Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Final Results of a Phase III Trial
Abstract
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 to 4 long-term AEs (16.0% v 26.3%, P = 0.002) and proctitis (33.6% v 41.7%, P = 0.049) compared with nCRT group. CONCLUSIONS The non-inferiority of nCT was not confirmed with a very low incidence of local recurrence in both group. But nCT offers comparable DFS and OS while mitigating the burden of toxicity as compared to nCRT. These insights shed light on a potential paradigm shift in the treatment for LARC with uninvolved MRF.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (40)
Wei-Jian Mei
Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, PR China
Xiao-Zhong Wang
Xuan Zhang
Yue-Ming Sun
The First Affiliated Hospital of Nanjing Medical University, Nanjing, PR China
Chun-Kang Yang
Fujian Medical University Cancer Hospital, Fuzhou, PR China
Jun-Zhong Lin
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou, China
Zu-Guang Wu
Department of Gastrointestinal Surgery, Meizhou People's Hospital, Meizhou, PR China
Rui Zhang
Wei Wang
Yong Li
Ye-Zhong Zhuang
Cancer Hospital of Shantou University Medical College, Shantou, PR China
Jian Lei
Department of Public Foundation
Xiang-Bin Wan
Department of General Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Henan Provincial Cancer Hospital, Zhengzhou, PR China
Ying-Kun Ren
Department of General Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Henan Provincial Cancer Hospital, Zhengzhou, PR China
Yong Cheng
Wen-Liang Li
First Affiliated Hospital of Kunming Medical University, Kunming, PR China
Zi-Qiang Wang
Dong-Bo Xu
Longyan First Hospital, Longyan, PR China
Xian-Wei Mo
Guangxi Medical University Cancer Center, Nanning, PR China
Hai-Xing Ju
Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, PR China
Sheng-Wei Ye
Hubei Cancer Hospital, Wuhan, PR China
Jing-Lin Zhao
Jiangmen Central Hospital, Jiangmen, China
Hong Zhang
Yuan-Hong Gao
Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China
Zhi-Fan Zeng
Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, PR China
Wei-Wei Xiao
Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China
Xiao-Peng Zhang
Shantou Central Hospital, Shantou, PR China
Yun-Feng Li
The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Hospital, Kunming, PR China
E Xie
Shantou Hospital of Traditional Chinese Medicine, Shantou, PR China
Yi-Fei Feng
The First Affiliated Hospital of Nanjing Medical University, Nanjing, PR China
Jing-Hua Tang
Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, PR China
Xiao-Jun Wu
Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, PR China
Gong Chen
State Key Laboratory and Institute of Elemento-Organic Chemistry, College of Chemistry
Li-Ren Li
Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China
Zhen-Hai Lu
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou, China
De-Sen Wan
Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, PR China
Jin-Xin Bei
Zhi-Zhong Pan
Jie-Hai Yu
Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, PR China
Pei-Rong Ding
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University, Guangzhou, China