Capecitabine or Capecitabine Plus Oxaliplatin Versus Fluorouracil Plus Cisplatin in Definitive Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (CRTCOESC): A Multicenter, Randomized, Open-Label, Phase 3 Trial

作者：Ruinuo Jia, Tanyou Shan, Anping Zheng, Yaowen Zhang, Ping Lu, Guifang Zhang, Wang Feng, Zhiqiao Xu, Guobao Zheng, Dongxia Tang, Weiguo Zhang, Wanying Li, Ruonan Li, Yibo Guo, Lina Liu, Xiaoyong Luo, Yingjuan Zheng, Zhiwei Chang, Qiming Wang, Xinshuai Wang, Xiaozhi Yuan, Guoqiang Kong, Shuoguo Li, Yang Ruina, Dan Zhou, Jing Ren, Weijiao Yin, Jingxia Li, Junqian Zhang, Ziqi Wang, Manxi Sheng, Bingyi Xu, Liuyan Li, Xiaoyi Liu, Zhihao Lu, Lixin Wan, Fuyou Zhou, Shegan Gao · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.23.02009 · 被引用次数：17 · 研究领域：Esophageal Cancer Research and Treatment、Head and Neck Cancer Studies、Pancreatic and Hepatic Oncology Research

PURPOSE This phase 3 trial aimed to compare the efficacy and safety of capecitabine or capecitabine plus oxaliplatin (XELOX) with those of fluorouracil plus cisplatin (PF) in definitive concurrent chemoradiotherapy (DCRT) for inoperable locally advanced esophageal squamous cell carcinoma (ESCC). METHODS Patients were randomly assigned to receive two cycles of capecitabine, XELOX, or PF along with concurrent intensity-modulated radiation therapy. Patients in each arm were again randomly assigned to receive two cycles of consolidation chemotherapy or not. The primary end points were 2-year overall survival (OS) rate and incidence of grade ≥3 adverse events (AEs). RESULTS A total of 246 patients were randomly assigned into the capecitabine (n = 80), XELOX (n = 85), and PF (n = 81) arms. In capecitabine, XELOX, and PF arms, the 2-year OS rate was 75%, 66.7%, and 70.9% (capecitabine v PF: hazard ratio [HR], 0.91 [95% CI, 0.61 to 1.35]; nominal P = .637; XELOX v PF: 0.86 [95% CI, 0.58 to 1.27]; P = .444); the median OS was 40.9 (95% CI, 34.4 to 49.9), 41.9 (95% CI, 28.6 to 52.1), and 35.4 (95% CI, 30.4 to 45.4) months. The incidence of grade ≥3 AEs during the entire treatment was 28.8%, 36.5%, and 45.7%, respectively. Comparing the consolidation chemotherapy with the nonconsolidation chemotherapy groups, the median OS was 41.9 (95% CI, 34.6 to 52.8) versus 36.9 (95% CI, 28.5 to 44) months (HR, 0.71 [95% CI, 0.52 to 0.99]; nominal P = .0403). CONCLUSION Capecitabine or XELOX did not...