Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer

作者：Seock‐Ah Im, Yen‐Shen Lu, Aditya Bardia, Nadia Harbeck, Marco Angelo Colleoni, Fabio Andre Franke, Louis W.C. Chow, Joohyuk Sohn, Keun-Seok Lee, Saúl Campos-Gómez, Rafael Villanueva-Vázquez, Kyung-Hae Jung, Arunava Chakravartty, Gareth Hughes, Ioannis Gounaris, Karen Rodriguez-Lorenc, Tetiana Taran, Sara A. Hurvitz, Debu Tripathy · 发表于：New England Journal of Medicine · 年份：2019 · DOI：10.1056/nejmoa1903765 · 被引用次数：1044 · 研究领域：Advanced Breast Cancer Therapies、Breast Cancer Treatment Studies、Cancer-related Molecular Pathways

BACKGROUND: An earlier analysis of this phase 3 trial showed that the addition of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor to endocrine therapy provided a greater benefit with regard to progression-free survival than endocrine therapy alone in premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here we report the results of a protocol-specified interim analysis of the key secondary end point of overall survival. METHODS: We randomly assigned patients to receive either ribociclib or placebo in addition to endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen). Overall survival was evaluated with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods. RESULTS: A total of 672 patients were included in the intention-to-treat population. There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group. The addition of ribociclib to endocrine therapy resulted in significantly longer overall survival than endocrine therapy alone. The estimated overall survival at 42 months was 70.2% (95% confidence interval [CI], 63.5 to 76.0) in the ribociclib group and 46.0% (95% CI, 32.0 to 58.9) in the placebo group (hazard ratio for death, 0.71; 95% CI, 0.54 to 0.95; P = 0.00973 by log-rank test). The survival benefit seen in the subgroup of 495 ...