Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial

作者：Zhuofeng Lin, Peipei Zhang, Ping Chi, Yi Xiao, Xiaoyue Xu, A.M. Zhang, Xin Qiu, Jun Wu, Ying Yuan, Zhenning Wang, Xiaomei Qu, Xinyu Li, Xin Nie, Mu Yang, Keke Cai, W.K. Zhang, Yisen Huang, Zhiguang Sun, Z.G. Hou, Chao Ma, F. Z. Cheng, Kaixiong Tao, Tao� Zhang · 发表于：Annals of Oncology · 年份：2024 · DOI：10.1016/j.annonc.2024.06.015 · 被引用次数：114 · 研究领域：Colorectal and Anal Carcinomas、Cancer Immunotherapy and Biomarkers、Colorectal Cancer Surgical Treatments

BACKGROUND: Neoadjuvant short-course radiotherapy (SCRT) followed by CAPOX and camrelizumab (a programmed cell death protein 1 monoclonal antibody) has shown potential clinical activity for locally advanced rectal cancer (LARC) in a phase II trial. This study aimed to further confirm the efficacy and safety of SCRT followed by CAPOX and camrelizumab compared to long-course chemoradiotherapy (LCRT) followed by CAPOX alone as neoadjuvant treatment for LARC. PATIENTS AND METHODS: In this randomized, phase III trial, patients with T3-4/N+ rectal adenocarcinoma were randomly assigned (1 : 1) to receive SCRT or long-course chemoradiotherapy (LCRT), followed by two cycles of camrelizumab and CAPOX or CAPOX alone, respectively. After surgery, each arm underwent either six cycles of camrelizumab and CAPOX, followed by up to 17 doses of camrelizumab, or six cycles of CAPOX. The primary endpoint was pathological complete response (pCR) rate (ypT0N0) assessed by a blinded independent review committee. Key secondary endpoints tested hierarchically were 3-year event-free survival (EFS) rate and overall survival (OS). RESULTS: Between July 2021 and March 2023, the intention-to-treat population comprised 113 patients in the experimental arm and 118 patients in the control arm, with surgery carried out in 92% and 83.9%, respectively. At data cut-off (11 July 2023), the pCR rates were 39.8% [95% confidence interval (CI) 30.7% to 49.5%] in the experimental arm compared to 15.3% (95% CI 9.3% to ...