Ribociclib plus Endocrine Therapy in Early Breast Cancer.

作者：D. Slamon, O. Lipatov, Z. Nowecki, Nicholas P. McAndrew, B. Kukiełka-Budny, D. Stroyakovskiy, D. Yardley, Chiun-Sheng Huang, P. Fasching, J. Crown, A. Bardia, S. Chia, Seock-Ah Im, M. Ruíz-Borrego, S. Loi, Binghe Xu, S. Hurvitz, Carlos H. Barrios, M. Untch, R. Moroose, Frances M. Visco, K. Afenjar, R. Fresco, I. Séverin, Yanlan Ji, F. Ghaznawi, Zheng Li, J. P. Zarate, A. Chakravartty, T. Taran, G. Hortobagyi · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/NEJMoa2305488 · 被引用次数：298 · 研究领域：Medicine

BACKGROUND Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear. METHODS In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for ≥5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy. RESULTS As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasi...