivering lectures or receiving honoraria, grant funding, or personal fees from several sources. Two authors declared being current or former employees of QUE Oncology.

Source: Vrselja A et al. Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: A phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2022;400(10364):1704-1711 (Nov 12). Doi: 10.1016/S0140-6736(22)01977-8

Key clinical point: Q-122, a novel nonhormonal oral treatment, significantly improved vasomotor symptoms and was well-tolerated in women with breast cancer (BC) who received oral adjuvant endocrine therapy (ET).

Major finding: After 28 days, Q-122 led to a significantly higher improvement in the mean Vasomotor Symptom Severity Score of moderate and severe hot flushes and night sweats than placebo (−39% vs −26%; P = .018). Q-122 was well tolerated, and most adverse events were mild-to-moderate in severity.

Study details: Findings are from a multicenter, phase 2 study including 131 women with BC who were receiving oral adjuvant ET and were randomly assigned to receive 100 mg oral Q-122 or identical placebo, twice daily for 28 days.

Disclosures: This study was funded by QUE Oncology. The authors declared delivering lectures or receiving honoraria, grant funding, or personal fees from several sources. Two authors declared being current or former employees of QUE Oncology.

Source: Vrselja A et al. Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: A phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2022;400(10364):1704-1711 (Nov 12). Doi: 10.1016/S0140-6736(22)01977-8

Key clinical point: Margetuximab failed to demonstrate a survival advantage over trastuzumab in patients with previously treated human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer (BC).

Major finding: After a median follow-up of 20.2 months, no benefit in overall survival (OS) was observed with margetuximab vs trastuzumab (hazard ratio [HR] 0.95; P = .620). The safety profile of margetuximab was acceptable and comparable to that of trastuzumab.

Study details: Findings are from the phase 3 SOPHIA study including 536 patients with HER2+ advanced BC who received ≥2 prior anti-HER2 regimens and were randomly assigned to receive chemotherapy with margetuximab or trastuzumab.

Disclosures: This study was supported by MacroGenics, Inc. The authors declared serving as employees, consultants, or on speaker’s bureaus, holding stock options, or receiving honoraria, research funding, or travel or accommodation expenses from several sources, including MacroGenics.

Source: Rugo HS et al  on behalf of the SOPHIA Study Group. Margetuximab versus trastuzumab in patients with previously treated her2-positive advanced breast cancer (SOPHIA): Final overall survival results from a randomized phase 3 trial. J Clin Oncol. 2022 (Nov 4). Doi: 10.1200/JCO.21.02937

Key clinical point: Margetuximab failed to demonstrate a survival advantage over trastuzumab in patients with previously treated human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer (BC).

Major finding: After a median follow-up of 20.2 months, no benefit in overall survival (OS) was observed with margetuximab vs trastuzumab (hazard ratio [HR] 0.95; P = .620). The safety profile of margetuximab was acceptable and comparable to that of trastuzumab.

Study details: Findings are from the phase 3 SOPHIA study including 536 patients with HER2+ advanced BC who received ≥2 prior anti-HER2 regimens and were randomly assigned to receive chemotherapy with margetuximab or trastuzumab.

Disclosures: This study was supported by MacroGenics, Inc. The authors declared serving as employees, consultants, or on speaker’s bureaus, holding stock options, or receiving honoraria, research funding, or travel or accommodation expenses from several sources, including MacroGenics.

Source: Rugo HS et al  on behalf of the SOPHIA Study Group. Margetuximab versus trastuzumab in patients with previously treated her2-positive advanced breast cancer (SOPHIA): Final overall survival results from a randomized phase 3 trial. J Clin Oncol. 2022 (Nov 4). Doi: 10.1200/JCO.21.02937

Key clinical point: Margetuximab failed to demonstrate a survival advantage over trastuzumab in patients with previously treated human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer (BC).

Major finding: After a median follow-up of 20.2 months, no benefit in overall survival (OS) was observed with margetuximab vs trastuzumab (hazard ratio [HR] 0.95; P = .620). The safety profile of margetuximab was acceptable and comparable to that of trastuzumab.

