Breast Cancer

Key clinical point: In patients with early-stage breast cancer (BC), breast conserving surgery with radiotherapy (BCT) provided a significant survival advantage over total mastectomy (TM) without increasing the rates of locoregional recurrence.

Major finding: BCT vs TM improved overall survival by 37% (hazard ratio [HR] 1.37; P < .001) and BC-specific survival by 49% (HR 1.49; P < .001), with rates of locoregional recurrence (P > .9) being comparable between the groups.

Study details: This study analyzed the data of 12,456 patients with pT1-2 pN0 BC from a prospectively maintained database, of which 8422 and 4034 patients underwent BCT and TM, respectively.

Disclosures: This study did not report the source of funding. The authors did not report any conflicts of interest.

Source: Vasilyeva E et al. Breast conserving surgery combined with radiation therapy offers improved survival over mastectomy in early-stage breast cancer. Am J Surg. 2023 (May 22). doi: 10.1016/j.amjsurg.2023.05.005

Key clinical point: In patients with early-stage breast cancer (BC), breast conserving surgery with radiotherapy (BCT) provided a significant survival advantage over total mastectomy (TM) without increasing the rates of locoregional recurrence.

Major finding: BCT vs TM improved overall survival by 37% (hazard ratio [HR] 1.37; P < .001) and BC-specific survival by 49% (HR 1.49; P < .001), with rates of locoregional recurrence (P > .9) being comparable between the groups.

Study details: This study analyzed the data of 12,456 patients with pT1-2 pN0 BC from a prospectively maintained database, of which 8422 and 4034 patients underwent BCT and TM, respectively.

Disclosures: This study did not report the source of funding. The authors did not report any conflicts of interest.

Source: Vasilyeva E et al. Breast conserving surgery combined with radiation therapy offers improved survival over mastectomy in early-stage breast cancer. Am J Surg. 2023 (May 22). doi: 10.1016/j.amjsurg.2023.05.005

Key clinical point: In patients with early-stage breast cancer (BC), breast conserving surgery with radiotherapy (BCT) provided a significant survival advantage over total mastectomy (TM) without increasing the rates of locoregional recurrence.

Major finding: BCT vs TM improved overall survival by 37% (hazard ratio [HR] 1.37; P < .001) and BC-specific survival by 49% (HR 1.49; P < .001), with rates of locoregional recurrence (P > .9) being comparable between the groups.

Study details: This study analyzed the data of 12,456 patients with pT1-2 pN0 BC from a prospectively maintained database, of which 8422 and 4034 patients underwent BCT and TM, respectively.

Disclosures: This study did not report the source of funding. The authors did not report any conflicts of interest.

Source: Vasilyeva E et al. Breast conserving surgery combined with radiation therapy offers improved survival over mastectomy in early-stage breast cancer. Am J Surg. 2023 (May 22). doi: 10.1016/j.amjsurg.2023.05.005

Key clinical point: Men with a family history of breast cancer (FHBC) in either mother or sister are at a higher risk of developing pancreatic, thyroid, prostate, and breast cancers than men without FHBC and, therefore, may need more vigilant cancer surveillance.

Major finding: An FHBC in both mother and sister was associated with an increased overall cancer risk (hazard ratio [HR] 1.69; 95% CI 1.11-2.57), whereas an FHBC in either mother or sister significantly increased the risk of developing pancreatic cancer (HR 1.35; 95% CI 1.07-1.70), breast cancer (HR 3.03; 95% CI 1.13-8.17), thyroid cancer (HR 1.33; 95% CI 1.12-1.56), and prostate cancer (HR 1.28; 95% CI 1.13-1.44).

Study details: Findings are from a population-based study including 2,734,889 men aged ≥40 years, of which 69,124 men had a FHBC in their mother or sister and 276,496 men had no history of cancer in any of their first-degree relatives.

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

Source: Song H, Jung YS, et al. Increased risk of pancreatic, thyroid, prostate and breast cancers in men with a family history of breast cancer: A population-based study. Int J Cancer. 2023 (May 29). doi: 10.1002/ijc.34573

Key clinical point: Men with a family history of breast cancer (FHBC) in either mother or sister are at a higher risk of developing pancreatic, thyroid, prostate, and breast cancers than men without FHBC and, therefore, may need more vigilant cancer surveillance.

