Endocrine-Sensitive Disease Rate in Postmenopausal Patients With Estrogen Receptor–Rich/ERBB2-Negative Breast Cancer Receiving Neoadjuvant Anastrozole, Fulvestrant, or Their Combination

作者：Cynthia X. Ma, Vera Jean Suman, Souzan Sanati, Kiran R. Vij, Meenakshi Anurag, Ann Marilyn Leitch, Gary Walter Unzeitig, Jeremy Hoog, Aranzazu Fernández-Martínez, Cheng Fan, Richard A. Gibbs, Mark A. Watson, Travis Dockter, Olwen Mary Hahn, Joseph Michael Guenther, Abigail Suzanne Caudle, Erika C. Crouch, Amy Tiersten, Monica M Mita, Wajeeha Razaq, Tina J. Hieken, Yang Wang, Mothaffar F. Rimawi, Anna Catherine Weiss, Eric P. Winer, Kelly K. Hunt, Charles M. Perou, Matthew J. Ellis, Ann H. Partridge, Lisa A. Carey · 发表于：JAMA Oncology · 年份：2024 · DOI：10.1001/jamaoncol.2023.6038 · 被引用次数：26 · 研究领域：Estrogen and related hormone effects、Breast Cancer Treatment Studies、Advanced Breast Cancer Therapies

Importance: Adding fulvestrant to anastrozole (A+F) improved survival in postmenopausal women with advanced estrogen receptor (ER)-positive/ERBB2 (formerly HER2)-negative breast cancer. However, the combination has not been tested in early-stage disease. Objective: To determine whether neoadjuvant fulvestrant or A+F increases the rate of pathologic complete response or ypT1-2N0/N1mic/Ki67 2.7% or less residual disease (referred to as endocrine-sensitive disease) over anastrozole alone. Design, Setting, and Participants: A phase 3 randomized clinical trial assessing differences in clinical and correlative outcomes between each of the fulvestrant-containing arms and the anastrozole arm. Postmenopausal women with clinical stage II to III, ER-rich (Allred score 6-8 or >66%)/ERBB2-negative breast cancer were included. All analyses were based on data frozen on March 2, 2023. Interventions: Patients received anastrozole, fulvestrant, or a combination for 6 months preoperatively. Tumor Ki67 was assessed at week 4 and optionally at week 12, and if greater than 10% at either time point, the patient switched to neoadjuvant chemotherapy or immediate surgery. Main Outcomes and Measures: The primary outcome was the endocrine-sensitive disease rate (ESDR). A secondary outcome was the percentage change in Ki67 after 4 weeks of neoadjuvant endocrine therapy (NET) (week 4 Ki67 suppression). Results: Between February 2014 and November 2018, 1362 female patients (mean [SD] age, 65.0 [8.2] years)...