Breast Cancer

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

However, concomitant use of vaginal estrogen and aromatase inhibitors was associated with a higher risk for breast cancer recurrence than was use of vaginal estrogen alone.

Although this important study’s findings have the limitations characteristic of observational studies, its large size and careful analyses suggest that in selected well-counseled breast cancer survivors, off-label use of vaginal estrogen may safely improve their sexual function and quality of life.

Dr. Kaunitz is associate chairman, department of obstetrics and gynecology, University of Florida College of Medicine, Jacksonville. This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Fear and a lack of health-related knowledge pose significant barriers to preventative cancer care access and effectiveness, recent survey data from The Harris Poll suggests.

The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.

Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.

Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.

For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.

Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.

The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.

The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.

“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.

“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”

Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.

The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.

Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”

As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.

An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”

Fear and a lack of health-related knowledge pose significant barriers to preventative cancer care access and effectiveness, recent survey data from The Harris Poll suggests.

The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.

Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.

Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.

For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.

Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.

The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.

The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.

“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.

“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”

Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.

The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.

Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”

As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.

An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”

Fear and a lack of health-related knowledge pose significant barriers to preventative cancer care access and effectiveness, recent survey data from The Harris Poll suggests.

The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.

Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.

Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.

For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.

Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.

The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.

The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.

“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.

“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”

Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.

The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.

Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”

As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.

An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”

Key clinical point: Compared with paclitaxel chemotherapy, treatment with first-line cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) demonstrated better survival outcomes and a similar speed of improvement in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who had a visceral crisis (VC) or impending VC (IVC).

Major finding: CDK4/6i vs paclitaxel improved time-to-treatment failure (hazard ratio [HR] 0.33; P  =  .0002), progression-free survival (HR 0.38; P  =  .002), and overall survival (HR 0.37; P  =  .002) outcomes. The median time to first improvement in IVC/VC was comparable between the treatment groups (P  =  .773).

Study details: Findings are from a retrospective study including 59 patients with ER+/HER2− advanced BC who had either VC or IVC, of whom 27 patients received first-line treatment with CDK4/6i + endocrine therapy and 32 patients who were treated with weekly paclitaxel.

Disclosures: This study did not receive any funding. Two authors declared having joint working agreements with or receiving honoraria, conference fees, travel expenses, or research funding from various sources.

Source: Behrouzi R et al. CDK4/6 inhibitors versus weekly paclitaxel for treatment of ER+/HER2− advanced breast cancer with impending or established visceral crisis. Breast Cancer Res Treat. 2023 (Aug 16). doi: 10.1007/s10549-023-07035-6

Key clinical point: Compared with paclitaxel chemotherapy, treatment with first-line cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) demonstrated better survival outcomes and a similar speed of improvement in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who had a visceral crisis (VC) or impending VC (IVC).

Major finding: CDK4/6i vs paclitaxel improved time-to-treatment failure (hazard ratio [HR] 0.33; P  =  .0002), progression-free survival (HR 0.38; P  =  .002), and overall survival (HR 0.37; P  =  .002) outcomes. The median time to first improvement in IVC/VC was comparable between the treatment groups (P  =  .773).

Study details: Findings are from a retrospective study including 59 patients with ER+/HER2− advanced BC who had either VC or IVC, of whom 27 patients received first-line treatment with CDK4/6i + endocrine therapy and 32 patients who were treated with weekly paclitaxel.

Disclosures: This study did not receive any funding. Two authors declared having joint working agreements with or receiving honoraria, conference fees, travel expenses, or research funding from various sources.

Source: Behrouzi R et al. CDK4/6 inhibitors versus weekly paclitaxel for treatment of ER+/HER2− advanced breast cancer with impending or established visceral crisis. Breast Cancer Res Treat. 2023 (Aug 16). doi: 10.1007/s10549-023-07035-6

Key clinical point: Compared with paclitaxel chemotherapy, treatment with first-line cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) demonstrated better survival outcomes and a similar speed of improvement in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who had a visceral crisis (VC) or impending VC (IVC).

Major finding: CDK4/6i vs paclitaxel improved time-to-treatment failure (hazard ratio [HR] 0.33; P  =  .0002), progression-free survival (HR 0.38; P  =  .002), and overall survival (HR 0.37; P  =  .002) outcomes. The median time to first improvement in IVC/VC was comparable between the treatment groups (P  =  .773).

