Pilot experience with adjuvant FOLFIRI with or without cetuximab in patients with resected stage III colon cancer: NCCTG Intergroup N0147.

3522 Background: Irinotecan (CPT-11) has antitumor activity against metastatic colorectal cancer alone or with 5-fluorouracil (5FU)/leucovorin (LV). Two arms with CPT-11, 5FU, and LV (FOLFIRI) +/- cetuximab (Cmab) were originally included in N0147. However, after CALGB 89803 (J Clin Oncol 25:3456, 2007), PETACC-3 (J Clin Oncol 27:3117, 2009), and Accord02 (Ann Oncol 20:674, 2009) showed no benefit to a CPT-11 combination in adjuvant therapy, the CPT-11 arms of N0147 were discontinued. We report the outcomes for patients given FOLFIRI and FOLFIRI+Cmab (F-Cmab). Methods: Patients with resected stage III colon cancer were randomized to one of 6 arms including 12 biweekly cycles of FOLFIRI (CPT-11 180 mg/m2 d1 with LV 400 mg/m2, 5FU 400 mg/m2 bolus IV, then 46-hr IV 5FU 2,400 mg/m2 on d1,2) without or with Cmab 400 mg/m2 d1 cycle 1, then 250 mg/m2 d1, 8. Primary endpoint was 3-year disease-free survival (DFS). Secondary endpoints included overall survival (OS) and toxicity. Results: 146 evaluable patients (Ar...