Key clinical point: The combination of neoadjuvant immunotherapy (nIO) and chemotherapy led to significant improvements in survival outcomes and should be administered as the standard treatment in patients with stages II-III triple-negative breast cancer (TNBC).

Major finding: Patients who did vs did not receive nIO had ~40% lower odds of disease recurrence or death (event-free survival: hazard ratio [HR] 0.61; P < .001) or only death (overall survival: HR 0.62; P < 0.001).

Study details: Findings are from a meta-analysis of four randomized controlled trials including patients with stages II-III TNBC who were randomly assigned to receive either chemotherapy plus nIO or treatment without nIO.

Disclosures: This study did not disclose any funding source. Some authors declared serving in consulting or advisory roles, receiving educational or financial support, research or travel grant, research funding, speaker fees, or honoraria from, or having other ties with various sources.

Source: Cunha MT et al. Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: An extracted individual patient data and trial-level meta-analysis. Br J Cancer. 2023 (Nov 27). doi: 10.1038/s41416-023-02501-w

Key clinical point: The combination of neoadjuvant immunotherapy (nIO) and chemotherapy led to significant improvements in survival outcomes and should be administered as the standard treatment in patients with stages II-III triple-negative breast cancer (TNBC).

Major finding: Patients who did vs did not receive nIO had ~40% lower odds of disease recurrence or death (event-free survival: hazard ratio [HR] 0.61; P < .001) or only death (overall survival: HR 0.62; P < 0.001).

Study details: Findings are from a meta-analysis of four randomized controlled trials including patients with stages II-III TNBC who were randomly assigned to receive either chemotherapy plus nIO or treatment without nIO.

Disclosures: This study did not disclose any funding source. Some authors declared serving in consulting or advisory roles, receiving educational or financial support, research or travel grant, research funding, speaker fees, or honoraria from, or having other ties with various sources.

Source: Cunha MT et al. Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: An extracted individual patient data and trial-level meta-analysis. Br J Cancer. 2023 (Nov 27). doi: 10.1038/s41416-023-02501-w

Key clinical point: The combination of neoadjuvant immunotherapy (nIO) and chemotherapy led to significant improvements in survival outcomes and should be administered as the standard treatment in patients with stages II-III triple-negative breast cancer (TNBC).

Major finding: Patients who did vs did not receive nIO had ~40% lower odds of disease recurrence or death (event-free survival: hazard ratio [HR] 0.61; P < .001) or only death (overall survival: HR 0.62; P < 0.001).

Study details: Findings are from a meta-analysis of four randomized controlled trials including patients with stages II-III TNBC who were randomly assigned to receive either chemotherapy plus nIO or treatment without nIO.

Disclosures: This study did not disclose any funding source. Some authors declared serving in consulting or advisory roles, receiving educational or financial support, research or travel grant, research funding, speaker fees, or honoraria from, or having other ties with various sources.

Source: Cunha MT et al. Long-term outcomes of neoadjuvant immunotherapy plus chemotherapy in patients with early-stage triple-negative breast cancer: An extracted individual patient data and trial-level meta-analysis. Br J Cancer. 2023 (Nov 27). doi: 10.1038/s41416-023-02501-w

Key clinical point: Taxane + anthracycline-based chemotherapy (ATAX) vs taxane-based chemotherapy (TAX) did not increase the risk for major cardiovascular adverse events in older patients with early-stage triple-negative breast cancer (TNBC) or affect survival outcomes in those who had a cardiac event.

Major finding: The risks for acute myocardial infarction, potentially fatal arrhythmia, and cerebral vascular accident did not increase (all P > .1) and the risk for subsequent heart failure was lower in patients receiving ATAX vs TAX (odds ratio 0.63; P < .01). In patients who experienced a cardiac event, ATAX vs TAX did not worsen the survival outcomes.

Study details: This study analyzed the data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and included 2215 older women (age ≥ 66 years) diagnosed with early-stage TNBC who received ATAX (39.78%) or TAX (60.26%) in an adjuvant setting.

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Major cardiovascular adverse events in older adults with early-stage triple-negative breast cancer treated with adjuvant taxane  + anthracycline versus taxane-based chemotherapy regimens: A SEER-Medicare study. Eur J Cancer. 2023;196:113426 (Nov 11). doi: 10.1016/j.ejca.2023.113426

Key clinical point: Taxane + anthracycline-based chemotherapy (ATAX) vs taxane-based chemotherapy (TAX) did not increase the risk for major cardiovascular adverse events in older patients with early-stage triple-negative breast cancer (TNBC) or affect survival outcomes in those who had a cardiac event.

Major finding: The risks for acute myocardial infarction, potentially fatal arrhythmia, and cerebral vascular accident did not increase (all P > .1) and the risk for subsequent heart failure was lower in patients receiving ATAX vs TAX (odds ratio 0.63; P < .01). In patients who experienced a cardiac event, ATAX vs TAX did not worsen the survival outcomes.

Study details: This study analyzed the data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and included 2215 older women (age ≥ 66 years) diagnosed with early-stage TNBC who received ATAX (39.78%) or TAX (60.26%) in an adjuvant setting.

