Initial safety report on the tolerability of modified FOLFOX6 as adjuvant therapy in patients with curatively resected stage II or III colon cancer (JFMC41-1001-C2: JOIN trial)
Adjuvant FOLFOX is a widely accepted standard therapy for resected colon cancer. The incidence of grade 3–4 peripheral sensory neuropathy (PSN) was 12.4 and 5.7 % in the MOSAIC and Eastern MASCOT trials, while that of grade 3–4 allergic reactions (AR) was 2.9 and 3.1 %, respectively. The JFMC41-1001-C2 trial (JOIN trial) investigated the tolerability of modified FOLFOX6 (mFOLFOX6) in Japanese colon cancer patients. Twelve cycles of mFOLFOX6 were given to patients with the same eligibility criteria as in the MOSAIC study: stage II or III curatively resected colon cancer, performance status of 0–1, aged 20 years or older, starting mFOLFOX6 within 7 weeks of surgery, and adequate organ function. The primary endpoints were the incidence of PSN persisting for ≥8 days that interfered with daily activities and the incidence of grade 3–4 AR. The target sample size was 800. From November 2010 to March 2012, 882 patients were enrolled at 198 institutions. Safety was analyzed in 828 patients with finalized data out of 848 patients receiving mFOLFOX6. The incidence of PSN persisting ≥8 days was 3.3 % [95 % confidence interval (CI) 2.2–4.7], while that of grade 3–4 AR was 1.7 % (95 % CI 0.9–2.8). The treatment completion rate was 67.0 %. The median total dosage of oxaliplatin was 811.1 mg/m2. The overall incidence of grade 3–4 PSN was 5.8 %. Interstitial pneumonitis occurred in one patient. There were no treatment-related deaths. Adjuvant mFOLFOX6 is tolerable for Japanese patients with colon cancer.