Study details: Findings are from the phase 3 SOPHIA study including 536 patients with HER2+ advanced BC who received ≥2 prior anti-HER2 regimens and were randomly assigned to receive chemotherapy with margetuximab or trastuzumab.

Disclosures: This study was supported by MacroGenics, Inc. The authors declared serving as employees, consultants, or on speaker’s bureaus, holding stock options, or receiving honoraria, research funding, or travel or accommodation expenses from several sources, including MacroGenics.

Source: Rugo HS et al  on behalf of the SOPHIA Study Group. Margetuximab versus trastuzumab in patients with previously treated her2-positive advanced breast cancer (SOPHIA): Final overall survival results from a randomized phase 3 trial. J Clin Oncol. 2022 (Nov 4). Doi: 10.1200/JCO.21.02937

Key clinical point: The risk for uterine diseases was significantly increased in premenopausal women with breast cancer (BC) who received tamoxifen as an adjuvant hormone therapy.

Major finding: Compared with patients who did not receive adjuvant hormone therapy, those who received tamoxifen had a significantly higher risk for endometrial cancer (hazard ratio [HR] 3.77; 95% CI 3.04-4.66), endometrial polyps (HR 3.90; 95% CI 3.65-4.16), hyperplasia (HR 5.56; 95% CI 5.06-6.12), and other uterine cancers (HR 2.27; 95% CI 1.54-3.33).

Study details: Findings are from a nationwide, retrospective, longitudinal cohort study including 78,320 premenopausal women with BC who received (tamoxifen only; n = 34,637) or did not receive (n = 43,683) an adjuvant hormone treatment.

Disclosures: This study was supported by a National Research Foundation of Korea grant. The authors declared no conflicts of interest.

Source: Ryu KJ et al. Risk of endometrial polyps, hyperplasia, carcinoma, and uterine cancer after tamoxifen treatment in premenopausal women with breast cancer. JAMA Netw Open. 2022 5(11):e2243951 (Nov 28). Doi: 10.1001/jamanetworkopen.2022.43951

Key clinical point: The risk for uterine diseases was significantly increased in premenopausal women with breast cancer (BC) who received tamoxifen as an adjuvant hormone therapy.

Major finding: Compared with patients who did not receive adjuvant hormone therapy, those who received tamoxifen had a significantly higher risk for endometrial cancer (hazard ratio [HR] 3.77; 95% CI 3.04-4.66), endometrial polyps (HR 3.90; 95% CI 3.65-4.16), hyperplasia (HR 5.56; 95% CI 5.06-6.12), and other uterine cancers (HR 2.27; 95% CI 1.54-3.33).

Study details: Findings are from a nationwide, retrospective, longitudinal cohort study including 78,320 premenopausal women with BC who received (tamoxifen only; n = 34,637) or did not receive (n = 43,683) an adjuvant hormone treatment.

Disclosures: This study was supported by a National Research Foundation of Korea grant. The authors declared no conflicts of interest.

Source: Ryu KJ et al. Risk of endometrial polyps, hyperplasia, carcinoma, and uterine cancer after tamoxifen treatment in premenopausal women with breast cancer. JAMA Netw Open. 2022 5(11):e2243951 (Nov 28). Doi: 10.1001/jamanetworkopen.2022.43951

Key clinical point: The risk for uterine diseases was significantly increased in premenopausal women with breast cancer (BC) who received tamoxifen as an adjuvant hormone therapy.

Major finding: Compared with patients who did not receive adjuvant hormone therapy, those who received tamoxifen had a significantly higher risk for endometrial cancer (hazard ratio [HR] 3.77; 95% CI 3.04-4.66), endometrial polyps (HR 3.90; 95% CI 3.65-4.16), hyperplasia (HR 5.56; 95% CI 5.06-6.12), and other uterine cancers (HR 2.27; 95% CI 1.54-3.33).