Major finding: An FHBC in both mother and sister was associated with an increased overall cancer risk (hazard ratio [HR] 1.69; 95% CI 1.11-2.57), whereas an FHBC in either mother or sister significantly increased the risk of developing pancreatic cancer (HR 1.35; 95% CI 1.07-1.70), breast cancer (HR 3.03; 95% CI 1.13-8.17), thyroid cancer (HR 1.33; 95% CI 1.12-1.56), and prostate cancer (HR 1.28; 95% CI 1.13-1.44).

Study details: Findings are from a population-based study including 2,734,889 men aged ≥40 years, of which 69,124 men had a FHBC in their mother or sister and 276,496 men had no history of cancer in any of their first-degree relatives.

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

Source: Song H, Jung YS, et al. Increased risk of pancreatic, thyroid, prostate and breast cancers in men with a family history of breast cancer: A population-based study. Int J Cancer. 2023 (May 29). doi: 10.1002/ijc.34573

Key clinical point: Men with a family history of breast cancer (FHBC) in either mother or sister are at a higher risk of developing pancreatic, thyroid, prostate, and breast cancers than men without FHBC and, therefore, may need more vigilant cancer surveillance.

Major finding: An FHBC in both mother and sister was associated with an increased overall cancer risk (hazard ratio [HR] 1.69; 95% CI 1.11-2.57), whereas an FHBC in either mother or sister significantly increased the risk of developing pancreatic cancer (HR 1.35; 95% CI 1.07-1.70), breast cancer (HR 3.03; 95% CI 1.13-8.17), thyroid cancer (HR 1.33; 95% CI 1.12-1.56), and prostate cancer (HR 1.28; 95% CI 1.13-1.44).

Study details: Findings are from a population-based study including 2,734,889 men aged ≥40 years, of which 69,124 men had a FHBC in their mother or sister and 276,496 men had no history of cancer in any of their first-degree relatives.

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

Source: Song H, Jung YS, et al. Increased risk of pancreatic, thyroid, prostate and breast cancers in men with a family history of breast cancer: A population-based study. Int J Cancer. 2023 (May 29). doi: 10.1002/ijc.34573

Key clinical point: Low vs no human epidermal growth factor receptor 2 (ERBB2, aka HER2) expression had no impact on survival outcomes in patients with hormone receptor-positive (HR+) metastatic breast cancer (BC) who were treated with targeted therapy (TT) plus endocrine therapy (ET).

Major finding: After a median follow-up of 17.9 months, both progression-free survival (P = .43) and overall survival (P = .41) were not significantly different between patients with low and no ERBB2 expression.

Study details: Findings are from an analysis of 1585 patients with HR+ metastatic BC treated with TT+ET from an institutional review board-approved breast cancer database, of which 572 and 1013 patients had no and low ERBB2 expression, respectively.

Disclosures: This study was supported by the National Cancer Institute and other sources. Some authors declared receiving personal fees, grants, or nonfinancial support from several sources.

Source: Mouabbi JA et al. Survival outcomes in patients with hormone receptor-positive metastatic breast cancer with low or no ERBB2 expression treated with targeted therapies plus endocrine therapy. JAMA Netw Open. 2023;6:e2313017 (May 11). doi: 10.1001/jamanetworkopen.2023.13017

Key clinical point: Low vs no human epidermal growth factor receptor 2 (ERBB2, aka HER2) expression had no impact on survival outcomes in patients with hormone receptor-positive (HR+) metastatic breast cancer (BC) who were treated with targeted therapy (TT) plus endocrine therapy (ET).

Major finding: After a median follow-up of 17.9 months, both progression-free survival (P = .43) and overall survival (P = .41) were not significantly different between patients with low and no ERBB2 expression.

Study details: Findings are from an analysis of 1585 patients with HR+ metastatic BC treated with TT+ET from an institutional review board-approved breast cancer database, of which 572 and 1013 patients had no and low ERBB2 expression, respectively.