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Major cardiovascular adverse events in older adults with early-stage triple-negative breast cancer treated with adjuvant taxane  + anthracycline versus taxane-based chemotherapy regimens: A SEER-Medicare study. Eur J Cancer. 2023;196:113426 (Nov 11). doi: 10.1016/j.ejca.2023.113426

Key clinical point: Taxane + anthracycline-based chemotherapy (ATAX) vs taxane-based chemotherapy (TAX) did not increase the risk for major cardiovascular adverse events in older patients with early-stage triple-negative breast cancer (TNBC) or affect survival outcomes in those who had a cardiac event.

Major finding: The risks for acute myocardial infarction, potentially fatal arrhythmia, and cerebral vascular accident did not increase (all P > .1) and the risk for subsequent heart failure was lower in patients receiving ATAX vs TAX (odds ratio 0.63; P < .01). In patients who experienced a cardiac event, ATAX vs TAX did not worsen the survival outcomes.

Study details: This study analyzed the data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database and included 2215 older women (age ≥ 66 years) diagnosed with early-stage TNBC who received ATAX (39.78%) or TAX (60.26%) in an adjuvant setting.

Disclosures: This study was funded by the Women’s Cancer Developmental Therapeutics Program, University of Colorado Cancer Center. The authors declared no conflicts of interest.

Source: Roy S et al. Major cardiovascular adverse events in older adults with early-stage triple-negative breast cancer treated with adjuvant taxane  + anthracycline versus taxane-based chemotherapy regimens: A SEER-Medicare study. Eur J Cancer. 2023;196:113426 (Nov 11). doi: 10.1016/j.ejca.2023.113426

Key clinical point: Tumor involvement within the axillary soft tissue extending beyond the positive lymph node (LN+) and extracapsular extension (ECE) should be pathologically evaluated in patients with LN+ breast cancer (BC) as it is a significant predictor of worsened prognostic outcomes for this population.

Major finding: Axillary soft tissue involvement is significantly associated with worsened distant failure (hazard ratio [HR] 1.6; P < .001), locoregional failure (HR 2.3; P < .001), and axillary failure (HR 3.3; P = .003). The delivery of regional lymph node radiation improved the locoregional tumor outcomes in patients with axillary soft tissue involvement, ECE, or both (HR 0.5; P = .03).

Study details: Findings are from a retrospective review including 2162 patients with LN+ invasive BC tumors.

Disclosures: One author declared receiving financial support for this study. Two authors declared being employees of, receiving research funding, or honoraria from, or having other ties with various sources.

Source: Naoum GE, Oladero O, et al. Pathological exploration of the axillary soft tissue microenvironment and its impact on axillary management and breast cancer outcomes. J Clin Oncol. 2023 (Nov 15). doi: 10.1200/JCO.23.01009

Key clinical point: Tumor involvement within the axillary soft tissue extending beyond the positive lymph node (LN+) and extracapsular extension (ECE) should be pathologically evaluated in patients with LN+ breast cancer (BC) as it is a significant predictor of worsened prognostic outcomes for this population.

Major finding: Axillary soft tissue involvement is significantly associated with worsened distant failure (hazard ratio [HR] 1.6; P < .001), locoregional failure (HR 2.3; P < .001), and axillary failure (HR 3.3; P = .003). The delivery of regional lymph node radiation improved the locoregional tumor outcomes in patients with axillary soft tissue involvement, ECE, or both (HR 0.5; P = .03).

Study details: Findings are from a retrospective review including 2162 patients with LN+ invasive BC tumors.

Disclosures: One author declared receiving financial support for this study. Two authors declared being employees of, receiving research funding, or honoraria from, or having other ties with various sources.

Source: Naoum GE, Oladero O, et al. Pathological exploration of the axillary soft tissue microenvironment and its impact on axillary management and breast cancer outcomes. J Clin Oncol. 2023 (Nov 15). doi: 10.1200/JCO.23.01009

Key clinical point: Tumor involvement within the axillary soft tissue extending beyond the positive lymph node (LN+) and extracapsular extension (ECE) should be pathologically evaluated in patients with LN+ breast cancer (BC) as it is a significant predictor of worsened prognostic outcomes for this population.

Major finding: Axillary soft tissue involvement is significantly associated with worsened distant failure (hazard ratio [HR] 1.6; P < .001), locoregional failure (HR 2.3; P < .001), and axillary failure (HR 3.3; P = .003). The delivery of regional lymph node radiation improved the locoregional tumor outcomes in patients with axillary soft tissue involvement, ECE, or both (HR 0.5; P = .03).

Study details: Findings are from a retrospective review including 2162 patients with LN+ invasive BC tumors.

Disclosures: One author declared receiving financial support for this study. Two authors declared being employees of, receiving research funding, or honoraria from, or having other ties with various sources.

Source: Naoum GE, Oladero O, et al. Pathological exploration of the axillary soft tissue microenvironment and its impact on axillary management and breast cancer outcomes. J Clin Oncol. 2023 (Nov 15). doi: 10.1200/JCO.23.01009

Key clinical point: Chemotherapy-related amenorrhea (CRA) was common in premenopausal women with stages I-III breast cancer (BC), particularly in those who were older, experienced hot flashes, or received adjuvant tamoxifen.

Major finding: The majority (57.1%) of premenopausal patients with BC reported having persistent CRA, with the likelihood increasing in those who were age ≥ 35 years (adjusted odds ratio [aOR] 35-39 years: 1.84, 40-44 years: 5.90, ≥45 years: 21.29; all P < .001), experienced hot flashes at diagnosis (aOR 1.83; P = .01), or received adjuvant tamoxifen (aOR 1.97; P < .001).