Study details: Findings are from a retrospective study including 59 patients with ER+/HER2− advanced BC who had either VC or IVC, of whom 27 patients received first-line treatment with CDK4/6i + endocrine therapy and 32 patients who were treated with weekly paclitaxel.

Disclosures: This study did not receive any funding. Two authors declared having joint working agreements with or receiving honoraria, conference fees, travel expenses, or research funding from various sources.

Source: Behrouzi R et al. CDK4/6 inhibitors versus weekly paclitaxel for treatment of ER+/HER2− advanced breast cancer with impending or established visceral crisis. Breast Cancer Res Treat. 2023 (Aug 16). doi: 10.1007/s10549-023-07035-6

Key clinical point: Patients who survive breast cancer (BC) may have an elevated risk of developing type 2 diabetes mellitus (T2D), especially after receiving tamoxifen therapy.

Major finding: The risk for incident T2D was elevated in patients with BC (effect estimate [EE] 1.23; 95% CI 1.13-1.33), particularly those who received endocrine therapy (EE 1.23; 95% CI 1.16-1.32), compared with individuals without BC. Moreover, the risk of developing T2D was higher among patients with BC who did vs did not receive tamoxifen (EE 1.28; 95% CI 1.18-1.38).

Study details: Findings are from a meta-analysis of 15 observational studies.

Disclosures: This study was funded by the Novo Nordisk Foundation and other sources. The authors declared no conflicts of interest.

Source: Jordt N et al. Breast cancer and incidence of type 2 diabetes mellitus: A systematic review and meta-analysis. Breast Cancer Res Treat. 2023 (Sep 1). doi: 10.1007/s10549-023-07043-6

Key clinical point: Patients who survive breast cancer (BC) may have an elevated risk of developing type 2 diabetes mellitus (T2D), especially after receiving tamoxifen therapy.

Major finding: The risk for incident T2D was elevated in patients with BC (effect estimate [EE] 1.23; 95% CI 1.13-1.33), particularly those who received endocrine therapy (EE 1.23; 95% CI 1.16-1.32), compared with individuals without BC. Moreover, the risk of developing T2D was higher among patients with BC who did vs did not receive tamoxifen (EE 1.28; 95% CI 1.18-1.38).

Study details: Findings are from a meta-analysis of 15 observational studies.

Disclosures: This study was funded by the Novo Nordisk Foundation and other sources. The authors declared no conflicts of interest.

Source: Jordt N et al. Breast cancer and incidence of type 2 diabetes mellitus: A systematic review and meta-analysis. Breast Cancer Res Treat. 2023 (Sep 1). doi: 10.1007/s10549-023-07043-6

Key clinical point: Patients who survive breast cancer (BC) may have an elevated risk of developing type 2 diabetes mellitus (T2D), especially after receiving tamoxifen therapy.

Major finding: The risk for incident T2D was elevated in patients with BC (effect estimate [EE] 1.23; 95% CI 1.13-1.33), particularly those who received endocrine therapy (EE 1.23; 95% CI 1.16-1.32), compared with individuals without BC. Moreover, the risk of developing T2D was higher among patients with BC who did vs did not receive tamoxifen (EE 1.28; 95% CI 1.18-1.38).

Study details: Findings are from a meta-analysis of 15 observational studies.

Disclosures: This study was funded by the Novo Nordisk Foundation and other sources. The authors declared no conflicts of interest.

Source: Jordt N et al. Breast cancer and incidence of type 2 diabetes mellitus: A systematic review and meta-analysis. Breast Cancer Res Treat. 2023 (Sep 1). doi: 10.1007/s10549-023-07043-6

Key clinical point: Certain preoperative clinicopathological factors can predict the presence of ≥4 pathologically positive lymph nodes in postmenopausal women with clinically node-negative (cN0) breast cancer (BC) who underwent sentinel lymph node biopsy (SLNB) with or without completion axillary lymph node dissection (cALND).

