Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer

作者：Li Chen, Hui Li, Hao Zhang, Huawei Yang, Jun Qian, Zhihua Li, Yu Ren, Shu Wang, Peifen Fu, Hongjian Yang, Yunjiang Liu, Jing Sun, Jian‐Yun Nie, Ruiwen Lei, Yongzhong Yao, Anqin Zhang, Shouman Wang, Xiaopeng Ma, Zhong Ouyang, Hongwei Yang, Song‐Yang Wu, Shuo-Wen Cao, Kun Wang, Aimei Jiang, Quchang Ouyang, Da Pang, Limin Wei, Xiaoming Zha, Yu Shen, Xueli Qu, Fei Wu, Xiaoyu Zhu, Zhonghua Wang, Lei Fan, Zhi-Ming Shao · 发表于：JAMA · 年份：2024 · DOI：10.1001/jama.2024.23560 · 被引用次数：47 · 研究领域：Breast Cancer Treatment Studies、Cancer Immunotherapy and Biomarkers、HER2/EGFR in Cancer Research

Importance: Preferred neoadjuvant strategies for early or locally advanced triple-negative breast cancer include a 4-drug chemotherapy regimen containing anthracyclines, cyclophosphamide, taxanes, and platinum. Blockade of the programmed death receptor 1/ligand-1 (PD-1/PD-L1) pathway may improve efficacy of classic neoadjuvant chemotherapy. Camrelizumab, an anti-PD-1 antibody, has showed antitumor activity in advanced triple-negative breast cancer. Objective: To evaluate the efficacy and adverse events of camrelizumab plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy for patients with early or locally advanced triple-negative breast cancer. Design, Setting, and Participants: This randomized, double-blind, phase 3 trial enrolled patients from 40 hospitals in China between November 25, 2020, and May 12, 2023 (data cutoff: September 30, 2023). A total of 441 eligible patients were enrolled. Interventions: Patients were randomized in a 1:1 ratio to receive either camrelizumab 200 mg (n = 222) or placebo (n = 219) combined with chemotherapy every 2 weeks. The chemotherapy included nab-paclitaxel (100 mg/m2) and carboplatin (area under the curve, 1.5) on days 1, 8, and 15 in 28-day cycles for the first 16 weeks followed by epirubicin (90 mg/m2) and cyclophosphamide (500 mg/m2) every 2 weeks for 8 weeks. Main Outcomes and Measures: The primary end point was pathological complete response (defined as no invasive tumor in breast and lymph nodes [ypT0/Tis ypN0]). Re...