This multicenter, open-label, randomized phase III trial conducted in Japan compared 3 versus 6 months of postoperative adjuvant chemotherapy in patients with curatively resected stage III colon cancer. Study participants received either a modified fluorouracil, leucovorin, and oxaliplatin, regimen, or capecitabine and oxaliplatin (CAPOX) regimen.
Five-year OS rates were comparable between the two groups: 87.0% in the 3-month treatment group and 86.4% in the 6-month treatment group. Peripheral sensory neuropathy lasting longer than 5 years was twice as common in the 6- compared with 3-month treatment group (16% v 8%, respectively) and in those receiving mFOLFOX6 compared with CAPOX (14% v 11%, respectively).