Major finding: Only 2.5% of the evaluated patients reported having ≥4 positive lymph nodes, with the factors serving as independent predictors of ≥4 positive nodes being larger tumor size (odds ratio [OR] 1.42; P < .0001), invasive lobular carcinoma (ILC) or mixed invasive ductal carcinoma/ILC histology (OR 3.03 or 1.99, respectively; P  =  .008), multifocality (OR 3.58; P < .0001), and the presence of lymphovascular invasion (OR 4.77; P < .0001).

Study details: This retrospective review included 2532 postmenopausal women with cN0 BC who underwent SLNB, of whom 24.3% underwent cALND.

Disclosures: This study was supported by an US National Institutes of Health/National Cancer Institute Cancer Center Support Grant. Some authors declared serving on medical or scientific advisory boards of, receiving research funding or support for clinical trials from, or having other ties with various sources.

Source: Farley C et al. To dissect or not to dissect: Can we predict the presence of four or more axillary lymph node metastases in postmenopausal women with clinically node-negative breast cancer? Ann Surg Oncol. 2023 (Sep 5). doi: 10.1245/s10434-023-14245-1

Key clinical point: Certain preoperative clinicopathological factors can predict the presence of ≥4 pathologically positive lymph nodes in postmenopausal women with clinically node-negative (cN0) breast cancer (BC) who underwent sentinel lymph node biopsy (SLNB) with or without completion axillary lymph node dissection (cALND).

Major finding: Only 2.5% of the evaluated patients reported having ≥4 positive lymph nodes, with the factors serving as independent predictors of ≥4 positive nodes being larger tumor size (odds ratio [OR] 1.42; P < .0001), invasive lobular carcinoma (ILC) or mixed invasive ductal carcinoma/ILC histology (OR 3.03 or 1.99, respectively; P  =  .008), multifocality (OR 3.58; P < .0001), and the presence of lymphovascular invasion (OR 4.77; P < .0001).

Study details: This retrospective review included 2532 postmenopausal women with cN0 BC who underwent SLNB, of whom 24.3% underwent cALND.

Disclosures: This study was supported by an US National Institutes of Health/National Cancer Institute Cancer Center Support Grant. Some authors declared serving on medical or scientific advisory boards of, receiving research funding or support for clinical trials from, or having other ties with various sources.

Source: Farley C et al. To dissect or not to dissect: Can we predict the presence of four or more axillary lymph node metastases in postmenopausal women with clinically node-negative breast cancer? Ann Surg Oncol. 2023 (Sep 5). doi: 10.1245/s10434-023-14245-1

Key clinical point: Certain preoperative clinicopathological factors can predict the presence of ≥4 pathologically positive lymph nodes in postmenopausal women with clinically node-negative (cN0) breast cancer (BC) who underwent sentinel lymph node biopsy (SLNB) with or without completion axillary lymph node dissection (cALND).

Major finding: Only 2.5% of the evaluated patients reported having ≥4 positive lymph nodes, with the factors serving as independent predictors of ≥4 positive nodes being larger tumor size (odds ratio [OR] 1.42; P < .0001), invasive lobular carcinoma (ILC) or mixed invasive ductal carcinoma/ILC histology (OR 3.03 or 1.99, respectively; P  =  .008), multifocality (OR 3.58; P < .0001), and the presence of lymphovascular invasion (OR 4.77; P < .0001).

Study details: This retrospective review included 2532 postmenopausal women with cN0 BC who underwent SLNB, of whom 24.3% underwent cALND.

Disclosures: This study was supported by an US National Institutes of Health/National Cancer Institute Cancer Center Support Grant. Some authors declared serving on medical or scientific advisory boards of, receiving research funding or support for clinical trials from, or having other ties with various sources.

Source: Farley C et al. To dissect or not to dissect: Can we predict the presence of four or more axillary lymph node metastases in postmenopausal women with clinically node-negative breast cancer? Ann Surg Oncol. 2023 (Sep 5). doi: 10.1245/s10434-023-14245-1

Key clinical point: Patients with obesity and stages I-III breast cancer (BC) who undergo mastectomy with immediate reconstruction have a higher likelihood of experiencing surgical complications than patients without obesity.