Disclosures: This study was supported by the National Cancer Institute and other sources. Some authors declared receiving personal fees, grants, or nonfinancial support from several sources.

Source: Mouabbi JA et al. Survival outcomes in patients with hormone receptor-positive metastatic breast cancer with low or no ERBB2 expression treated with targeted therapies plus endocrine therapy. JAMA Netw Open. 2023;6:e2313017 (May 11). doi: 10.1001/jamanetworkopen.2023.13017

Key clinical point: Low vs no human epidermal growth factor receptor 2 (ERBB2, aka HER2) expression had no impact on survival outcomes in patients with hormone receptor-positive (HR+) metastatic breast cancer (BC) who were treated with targeted therapy (TT) plus endocrine therapy (ET).

Major finding: After a median follow-up of 17.9 months, both progression-free survival (P = .43) and overall survival (P = .41) were not significantly different between patients with low and no ERBB2 expression.

Study details: Findings are from an analysis of 1585 patients with HR+ metastatic BC treated with TT+ET from an institutional review board-approved breast cancer database, of which 572 and 1013 patients had no and low ERBB2 expression, respectively.

Disclosures: This study was supported by the National Cancer Institute and other sources. Some authors declared receiving personal fees, grants, or nonfinancial support from several sources.

Source: Mouabbi JA et al. Survival outcomes in patients with hormone receptor-positive metastatic breast cancer with low or no ERBB2 expression treated with targeted therapies plus endocrine therapy. JAMA Netw Open. 2023;6:e2313017 (May 11). doi: 10.1001/jamanetworkopen.2023.13017

Key clinical point: In postmenopausal women with early-stage hormone receptor-positive (HR+) breast cancer (BC) who were disease free after 5 years of endocrine therapy (ET), extended adjuvant treatment with letrozole for 5 years led to improved disease-free survival (DFS) at >10-year median follow-up.

Major finding: After median follow-up of 10.3 years, letrozole vs placebo significantly improved DFS (10-year absolute benefit 3.4%; hazard ratio 0.85; P = .01). There were no notable differences in toxicity outcomes between the groups.

Study details: Findings are from the phase 3 National Surgical Adjuvant Breast and Bowel Project B-42 trial including 3966 postmenopausal women with stage I-IIIA HR+ BC who were disease free after 5 years of adjuvant ET and were randomly assigned to receive letrozole or placebo for 5 more years.

Disclosures: This study was funded by Novartis and others. Some authors declared receiving grants, honoraria, travel support, or consulting fees or serving on advisory boards or data and safety monitoring boards for various sources, including Novartis.

Source: Mamounas EP et al. Ten-year update: NRG Oncology/NSABP B-42 randomized trial: Extended letrozole therapy in early-stage breast cancer. J Natl Cancer Inst. 2023 (May 15). doi: 10.1093/jnci/djad078

Key clinical point: In postmenopausal women with early-stage hormone receptor-positive (HR+) breast cancer (BC) who were disease free after 5 years of endocrine therapy (ET), extended adjuvant treatment with letrozole for 5 years led to improved disease-free survival (DFS) at >10-year median follow-up.

Major finding: After median follow-up of 10.3 years, letrozole vs placebo significantly improved DFS (10-year absolute benefit 3.4%; hazard ratio 0.85; P = .01). There were no notable differences in toxicity outcomes between the groups.

Study details: Findings are from the phase 3 National Surgical Adjuvant Breast and Bowel Project B-42 trial including 3966 postmenopausal women with stage I-IIIA HR+ BC who were disease free after 5 years of adjuvant ET and were randomly assigned to receive letrozole or placebo for 5 more years.

Disclosures: This study was funded by Novartis and others. Some authors declared receiving grants, honoraria, travel support, or consulting fees or serving on advisory boards or data and safety monitoring boards for various sources, including Novartis.

Source: Mamounas EP et al. Ten-year update: NRG Oncology/NSABP B-42 randomized trial: Extended letrozole therapy in early-stage breast cancer. J Natl Cancer Inst. 2023 (May 15). doi: 10.1093/jnci/djad078

Key clinical point: In postmenopausal women with early-stage hormone receptor-positive (HR+) breast cancer (BC) who were disease free after 5 years of endocrine therapy (ET), extended adjuvant treatment with letrozole for 5 years led to improved disease-free survival (DFS) at >10-year median follow-up.

