Breast Cancer ICYMI

Key clinical point: Women with early-stage invasive breast cancer (BC) who underwent breast-conserving surgery with radiotherapy (BCS) had better overall survival (OS) than those who underwent mastectomy.

Major finding: Compared with mastectomy, BCS was associated with improved OS in the overall population of patients with early-stage invasive BC (relative risk [RR] 0.64; 95% CI 0.55-0.74), with stronger effects observed in women followed-up for <10 years (RR 0.54; 95% CI 0.46-0.64).

Study details: Findings are from a meta-analysis of 30 studies including 1,802,128 women with early-stage invasive BC, of which 1,075,563 and 744,565 patients underwent BCS and mastectomy, respectively, and were followed-up for 4-20 years.

Disclosures: This study did not receive any external funding. Dr. Chatterjee declared serving as a consultant for 3M and Royal.

Source: De la Cruz Ku G et al. Does breast-conserving surgery with radiotherapy have a better survival than mastectomy? A meta-analysis of more than 1,500,000 patients. Ann Surg Oncol. 2022 (Jul 25). Doi: 10.1245/s10434-022-12133-8

Key clinical point: Women with early-stage invasive breast cancer (BC) who underwent breast-conserving surgery with radiotherapy (BCS) had better overall survival (OS) than those who underwent mastectomy.

Major finding: Compared with mastectomy, BCS was associated with improved OS in the overall population of patients with early-stage invasive BC (relative risk [RR] 0.64; 95% CI 0.55-0.74), with stronger effects observed in women followed-up for <10 years (RR 0.54; 95% CI 0.46-0.64).

Study details: Findings are from a meta-analysis of 30 studies including 1,802,128 women with early-stage invasive BC, of which 1,075,563 and 744,565 patients underwent BCS and mastectomy, respectively, and were followed-up for 4-20 years.

Disclosures: This study did not receive any external funding. Dr. Chatterjee declared serving as a consultant for 3M and Royal.

Source: De la Cruz Ku G et al. Does breast-conserving surgery with radiotherapy have a better survival than mastectomy? A meta-analysis of more than 1,500,000 patients. Ann Surg Oncol. 2022 (Jul 25). Doi: 10.1245/s10434-022-12133-8

Key clinical point: Women with early-stage invasive breast cancer (BC) who underwent breast-conserving surgery with radiotherapy (BCS) had better overall survival (OS) than those who underwent mastectomy.

Major finding: Compared with mastectomy, BCS was associated with improved OS in the overall population of patients with early-stage invasive BC (relative risk [RR] 0.64; 95% CI 0.55-0.74), with stronger effects observed in women followed-up for <10 years (RR 0.54; 95% CI 0.46-0.64).

Study details: Findings are from a meta-analysis of 30 studies including 1,802,128 women with early-stage invasive BC, of which 1,075,563 and 744,565 patients underwent BCS and mastectomy, respectively, and were followed-up for 4-20 years.

Disclosures: This study did not receive any external funding. Dr. Chatterjee declared serving as a consultant for 3M and Royal.

Source: De la Cruz Ku G et al. Does breast-conserving surgery with radiotherapy have a better survival than mastectomy? A meta-analysis of more than 1,500,000 patients. Ann Surg Oncol. 2022 (Jul 25). Doi: 10.1245/s10434-022-12133-8

Key clinical point: A live birth (LB) after the diagnosis of breast cancer (BC) does not have a negative impact on a woman’s overall survival.

Major finding: Compared with women with no subsequent LB after BC diagnosis, the overall cohort of women with subsequent LB (hazard ratio [HR] 0.65; P  =  .002), women with only 1 subsequent LB (HR 0.73; P  =  .033), women with subsequent LB and no prior history of pregnancy (HR 0.56; P  =  .003), and women with LB within 5 years of BC diagnosis (HR 0.66; P  =  .006) had improved survival.

Study details: Findings are from a survival analysis in a national cohort of 5181 women diagnosed with BC at the age of 20-39 years, of which 290 had ≥1 LB and 1682 had no LB after BC diagnosis.

Disclosures: This study was partly supported by the MRC Centre for Reproductive Health, UK. Two authors declared serving as consultants or receiving speaker honoraria from several sources.

Source: Anderson RA et al. Survival after breast cancer in women with a subsequent live birth: Influence of age at diagnosis and interval to subsequent pregnancy. Eur J Cancer. 2022;173:113-122 (Jul 19). Doi:  10.1016/j.ejca.2022.06.048

Key clinical point: A live birth (LB) after the diagnosis of breast cancer (BC) does not have a negative impact on a woman’s overall survival.

Major finding: Compared with women with no subsequent LB after BC diagnosis, the overall cohort of women with subsequent LB (hazard ratio [HR] 0.65; P  =  .002), women with only 1 subsequent LB (HR 0.73; P  =  .033), women with subsequent LB and no prior history of pregnancy (HR 0.56; P  =  .003), and women with LB within 5 years of BC diagnosis (HR 0.66; P  =  .006) had improved survival.