Major finding: Compared with patients who underwent lumpectomy, the risk for surgical complications was significantly higher in those who underwent mastectomy with (odds ratio [OR] 7.45; P < .0001) or without (OR 3.15; P  =  .002) immediate reconstruction. Moreover, obesity vs non-obesity was associated with worse surgical complications among patients undergoing mastectomy with reconstruction (OR 2.25; P  =  .02).

Study details: Findings are from a retrospective study including 692 patients with stages I-III BC who underwent surgery and received body composition measurements using bioelectrical impedance spectrometry.

Disclosures: This study did not disclose the funding source. SA Valente and HCF Moore declared serving as consultants for, receiving fees or grants from, or having contracts with various sources.

Source: Aleixo GFP et al. Association of body composition and surgical outcomes in patients with early-stage breast cancer. Breast Cancer Res Treat. 2023 (Aug 28). doi: 10.1007/s10549-023-07060-5

Key clinical point: Patients with obesity and stages I-III breast cancer (BC) who undergo mastectomy with immediate reconstruction have a higher likelihood of experiencing surgical complications than patients without obesity.

Major finding: Compared with patients who underwent lumpectomy, the risk for surgical complications was significantly higher in those who underwent mastectomy with (odds ratio [OR] 7.45; P < .0001) or without (OR 3.15; P  =  .002) immediate reconstruction. Moreover, obesity vs non-obesity was associated with worse surgical complications among patients undergoing mastectomy with reconstruction (OR 2.25; P  =  .02).

Study details: Findings are from a retrospective study including 692 patients with stages I-III BC who underwent surgery and received body composition measurements using bioelectrical impedance spectrometry.

Disclosures: This study did not disclose the funding source. SA Valente and HCF Moore declared serving as consultants for, receiving fees or grants from, or having contracts with various sources.

Source: Aleixo GFP et al. Association of body composition and surgical outcomes in patients with early-stage breast cancer. Breast Cancer Res Treat. 2023 (Aug 28). doi: 10.1007/s10549-023-07060-5

Key clinical point: Patients with obesity and stages I-III breast cancer (BC) who undergo mastectomy with immediate reconstruction have a higher likelihood of experiencing surgical complications than patients without obesity.

Major finding: Compared with patients who underwent lumpectomy, the risk for surgical complications was significantly higher in those who underwent mastectomy with (odds ratio [OR] 7.45; P < .0001) or without (OR 3.15; P  =  .002) immediate reconstruction. Moreover, obesity vs non-obesity was associated with worse surgical complications among patients undergoing mastectomy with reconstruction (OR 2.25; P  =  .02).

Study details: Findings are from a retrospective study including 692 patients with stages I-III BC who underwent surgery and received body composition measurements using bioelectrical impedance spectrometry.

Disclosures: This study did not disclose the funding source. SA Valente and HCF Moore declared serving as consultants for, receiving fees or grants from, or having contracts with various sources.

Source: Aleixo GFP et al. Association of body composition and surgical outcomes in patients with early-stage breast cancer. Breast Cancer Res Treat. 2023 (Aug 28). doi: 10.1007/s10549-023-07060-5

Key clinical point: Home-based exercise and nutritional intervention vs usual care (UC) routine improved the physical activity levels, diet quality, and pathological complete response (pCR) rates in patients who initiated chemotherapy after a breast cancer (BC) diagnosis.

Major finding: Women in the intervention vs UC group reported greater improvements in physical activity (143.4 vs 47.7 minutes/week; P < .001) and a higher intake of fruits, vegetables, and dietary fiber (P ≤ .01) along with increased pCR rates (53% vs 28%; P  =  .037).

Study details: Findings are from the Lifestyle, Exercise, and Nutrition Early After Breast Cancer study including 173 women with newly diagnosed stages I-III breast cancer who initiated chemotherapy and were randomly assigned to undergo either a UC routine or a home-based exercise and nutritional intervention.

Disclosures: This study was financially supported by the corresponding author ML Irwin. Some authors declared serving in the speakers’ bureau of or in consulting, advisory, or leadership roles in or receiving honoraria from various sources.

Source: Sanft T et al. Randomized trial of exercise and nutrition on chemotherapy completion and pathologic complete response in women with breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis study. J Clin Oncol. 2023 (Sep 1). doi: 10.1200/JCO.23.00871

Key clinical point: Home-based exercise and nutritional intervention vs usual care (UC) routine improved the physical activity levels, diet quality, and pathological complete response (pCR) rates in patients who initiated chemotherapy after a breast cancer (BC) diagnosis.