Study details: This study analyzed the data from the Cancer Toxicities Study and included 1636 premenopausal women with stages I-III BC who were age < 50 years and received chemotherapy but not ovarian function suppressants.

Disclosures: MA Franzoi, M Lambertini, and A Di Meglio received grants or awards for this study. Some authors declared receiving personal fees, speaking fees, grants, or honoraria from or having other ties with various sources.

Source: Kabirian R et al. Chemotherapy-related amenorrhea and quality of life among premenopausal women with breast cancer. JAMA Netw Open. 2023;6(11):e2343910 (Nov 16). doi: 10.1001/jamanetworkopen.2023.43910

Key clinical point: Chemotherapy-related amenorrhea (CRA) was common in premenopausal women with stages I-III breast cancer (BC), particularly in those who were older, experienced hot flashes, or received adjuvant tamoxifen.

Major finding: The majority (57.1%) of premenopausal patients with BC reported having persistent CRA, with the likelihood increasing in those who were age ≥ 35 years (adjusted odds ratio [aOR] 35-39 years: 1.84, 40-44 years: 5.90, ≥45 years: 21.29; all P < .001), experienced hot flashes at diagnosis (aOR 1.83; P = .01), or received adjuvant tamoxifen (aOR 1.97; P < .001).

Study details: This study analyzed the data from the Cancer Toxicities Study and included 1636 premenopausal women with stages I-III BC who were age < 50 years and received chemotherapy but not ovarian function suppressants.

Disclosures: MA Franzoi, M Lambertini, and A Di Meglio received grants or awards for this study. Some authors declared receiving personal fees, speaking fees, grants, or honoraria from or having other ties with various sources.

Source: Kabirian R et al. Chemotherapy-related amenorrhea and quality of life among premenopausal women with breast cancer. JAMA Netw Open. 2023;6(11):e2343910 (Nov 16). doi: 10.1001/jamanetworkopen.2023.43910

Key clinical point: Chemotherapy-related amenorrhea (CRA) was common in premenopausal women with stages I-III breast cancer (BC), particularly in those who were older, experienced hot flashes, or received adjuvant tamoxifen.

Major finding: The majority (57.1%) of premenopausal patients with BC reported having persistent CRA, with the likelihood increasing in those who were age ≥ 35 years (adjusted odds ratio [aOR] 35-39 years: 1.84, 40-44 years: 5.90, ≥45 years: 21.29; all P < .001), experienced hot flashes at diagnosis (aOR 1.83; P = .01), or received adjuvant tamoxifen (aOR 1.97; P < .001).

Study details: This study analyzed the data from the Cancer Toxicities Study and included 1636 premenopausal women with stages I-III BC who were age < 50 years and received chemotherapy but not ovarian function suppressants.

Disclosures: MA Franzoi, M Lambertini, and A Di Meglio received grants or awards for this study. Some authors declared receiving personal fees, speaking fees, grants, or honoraria from or having other ties with various sources.

Source: Kabirian R et al. Chemotherapy-related amenorrhea and quality of life among premenopausal women with breast cancer. JAMA Netw Open. 2023;6(11):e2343910 (Nov 16). doi: 10.1001/jamanetworkopen.2023.43910

Key clinical point: Neoadjuvant carboplatin and docetaxel + pembrolizumab showed encouraging pathological complete response (pCR) rates and 3-year event-free survival (EFS) outcomes and had a manageable safety profile in patients with stages I-III triple-negative breast cancer (TNBC).

Major finding: The overall pCR rate was 58% (95% CI 48%-67%), with the estimated 3-year EFS rates being 86% (95% CI 77%-95%) in all patients and 98% (95% CI 95%-100%) in patients who achieved pCR. Diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%) were the most common grade ≥ 3 treatment-related adverse events, and one study-related death was reported.

Study details: Findings are from the phase 2 NeoPACT trial including 115 female patients with stages I-III TNBC who received carboplatin and docetaxel + pembrolizumab in a neoadjuvant setting.

Disclosures: This study was supported by the University of Kansas Cancer Center and others. The lead author and other authors declared receiving research funding, royalties, personal, consulting or speaking fees from, being advisory board members of, or having other ties with various sources.

Source: Sharma P et al. Clinical and biomarker findings of neoadjuvant pembrolizumab and carboplatin plus docetaxel in triple-negative breast cancer: NeoPACT phase 2 clinical trial. JAMA Oncol. 2023 (Nov 22). doi: 10.1001/jamaoncol.2023.5033

Key clinical point: Neoadjuvant carboplatin and docetaxel + pembrolizumab showed encouraging pathological complete response (pCR) rates and 3-year event-free survival (EFS) outcomes and had a manageable safety profile in patients with stages I-III triple-negative breast cancer (TNBC).

Major finding: The overall pCR rate was 58% (95% CI 48%-67%), with the estimated 3-year EFS rates being 86% (95% CI 77%-95%) in all patients and 98% (95% CI 95%-100%) in patients who achieved pCR. Diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%) were the most common grade ≥ 3 treatment-related adverse events, and one study-related death was reported.

Study details: Findings are from the phase 2 NeoPACT trial including 115 female patients with stages I-III TNBC who received carboplatin and docetaxel + pembrolizumab in a neoadjuvant setting.