Major finding: After median follow-up of 10.3 years, letrozole vs placebo significantly improved DFS (10-year absolute benefit 3.4%; hazard ratio 0.85; P = .01). There were no notable differences in toxicity outcomes between the groups.

Study details: Findings are from the phase 3 National Surgical Adjuvant Breast and Bowel Project B-42 trial including 3966 postmenopausal women with stage I-IIIA HR+ BC who were disease free after 5 years of adjuvant ET and were randomly assigned to receive letrozole or placebo for 5 more years.

Disclosures: This study was funded by Novartis and others. Some authors declared receiving grants, honoraria, travel support, or consulting fees or serving on advisory boards or data and safety monitoring boards for various sources, including Novartis.

Source: Mamounas EP et al. Ten-year update: NRG Oncology/NSABP B-42 randomized trial: Extended letrozole therapy in early-stage breast cancer. J Natl Cancer Inst. 2023 (May 15). doi: 10.1093/jnci/djad078

Key clinical point: Adding cyclin-dependent kinase 4/6 (CDK4/6) inhibitors to endocrine therapy (ET) improved survival outcomes in elderly patients aged ≥65 years with advanced estrogen receptor-positive (ER+) breast cancer (BC).

Major finding: Adding CDK4/6 inhibitors to ET (letrozole or fulvestrant) significantly reduced the mortality risk by 21% (hazard ratio [HR] 0.79; 95% CI 0.69-0.91) and progression risk by 41% (HR 0.59; 95% CI 0.51-0.69) in older patients aged >65 years with BC.

Study details: Findings are from a meta-analysis of 10 trials including 1985 older patients with advanced ER+ BC who received ET with or without CDK4/6 inhibitors.

Disclosures: This study did not report the source of funding. The authors did not declare any conflicts of interest.

Source: Petrelli F et al. The role of CDK4/6 inhibitors in older and younger patients with breast cancer: A systematic review and meta-analysis. Breast. 2023 (May 12). doi: 10.1016/j.breast.2023.05.002

Key clinical point: Adding cyclin-dependent kinase 4/6 (CDK4/6) inhibitors to endocrine therapy (ET) improved survival outcomes in elderly patients aged ≥65 years with advanced estrogen receptor-positive (ER+) breast cancer (BC).

Major finding: Adding CDK4/6 inhibitors to ET (letrozole or fulvestrant) significantly reduced the mortality risk by 21% (hazard ratio [HR] 0.79; 95% CI 0.69-0.91) and progression risk by 41% (HR 0.59; 95% CI 0.51-0.69) in older patients aged >65 years with BC.

Study details: Findings are from a meta-analysis of 10 trials including 1985 older patients with advanced ER+ BC who received ET with or without CDK4/6 inhibitors.

Disclosures: This study did not report the source of funding. The authors did not declare any conflicts of interest.

Source: Petrelli F et al. The role of CDK4/6 inhibitors in older and younger patients with breast cancer: A systematic review and meta-analysis. Breast. 2023 (May 12). doi: 10.1016/j.breast.2023.05.002

Key clinical point: Adding cyclin-dependent kinase 4/6 (CDK4/6) inhibitors to endocrine therapy (ET) improved survival outcomes in elderly patients aged ≥65 years with advanced estrogen receptor-positive (ER+) breast cancer (BC).

Major finding: Adding CDK4/6 inhibitors to ET (letrozole or fulvestrant) significantly reduced the mortality risk by 21% (hazard ratio [HR] 0.79; 95% CI 0.69-0.91) and progression risk by 41% (HR 0.59; 95% CI 0.51-0.69) in older patients aged >65 years with BC.

Study details: Findings are from a meta-analysis of 10 trials including 1985 older patients with advanced ER+ BC who received ET with or without CDK4/6 inhibitors.

Disclosures: This study did not report the source of funding. The authors did not declare any conflicts of interest.