Study details: Findings are from a survival analysis in a national cohort of 5181 women diagnosed with BC at the age of 20-39 years, of which 290 had ≥1 LB and 1682 had no LB after BC diagnosis.

Disclosures: This study was partly supported by the MRC Centre for Reproductive Health, UK. Two authors declared serving as consultants or receiving speaker honoraria from several sources.

Source: Anderson RA et al. Survival after breast cancer in women with a subsequent live birth: Influence of age at diagnosis and interval to subsequent pregnancy. Eur J Cancer. 2022;173:113-122 (Jul 19). Doi:  10.1016/j.ejca.2022.06.048

Key clinical point: A live birth (LB) after the diagnosis of breast cancer (BC) does not have a negative impact on a woman’s overall survival.

Major finding: Compared with women with no subsequent LB after BC diagnosis, the overall cohort of women with subsequent LB (hazard ratio [HR] 0.65; P  =  .002), women with only 1 subsequent LB (HR 0.73; P  =  .033), women with subsequent LB and no prior history of pregnancy (HR 0.56; P  =  .003), and women with LB within 5 years of BC diagnosis (HR 0.66; P  =  .006) had improved survival.

Study details: Findings are from a survival analysis in a national cohort of 5181 women diagnosed with BC at the age of 20-39 years, of which 290 had ≥1 LB and 1682 had no LB after BC diagnosis.

Disclosures: This study was partly supported by the MRC Centre for Reproductive Health, UK. Two authors declared serving as consultants or receiving speaker honoraria from several sources.

Source: Anderson RA et al. Survival after breast cancer in women with a subsequent live birth: Influence of age at diagnosis and interval to subsequent pregnancy. Eur J Cancer. 2022;173:113-122 (Jul 19). Doi:  10.1016/j.ejca.2022.06.048

Key clinical point: Adjuvant endocrine therapy (ET) for 2 years showed a long-term (20 years) advantage in premenopausal women with estrogen receptor-positive (ER+) breast cancer (BC), with differential treatment benefit observed in genomic high-risk vs low-risk tumors.

Major finding: Goserelin (hazard ratio [HR] 0.49; 95% CI 0.32-0.75), tamoxifen (HR 0.57; 95% CI 0.38-0.87), and combined goserelin-tamoxifen (HR 0.63; 95% CI 0.42-0.94) vs no adjuvant ET improved long-term distant recurrence-free interval in the overall cohort of patients, with tamoxifen and goserelin benefitting genomic low-risk (HR 0.24; 95% CI 0.10-0.60) and high-risk (HR 0.24; 95% CI 0.10-0.54) patients, respectively.

Study details: Findings are from the secondary analysis of the Stockholm trial including 584 premenopausal patients with ER+ BC who were randomly assigned to receive goserelin, tamoxifen, combined goserelin-tamoxifen, or no adjuvant ET for 2 years.

Disclosures: This study was supported by the Swedish Research Council and other sources. Some authors declared serving as consultants or advisors or leaders for, being employees or stockowners of, or receiving research funding, honoraria, travel, or accommodation expense from several sources.

Source: Johansson A et al. Twenty-year benefit from adjuvant goserelin and tamoxifen in premenopausal patients with breast cancer in a controlled randomized clinical trial. J Clin Oncol. 2022 (Jul 21). Doi: 10.1200/JCO.21.02844

Key clinical point: Adjuvant endocrine therapy (ET) for 2 years showed a long-term (20 years) advantage in premenopausal women with estrogen receptor-positive (ER+) breast cancer (BC), with differential treatment benefit observed in genomic high-risk vs low-risk tumors.

Major finding: Goserelin (hazard ratio [HR] 0.49; 95% CI 0.32-0.75), tamoxifen (HR 0.57; 95% CI 0.38-0.87), and combined goserelin-tamoxifen (HR 0.63; 95% CI 0.42-0.94) vs no adjuvant ET improved long-term distant recurrence-free interval in the overall cohort of patients, with tamoxifen and goserelin benefitting genomic low-risk (HR 0.24; 95% CI 0.10-0.60) and high-risk (HR 0.24; 95% CI 0.10-0.54) patients, respectively.

Study details: Findings are from the secondary analysis of the Stockholm trial including 584 premenopausal patients with ER+ BC who were randomly assigned to receive goserelin, tamoxifen, combined goserelin-tamoxifen, or no adjuvant ET for 2 years.

Disclosures: This study was supported by the Swedish Research Council and other sources. Some authors declared serving as consultants or advisors or leaders for, being employees or stockowners of, or receiving research funding, honoraria, travel, or accommodation expense from several sources.