Major finding: Women in the intervention vs UC group reported greater improvements in physical activity (143.4 vs 47.7 minutes/week; P < .001) and a higher intake of fruits, vegetables, and dietary fiber (P ≤ .01) along with increased pCR rates (53% vs 28%; P  =  .037).

Study details: Findings are from the Lifestyle, Exercise, and Nutrition Early After Breast Cancer study including 173 women with newly diagnosed stages I-III breast cancer who initiated chemotherapy and were randomly assigned to undergo either a UC routine or a home-based exercise and nutritional intervention.

Disclosures: This study was financially supported by the corresponding author ML Irwin. Some authors declared serving in the speakers’ bureau of or in consulting, advisory, or leadership roles in or receiving honoraria from various sources.

Source: Sanft T et al. Randomized trial of exercise and nutrition on chemotherapy completion and pathologic complete response in women with breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis study. J Clin Oncol. 2023 (Sep 1). doi: 10.1200/JCO.23.00871

Key clinical point: Home-based exercise and nutritional intervention vs usual care (UC) routine improved the physical activity levels, diet quality, and pathological complete response (pCR) rates in patients who initiated chemotherapy after a breast cancer (BC) diagnosis.

Major finding: Women in the intervention vs UC group reported greater improvements in physical activity (143.4 vs 47.7 minutes/week; P < .001) and a higher intake of fruits, vegetables, and dietary fiber (P ≤ .01) along with increased pCR rates (53% vs 28%; P  =  .037).

Study details: Findings are from the Lifestyle, Exercise, and Nutrition Early After Breast Cancer study including 173 women with newly diagnosed stages I-III breast cancer who initiated chemotherapy and were randomly assigned to undergo either a UC routine or a home-based exercise and nutritional intervention.

Disclosures: This study was financially supported by the corresponding author ML Irwin. Some authors declared serving in the speakers’ bureau of or in consulting, advisory, or leadership roles in or receiving honoraria from various sources.

Source: Sanft T et al. Randomized trial of exercise and nutrition on chemotherapy completion and pathologic complete response in women with breast cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis study. J Clin Oncol. 2023 (Sep 1). doi: 10.1200/JCO.23.00871

Key clinical point: Pyrotinib led to promising long-term outcomes and was well-tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases (BM).

Major finding: In patients with BM, the overall median progression-free survival (PFS), considering both intracranial and extracranial lesions, was 7.50 months (95% CI 5.84-9.16) and median overall survival was 21.27 months (95% CI 20.10-22.44), with the median PFS not improving in patients who received vs did not receive radiotherapy (P  =  .319). Diarrhea (any grade) was the most common adverse event.

Study details: This real-world study included 239 patients with HER2+ metastatic BC who received pyrotinib-based therapy, of whom 61 patients had BM.

Disclosures: This study was supported by the keyAtlas precision medicine and clinical research project of Shanghai Science & Technology Development Foundation, China. The authors declared no conflicts of interest.

Source: Liang X et al. Long-term outcome analysis of pyrotinib in patients with HER2-Positive metastatic breast cancer and brain metastasis: A real-world study. Oncologist. 2023 (Aug 17). doi: 10.1093/oncolo/oyad228

Key clinical point: Pyrotinib led to promising long-term outcomes and was well-tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases (BM).

Major finding: In patients with BM, the overall median progression-free survival (PFS), considering both intracranial and extracranial lesions, was 7.50 months (95% CI 5.84-9.16) and median overall survival was 21.27 months (95% CI 20.10-22.44), with the median PFS not improving in patients who received vs did not receive radiotherapy (P  =  .319). Diarrhea (any grade) was the most common adverse event.

Study details: This real-world study included 239 patients with HER2+ metastatic BC who received pyrotinib-based therapy, of whom 61 patients had BM.

Disclosures: This study was supported by the keyAtlas precision medicine and clinical research project of Shanghai Science & Technology Development Foundation, China. The authors declared no conflicts of interest.