Source: Petrelli F et al. The role of CDK4/6 inhibitors in older and younger patients with breast cancer: A systematic review and meta-analysis. Breast. 2023 (May 12). doi: 10.1016/j.breast.2023.05.002

Key clinical point: Compared with whole breast irradiation (WBI), partial breast irradiation (PBI) led to a similar rate of ipsilateral breast recurrences (IBR) and demonstrated a better toxicity profile in patients with early-stage breast cancer (BC).

Major finding: Rate of IBR was comparable with PBI vs WBI at 5 years (relative risk [RR] 1.34; 95% CI 0.83-2.18) and 10 years (RR 1.29; 95% CI 0.87-1.91). Patients undergoing PBI vs WBI reported fewer acute adverse events (AE; incidence rate ratio [IRR] 0.53; 95% CI 0.31-0.92) and acute grade ≥2 AE (IRR 0.21; 95% CI 0.07-0.62).

Study details: Findings are from a meta-analysis of 14 randomized controlled trials and six comparative observational studies comparing any PBI modality with WBI in 17,234 adults with early-stage BC.

Disclosures: This study was supported by the US Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Shumway DA et al. Partial breast irradiation compared with whole breast irradiation: A systematic review and meta-analysis. J Natl Cancer Inst. 2023 (Jun 8). doi: 10.1093/jnci/djad100

Key clinical point: Compared with whole breast irradiation (WBI), partial breast irradiation (PBI) led to a similar rate of ipsilateral breast recurrences (IBR) and demonstrated a better toxicity profile in patients with early-stage breast cancer (BC).

Major finding: Rate of IBR was comparable with PBI vs WBI at 5 years (relative risk [RR] 1.34; 95% CI 0.83-2.18) and 10 years (RR 1.29; 95% CI 0.87-1.91). Patients undergoing PBI vs WBI reported fewer acute adverse events (AE; incidence rate ratio [IRR] 0.53; 95% CI 0.31-0.92) and acute grade ≥2 AE (IRR 0.21; 95% CI 0.07-0.62).

Study details: Findings are from a meta-analysis of 14 randomized controlled trials and six comparative observational studies comparing any PBI modality with WBI in 17,234 adults with early-stage BC.

Disclosures: This study was supported by the US Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Shumway DA et al. Partial breast irradiation compared with whole breast irradiation: A systematic review and meta-analysis. J Natl Cancer Inst. 2023 (Jun 8). doi: 10.1093/jnci/djad100

Key clinical point: Compared with whole breast irradiation (WBI), partial breast irradiation (PBI) led to a similar rate of ipsilateral breast recurrences (IBR) and demonstrated a better toxicity profile in patients with early-stage breast cancer (BC).

Major finding: Rate of IBR was comparable with PBI vs WBI at 5 years (relative risk [RR] 1.34; 95% CI 0.83-2.18) and 10 years (RR 1.29; 95% CI 0.87-1.91). Patients undergoing PBI vs WBI reported fewer acute adverse events (AE; incidence rate ratio [IRR] 0.53; 95% CI 0.31-0.92) and acute grade ≥2 AE (IRR 0.21; 95% CI 0.07-0.62).

Study details: Findings are from a meta-analysis of 14 randomized controlled trials and six comparative observational studies comparing any PBI modality with WBI in 17,234 adults with early-stage BC.

Disclosures: This study was supported by the US Agency for Healthcare Research and Quality. The authors declared no conflicts of interest.

Source: Shumway DA et al. Partial breast irradiation compared with whole breast irradiation: A systematic review and meta-analysis. J Natl Cancer Inst. 2023 (Jun 8). doi: 10.1093/jnci/djad100

Key clinical point: Targeted axillary dissection (TAD) after neoadjuvant systemic therapy was oncologically safe and led to excellent clinical outcomes in patients with node-positive early breast cancer (BC) who did not undergo axillary lymph node dissection (ALND).

Major finding: TAD alone vs TAD plus ALND was not associated with a higher risk for invasive disease-free survival (adjusted hazard ratio [aHR] 0.83; P = .69) and overall survival (aHR 1.07; P = .91).