Source: Johansson A et al. Twenty-year benefit from adjuvant goserelin and tamoxifen in premenopausal patients with breast cancer in a controlled randomized clinical trial. J Clin Oncol. 2022 (Jul 21). Doi: 10.1200/JCO.21.02844

Key clinical point: Adjuvant endocrine therapy (ET) for 2 years showed a long-term (20 years) advantage in premenopausal women with estrogen receptor-positive (ER+) breast cancer (BC), with differential treatment benefit observed in genomic high-risk vs low-risk tumors.

Major finding: Goserelin (hazard ratio [HR] 0.49; 95% CI 0.32-0.75), tamoxifen (HR 0.57; 95% CI 0.38-0.87), and combined goserelin-tamoxifen (HR 0.63; 95% CI 0.42-0.94) vs no adjuvant ET improved long-term distant recurrence-free interval in the overall cohort of patients, with tamoxifen and goserelin benefitting genomic low-risk (HR 0.24; 95% CI 0.10-0.60) and high-risk (HR 0.24; 95% CI 0.10-0.54) patients, respectively.

Study details: Findings are from the secondary analysis of the Stockholm trial including 584 premenopausal patients with ER+ BC who were randomly assigned to receive goserelin, tamoxifen, combined goserelin-tamoxifen, or no adjuvant ET for 2 years.

Disclosures: This study was supported by the Swedish Research Council and other sources. Some authors declared serving as consultants or advisors or leaders for, being employees or stockowners of, or receiving research funding, honoraria, travel, or accommodation expense from several sources.

Source: Johansson A et al. Twenty-year benefit from adjuvant goserelin and tamoxifen in premenopausal patients with breast cancer in a controlled randomized clinical trial. J Clin Oncol. 2022 (Jul 21). Doi: 10.1200/JCO.21.02844

Key clinical point: Vaginal estrogen therapy (VET) or menopausal hormone therapy (MHT) did not increase the risk for recurrence/mortality in postmenopausal women with early-stage, estrogen receptor-positive (ER+) BC; however, the recurrence risk was higher in patients receiving aromatase inhibitors (AI)+VET.

Major finding: The recurrence risk among women receiving VET (adjusted hazard ratio [aHR] 1.08; 95% CI 0.89-1.32) or MHT (aHR 1.05; 95% CI 0.62-1.78) was similar to that among never-users of hormone therapy; however, the risk was elevated in patients receiving VET+AI (aHR 1.39; 95% CI 1.04-1.85). Neither VET (aHR 0.78; 95% CI 0.71-0.87) nor MHT (aHR 0.94; 95% CI 0.70-1.26) was associated with increased overall mortality, irrespective of the receipt of AI.

Study details: Findings are from an observational cohort study including 8461 postmenopausal women with early-stage, invasive, nonmetastatic, ER+ BC who received no endocrine treatment or 5-year adjuvant endocrine therapy.

Disclosures: This study was supported by Breast Friends, a part of the Danish Cancer Society. Some authors declared receiving support, honoraria, or institutional grants from several sources.

Source: Cold S et al. Systemic or vaginal hormone therapy after early breast cancer: A Danish observational cohort study. J Natl Cancer Inst. 2022 (Jul 20). Doi: 10.1093/jnci/djac112

Key clinical point: Vaginal estrogen therapy (VET) or menopausal hormone therapy (MHT) did not increase the risk for recurrence/mortality in postmenopausal women with early-stage, estrogen receptor-positive (ER+) BC; however, the recurrence risk was higher in patients receiving aromatase inhibitors (AI)+VET.

Major finding: The recurrence risk among women receiving VET (adjusted hazard ratio [aHR] 1.08; 95% CI 0.89-1.32) or MHT (aHR 1.05; 95% CI 0.62-1.78) was similar to that among never-users of hormone therapy; however, the risk was elevated in patients receiving VET+AI (aHR 1.39; 95% CI 1.04-1.85). Neither VET (aHR 0.78; 95% CI 0.71-0.87) nor MHT (aHR 0.94; 95% CI 0.70-1.26) was associated with increased overall mortality, irrespective of the receipt of AI.

Study details: Findings are from an observational cohort study including 8461 postmenopausal women with early-stage, invasive, nonmetastatic, ER+ BC who received no endocrine treatment or 5-year adjuvant endocrine therapy.

Disclosures: This study was supported by Breast Friends, a part of the Danish Cancer Society. Some authors declared receiving support, honoraria, or institutional grants from several sources.

Source: Cold S et al. Systemic or vaginal hormone therapy after early breast cancer: A Danish observational cohort study. J Natl Cancer Inst. 2022 (Jul 20). Doi: 10.1093/jnci/djac112

Key clinical point: Vaginal estrogen therapy (VET) or menopausal hormone therapy (MHT) did not increase the risk for recurrence/mortality in postmenopausal women with early-stage, estrogen receptor-positive (ER+) BC; however, the recurrence risk was higher in patients receiving aromatase inhibitors (AI)+VET.