Disclosures: This study was supported by the University of Kansas Cancer Center and others. The lead author and other authors declared receiving research funding, royalties, personal, consulting or speaking fees from, being advisory board members of, or having other ties with various sources.

Source: Sharma P et al. Clinical and biomarker findings of neoadjuvant pembrolizumab and carboplatin plus docetaxel in triple-negative breast cancer: NeoPACT phase 2 clinical trial. JAMA Oncol. 2023 (Nov 22). doi: 10.1001/jamaoncol.2023.5033

Key clinical point: Neoadjuvant carboplatin and docetaxel + pembrolizumab showed encouraging pathological complete response (pCR) rates and 3-year event-free survival (EFS) outcomes and had a manageable safety profile in patients with stages I-III triple-negative breast cancer (TNBC).

Major finding: The overall pCR rate was 58% (95% CI 48%-67%), with the estimated 3-year EFS rates being 86% (95% CI 77%-95%) in all patients and 98% (95% CI 95%-100%) in patients who achieved pCR. Diarrhea (4.3%), anemia (3.5%), and peripheral sensory neuropathy (2.6%) were the most common grade ≥ 3 treatment-related adverse events, and one study-related death was reported.

Study details: Findings are from the phase 2 NeoPACT trial including 115 female patients with stages I-III TNBC who received carboplatin and docetaxel + pembrolizumab in a neoadjuvant setting.

Disclosures: This study was supported by the University of Kansas Cancer Center and others. The lead author and other authors declared receiving research funding, royalties, personal, consulting or speaking fees from, being advisory board members of, or having other ties with various sources.

Source: Sharma P et al. Clinical and biomarker findings of neoadjuvant pembrolizumab and carboplatin plus docetaxel in triple-negative breast cancer: NeoPACT phase 2 clinical trial. JAMA Oncol. 2023 (Nov 22). doi: 10.1001/jamaoncol.2023.5033

Key clinical point: Women with apparently unifocal, non–triple-negative breast cancer (BC) who underwent preoperative magnetic resonance imaging (MRI) and did not have any occult malignancy may safely forgo radiation therapy.

Major finding: Preoperative MRI detected malignant occult lesions in 11% of patients with BC. At 5 years, the ipsilateral invasive recurrence rate was very low (1.0%; upper 95% CI 5.4%) in patients with no occult malignancy who did not receive adjuvant radiotherapy.

Study details: Findings are from the prospective 2-arm PROSPECT study that included 443 patients with non–triple-negative, clinical stage T1N0, apparently unifocal BC who underwent MRI, of whom 201 patients underwent breast-conserving surgery without radiotherapy and 242 women were deemed ineligible for radiotherapy omission.

Disclosures: This study was funded by the Breast Cancer Trials, Australia, and other sources. The authors declared no conflicts of interest.

Source: Mann GB et al. Postoperative radiotherapy omission in selected patients with early breast cancer following preoperative breast MRI (PROSPECT): Primary results of a prospective two-arm study. Lancet. 2023 (Dec 5). doi: 10.1016/S0140-6736(23)02476-5

Key clinical point: Women with apparently unifocal, non–triple-negative breast cancer (BC) who underwent preoperative magnetic resonance imaging (MRI) and did not have any occult malignancy may safely forgo radiation therapy.

Major finding: Preoperative MRI detected malignant occult lesions in 11% of patients with BC. At 5 years, the ipsilateral invasive recurrence rate was very low (1.0%; upper 95% CI 5.4%) in patients with no occult malignancy who did not receive adjuvant radiotherapy.

Study details: Findings are from the prospective 2-arm PROSPECT study that included 443 patients with non–triple-negative, clinical stage T1N0, apparently unifocal BC who underwent MRI, of whom 201 patients underwent breast-conserving surgery without radiotherapy and 242 women were deemed ineligible for radiotherapy omission.

Disclosures: This study was funded by the Breast Cancer Trials, Australia, and other sources. The authors declared no conflicts of interest.

Source: Mann GB et al. Postoperative radiotherapy omission in selected patients with early breast cancer following preoperative breast MRI (PROSPECT): Primary results of a prospective two-arm study. Lancet. 2023 (Dec 5). doi: 10.1016/S0140-6736(23)02476-5

Key clinical point: Women with apparently unifocal, non–triple-negative breast cancer (BC) who underwent preoperative magnetic resonance imaging (MRI) and did not have any occult malignancy may safely forgo radiation therapy.

Major finding: Preoperative MRI detected malignant occult lesions in 11% of patients with BC. At 5 years, the ipsilateral invasive recurrence rate was very low (1.0%; upper 95% CI 5.4%) in patients with no occult malignancy who did not receive adjuvant radiotherapy.

Study details: Findings are from the prospective 2-arm PROSPECT study that included 443 patients with non–triple-negative, clinical stage T1N0, apparently unifocal BC who underwent MRI, of whom 201 patients underwent breast-conserving surgery without radiotherapy and 242 women were deemed ineligible for radiotherapy omission.

Disclosures: This study was funded by the Breast Cancer Trials, Australia, and other sources. The authors declared no conflicts of interest.

Source: Mann GB et al. Postoperative radiotherapy omission in selected patients with early breast cancer following preoperative breast MRI (PROSPECT): Primary results of a prospective two-arm study. Lancet. 2023 (Dec 5). doi: 10.1016/S0140-6736(23)02476-5

Key clinical point: The post-diagnostic use of statins lowered the risk for mortality in patients with newly diagnosed breast cancer (BC) only in case of a subsequent lowering of serum cholesterol levels.

