Anthracycline-free or short-term regimen as adjuvant chemotherapy for operable breast cancer: A phase III randomized non-inferiority trial

作者：Ke‐Da Yu, Xiyu Liu, Li Chen, Miao Mo, Jiong Wu, Guangyu Liu, Gen‐Hong Di, Claire F. Verschraegen, Daniel G. Stover, Zhigang Zhuang, François Bertucci, Armando Orlandi, Jie Wang, Giuseppe Lippi, Kejin Wu, Mohammed A. Osman, Lei Fan, Zhi‐Ming Shao · 发表于：The Lancet Regional Health - Western Pacific · 年份：2021 · DOI：10.1016/j.lanwpc.2021.100158 · 被引用次数：14 · 研究领域：Breast Cancer Treatment Studies、Cancer Treatment and Pharmacology、Advanced Breast Cancer Therapies

Background De-escalating anthracycline is gaining popularity for breast cancer patients. We aim to evaluate the non-inferiority of an anthracycline-free or short-term regimen to the standard anthracycline-based regimen for operable patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Methods It is a prospective, open-label, phase 3, randomized non-inferiority trial from June 1, 2010 to June 1, 2017. Follow-up had been kept until July 2019. This trial was conducted at Fudan University Shanghai Cancer Center. Patients with pT1–3N+ or pT2–3N0 but high-risk (grade II/III, lymphovascular invasion, ≤35 years of age or hormone-receptor negative) HER2-negative operable breast cancer were eligible and stratified by age, pathological tumour stage, pathological node status and hormone-receptor status. Patients were randomized to 6 cycles of docetaxel and cyclophosphamide (TC, n = 524), 3 cycles of cyclophosphamide/epirubicin/fluorouracil followed by 3 cycles of docetaxel (CEF-T, n = 523) or epirubicin and cyclophosphamide for 4 cycles followed by paclitaxel for 12 weeks (EC-P, n = 524) as the intention-to-treat population. Of these patients, 94% completed allocated therapy. Difference in disease-free survival (DFS) compared to EC-P. The prespecified non-inferiority margin was 4.5%, corresponding to the hazard ratio (HR) of 1.44 (one-sided α = 0.05), with an assumed 5-year DFS of 89% for EC-P. Findings Included in the intention-to-treat population were 15...