Major finding: The recurrence risk among women receiving VET (adjusted hazard ratio [aHR] 1.08; 95% CI 0.89-1.32) or MHT (aHR 1.05; 95% CI 0.62-1.78) was similar to that among never-users of hormone therapy; however, the risk was elevated in patients receiving VET+AI (aHR 1.39; 95% CI 1.04-1.85). Neither VET (aHR 0.78; 95% CI 0.71-0.87) nor MHT (aHR 0.94; 95% CI 0.70-1.26) was associated with increased overall mortality, irrespective of the receipt of AI.

Study details: Findings are from an observational cohort study including 8461 postmenopausal women with early-stage, invasive, nonmetastatic, ER+ BC who received no endocrine treatment or 5-year adjuvant endocrine therapy.

Disclosures: This study was supported by Breast Friends, a part of the Danish Cancer Society. Some authors declared receiving support, honoraria, or institutional grants from several sources.

Source: Cold S et al. Systemic or vaginal hormone therapy after early breast cancer: A Danish observational cohort study. J Natl Cancer Inst. 2022 (Jul 20). Doi: 10.1093/jnci/djac112

Key clinical point: Postmenopausal patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who achieve a preoperative endocrine prognostic index (PEPI) score of 0-1/pathological complete response (pCR) with only neoadjuvant endocrine therapy (NET) can be safely treated without adjuvant chemotherapy.

Major finding: After a median follow-up of 60 months, the 5-year recurrence-free survival (RFS) improved significantly in patients who had PEPI 0-1/pCR without chemotherapy vs PEPI ≥2 (hazard ratio 0.18; P  =  .028). In patients who had PEPI ≥2, the 5-year RFS was similar regardless of the receipt of adjuvant chemotherapy (P  =  .432).

Study details: Findings are from a phase 2 trial including 352 postmenopausal women with early-stage, strongly ER+ and HER2− BC who received NET for 4 months before surgery; after surgery, patients with PEPI 0-1/pCR and PEPI ≥2 were recommended only adjuvant ET and adjuvant ET±chemotherapy, respectively.

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

Source: Wang X et al. Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study. Breast Cancer Res Treat. 2022 (Aug 2(. Doi: 10.1007/s10549-022-06686-1

Key clinical point: Postmenopausal patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who achieve a preoperative endocrine prognostic index (PEPI) score of 0-1/pathological complete response (pCR) with only neoadjuvant endocrine therapy (NET) can be safely treated without adjuvant chemotherapy.

Major finding: After a median follow-up of 60 months, the 5-year recurrence-free survival (RFS) improved significantly in patients who had PEPI 0-1/pCR without chemotherapy vs PEPI ≥2 (hazard ratio 0.18; P  =  .028). In patients who had PEPI ≥2, the 5-year RFS was similar regardless of the receipt of adjuvant chemotherapy (P  =  .432).

Study details: Findings are from a phase 2 trial including 352 postmenopausal women with early-stage, strongly ER+ and HER2− BC who received NET for 4 months before surgery; after surgery, patients with PEPI 0-1/pCR and PEPI ≥2 were recommended only adjuvant ET and adjuvant ET±chemotherapy, respectively.

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

Source: Wang X et al. Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study. Breast Cancer Res Treat. 2022 (Aug 2(. Doi: 10.1007/s10549-022-06686-1

Key clinical point: Postmenopausal patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who achieve a preoperative endocrine prognostic index (PEPI) score of 0-1/pathological complete response (pCR) with only neoadjuvant endocrine therapy (NET) can be safely treated without adjuvant chemotherapy.

Major finding: After a median follow-up of 60 months, the 5-year recurrence-free survival (RFS) improved significantly in patients who had PEPI 0-1/pCR without chemotherapy vs PEPI ≥2 (hazard ratio 0.18; P  =  .028). In patients who had PEPI ≥2, the 5-year RFS was similar regardless of the receipt of adjuvant chemotherapy (P  =  .432).

Study details: Findings are from a phase 2 trial including 352 postmenopausal women with early-stage, strongly ER+ and HER2− BC who received NET for 4 months before surgery; after surgery, patients with PEPI 0-1/pCR and PEPI ≥2 were recommended only adjuvant ET and adjuvant ET±chemotherapy, respectively.

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

Source: Wang X et al. Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study. Breast Cancer Res Treat. 2022 (Aug 2(. Doi: 10.1007/s10549-022-06686-1

Key clinical point: Patients with metastatic breast cancer (BC) who received oral paclitaxel plus encequidar to facilitate the absorption of oral paclitaxel showed higher confirmed tumor response compared with 3 weekly intravenous (IV) paclitaxel doses.

