Laparoscopic-assisted vs open surgery for low rectal cancer: 5-year outcomes of the LASRE randomized clinical trial.

person Pan Chi Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China info_outline Pan Chi, Weizhong Jiang, Xiangqian Su, Jianmin Xu, Huizhong Qiu, Liang Kang, Haijun Deng, Weiping Chen, Qingtong Zhang, Chunkang Yang, Yincong Guo, Ming Zhong, Kai Ye, Jun You, Dongbo Xu, Xinxiang Li, Ke-Feng Ding, Kaixiong Tao

Authors person Pan Chi Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China info_outline Pan Chi, Weizhong Jiang, Xiangqian Su, Jianmin Xu, Huizhong Qiu, Liang Kang, Haijun Deng, Weiping Chen, Qingtong Zhang, Chunkang Yang, Yincong Guo, Ming Zhong, Kai Ye, Jun You, Dongbo Xu, Xinxiang Li, Ke-Feng Ding, Kaixiong Tao Organizations Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Gastrointestinal Cancer Center, Peking University Cancer Hospital and Institute, Beijing, China, Department of Colorectal Surgery, Zhongshan Hospital Fudan University, Shanghai, China, Peking Union Medical College Hospital, Academy of Medical Sciences & Peking Union Medical College, Beijing, China, Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, China, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China, Fujian Provincial Cancer Hospital, Fuzhou, China, Zhangzhou Affiliated Hospital, Fujian Medical University, Zhangzhou, China, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, The Second Affiliated Hospital, Fujian Medical University, Quanzhou, China, The First Affiliated Hospital, Xiamen University, Xiamen, China, Longyan Affiliated Hospital, Fujian Medical University, Longyan, China, Shanghai Cancer Center, Shanghai, China, Department of Colorectal Surgery and Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, Union Hospital Medical College, Huazhong University of Science and Technology, Wuhan, China Abstract Disclosures Research Funding the Key Clinical Specialty Discipline Construction Program of the National Health and Family Planning Commission of China((2012-649)) the Minimally Invasive Medical Center Construction Program from the Fujian Province of China([2017]171), Joint Funds for the Innovation of Science and Technology, Fujian Province (2019Y9065) Background: The long-term efficacy of laparoscopic versus open surgery for low rectal cancer has not yet been established. The primary outcome of 3-year disease free survival (DFS) have been published (Chi et al., ASCO GI 2024). Here, we presented the data of 5-year outcomes, including DFS and overall survival (OS) and locoregional recurrence. Methods: This is a multicenter, noninferiority trial. A total of 1070 patients scheduled for curative-intent resection of low rectal cancer were randomized at a 2:1 ratio to undergo laparoscopic or open surgery from November 2013 to June 2018. All analyses were performed on an modified intention-to-treat (mITT) basis. Results: The final analysis included 1039 patients (median age: 57 years, 620 men; 685 and 354 in laparoscopic and open groups, respectively). Clinical TNM stage was II/III in 659 patients, and I in the remaining 380 patients. The 5-year DFS rate was 76.4% in the laparoscopic group versus 75.6% in the open group (log-rank P = 0.766). The 5-year OS rate was 84.6% in the laparoscopic group versus 86.6% in the open group (log-rank P = 0.405). The 5-year locoregional recurrence rate was 5.5% and 3.1%, respectively (log-rank P = 0.079). Conclusions: The findings of the LASRE trial demonstrate that the noninferiority of laparoscopic surgery compared to open surgery for low rectal cancer, as evidenced by the 3-year outcomes, is sustained over a 5-year period when conducted by skilled surgeons. These results affirm laparoscopic surgery as a secure and minimally invasive option for the treatment of low rectal cancer. Clinical trial information: NCT01899547.

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