Source: Liang X et al. Long-term outcome analysis of pyrotinib in patients with HER2-Positive metastatic breast cancer and brain metastasis: A real-world study. Oncologist. 2023 (Aug 17). doi: 10.1093/oncolo/oyad228

Key clinical point: Pyrotinib led to promising long-term outcomes and was well-tolerated in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (BC) and brain metastases (BM).

Major finding: In patients with BM, the overall median progression-free survival (PFS), considering both intracranial and extracranial lesions, was 7.50 months (95% CI 5.84-9.16) and median overall survival was 21.27 months (95% CI 20.10-22.44), with the median PFS not improving in patients who received vs did not receive radiotherapy (P  =  .319). Diarrhea (any grade) was the most common adverse event.

Study details: This real-world study included 239 patients with HER2+ metastatic BC who received pyrotinib-based therapy, of whom 61 patients had BM.

Disclosures: This study was supported by the keyAtlas precision medicine and clinical research project of Shanghai Science & Technology Development Foundation, China. The authors declared no conflicts of interest.

Source: Liang X et al. Long-term outcome analysis of pyrotinib in patients with HER2-Positive metastatic breast cancer and brain metastasis: A real-world study. Oncologist. 2023 (Aug 17). doi: 10.1093/oncolo/oyad228

Key clinical point: Adjuvant capecitabine plus ibandronate failed to show improved survival outcomes compared with ibandronate alone in older patients with node-positive/high-risk node-negative breast cancer (BC).

Major finding: At a median follow-up of 61 months, the 5-year invasive disease-free survival rates were comparable between the adjuvant ibandronate + capecitabine and ibandronate arms (hazard ratio 0.96; 95% CI 0.78-1.19). The incidences of high-grade gastrointestinal disorders (6.7% vs 1.0%; P < .001) and skin toxicity (14.6% vs 0.6%; P < .01) were significantly higher in the ibandronate + capecitabine vs ibandronate arm.

Study details: Findings are from a phase 3 study including 1358 patients age ≥ 65 years with early BC who were randomly assigned to receive ibandronate with or without capecitabine.

Disclosures: This study was sponsored by the German Breast Group. Some authors declared receiving personal fees, grants, contracts, consulting fees, payment, honoraria, support for attending meetings, or travel support from or having other ties with various sources.

Source: Schmidt M et al. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE Randomized Clinical Trial. Eur J Cancer. 2023;113324 (Sep 6). doi: 10.1016/j.ejca.2023.113324

Key clinical point: Adjuvant capecitabine plus ibandronate failed to show improved survival outcomes compared with ibandronate alone in older patients with node-positive/high-risk node-negative breast cancer (BC).

Major finding: At a median follow-up of 61 months, the 5-year invasive disease-free survival rates were comparable between the adjuvant ibandronate + capecitabine and ibandronate arms (hazard ratio 0.96; 95% CI 0.78-1.19). The incidences of high-grade gastrointestinal disorders (6.7% vs 1.0%; P < .001) and skin toxicity (14.6% vs 0.6%; P < .01) were significantly higher in the ibandronate + capecitabine vs ibandronate arm.

Study details: Findings are from a phase 3 study including 1358 patients age ≥ 65 years with early BC who were randomly assigned to receive ibandronate with or without capecitabine.

Disclosures: This study was sponsored by the German Breast Group. Some authors declared receiving personal fees, grants, contracts, consulting fees, payment, honoraria, support for attending meetings, or travel support from or having other ties with various sources.

Source: Schmidt M et al. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE Randomized Clinical Trial. Eur J Cancer. 2023;113324 (Sep 6). doi: 10.1016/j.ejca.2023.113324

Key clinical point: Adjuvant capecitabine plus ibandronate failed to show improved survival outcomes compared with ibandronate alone in older patients with node-positive/high-risk node-negative breast cancer (BC).

Major finding: At a median follow-up of 61 months, the 5-year invasive disease-free survival rates were comparable between the adjuvant ibandronate + capecitabine and ibandronate arms (hazard ratio 0.96; 95% CI 0.78-1.19). The incidences of high-grade gastrointestinal disorders (6.7% vs 1.0%; P < .001) and skin toxicity (14.6% vs 0.6%; P < .01) were significantly higher in the ibandronate + capecitabine vs ibandronate arm.