Major finding: Confirmed tumor response rate improved significantly with oral paclitaxel+encequidar vs IV paclitaxel (36% vs 23%; P  =  .011). The incidence of grade ≥2 neuropathy (31% vs 8%) and grade 2 alopecia (48% vs 29%) were higher with IV paclitaxel vs oral paclitaxel+encequidar; however, the incidence of grade ≥3 gastrointestinal disorders (11.7% vs 3.7%) was higher with oral paclitaxel+encequidar vs IV paclitaxel.

Study details: Findings are from the open-label, phase 3 study including 402 postmenopausal women with metastatic BC who were randomly assigned to receive oral paclitaxel+encequidar or IV paclitaxel.

Disclosures: This study was supported by Athenex, Inc. Four authors declared being employees and owning stocks in Athenex, and the other authors reported ties with several sources, including Athenex.

Source: Rugo HS et al. Open-label, randomized, multicenter, phase III study comparing oral paclitaxel plus encequidar versus intravenous paclitaxel in patients with metastatic breast cancer. J Clin Oncol. 2022 (Jul 20). Doi: 10.1200/JCO.21.02953

Key clinical point: Patients with metastatic breast cancer (BC) who received oral paclitaxel plus encequidar to facilitate the absorption of oral paclitaxel showed higher confirmed tumor response compared with 3 weekly intravenous (IV) paclitaxel doses.

Major finding: Confirmed tumor response rate improved significantly with oral paclitaxel+encequidar vs IV paclitaxel (36% vs 23%; P  =  .011). The incidence of grade ≥2 neuropathy (31% vs 8%) and grade 2 alopecia (48% vs 29%) were higher with IV paclitaxel vs oral paclitaxel+encequidar; however, the incidence of grade ≥3 gastrointestinal disorders (11.7% vs 3.7%) was higher with oral paclitaxel+encequidar vs IV paclitaxel.

Study details: Findings are from the open-label, phase 3 study including 402 postmenopausal women with metastatic BC who were randomly assigned to receive oral paclitaxel+encequidar or IV paclitaxel.

Disclosures: This study was supported by Athenex, Inc. Four authors declared being employees and owning stocks in Athenex, and the other authors reported ties with several sources, including Athenex.

Source: Rugo HS et al. Open-label, randomized, multicenter, phase III study comparing oral paclitaxel plus encequidar versus intravenous paclitaxel in patients with metastatic breast cancer. J Clin Oncol. 2022 (Jul 20). Doi: 10.1200/JCO.21.02953

Key clinical point: Patients with metastatic breast cancer (BC) who received oral paclitaxel plus encequidar to facilitate the absorption of oral paclitaxel showed higher confirmed tumor response compared with 3 weekly intravenous (IV) paclitaxel doses.

Major finding: Confirmed tumor response rate improved significantly with oral paclitaxel+encequidar vs IV paclitaxel (36% vs 23%; P  =  .011). The incidence of grade ≥2 neuropathy (31% vs 8%) and grade 2 alopecia (48% vs 29%) were higher with IV paclitaxel vs oral paclitaxel+encequidar; however, the incidence of grade ≥3 gastrointestinal disorders (11.7% vs 3.7%) was higher with oral paclitaxel+encequidar vs IV paclitaxel.

Study details: Findings are from the open-label, phase 3 study including 402 postmenopausal women with metastatic BC who were randomly assigned to receive oral paclitaxel+encequidar or IV paclitaxel.

Disclosures: This study was supported by Athenex, Inc. Four authors declared being employees and owning stocks in Athenex, and the other authors reported ties with several sources, including Athenex.

Source: Rugo HS et al. Open-label, randomized, multicenter, phase III study comparing oral paclitaxel plus encequidar versus intravenous paclitaxel in patients with metastatic breast cancer. J Clin Oncol. 2022 (Jul 20). Doi: 10.1200/JCO.21.02953

Key clinical point: Neoadjuvant atezolizumab plus docetaxel, trastuzumab, and pertuzumab (PATH) demonstrated an acceptable pathological complete response (pCR) rate and a modest safety profile in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC).

Major finding: Rate of pCR was 61% in the overall cohort and was higher in patients with hormone receptor-negative vs -positive subtype (77% vs 44%), stages IIA and IIB vs stage III BC (69% and 70% vs 39% respectively), and positive vs negative programmed cell death 1 expression (100% vs 53%). Few patients reported grade ≥3 neutropenia (12%) and febrile neutropenia (8%).

Study details: Findings are from a single-arm phase 2 trial including 67 patients with ERBB2-positive stage II/III BC who initiated 6 cycles of PATH+atezolizumab every 3 weeks.

Disclosures: This study was supported by the Ministry of Health and Welfare, Republic of Korea, and other sources. The authors declared serving on advisory boards or receiving personal fees, grants, honoraria, consulting fees, or nonfinancial support from several sources.

