Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Final Results of a Phase III Trial

作者：Wei-Jian Mei, Xiaozhong Wang, Xi Zhang, Yueming Sun, C Chia-Kai Yang, Jun-Zhong Lin, Zuguang Wu, Rui Zhang, Wei Wang, Y. Li, Yezhong Zhuang, Jian Lei, Xiang Bin Wan, Yingkun Ren, Yong Cheng, Wen-Liang Li, Zi-Qiang Wang, Dongbo Xu, Xianwei Mo, Haixing Ju, Sheng-Wei Ye, Jing-Lin Zhao, Heng Zhang, Yuan-Hong Gao, Zhi-Fan Zeng, Wei-Wei Xiao, Xiao-Peng Zhang, Y. Li, Enzehua Xie, Yifei Feng, J. Tang, Xiao-Jun Wu, G. Chen, Li Ren Li, Zhen-Hai Lu, De-Sen Wan, Jin-xin Bei, Zhi-Zhong Pan, Jiehai Yu, Pei-Rong Ding · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco-25-00731 · 被引用次数：4 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Anorectal Disease Treatments and Outcomes

PURPOSE The neoadjuvant chemoradiotherapy (nCRT) might accentuate surgical complications and toxicity in the treatment of locally advanced rectal cancer (LARC) while neoadjuvant chemotherapy (nCT) alone shows promise as an alternative treatment. However, which patients deserve most from the nCT need further clarify. This trial aimed to assess the non-inferiority of nCT with capecitabine plus oxaliplatin (CAPOX) versus nCRT with capecitabine in LARC with uninvolved mesorectal fascia (MRF). METHODS Patients with LARC within 12 cm from the anal verge and uninvolved MRF were randomly assigned to receive 4 cycles of CAPOX chemotherapy alone (nCT group) or CRT with concurrent Capecitabine (nCRT group). The primary end point is 3-year locoregional recurrence-free survival (LRRFS). Secondary end points, such as 3-year disease-free survival (DFS), 3-year overall survival (OS), and adverse events (AEs), were also reported. RESULTS A total of 663 patients were enrolled and 589 patients received the allocated treatment (nCT, n = 300; nCRT, n = 289). LRRFS was analyzed with a median follow-up of 48 months. 3-year LRRFS was 97.4% (95% CI, 95.5 to 99.3) in the nCRT group and 96.3% (95% CI, 94.0 to 98.6) in the nCT group, resulting in a hazard ratio (HR) of 1.40 (95% CI, 0.53 to 3.68). The nCT and nCRT achieved similar 3-year DFS (89.2% v 87.9%; HR, 0.88 [95% CI, 0.54 to 1.44]) and 3-year OS (95.0% v 94.1%; HR, 0.86 [95% CI, 0.42 to 1.76]). The nCT group showed a lower incidence of grade 2 t...