Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival

作者：John Crown, Daniil Stroyakovskii, Denise A. Yardley, Chiun‐Sheng Huang, Peter A. Fasching, Amit Bardia, S. Chia, Seock‐Ah Im, Miguel Martín, B. Xu, Carlos H. Barrios, Michael Untch, R Moroose, Sara A. Hurvitz, Gabriel N. Hortobágyi, Dennis J. Slamon, F. Visco, Gonzalo Spera, Juan Pablo Zarate, Doug N. Halligan, Zheng Li, Sherene Loi · 发表于：ESMO Open · 年份：2025 · DOI：10.1016/j.esmoop.2025.105858 · 被引用次数：34 · 研究领域：Advanced Breast Cancer Therapies、HER2/EGFR in Cancer Research、Breast Cancer Treatment Studies

At the primary efficacy analysis of the NATALEE phase III trial, ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) demonstrated a statistically significant improvement in invasive disease-free survival (iDFS) versus NSAI alone in patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC). Continued follow-up of efficacy outcomes is important in assessing the durability of treatment benefit. We report 5-year estimates of efficacy outcomes, including an udpated analysis of overall survival (OS). Eligible patients included pre/postmenopausal women and men with HR-positive/HER2-negative EBC and anatomic stage IIA (N1 or N0 with high-risk factors), IIB, or III disease. Patients were randomized 1 : 1 to ribociclib 400 mg/day (3 weeks on/1 week off for 3 years) + NSAI (letrozole 2.5 mg/day or anastrozole 1 mg/day for 5 years) or NSAI alone. Premenopausal women and men received goserelin. The primary endpoint was iDFS, and secondary/exploratory endpoints included distant disease-free survival, recurrence-free survival, distant recurrence-free survival, and OS. With a median iDFS follow-up of 55.4 months, ribociclib + NSAI demonstrated persistent iDFS benefit versus NSAI alone [hazard ratio 0.716, 95% confidence interval (CI) 0.618-0.829, nominal one-sided log-rank P < 0.0001]. Absolute iDFS improvement between treatment arms increased from the 3- (Δ2.7%) to the 5-year (Δ4.5%) time points. Persistent benefit ...