Source: Ahn HK et al. Response rate and safety of a neoadjuvant pertuzumab, atezolizumab, docetaxel, and trastuzumab regimen for patients with ERBB2-positive stage II/III breast cancer: The neo-PATH phase 2 nonrandomized clinical trial. JAMA Oncol. 2022 (Jul 7). Doi: 10.1001/jamaoncol.2022.2310

Key clinical point: Neoadjuvant atezolizumab plus docetaxel, trastuzumab, and pertuzumab (PATH) demonstrated an acceptable pathological complete response (pCR) rate and a modest safety profile in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC).

Major finding: Rate of pCR was 61% in the overall cohort and was higher in patients with hormone receptor-negative vs -positive subtype (77% vs 44%), stages IIA and IIB vs stage III BC (69% and 70% vs 39% respectively), and positive vs negative programmed cell death 1 expression (100% vs 53%). Few patients reported grade ≥3 neutropenia (12%) and febrile neutropenia (8%).

Study details: Findings are from a single-arm phase 2 trial including 67 patients with ERBB2-positive stage II/III BC who initiated 6 cycles of PATH+atezolizumab every 3 weeks.

Disclosures: This study was supported by the Ministry of Health and Welfare, Republic of Korea, and other sources. The authors declared serving on advisory boards or receiving personal fees, grants, honoraria, consulting fees, or nonfinancial support from several sources.

Source: Ahn HK et al. Response rate and safety of a neoadjuvant pertuzumab, atezolizumab, docetaxel, and trastuzumab regimen for patients with ERBB2-positive stage II/III breast cancer: The neo-PATH phase 2 nonrandomized clinical trial. JAMA Oncol. 2022 (Jul 7). Doi: 10.1001/jamaoncol.2022.2310

Key clinical point: Neoadjuvant atezolizumab plus docetaxel, trastuzumab, and pertuzumab (PATH) demonstrated an acceptable pathological complete response (pCR) rate and a modest safety profile in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC).

Major finding: Rate of pCR was 61% in the overall cohort and was higher in patients with hormone receptor-negative vs -positive subtype (77% vs 44%), stages IIA and IIB vs stage III BC (69% and 70% vs 39% respectively), and positive vs negative programmed cell death 1 expression (100% vs 53%). Few patients reported grade ≥3 neutropenia (12%) and febrile neutropenia (8%).

Study details: Findings are from a single-arm phase 2 trial including 67 patients with ERBB2-positive stage II/III BC who initiated 6 cycles of PATH+atezolizumab every 3 weeks.

Disclosures: This study was supported by the Ministry of Health and Welfare, Republic of Korea, and other sources. The authors declared serving on advisory boards or receiving personal fees, grants, honoraria, consulting fees, or nonfinancial support from several sources.

Source: Ahn HK et al. Response rate and safety of a neoadjuvant pertuzumab, atezolizumab, docetaxel, and trastuzumab regimen for patients with ERBB2-positive stage II/III breast cancer: The neo-PATH phase 2 nonrandomized clinical trial. JAMA Oncol. 2022 (Jul 7). Doi: 10.1001/jamaoncol.2022.2310

Key clinical point: In patients with metastatic triple-negative breast cancer (TNBC), first-line treatment with nanoparticle albumin-bound (nab)-paclitaxel+cisplatin significantly reduced the risk for disease progression/death compared with gemcitabine+cisplatin, with both the combinations showing a consistent safety profile.

Major finding: Progression-free survival (stratified hazard ratio 0.67; P  =  .004) and objective response rate (81.1% vs 56.3%; P < .001) improved significantly in patients receiving nab-paclitaxel+cisplatin vs gemcitabine+cisplatin. Grade ≥3 only neuropathy (19% vs 0%) and nausea and vomiting (6% vs 1%) were higher in the nab-paclitaxel+cisplatin vs gemcitabine+cisplatin arm, whereas grade ≥3 thrombocytopenia (29.4% vs 3.9%) was more common in the gemcitabine+cisplatin vs nab-paclitaxel+cisplatin arm.

Study details: Findings are from an open-label phase 3 study including 254 patients with untreated metastatic TNBC who were randomly assigned to receive nab-paclitaxel+cisplatin or gemcitabine+cisplatin.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang B et al. A randomized phase 3 trial of gemcitabine or nab-paclitaxel combined with cisplatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022;13:4025 (Jul 12). Doi: 10.1038/s41467-022-31704-7

Key clinical point: In patients with metastatic triple-negative breast cancer (TNBC), first-line treatment with nanoparticle albumin-bound (nab)-paclitaxel+cisplatin significantly reduced the risk for disease progression/death compared with gemcitabine+cisplatin, with both the combinations showing a consistent safety profile.