Study details: Findings are from a phase 3 study including 1358 patients age ≥ 65 years with early BC who were randomly assigned to receive ibandronate with or without capecitabine.

Disclosures: This study was sponsored by the German Breast Group. Some authors declared receiving personal fees, grants, contracts, consulting fees, payment, honoraria, support for attending meetings, or travel support from or having other ties with various sources.

Source: Schmidt M et al. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE Randomized Clinical Trial. Eur J Cancer. 2023;113324 (Sep 6). doi: 10.1016/j.ejca.2023.113324

Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen for 2 years demonstrated consistent improvement in disease-free survival (DFS) outcomes and high overall survival (OS) rates in women with estrogen receptor-positive (ER+) breast cancer (BC) who remained premenopausal or regained ovarian function after chemotherapy.

Major finding: The 8-year DFS rates improved consistently in women who received tamoxifen + OFS vs tamoxifen only (85.4% vs 80.2%; hazard ratio 0.67; P  =  .003). Although the 8-year OS rates were comparable between both treatment groups (P  =  .305), they were considerably high (>95%).

Study details: Findings are from an 8-year follow-up of the phase 3 ASTRRA trial including 1282 premenopausal women with ER+ BC, who remained premenopausal or regained ovarian function after chemotherapy and were randomly assigned to receive tamoxifen with or without OFS.

Disclosures: This study was supported by the Korea Health Industry Development Institute, Republic of Korea. Some authors declared receiving honoraria or research funding from or serving in consulting or advisory roles with various sources.

Source: Baek SY et al. Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: An 8-year follow-up of the ASTRRA trial. J Clin Oncol. 2023 (Aug 22). doi: 10.1200/JCO.23.00557

Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen for 2 years demonstrated consistent improvement in disease-free survival (DFS) outcomes and high overall survival (OS) rates in women with estrogen receptor-positive (ER+) breast cancer (BC) who remained premenopausal or regained ovarian function after chemotherapy.

Major finding: The 8-year DFS rates improved consistently in women who received tamoxifen + OFS vs tamoxifen only (85.4% vs 80.2%; hazard ratio 0.67; P  =  .003). Although the 8-year OS rates were comparable between both treatment groups (P  =  .305), they were considerably high (>95%).

Study details: Findings are from an 8-year follow-up of the phase 3 ASTRRA trial including 1282 premenopausal women with ER+ BC, who remained premenopausal or regained ovarian function after chemotherapy and were randomly assigned to receive tamoxifen with or without OFS.

Disclosures: This study was supported by the Korea Health Industry Development Institute, Republic of Korea. Some authors declared receiving honoraria or research funding from or serving in consulting or advisory roles with various sources.

Source: Baek SY et al. Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: An 8-year follow-up of the ASTRRA trial. J Clin Oncol. 2023 (Aug 22). doi: 10.1200/JCO.23.00557

Key clinical point: Adding ovarian function suppression (OFS) to adjuvant tamoxifen for 2 years demonstrated consistent improvement in disease-free survival (DFS) outcomes and high overall survival (OS) rates in women with estrogen receptor-positive (ER+) breast cancer (BC) who remained premenopausal or regained ovarian function after chemotherapy.

Major finding: The 8-year DFS rates improved consistently in women who received tamoxifen + OFS vs tamoxifen only (85.4% vs 80.2%; hazard ratio 0.67; P  =  .003). Although the 8-year OS rates were comparable between both treatment groups (P  =  .305), they were considerably high (>95%).

Study details: Findings are from an 8-year follow-up of the phase 3 ASTRRA trial including 1282 premenopausal women with ER+ BC, who remained premenopausal or regained ovarian function after chemotherapy and were randomly assigned to receive tamoxifen with or without OFS.

Disclosures: This study was supported by the Korea Health Industry Development Institute, Republic of Korea. Some authors declared receiving honoraria or research funding from or serving in consulting or advisory roles with various sources.

Source: Baek SY et al. Adding ovarian suppression to tamoxifen for premenopausal women with hormone receptor-positive breast cancer after chemotherapy: An 8-year follow-up of the ASTRRA trial. J Clin Oncol. 2023 (Aug 22). doi: 10.1200/JCO.23.00557