Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age.

作者：Kevin Kalinsky, Mattea Reinisch, Yen‐Shen Lu, Marc Debled, Binghe Xu, Lowell L. Hart, Stephanie L. Graff, Qiang Liu, Michael Untch, Sherene Loi, Priyanka Sharma, Viktoriya Sakalosh, Melissa Gao, Elizabeth Chertow Santarsiero, Sorcha Waters, Shaheen Islam, Seock-Ah Im · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.516 · 被引用次数：4 · 研究领域：Advanced Breast Cancer Therapies、Neuroendocrine Tumor Research Advances

516 Background: The NATALEE trial demonstrated significant invasive disease–free survival benefit with RIB + NSAI vs NSAI alone in patients (pts) with stage II/III HR+/HER2− early breast cancer (EBC) at high risk of recurrence. Here, we report outcomes by menopausal status and age. Methods: Pts were treated with RIB + NSAI or NSAI alone in NATALEE; premenopausal (PreM) women also received goserelin. Men were excluded from this analysis. Efficacy, safety, and quality of life were analyzed by menopausal status (assessed at randomization or start of adjuvant endocrine therapy, whichever was first) and age (PreM [<40 y, ≥40 y]; postmenopausal [PostM; <60 y, ≥60 y]). Data cutoff was April 29, 2024. Results: A greater portion of PreM vs PostM pts had ECOG performance status 0 (86.8% vs 80.1%), Ki-67 >20% (39.9% vs 34.4%), N1-N3 nodal stage (63.4% vs 56.9%), and T3/T4 tumors (28.7% vs 24.0%) at diagnosis. There was consistent treatment benefit with RIB + NSAI vs NSAI alone across groups and ages (median follow-up, 44.2 months) (Table). Fewer PreM pts discontinued RIB due to AEs vs PostM (16.1% vs 22.9%); reductions due to AEs were similar (22.4% vs 23.6%). Of pts who discontinued due to AEs, more PreM pts did so without a dose reduction vs PostM (75.4% vs 67.5%). Within menopausal groups, fewer pts in the younger cohorts discontinued RIB due to AEs (Table). Alanine aminotransferase elevation was the most common AE leading to discontinuation in the PreM (6.2%) and PostM grou...