Major finding: Compared with patients who did not receive statins, the risk for BC-specific mortality was significantly reduced in those who received statins after BC diagnosis and reported a subsequent reduction in the median total cholesterol level (adjusted hazard ratio 0.49; P = .001). No mortality-risk reduction was observed in patients whose cholesterol levels did not decrease after the post-diagnostic initiation of statins (P = .30).

Study details: This retrospective population-based cohort study included 13,378 patients with newly diagnosed invasive BC, of whom 980 patients initiated statins after BC diagnosis.

Disclosures: This study was supported by research funds and a grant from the Pirkanmaa Hospital District and Duodecim, Finland, respectively. Two authors declared receiving grants or personal fees from various sources, including the Pirkanmaa Hospital District. The other authors declared no conflicts of interest.

Source: Murto MO et al. Statin use, cholesterol level, and mortality among females with breast cancer. JAMA Netw Open. 2023;6(11):e2343861 (Nov 17). doi: 10.1001/jamanetworkopen.2023.43861

Key clinical point: The post-diagnostic use of statins lowered the risk for mortality in patients with newly diagnosed breast cancer (BC) only in case of a subsequent lowering of serum cholesterol levels.

Major finding: Compared with patients who did not receive statins, the risk for BC-specific mortality was significantly reduced in those who received statins after BC diagnosis and reported a subsequent reduction in the median total cholesterol level (adjusted hazard ratio 0.49; P = .001). No mortality-risk reduction was observed in patients whose cholesterol levels did not decrease after the post-diagnostic initiation of statins (P = .30).

Study details: This retrospective population-based cohort study included 13,378 patients with newly diagnosed invasive BC, of whom 980 patients initiated statins after BC diagnosis.

Disclosures: This study was supported by research funds and a grant from the Pirkanmaa Hospital District and Duodecim, Finland, respectively. Two authors declared receiving grants or personal fees from various sources, including the Pirkanmaa Hospital District. The other authors declared no conflicts of interest.

Source: Murto MO et al. Statin use, cholesterol level, and mortality among females with breast cancer. JAMA Netw Open. 2023;6(11):e2343861 (Nov 17). doi: 10.1001/jamanetworkopen.2023.43861

Key clinical point: The post-diagnostic use of statins lowered the risk for mortality in patients with newly diagnosed breast cancer (BC) only in case of a subsequent lowering of serum cholesterol levels.

Major finding: Compared with patients who did not receive statins, the risk for BC-specific mortality was significantly reduced in those who received statins after BC diagnosis and reported a subsequent reduction in the median total cholesterol level (adjusted hazard ratio 0.49; P = .001). No mortality-risk reduction was observed in patients whose cholesterol levels did not decrease after the post-diagnostic initiation of statins (P = .30).

Study details: This retrospective population-based cohort study included 13,378 patients with newly diagnosed invasive BC, of whom 980 patients initiated statins after BC diagnosis.

Disclosures: This study was supported by research funds and a grant from the Pirkanmaa Hospital District and Duodecim, Finland, respectively. Two authors declared receiving grants or personal fees from various sources, including the Pirkanmaa Hospital District. The other authors declared no conflicts of interest.

Source: Murto MO et al. Statin use, cholesterol level, and mortality among females with breast cancer. JAMA Netw Open. 2023;6(11):e2343861 (Nov 17). doi: 10.1001/jamanetworkopen.2023.43861

Key clinical point: Pemetrexed + vinorelbine vs vinorelbine monotherapy led to a greater improvement in progression-free survival (PFS) outcomes and had a manageable safety profile in patients with metastatic breast cancer (BC) previously treated with anthracycline and taxane.

Major finding: The median PFS improved by 45% with pemetrexed + vinorelbine vs vinorelbine monotherapy (5.7 vs 1.6 months; hazard ratio 0.55; P = .001). Pemetrexed + vinorelbine also had a manageable safety profile in general.

Study details: Findings are from the phase 2 KCSG-BR15-17 trial including 125 patients with metastatic BC who had been treated with anthracycline and taxane previously and were randomly assigned to receive pemetrexed + vinorelbine or vinorelbine monotherapy.

Disclosures: This study was funded by a grant from the Ministry of Health and Welfare, Republic of Korea. Two authors declared receiving research funding or research drug supply from or serving in consulting or advisory roles for various sources. The other authors declared no conflicts of interest.

Source: Lee DW, Jung KH, et al. Pemetrexed plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer (KCSG-BR15-17): A randomized, open label, multicenter, phase II trial. Eur J Cancer. 2023;113456 (Nov 20). doi: 10.1016/j.ejca.2023.113456

Key clinical point: Pemetrexed + vinorelbine vs vinorelbine monotherapy led to a greater improvement in progression-free survival (PFS) outcomes and had a manageable safety profile in patients with metastatic breast cancer (BC) previously treated with anthracycline and taxane.

Major finding: The median PFS improved by 45% with pemetrexed + vinorelbine vs vinorelbine monotherapy (5.7 vs 1.6 months; hazard ratio 0.55; P = .001). Pemetrexed + vinorelbine also had a manageable safety profile in general.

Study details: Findings are from the phase 2 KCSG-BR15-17 trial including 125 patients with metastatic BC who had been treated with anthracycline and taxane previously and were randomly assigned to receive pemetrexed + vinorelbine or vinorelbine monotherapy.

