Ribociclib Plus Endocrine Therapy in Hormone Receptor–Positive/ ERBB2 -Negative Early Breast Cancer

作者：Peter A. Fasching, Daniil Stroyakovskiy, DA Yardley, Chiun‐Sheng Huang, John Crown, Aditya Bardia, Stephen Chia, Seock‐Ah Im, Miguel Martín, Binghe Xu, Sherene Loi, Carlos H. Barrios, Michael Untch, Rebecca Moroose, F. Visco, Gabriel N. Hortobágyi, Dennis J. Slamon, Rodrigo Fresco, Juan Pablo Zarate, Zheng Li, Sorcha Waters, Sara A. Hurvitz · 发表于：JAMA Oncology · 年份：2025 · DOI：10.1001/jamaoncol.2025.3700 · 被引用次数：21 · 研究领域：Advanced Breast Cancer Therapies、Breast Cancer Treatment Studies、HER2/EGFR in Cancer Research

Importance: Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) has demonstrated a statistically significant invasive disease-free survival (iDFS) benefit over NSAI alone in patients with hormone receptor-positive/ERBB2 (formerly HER2)-negative early breast cancer. Evaluating the efficacy and safety of adjuvant ribociclib beyond the planned 3-year treatment period is critical for understanding the long-term impact on recurrences. Objective: To evaluate efficacy and safety of adjuvant ribociclib in an exploratory 4-year analysis of the NATALEE (New Adjuvant Trial With Ribociclib [LEE011]) randomized clinical trial, with all patients no longer receiving ribociclib treatment. Design, Setting, and Participants: This exploratory analysis of an international, open-label, randomized phase 3 trial analyzed adjuvant treatment for premenopausal and postmenopausal women and men with hormone receptor-positive/ERBB2-negative early breast cancer. Eligible patients had anatomic stage IIA (either N0 with additional risk factors or N1 [1-3 axillary lymph nodes]), IIB, or III disease per the American Joint Committee on Cancer Staging Manual, eighth edition. The data cutoff date was April 29, 2024. Interventions: Patients were randomized 1:1 to receive ribociclib (400 mg once daily, days 1-21 of a 28-day cycle, over 36 months) plus NSAI (letrozole, 2.5 mg, or anastrozole, 1 mg, once daily continuously for 60 months) or NSAI alone. Men and premenopausal women also received goserelin (3.6 m...