Major finding: Progression-free survival (stratified hazard ratio 0.67; P  =  .004) and objective response rate (81.1% vs 56.3%; P < .001) improved significantly in patients receiving nab-paclitaxel+cisplatin vs gemcitabine+cisplatin. Grade ≥3 only neuropathy (19% vs 0%) and nausea and vomiting (6% vs 1%) were higher in the nab-paclitaxel+cisplatin vs gemcitabine+cisplatin arm, whereas grade ≥3 thrombocytopenia (29.4% vs 3.9%) was more common in the gemcitabine+cisplatin vs nab-paclitaxel+cisplatin arm.

Study details: Findings are from an open-label phase 3 study including 254 patients with untreated metastatic TNBC who were randomly assigned to receive nab-paclitaxel+cisplatin or gemcitabine+cisplatin.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang B et al. A randomized phase 3 trial of gemcitabine or nab-paclitaxel combined with cisplatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022;13:4025 (Jul 12). Doi: 10.1038/s41467-022-31704-7

Key clinical point: In patients with metastatic triple-negative breast cancer (TNBC), first-line treatment with nanoparticle albumin-bound (nab)-paclitaxel+cisplatin significantly reduced the risk for disease progression/death compared with gemcitabine+cisplatin, with both the combinations showing a consistent safety profile.

Major finding: Progression-free survival (stratified hazard ratio 0.67; P  =  .004) and objective response rate (81.1% vs 56.3%; P < .001) improved significantly in patients receiving nab-paclitaxel+cisplatin vs gemcitabine+cisplatin. Grade ≥3 only neuropathy (19% vs 0%) and nausea and vomiting (6% vs 1%) were higher in the nab-paclitaxel+cisplatin vs gemcitabine+cisplatin arm, whereas grade ≥3 thrombocytopenia (29.4% vs 3.9%) was more common in the gemcitabine+cisplatin vs nab-paclitaxel+cisplatin arm.

Study details: Findings are from an open-label phase 3 study including 254 patients with untreated metastatic TNBC who were randomly assigned to receive nab-paclitaxel+cisplatin or gemcitabine+cisplatin.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang B et al. A randomized phase 3 trial of gemcitabine or nab-paclitaxel combined with cisplatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022;13:4025 (Jul 12). Doi: 10.1038/s41467-022-31704-7

Key clinical point: In patients with ductal carcinoma in situ (DCIS), tumor bed boost after postoperative whole breast irradiation (WBI) reduced local recurrence but with higher toxicity. Hypofractionated WBI was as effective as conventional WBI.

Major finding: The 5-year free-from-local-recurrence rates improved significantly with vs without tumor bed boost after postoperative WBI (hazard ratio 0.47; P < .001) and did not worsen with hypofractionated vs conventional WBI (P  =  .85). The rates of grade ≥2 breast pain (P  =  .003) and induration (P < .001) were higher with vs without tumor bed boost.

Study details: Findings are from a multicenter, phase 3 study including 1608 adult women with unilateral, non-low-risk DCIS who underwent breast-conserving surgery and were randomly assigned to receive WBI (conventional or hypofractionated) with or without tumor bed boost.

Disclosures: This study was funded by the National Health and Medical Research Council of Australia and other sources. Some authors declared receiving research grants, funding, or non-direct financial support from several sources.

Source: Chua BH et al. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3–07/TROG 07.01): A randomised, factorial, multicentre, open-label, phase 3 study Lancet. 2022;400(10350):431-440 (Aug 6). Doi: 10.1016/S0140-6736(22)01246-6

Key clinical point: In patients with ductal carcinoma in situ (DCIS), tumor bed boost after postoperative whole breast irradiation (WBI) reduced local recurrence but with higher toxicity. Hypofractionated WBI was as effective as conventional WBI.

Major finding: The 5-year free-from-local-recurrence rates improved significantly with vs without tumor bed boost after postoperative WBI (hazard ratio 0.47; P < .001) and did not worsen with hypofractionated vs conventional WBI (P  =  .85). The rates of grade ≥2 breast pain (P  =  .003) and induration (P < .001) were higher with vs without tumor bed boost.

Study details: Findings are from a multicenter, phase 3 study including 1608 adult women with unilateral, non-low-risk DCIS who underwent breast-conserving surgery and were randomly assigned to receive WBI (conventional or hypofractionated) with or without tumor bed boost.

Disclosures: This study was funded by the National Health and Medical Research Council of Australia and other sources. Some authors declared receiving research grants, funding, or non-direct financial support from several sources.

Source: Chua BH et al. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3–07/TROG 07.01): A randomised, factorial, multicentre, open-label, phase 3 study Lancet. 2022;400(10350):431-440 (Aug 6). Doi: 10.1016/S0140-6736(22)01246-6

Key clinical point: In patients with ductal carcinoma in situ (DCIS), tumor bed boost after postoperative whole breast irradiation (WBI) reduced local recurrence but with higher toxicity. Hypofractionated WBI was as effective as conventional WBI.