Study details: Findings are from a cohort study including 199 patients with clinical stage T1-T4, node-positive early BC without distant metastases who underwent TAD with (40.2%) or without (59.8%) further axillary surgery.

Disclosures: The clips used to mark the targeted lymph nodes were provided for free by Tumark Vision (SOMATEX) and O-Twist (BIP). The authors declared receiving personal fees, honoraria, research funding, or other nonfinancial supports from various sources.

Source: Kuemmel S et al. Safety of targeted axillary dissection after neoadjuvant therapy in patients with node-positive breast cancer. JAMA Surg. 2023 (Jun 7). doi: 10.1001/jamasurg.2023.1772

Key clinical point: Targeted axillary dissection (TAD) after neoadjuvant systemic therapy was oncologically safe and led to excellent clinical outcomes in patients with node-positive early breast cancer (BC) who did not undergo axillary lymph node dissection (ALND).

Major finding: TAD alone vs TAD plus ALND was not associated with a higher risk for invasive disease-free survival (adjusted hazard ratio [aHR] 0.83; P = .69) and overall survival (aHR 1.07; P = .91).

Study details: Findings are from a cohort study including 199 patients with clinical stage T1-T4, node-positive early BC without distant metastases who underwent TAD with (40.2%) or without (59.8%) further axillary surgery.

Disclosures: The clips used to mark the targeted lymph nodes were provided for free by Tumark Vision (SOMATEX) and O-Twist (BIP). The authors declared receiving personal fees, honoraria, research funding, or other nonfinancial supports from various sources.

Source: Kuemmel S et al. Safety of targeted axillary dissection after neoadjuvant therapy in patients with node-positive breast cancer. JAMA Surg. 2023 (Jun 7). doi: 10.1001/jamasurg.2023.1772

Key clinical point: Targeted axillary dissection (TAD) after neoadjuvant systemic therapy was oncologically safe and led to excellent clinical outcomes in patients with node-positive early breast cancer (BC) who did not undergo axillary lymph node dissection (ALND).

Major finding: TAD alone vs TAD plus ALND was not associated with a higher risk for invasive disease-free survival (adjusted hazard ratio [aHR] 0.83; P = .69) and overall survival (aHR 1.07; P = .91).

Study details: Findings are from a cohort study including 199 patients with clinical stage T1-T4, node-positive early BC without distant metastases who underwent TAD with (40.2%) or without (59.8%) further axillary surgery.

Disclosures: The clips used to mark the targeted lymph nodes were provided for free by Tumark Vision (SOMATEX) and O-Twist (BIP). The authors declared receiving personal fees, honoraria, research funding, or other nonfinancial supports from various sources.

Source: Kuemmel S et al. Safety of targeted axillary dissection after neoadjuvant therapy in patients with node-positive breast cancer. JAMA Surg. 2023 (Jun 7). doi: 10.1001/jamasurg.2023.1772

Key clinical point: In addition to switching endocrine therapy (ET), continuing the cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with ribociclib therapy vs placebo demonstrated progression-free survival (PFS) benefits in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) who had progressed on previous ET and CDK4/6i.

Major finding: At a median follow-up of 18.2 months, a significant improvement in PFS was observed in the ET+ribociclib+CDK4/6i vs ET+placebo group (hazard ratio 0.57; P = .006). ET+ribociclib+CDK4/6i demonstrated a manageable safety profile.

Study details: Findings are from the phase 2 MAINTAIN trial including 119 patients with HR+/HER2− metastatic BC who progressed on ET and CDK4/6i and were randomly assigned to receive a different ET with ribociclib plus CDK4/6i or placebo.

Disclosures: This study was supported by Novartis Pharmaceuticals and other sources. The authors declared no conflicts of interest.

Source: Kalinsky K et al. Randomized phase II trial of endocrine therapy with or without ribociclib after progression on cyclin-dependent kinase 4/6 inhibition in hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: MAINTAIN trial. J Clin Oncol. 2023 (May 19). doi: 10.1200/JCO.22.02392

Key clinical point: In addition to switching endocrine therapy (ET), continuing the cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with ribociclib therapy vs placebo demonstrated progression-free survival (PFS) benefits in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) who had progressed on previous ET and CDK4/6i.

