BERENICE最终分析：新辅助帕妥珠单抗、曲妥珠单抗及化疗后序贯辅助帕妥珠单抗和曲妥珠单抗用于HER2阳性早期乳腺癌的心脏安全性研究

BERENICE Final Analysis: Cardiac Safety Study of Neoadjuvant Pertuzumab, Trastuzumab, and Chemotherapy Followed by Adjuvant Pertuzumab and Trastuzumab in HER2-Positive Early Breast Cancer.

作者信息

Dang Chau, Ewer Michael S, Delaloge Suzette, Ferrero Jean-Marc, Colomer Ramon, de la Cruz-Merino Luis, Werner Theresa L, Dadswell Katherine, Verrill Mark, Eiger Daniel, Sarkar Sriparna, de Haas Sanne Lysbet, Restuccia Eleonora, Swain Sandra M

机构信息

Department of Medicine, Breast Medicine Service, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.

Department of Cardiology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.

出版信息

Cancers (Basel). 2022 May 24;14(11):2596. doi: 10.3390/cancers14112596.

DOI:10.3390/cancers14112596

PMID:35681574

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9179451/

Abstract

BERENICE (NCT02132949) assessed the cardiac safety of the neoadjuvant−adjuvant pertuzumab−trastuzumab-based therapy for high-risk, HER2-positive early breast cancer (EBC). We describe key secondary objectives at final analysis. Eligible patients received dose-dense doxorubicin and cyclophosphamide q2w × 4 ➝ paclitaxel qw × 12 (Cohort A) or 5-fluorouracil, epirubicin, cyclophosphamide q3w × 4 ➝ docetaxel q3w × 4 (B) as per physician’s choice. Pertuzumab−trastuzumab (q3w) was initiated from the taxane start and continued post-surgery to complete 1 year. Median follow-up: 64.5 months. There were no new cardiac issues and a low incidence of Class III/IV heart failure (Cohort B only: one patient (0.5%) in the adjuvant and treatment-free follow-up (TFFU) periods). Fourteen patients (7.7%) had LVEF declines of ≥10% points from baseline to <50% in Cohort A, as did 20 (10.5%) in B during the adjuvant period (12 (6.2%) in A and 7 (3.6%) in B during TFFU). The five-year event-free survival rates in Cohorts A and B were 90.8% (95% CI: 86.5, 95.2) and 89.2% (84.8, 93.6), respectively. The five-year overall survival rates were 96.1% (95% CI: 93.3, 98.9) and 93.8% (90.3, 97.2), respectively. The final analysis of BERENICE further supports pertuzumab−trastuzumab-based therapies as standard of care for high-risk, HER2-positive EBC.

摘要

BERENICE（NCT02132949）评估了以新辅助-辅助帕妥珠单抗-曲妥珠单抗为基础的治疗方案对高危、HER2阳性早期乳腺癌（EBC）的心脏安全性。我们在最终分析中描述了关键次要目标。符合条件的患者根据医生选择接受剂量密集型阿霉素和环磷酰胺，每2周一次，共4次➝紫杉醇，每周一次，共12次（A组），或5-氟尿嘧啶、表柔比星、环磷酰胺，每3周一次，共4次➝多西他赛，每3周一次，共4次（B组）。帕妥珠单抗-曲妥珠单抗（每3周一次）从紫杉烷开始使用时启动，并在术后继续使用以完成1年。中位随访时间：64.5个月。没有新的心脏问题，III/IV级心力衰竭发生率较低（仅B组：在辅助治疗和无治疗随访（TFFU）期间有1例患者（0.5%））。A组有14例患者（7.7%）左心室射血分数（LVEF）从基线下降≥10个百分点至<50%，B组在辅助治疗期间有20例患者（10.5%）出现这种情况（A组在TFFU期间有12例患者（6.2%），B组有7例患者（3.6%））。A组和B组的五年无事件生存率分别为90.8%（95%CI：86.5，95.2）和89.2%（84.8，93.6）。五年总生存率分别为96.1%（95%CI：93.3，98.9）和93.8%（90.3，97.2）。BERENICE的最终分析进一步支持以帕妥珠单抗-曲妥珠单抗为基础的治疗方案作为高危、HER2阳性EBC的标准治疗。