Disclosures: This study was funded by a grant from the Ministry of Health and Welfare, Republic of Korea. Two authors declared receiving research funding or research drug supply from or serving in consulting or advisory roles for various sources. The other authors declared no conflicts of interest.

Source: Lee DW, Jung KH, et al. Pemetrexed plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer (KCSG-BR15-17): A randomized, open label, multicenter, phase II trial. Eur J Cancer. 2023;113456 (Nov 20). doi: 10.1016/j.ejca.2023.113456

Key clinical point: Pemetrexed + vinorelbine vs vinorelbine monotherapy led to a greater improvement in progression-free survival (PFS) outcomes and had a manageable safety profile in patients with metastatic breast cancer (BC) previously treated with anthracycline and taxane.

Major finding: The median PFS improved by 45% with pemetrexed + vinorelbine vs vinorelbine monotherapy (5.7 vs 1.6 months; hazard ratio 0.55; P = .001). Pemetrexed + vinorelbine also had a manageable safety profile in general.

Study details: Findings are from the phase 2 KCSG-BR15-17 trial including 125 patients with metastatic BC who had been treated with anthracycline and taxane previously and were randomly assigned to receive pemetrexed + vinorelbine or vinorelbine monotherapy.

Disclosures: This study was funded by a grant from the Ministry of Health and Welfare, Republic of Korea. Two authors declared receiving research funding or research drug supply from or serving in consulting or advisory roles for various sources. The other authors declared no conflicts of interest.

Source: Lee DW, Jung KH, et al. Pemetrexed plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer (KCSG-BR15-17): A randomized, open label, multicenter, phase II trial. Eur J Cancer. 2023;113456 (Nov 20). doi: 10.1016/j.ejca.2023.113456

Key clinical point: Women with germline BRCA1 or BRCA2 pathogenic mutations who had a pregnancy after diagnosis of early breast cancer (BC) reported prognostic outcomes similar to that of women without a pregnancy.

Major finding: The cumulative incidence of pregnancy was 22% at 10 years. The disease-free survival outcomes were comparable between patients with BC who did vs did not become pregnant (adjusted hazard ratio 0.99; P = .90).

Study details: Findings are from a retrospective cohort study including 4732 young women age ≤ 40 years with a history of BC who had germline pathogenic BRCA mutations, of whom 659 women reported ≥1 pregnancy after BC.

Disclosures: The study was partly supported by the Italian Association for Cancer Research and the 2022 Gilead Research Scholars Program in Solid Tumors. The authors declared receiving speaker honoraria, travel grants, research funding, or speaker fees from and having other ties with Gilead and several other sources.

Source: Lambertini M et al. Pregnancy after breast cancer in young BRCA carriers: An international hospital-based cohort study. JAMA. 2023 (Dec 7). doi: 10.1001/jama.2023.25463

Key clinical point: Women with germline BRCA1 or BRCA2 pathogenic mutations who had a pregnancy after diagnosis of early breast cancer (BC) reported prognostic outcomes similar to that of women without a pregnancy.

Major finding: The cumulative incidence of pregnancy was 22% at 10 years. The disease-free survival outcomes were comparable between patients with BC who did vs did not become pregnant (adjusted hazard ratio 0.99; P = .90).

Study details: Findings are from a retrospective cohort study including 4732 young women age ≤ 40 years with a history of BC who had germline pathogenic BRCA mutations, of whom 659 women reported ≥1 pregnancy after BC.

Disclosures: The study was partly supported by the Italian Association for Cancer Research and the 2022 Gilead Research Scholars Program in Solid Tumors. The authors declared receiving speaker honoraria, travel grants, research funding, or speaker fees from and having other ties with Gilead and several other sources.

Source: Lambertini M et al. Pregnancy after breast cancer in young BRCA carriers: An international hospital-based cohort study. JAMA. 2023 (Dec 7). doi: 10.1001/jama.2023.25463

Key clinical point: Women with germline BRCA1 or BRCA2 pathogenic mutations who had a pregnancy after diagnosis of early breast cancer (BC) reported prognostic outcomes similar to that of women without a pregnancy.

Major finding: The cumulative incidence of pregnancy was 22% at 10 years. The disease-free survival outcomes were comparable between patients with BC who did vs did not become pregnant (adjusted hazard ratio 0.99; P = .90).

Study details: Findings are from a retrospective cohort study including 4732 young women age ≤ 40 years with a history of BC who had germline pathogenic BRCA mutations, of whom 659 women reported ≥1 pregnancy after BC.

Disclosures: The study was partly supported by the Italian Association for Cancer Research and the 2022 Gilead Research Scholars Program in Solid Tumors. The authors declared receiving speaker honoraria, travel grants, research funding, or speaker fees from and having other ties with Gilead and several other sources.

Source: Lambertini M et al. Pregnancy after breast cancer in young BRCA carriers: An international hospital-based cohort study. JAMA. 2023 (Dec 7). doi: 10.1001/jama.2023.25463

In September 2023, Goldman et al. published a communication in Dermatologic Surgery describing their use of subcutaneous sodium deoxycholate injection (SDOC), with or without triamcinolone acetonide, for reduction of submental fat.Because of the variability and severity of postprocedure edema with SDOC treatment, they hypothesized that injection of triamcinolone in conjunction with SDOC (Kybella) would improve posttreatment edema and patient tolerability.

