Three-Year Follow-Up of the Randomized Trial Comparing Open Versus Laparoscopic Surgery for Primary Tumor Resection in Patients With Non-Curable Stage IV Colon Cancer (JCOG1107).

Abstract

JCOG1107 (UMIN-CTR, number UMIN000009715) was a non-inferiority phase III trial comparing laparoscopic and open surgery for symptomatic, non-curable stage IV colon cancer. The primary analysis confirmed the non-inferiority of laparoscopic surgery in terms of progression-free survival. To compare long-term outcomes of laparoscopic and open surgery for stage IV colon cancer. Multicenter, open-label, randomized, controlled phase III trial. Forty-two Japanese institutions. Participants were considered eligible if they had pathologically confirmed adenocarcinoma or adenosquamous carcinoma with a primary tumor between the cecum and rectosigmoid, presenting with stenosis and/or bleeding, and one to three non-curable factors. The required sample size was 194 to ensure 70% power, a one-sided alpha of 5%, and a non-inferiority hazard ratio margin of 1.38. Patients were randomized to receive either open or laparoscopic primary tumor resection, followed by modified FOLFOX6 plus bevacizumab or capecitabine plus oxaliplatin with bevacizumab. The primary endpoint was progression-free survival. A total of 195 patients were randomized, including 95 open and 100 laparoscopic surgeries. Postoperative chemotherapy was given to 82 and 86 patients, respectively. The median follow-up period for all randomized patients was 24.4 months. Grade ≥3 late complications occurred in one open (1.1%) and two laparoscopic (2.0%) patients. Three-year progression-free survival was 5.3% (95% confidence interval: 2.0-11.0) for open surgery and 3.0% (0.8-7.8) for laparoscopic surgery (hazard ratio: 1.028; 95% confidence interval: 0.772-1.370; p for non-inferiority = 0.02). The three-year overall survival was 31.5% (22.5-41.0) and 28.5% (20.0-37.6) (hazard ratio: 1.048; 95% confidence interval: 0.780-1.410), respectively. Chemotherapy was administered without knowledge of microsatellite instability or RAS/BRAF mutation status. Laparoscopic surgery is non-inferior to open surgery for non-curable stage IV colon cancer and should be considered an acceptable surgical option. See Video Abstract .