FOLFOX4 (12 cycles) versus sequential dose-dense FOLFOX7 (6 cycles) followed by FOLFIRI (6 cycles) in patients with initially resectable metastatic colorectal cancer: A GERCOR randomized phase III study (MIROX).

3506 Background: Perioperative FOLFOX4 is the standard chemotherapy (CT) in patients with resectable metastases from colorectal cancer (CRC) (Nordlinger et al, Lancet 2008). To increase curability and reduce the risk of severe neuropathy, we evaluated the sequential administration of a dose-dense oxaliplatin-based regimen followed by an irinotecan-based regimen. Methods: Patients with CRC and initially resectable or resected metastases were randomized between arm A (control): FOLFOX4 (12 cycles; oxaliplatin 85 mg/m²) or arm B (investigational): FOLFOX7 (6 cycles; oxaliplatin 130 mg/m²) followed by FOLFIRI (6 cycles; irinotecan 180 mg/m²). CT was either perioperative or postoperative. Stratification criteria were: perioperative vs. postoperative CT, surgery alone vs. radiofrequency ablation +/- surgery, Blumgart’s prognostic score (0-1 vs. 2-3 vs. 4-5). Only one metastatic site was allowed, but the number of metastases per organ was not limited. The primary endpoint was disease-free survival (DFS). Results...