As they note, “patients experience a variable degree of edema and discomfort following subcutaneous injection,” of SDOC, something that I and others have also observed in our practices.

In their double-blind study of 20 patients with a baseline Clinician-Reported Submental Fat Rating Scale of 2 or 3 out of 4, 5 patients were randomized to receive SDOC as recommended in the label, while 15 received SDOC plus triamcinolone. In the latter group, 2 mL of SDOC was mixed with 0.5 mL of 40 mg/mL of triamcinolone acetate, then administered in up to 50 injections in the submentum spaced 1.0 cm apart at 0.25 mL per injection. Three treatments were administered 1 month apart.

For both groups, volumes between 5 mL and 8 mL per treatment were delivered. There were no significant differences in efficacy 30, 60, and 90 days after the final injection between the two groups. However, at day 180, the group that received only SDOC had a significantly greater reduction in submental fat, which the authors wrote indicated that the addition of triamcinolone “may mildly diminish the fat reduction effects” at that time point.

Subcutaneous SDOC (deoxycholic acid) injections for reduction of submental fullness was approved by the Food and Drug Administration in 2015 for improving the appearance of moderate to severe convexity or fullness associated with submental fat in adults. (I was involved in the clinical trials.) We found that in the trial, for optimal efficacy, most patients require two to four treatments spread at least a month apart, with patients who had larger treatment areas requiring up to six treatments.

While the clinical trial treatments were spaced 4 weeks apart, post approval, we found that patients would sometimes report further efficacy even 2-3 months post injection. Since not everyone wants to go around with edema every month for 2-4 consecutive months, spacing the treatments farther apart allows patients more time to heal and coordinate the recovery appearance around their work and social schedules.

In my practice, very rarely have we seen minimal to moderate prolonged edema, particularly in younger patients, beyond 1 month post injection. Most people have the most noticeable edema — the “bull-frog” appearance — for the first 1-3 days, with some minor fullness that appears to be almost back to baseline at 1 week. In some of these patients with prolonged submental fullness, it looks fuller than it appeared pretreatment even months afterwards.

While rare, like the study authors, I have found intralesional triamcinolone to be helpful at reducing this persistent fullness should it occur. It is likely to be reducing any persistent inflammation or posttreatment fibrosis in these patients.

Unlike the study authors, I do not combine SDOC and triamcinolone injections at the time of treatment. Rather, I consider injecting triamcinolone if submental fullness is greater than at baseline or edema persists after SDOC treatment. It is rare that I’ve had to do this, as most cases self-resolve, but I have used triamcinolone 10 mg/mL, up to 1cc total, injected 6-8 weeks apart one to three times to the affected area and found it to be effective if fullness has persisted beyond 6 months. Liposuction may also be an option, if needed, if fullness/edema persists.

Overall, SDOC is an effective treatment for small pockets of subcutaneous fat. Approved for submental fullness, it is now sometimes used off-label for other parts of the body, such as bra fat, small pockets of the abdomen, and lipomas. While some inflammation after treatment is expected — and desired — to achieve an effective outcome of fat apoptosis, intralesional triamcinolone is an interesting tool to utilize should inflammation or posttreatment fullness persist.

Dr. Wesley practices dermatology in Beverly Hills, California. Write to her at dermnews@mdedge.com. She was an investigator in clinical trials of Kybella.

In September 2023, Goldman et al. published a communication in Dermatologic Surgery describing their use of subcutaneous sodium deoxycholate injection (SDOC), with or without triamcinolone acetonide, for reduction of submental fat.Because of the variability and severity of postprocedure edema with SDOC treatment, they hypothesized that injection of triamcinolone in conjunction with SDOC (Kybella) would improve posttreatment edema and patient tolerability.

As they note, “patients experience a variable degree of edema and discomfort following subcutaneous injection,” of SDOC, something that I and others have also observed in our practices.

In their double-blind study of 20 patients with a baseline Clinician-Reported Submental Fat Rating Scale of 2 or 3 out of 4, 5 patients were randomized to receive SDOC as recommended in the label, while 15 received SDOC plus triamcinolone. In the latter group, 2 mL of SDOC was mixed with 0.5 mL of 40 mg/mL of triamcinolone acetate, then administered in up to 50 injections in the submentum spaced 1.0 cm apart at 0.25 mL per injection. Three treatments were administered 1 month apart.

For both groups, volumes between 5 mL and 8 mL per treatment were delivered. There were no significant differences in efficacy 30, 60, and 90 days after the final injection between the two groups. However, at day 180, the group that received only SDOC had a significantly greater reduction in submental fat, which the authors wrote indicated that the addition of triamcinolone “may mildly diminish the fat reduction effects” at that time point.

Subcutaneous SDOC (deoxycholic acid) injections for reduction of submental fullness was approved by the Food and Drug Administration in 2015 for improving the appearance of moderate to severe convexity or fullness associated with submental fat in adults. (I was involved in the clinical trials.) We found that in the trial, for optimal efficacy, most patients require two to four treatments spread at least a month apart, with patients who had larger treatment areas requiring up to six treatments.

While the clinical trial treatments were spaced 4 weeks apart, post approval, we found that patients would sometimes report further efficacy even 2-3 months post injection. Since not everyone wants to go around with edema every month for 2-4 consecutive months, spacing the treatments farther apart allows patients more time to heal and coordinate the recovery appearance around their work and social schedules.

