Effect of laparoscopy-assisted vs open surgery on 3-year disease-free survival in patients with low rectal cancer: The LASRE randomized clinical trial.

Authors

null

Pan Chi

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

Pan Chi , Xiangqian Su , Jianmin Xu , Huizhong Qiu , Ziqiang Wang , Liang Kang , Haijun Deng , Weiping Chen , Qingtong Zhang , Xiaohui Du , Chunkang Yang , Yincong Guo , Ming Zhong , Kai Ye , Jun You , Dongbo Xu , Xinxiang Li , Zhiguo Xiong , Kaixiong Tao , Ke-Feng Ding

Organizations

Fujian Medical University Union Hospital, Fuzhou, Fujian, China, Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, Gastrointestinal Cancer Center, Peking University Cancer Hospital and Institute, Beijing, China, Zhongshan Hospital, Fudan University, Shanghai, China, Peking Union Medical College Hospital, Academy of Medical Sciences & Peking Union Medical College, Beijing, China, West China Hospital Sichuan University, Chengdu, Sichuan, 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, People's Liberation Army General Hospital, Beijing, China, Fujian Provincial Cancer Hospital, Fuzhou, China, Zhangzhou Affiliated Hospital, Fujian Medical University, Zhangzhou, Fujian, 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, Fujian, China, Longyan Affiliated Hospital, Fujian Medical University, Longyan, China, Shanghai Cancer Center, Shanghai, China, Hubei Cancer Hospital, Wuhan, China, Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 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

Research Funding

the Key Clinical Specialty Discipline Construction Program of the National Health and Family Planning Commission of China
the Minimally Invasive Medical Center Construction Program from the Fujian Province of China, Joint Funds for the Innovation of Science and Technology, Fujian Province

Background: Laparoscopic surgery has been increasingly used for low rectal cancer due to short-term benefits versus open surgery, but the long-term oncologic outcomes have not been fully established. Methods: This is a multicenter, noninferiority trial. Surgeons who had completed ≥100 laparoscopic TME surgeries from 22 high-volume centers in China participated in this trial. A total of 1070 patients scheduled for curative-intent resection of low rectal cancer (lower margin <5.0 cm dentate line) were randomized at a 2:1 ratio to undergo laparoscopic or open surgery from November 2013 to June 2018.The primary outcome was 3-year DFS; the noninferiority margin was 10% in the modified intent-to-treat population. Secondary outcomes included 3-year overall survival (OS) and locoregional recurrence. 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 3-year DFS rate was 81.4% in the laparoscopic group versus 79.8% in the open group (HR, 0.9 [95% CI, 0.7 to 1.2]; log-rank P = .558). The absolute difference was 1.6% (1-sided 97.5% CI, -3.34% to ∞), not exceeding the noninferiority . The 3-year OS rate was 91.7% in the laparoscopic group versus 93.7% in the open group (95% CI, -5.12% to1.54%, log-rank P = .243). The 3-year locoregional recurrence rate was 3.8% and 2.4%, respectively (95% CI, -1.07% to 3.45%, log-rank P = .209). Results of the per-protocol and as-treated analysis were consistent with the main analysis. Conclusions: Among patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons is not inferior to open surgery concerning 3-year disease-free survival. These results support laparoscopic surgery as a safe, minimally invasive approach for low rectal cancer. Clinical trial information: NCT01899547.

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Abstract Details

Meeting

2024 ASCO Gastrointestinal Cancers Symposium

Session Type

Oral Abstract Session

Session Title

Oral Abstract Session C: Cancers of the Colon, Rectum, and Anus

Track

Colorectal Cancer,Anal Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT01899547

Citation

J Clin Oncol 42, 2024 (suppl 3; abstr 8)

DOI

10.1200/JCO.2024.42.3_suppl.8

Abstract #

8

Abstract Disclosures

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