Major finding: At a median follow-up of 18.2 months, a significant improvement in PFS was observed in the ET+ribociclib+CDK4/6i vs ET+placebo group (hazard ratio 0.57; P = .006). ET+ribociclib+CDK4/6i demonstrated a manageable safety profile.

Study details: Findings are from the phase 2 MAINTAIN trial including 119 patients with HR+/HER2− metastatic BC who progressed on ET and CDK4/6i and were randomly assigned to receive a different ET with ribociclib plus CDK4/6i or placebo.

Disclosures: This study was supported by Novartis Pharmaceuticals and other sources. The authors declared no conflicts of interest.

Source: Kalinsky K et al. Randomized phase II trial of endocrine therapy with or without ribociclib after progression on cyclin-dependent kinase 4/6 inhibition in hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: MAINTAIN trial. J Clin Oncol. 2023 (May 19). doi: 10.1200/JCO.22.02392

Key clinical point: In addition to switching endocrine therapy (ET), continuing the cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with ribociclib therapy vs placebo demonstrated progression-free survival (PFS) benefits in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) who had progressed on previous ET and CDK4/6i.

Major finding: At a median follow-up of 18.2 months, a significant improvement in PFS was observed in the ET+ribociclib+CDK4/6i vs ET+placebo group (hazard ratio 0.57; P = .006). ET+ribociclib+CDK4/6i demonstrated a manageable safety profile.

Study details: Findings are from the phase 2 MAINTAIN trial including 119 patients with HR+/HER2− metastatic BC who progressed on ET and CDK4/6i and were randomly assigned to receive a different ET with ribociclib plus CDK4/6i or placebo.

Disclosures: This study was supported by Novartis Pharmaceuticals and other sources. The authors declared no conflicts of interest.

Source: Kalinsky K et al. Randomized phase II trial of endocrine therapy with or without ribociclib after progression on cyclin-dependent kinase 4/6 inhibition in hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: MAINTAIN trial. J Clin Oncol. 2023 (May 19). doi: 10.1200/JCO.22.02392

Key clinical point: Dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor, plus letrozole or anastrozole demonstrated progression-free survival (PFS) benefits and a manageable safety profile in untreated patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A 12.4-month improvement in PFS was observed with dalpiciclib vs placebo, with both letrozole and anastrozole (stratified hazard ratio 0.51; P < .0001). Dalpiciclib plus letrozole or anastrozole demonstrated a manageable safety profile, with similar proportions of patients in the dalpiciclib and placebo groups (4% and 2%, respectively) discontinuing the treatment.

Study details: Findings are from the phase 3 DAWNA-2 study including 456 patients with HR+/HER2− advanced BC who were randomly assigned to receive either letrozole or anastrozole with dalpiciclib or placebo.

Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals and partly by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Three authors declared being employees of Hengrui, and Binghe Xu declared receiving research grants and fees from some sources.

Source: Zhang P et al. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023;24:646-657 (May 11). doi: 10.1016/S1470-2045(23)00172-9

Key clinical point: Dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor, plus letrozole or anastrozole demonstrated progression-free survival (PFS) benefits and a manageable safety profile in untreated patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A 12.4-month improvement in PFS was observed with dalpiciclib vs placebo, with both letrozole and anastrozole (stratified hazard ratio 0.51; P < .0001). Dalpiciclib plus letrozole or anastrozole demonstrated a manageable safety profile, with similar proportions of patients in the dalpiciclib and placebo groups (4% and 2%, respectively) discontinuing the treatment.

Study details: Findings are from the phase 3 DAWNA-2 study including 456 patients with HR+/HER2− advanced BC who were randomly assigned to receive either letrozole or anastrozole with dalpiciclib or placebo.

Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals and partly by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Three authors declared being employees of Hengrui, and Binghe Xu declared receiving research grants and fees from some sources.

