N0147: a randomized phase III trial of oxaliplatin plus 5-fluorouracil/leucovorin with or without cetuximab after curative resection of stage III colon cancer.

摘要: Rationale For many years, adjuvant therapy for resected stage III colon cancer consisted of 5-fluorouracil (5-FU) and leucovorin (LV) administered on one several different schedules. More recently, oxaliplatin was introduced into the treatment patients with colorectal cancer, a trial or demonstrated significant benefit use this drug when added to 5-FU/LV. In pivotal MOSAIC trial, received LV5FU2 regimen (bolus 5-FU/LV followed by infusional 5-FU days 1 2) FOLFOX4 regimen, which is addition day 1.1 As recently reported, 3year disease-free survival (DFS) rate improved from 73% 78%, 23% reduction in risk recurrence. Recognizing that further gains DFS chemotherapy alone are unlikely, focus current national international trials access potential biologic agents chemotherapy. Recently, 2 monoclonal antibodies targeting specific molecular characteristics malignant tumors, bevacizumab cetuximab, have been approved metastatic cancer. Of these antibodies, cetuximab exerts direct tumor-targeted effect binding transmembranous epidermal growth factor receptor (EGFR) surface tumor cells documented single-agent activity salvage setting.2,3 This enhanced combination conventional cytotoxic randomized led Food Drug Administration’s approval cetuximab/irinotecan produced higher response rates longer times progression than alone.2 Although experience as component first-line limited, recent results phase II studies demonstrate high FOLFOX regimens (oxaliplatin/5-FU/LV).4,5 Cetuximab’s setting appears promising ability directly target thereby micrometastatic disease angiogenesis has not yet occurred. The North Central Cancer Treatment Group N0147 study US Intergroup assess adding modified FOLFOX6 completely