Major finding: The 5-year free-from-local-recurrence rates improved significantly with vs without tumor bed boost after postoperative WBI (hazard ratio 0.47; P < .001) and did not worsen with hypofractionated vs conventional WBI (P  =  .85). The rates of grade ≥2 breast pain (P  =  .003) and induration (P < .001) were higher with vs without tumor bed boost.

Study details: Findings are from a multicenter, phase 3 study including 1608 adult women with unilateral, non-low-risk DCIS who underwent breast-conserving surgery and were randomly assigned to receive WBI (conventional or hypofractionated) with or without tumor bed boost.

Disclosures: This study was funded by the National Health and Medical Research Council of Australia and other sources. Some authors declared receiving research grants, funding, or non-direct financial support from several sources.

Source: Chua BH et al. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3–07/TROG 07.01): A randomised, factorial, multicentre, open-label, phase 3 study Lancet. 2022;400(10350):431-440 (Aug 6). Doi: 10.1016/S0140-6736(22)01246-6

Key clinical point: First-line treatment with pembrolizumab and chemotherapy improved overall survival (OS) compared with chemotherapy alone in patients with advanced triple-negative breast cancer (TNBC) whose tumors expressed programmed death ligand 1 (PD-L1) with a combined positive score (CPS) of ≥10.

Major finding: Pembrolizumab+chemotherapy vs placebo+chemotherapy improved OS in patients whose tumors expressed PD-L1 with a CPS of ≥10 (hazard ratio for death 0.73; P  =  .0185); however, no survival benefits were observed in patients with PD-L1 CPS of ≥1 (P  =  .1125). Grade ≥3 adverse events were reported by 68.1% and 66.9% of patients in the pembrolizumab+chemotherapy and placebo+chemotherapy groups, respectively.

Study details: Findings are from an interim analysis of the phase 3 KEYNOTE-355 trial including 847 patients with locally recurrent inoperable or metastatic TNBC who were randomly assigned to receive pembrolizumab+chemotherapy or placebo+chemotherapy.

Disclosures: This study was funded by Merck Sharp and Dohme. Four authors declared being employees of or owning stocks in Merck, and the other authors reported ties with several sources, including Merck.

Source: Cortes J et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med. 2022;387:217-226 (Jul 21). Doi: 10.1056/NEJMoa2202809

Key clinical point: First-line treatment with pembrolizumab and chemotherapy improved overall survival (OS) compared with chemotherapy alone in patients with advanced triple-negative breast cancer (TNBC) whose tumors expressed programmed death ligand 1 (PD-L1) with a combined positive score (CPS) of ≥10.

Major finding: Pembrolizumab+chemotherapy vs placebo+chemotherapy improved OS in patients whose tumors expressed PD-L1 with a CPS of ≥10 (hazard ratio for death 0.73; P  =  .0185); however, no survival benefits were observed in patients with PD-L1 CPS of ≥1 (P  =  .1125). Grade ≥3 adverse events were reported by 68.1% and 66.9% of patients in the pembrolizumab+chemotherapy and placebo+chemotherapy groups, respectively.

Study details: Findings are from an interim analysis of the phase 3 KEYNOTE-355 trial including 847 patients with locally recurrent inoperable or metastatic TNBC who were randomly assigned to receive pembrolizumab+chemotherapy or placebo+chemotherapy.

Disclosures: This study was funded by Merck Sharp and Dohme. Four authors declared being employees of or owning stocks in Merck, and the other authors reported ties with several sources, including Merck.

Source: Cortes J et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med. 2022;387:217-226 (Jul 21). Doi: 10.1056/NEJMoa2202809

Key clinical point: First-line treatment with pembrolizumab and chemotherapy improved overall survival (OS) compared with chemotherapy alone in patients with advanced triple-negative breast cancer (TNBC) whose tumors expressed programmed death ligand 1 (PD-L1) with a combined positive score (CPS) of ≥10.

Major finding: Pembrolizumab+chemotherapy vs placebo+chemotherapy improved OS in patients whose tumors expressed PD-L1 with a CPS of ≥10 (hazard ratio for death 0.73; P  =  .0185); however, no survival benefits were observed in patients with PD-L1 CPS of ≥1 (P  =  .1125). Grade ≥3 adverse events were reported by 68.1% and 66.9% of patients in the pembrolizumab+chemotherapy and placebo+chemotherapy groups, respectively.

Study details: Findings are from an interim analysis of the phase 3 KEYNOTE-355 trial including 847 patients with locally recurrent inoperable or metastatic TNBC who were randomly assigned to receive pembrolizumab+chemotherapy or placebo+chemotherapy.

Disclosures: This study was funded by Merck Sharp and Dohme. Four authors declared being employees of or owning stocks in Merck, and the other authors reported ties with several sources, including Merck.

Source: Cortes J et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med. 2022;387:217-226 (Jul 21). Doi: 10.1056/NEJMoa2202809