Source: Zhang P et al. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023;24:646-657 (May 11). doi: 10.1016/S1470-2045(23)00172-9

Key clinical point: Dalpiciclib, a cyclin-dependent kinase 4/6 inhibitor, plus letrozole or anastrozole demonstrated progression-free survival (PFS) benefits and a manageable safety profile in untreated patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A 12.4-month improvement in PFS was observed with dalpiciclib vs placebo, with both letrozole and anastrozole (stratified hazard ratio 0.51; P < .0001). Dalpiciclib plus letrozole or anastrozole demonstrated a manageable safety profile, with similar proportions of patients in the dalpiciclib and placebo groups (4% and 2%, respectively) discontinuing the treatment.

Study details: Findings are from the phase 3 DAWNA-2 study including 456 patients with HR+/HER2− advanced BC who were randomly assigned to receive either letrozole or anastrozole with dalpiciclib or placebo.

Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals and partly by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences. Three authors declared being employees of Hengrui, and Binghe Xu declared receiving research grants and fees from some sources.

Source: Zhang P et al. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023;24:646-657 (May 11). doi: 10.1016/S1470-2045(23)00172-9

Key clinical point: The combination of apatinib and etoposide proved to be a feasible treatment option for patients with triple-negative breast cancer (TNBC) who had failed ≥1 line of chemotherapy in the advanced setting.

Major finding: The median progression-free survival and overall survival were 6.0 and 24.5 months, respectively, with an objective response rate of 10.0% and a disease control rate of 62.5%. Overall, 95.0% of patients experienced adverse events (AE) of any grade, mostly grade 1 and 2. Hypertension (65.0%), nausea (47.5%), vomiting (42.5%), and hand-foot syndrome (32.5%) were the most common AE.

Study details: Findings are from a single-arm phase 2 study including 40 patients with advanced TNBC who had failed ≥1 line of chemotherapy and received oral apatinib plus oral etoposide.

Disclosures: This study was funded by National Cancer Fund Climbing Fund. The authors declared no conflicts of interest.

Source: Cao M et al. Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: A phase II trial. BMC Cancer. 2023;23:463 (May 19). doi: 10.1186/s12885-023-10768-8

Key clinical point: The combination of apatinib and etoposide proved to be a feasible treatment option for patients with triple-negative breast cancer (TNBC) who had failed ≥1 line of chemotherapy in the advanced setting.

Major finding: The median progression-free survival and overall survival were 6.0 and 24.5 months, respectively, with an objective response rate of 10.0% and a disease control rate of 62.5%. Overall, 95.0% of patients experienced adverse events (AE) of any grade, mostly grade 1 and 2. Hypertension (65.0%), nausea (47.5%), vomiting (42.5%), and hand-foot syndrome (32.5%) were the most common AE.

Study details: Findings are from a single-arm phase 2 study including 40 patients with advanced TNBC who had failed ≥1 line of chemotherapy and received oral apatinib plus oral etoposide.

Disclosures: This study was funded by National Cancer Fund Climbing Fund. The authors declared no conflicts of interest.

Source: Cao M et al. Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: A phase II trial. BMC Cancer. 2023;23:463 (May 19). doi: 10.1186/s12885-023-10768-8

Key clinical point: The combination of apatinib and etoposide proved to be a feasible treatment option for patients with triple-negative breast cancer (TNBC) who had failed ≥1 line of chemotherapy in the advanced setting.

Major finding: The median progression-free survival and overall survival were 6.0 and 24.5 months, respectively, with an objective response rate of 10.0% and a disease control rate of 62.5%. Overall, 95.0% of patients experienced adverse events (AE) of any grade, mostly grade 1 and 2. Hypertension (65.0%), nausea (47.5%), vomiting (42.5%), and hand-foot syndrome (32.5%) were the most common AE.

Study details: Findings are from a single-arm phase 2 study including 40 patients with advanced TNBC who had failed ≥1 line of chemotherapy and received oral apatinib plus oral etoposide.

Disclosures: This study was funded by National Cancer Fund Climbing Fund. The authors declared no conflicts of interest.

Source: Cao M et al. Apatinib plus etoposide in pretreated patients with advanced triple-negative breast cancer: A phase II trial. BMC Cancer. 2023;23:463 (May 19). doi: 10.1186/s12885-023-10768-8