In my practice, very rarely have we seen minimal to moderate prolonged edema, particularly in younger patients, beyond 1 month post injection. Most people have the most noticeable edema — the “bull-frog” appearance — for the first 1-3 days, with some minor fullness that appears to be almost back to baseline at 1 week. In some of these patients with prolonged submental fullness, it looks fuller than it appeared pretreatment even months afterwards.

While rare, like the study authors, I have found intralesional triamcinolone to be helpful at reducing this persistent fullness should it occur. It is likely to be reducing any persistent inflammation or posttreatment fibrosis in these patients.

Unlike the study authors, I do not combine SDOC and triamcinolone injections at the time of treatment. Rather, I consider injecting triamcinolone if submental fullness is greater than at baseline or edema persists after SDOC treatment. It is rare that I’ve had to do this, as most cases self-resolve, but I have used triamcinolone 10 mg/mL, up to 1cc total, injected 6-8 weeks apart one to three times to the affected area and found it to be effective if fullness has persisted beyond 6 months. Liposuction may also be an option, if needed, if fullness/edema persists.

Overall, SDOC is an effective treatment for small pockets of subcutaneous fat. Approved for submental fullness, it is now sometimes used off-label for other parts of the body, such as bra fat, small pockets of the abdomen, and lipomas. While some inflammation after treatment is expected — and desired — to achieve an effective outcome of fat apoptosis, intralesional triamcinolone is an interesting tool to utilize should inflammation or posttreatment fullness persist.

Dr. Wesley practices dermatology in Beverly Hills, California. Write to her at dermnews@mdedge.com. She was an investigator in clinical trials of Kybella.

In September 2023, Goldman et al. published a communication in Dermatologic Surgery describing their use of subcutaneous sodium deoxycholate injection (SDOC), with or without triamcinolone acetonide, for reduction of submental fat.Because of the variability and severity of postprocedure edema with SDOC treatment, they hypothesized that injection of triamcinolone in conjunction with SDOC (Kybella) would improve posttreatment edema and patient tolerability.

As they note, “patients experience a variable degree of edema and discomfort following subcutaneous injection,” of SDOC, something that I and others have also observed in our practices.

In their double-blind study of 20 patients with a baseline Clinician-Reported Submental Fat Rating Scale of 2 or 3 out of 4, 5 patients were randomized to receive SDOC as recommended in the label, while 15 received SDOC plus triamcinolone. In the latter group, 2 mL of SDOC was mixed with 0.5 mL of 40 mg/mL of triamcinolone acetate, then administered in up to 50 injections in the submentum spaced 1.0 cm apart at 0.25 mL per injection. Three treatments were administered 1 month apart.

For both groups, volumes between 5 mL and 8 mL per treatment were delivered. There were no significant differences in efficacy 30, 60, and 90 days after the final injection between the two groups. However, at day 180, the group that received only SDOC had a significantly greater reduction in submental fat, which the authors wrote indicated that the addition of triamcinolone “may mildly diminish the fat reduction effects” at that time point.

Subcutaneous SDOC (deoxycholic acid) injections for reduction of submental fullness was approved by the Food and Drug Administration in 2015 for improving the appearance of moderate to severe convexity or fullness associated with submental fat in adults. (I was involved in the clinical trials.) We found that in the trial, for optimal efficacy, most patients require two to four treatments spread at least a month apart, with patients who had larger treatment areas requiring up to six treatments.

While the clinical trial treatments were spaced 4 weeks apart, post approval, we found that patients would sometimes report further efficacy even 2-3 months post injection. Since not everyone wants to go around with edema every month for 2-4 consecutive months, spacing the treatments farther apart allows patients more time to heal and coordinate the recovery appearance around their work and social schedules.

In my practice, very rarely have we seen minimal to moderate prolonged edema, particularly in younger patients, beyond 1 month post injection. Most people have the most noticeable edema — the “bull-frog” appearance — for the first 1-3 days, with some minor fullness that appears to be almost back to baseline at 1 week. In some of these patients with prolonged submental fullness, it looks fuller than it appeared pretreatment even months afterwards.

While rare, like the study authors, I have found intralesional triamcinolone to be helpful at reducing this persistent fullness should it occur. It is likely to be reducing any persistent inflammation or posttreatment fibrosis in these patients.

Unlike the study authors, I do not combine SDOC and triamcinolone injections at the time of treatment. Rather, I consider injecting triamcinolone if submental fullness is greater than at baseline or edema persists after SDOC treatment. It is rare that I’ve had to do this, as most cases self-resolve, but I have used triamcinolone 10 mg/mL, up to 1cc total, injected 6-8 weeks apart one to three times to the affected area and found it to be effective if fullness has persisted beyond 6 months. Liposuction may also be an option, if needed, if fullness/edema persists.

Overall, SDOC is an effective treatment for small pockets of subcutaneous fat. Approved for submental fullness, it is now sometimes used off-label for other parts of the body, such as bra fat, small pockets of the abdomen, and lipomas. While some inflammation after treatment is expected — and desired — to achieve an effective outcome of fat apoptosis, intralesional triamcinolone is an interesting tool to utilize should inflammation or posttreatment fullness persist.

Dr. Wesley practices dermatology in Beverly Hills, California. Write to her at dermnews@mdedge.com. She was an investigator in clinical trials of Kybella.