OBJECTIVE

To confirm noninferiority of laparoscopic (LAP) to open surgery (OP) for progression-free survival (PFS) of patients with non-curable stage IV colorectal cancer (CRC).

BACKGROUND

Benefits of LAP versus OP are suggested, but long-term survival following LAP for symptomatic, noncurable CRC remains unclear.

METHODS

In this open-label, multicenter, randomized controlled trial, only accredited surgeons from 42 Japanese institutions participated. Eligibility criteria included pathologically proven adenocarcinoma or adenosquamous carcinoma; primary tumor anywhere in the colon causing bowel stenosis and/or bleeding; and at least 1 to 3 noncurable factors. Patients received mFOLFOX6+bevacizumab or CapeOX+bevacizumab postoperatively and were randomly assigned 1:1 to the OP or LAP group. The primary endpoint was PFS, with noninferiority margin for the hazard ratio (HR) set at 1.38.

RESULTS

Between January 2013 and January 2021, 195 patients were randomized (OP, n = 95, LAP, n = 100). Ninety-two patients received OP and 98 LAP, with 82 OP and 86 LAP patients receiving postoperative chemotherapy. Median PFS was 9.7 months (95% CI = 8.7-11.3) for OP and 10.4 months (9.1-12.4) for LAP. Noninferiority of LAP was confirmed [HR = 1.02; 91.4% CI = 0.79-1.32 (<1.38), for noninferiority = 0.021]. Median overall survival was 23.9 months (95% CI = 18.6-29.4) for OP and 25.4 months (19.4-29.0) for LAP (HR = 0.99; 95% CI, 0.72-1.36). In-hospital mortality was 1.1% (OP) and 0% (LAP). Postoperative complications (Grade 2-4) included ileus (OP = 12.0%; LAP = 5.1%), wound infection (OP = 2.2%; LAP = 2.0%), and anastomotic leakage (OP = 0%; LAP = 2.0%).

CONCLUSIONS

LAP appears to be an acceptable standard treatment for symptomatic, noncurable stage IV CRC.

TRIAL REGISTRATION

UMIN-CTR, number UMIN000009715.