416P A randomized controlled trial to compare laparoscopic surgery with open surgery for symptomatic, non-curable stage IV colorectal cancer (CRC): First efficacy results from Japan clinical oncology group study JCOG1107

Abstract

The benefits of laparoscopic surgery (LAP) compared with open surgery (OP) have been suggested; however, the long-term survival of LAP for symptomatic, non-curable colorectal cancer (CRC) is still unclear. We conducted a trial to confirm the non-inferiority of LAP to OP in terms of progression-free survival (PFS). Only accredited surgeons from 42 Japanese institutions participated. Eligibility criteria included (1) pathologically proven adenocarcinoma or adenosquamous carcinoma; (2) primary tumor located at the cecum, ascending, transverse, descending, sigmoid and rectosigmoid colon; (3) primary tumor with bowel stenosis and/or bleeding. (4) having at least one to three incurable factors. Patients received mFOLFOX6+BEV or CapeOX+BEV after surgery. The planned sample size was 194 patients with a power of 70%, a one-sided alpha of 5% and the non-inferiority margin of the hazard ratio (HR) as 1.38. A total of 195 patients were randomized (OP 95, LAP 100) between Jan 2013 and Jan 2021. Surgery was performed 92 in OP and 98 in LAP. Postoperative chemotherapy was given in 82 in OP and 86 in LAP. Median PFS was 9.7 months (95% CI: 8.7-11.3) in OP, and 10.4 months (9.1-12.4) in LAP. The non-inferiority of LAP was confirmed (HR: 1.02 [91.4% CI: 0.79-1.32 (< 1.38)], p for non-inferiority = 0.021). Median OS was 23.9 months (95% CI: 18.6-29.4) in OP, and 25.4 months (19.4-29.0) in LAP (HR: 0.99, 95% CI [0.72-1.36]). Proportion of mortality in hospital was 1.1% in OP, 0% in LAP. Postoperative complications (G2-G4) included ileus (OP 12.0%, LAP 5.1%), wound infection (OP 2.2%, LAP 2.0%), and anastomotic leakage (OP 0%, LAP 2.0%). LAP is acceptable as a standard treatment for symptomatic, non-curable stage IV CRC.