Study details: Findings are from a nationwide, retrospective, longitudinal cohort study including 78,320 premenopausal women with BC who received (tamoxifen only; n = 34,637) or did not receive (n = 43,683) an adjuvant hormone treatment.

Disclosures: This study was supported by a National Research Foundation of Korea grant. The authors declared no conflicts of interest.

Source: Ryu KJ et al. Risk of endometrial polyps, hyperplasia, carcinoma, and uterine cancer after tamoxifen treatment in premenopausal women with breast cancer. JAMA Netw Open. 2022 5(11):e2243951 (Nov 28). Doi: 10.1001/jamanetworkopen.2022.43951

Key clinical point: The addition of weekly carboplatin to standard anthracycline-weekly paclitaxel-based neoadjuvant chemotherapy improved pathological complete response (pCR) rates in patients with triple-negative breast cancer (TNBC).

Major finding: The rate of pCR was significantly higher in the anthracycline-paclitaxel+carboplatin vs anthracycline-paclitaxel treatment group (51.9% vs 34.2%; odds ratio 2.40; P = .01); however, no significant differences were observed in grade ≥3 hematological toxicities between both groups.

Study details: Findings are from a multicenter study including 247 patients with TNBC who received sequential treatment with anthracycline and weekly paclitaxel with or without weekly carboplatin.

Disclosures: This study was supported by the Italian Ministry of Health. The authors declared receiving personal fees, grants, or non-financial support from several sources.

Source: Dieci MV et al. Incorporating weekly carboplatin in anthracycline and paclitaxel-containing neoadjuvant chemotherapy for triple-negative breast cancer: Propensity-score matching analysis and TIL evaluation. Br J Cancer. 2022 (Nov 17). Doi: 10.1038/s41416-022-02050-8

Key clinical point: The addition of weekly carboplatin to standard anthracycline-weekly paclitaxel-based neoadjuvant chemotherapy improved pathological complete response (pCR) rates in patients with triple-negative breast cancer (TNBC).

Major finding: The rate of pCR was significantly higher in the anthracycline-paclitaxel+carboplatin vs anthracycline-paclitaxel treatment group (51.9% vs 34.2%; odds ratio 2.40; P = .01); however, no significant differences were observed in grade ≥3 hematological toxicities between both groups.

Study details: Findings are from a multicenter study including 247 patients with TNBC who received sequential treatment with anthracycline and weekly paclitaxel with or without weekly carboplatin.

Disclosures: This study was supported by the Italian Ministry of Health. The authors declared receiving personal fees, grants, or non-financial support from several sources.

Source: Dieci MV et al. Incorporating weekly carboplatin in anthracycline and paclitaxel-containing neoadjuvant chemotherapy for triple-negative breast cancer: Propensity-score matching analysis and TIL evaluation. Br J Cancer. 2022 (Nov 17). Doi: 10.1038/s41416-022-02050-8

Key clinical point: The addition of weekly carboplatin to standard anthracycline-weekly paclitaxel-based neoadjuvant chemotherapy improved pathological complete response (pCR) rates in patients with triple-negative breast cancer (TNBC).

Major finding: The rate of pCR was significantly higher in the anthracycline-paclitaxel+carboplatin vs anthracycline-paclitaxel treatment group (51.9% vs 34.2%; odds ratio 2.40; P = .01); however, no significant differences were observed in grade ≥3 hematological toxicities between both groups.

Study details: Findings are from a multicenter study including 247 patients with TNBC who received sequential treatment with anthracycline and weekly paclitaxel with or without weekly carboplatin.

Disclosures: This study was supported by the Italian Ministry of Health. The authors declared receiving personal fees, grants, or non-financial support from several sources.

Source: Dieci MV et al. Incorporating weekly carboplatin in anthracycline and paclitaxel-containing neoadjuvant chemotherapy for triple-negative breast cancer: Propensity-score matching analysis and TIL evaluation. Br J Cancer. 2022 (Nov 17). Doi: 10.1038/s41416-022-02050-8