Phase III Multicenter Randomized Trial of Oxaliplatin Added to Chronomodulated Fluorouracil–Leucovorin as First-Line Treatment of Metastatic Colorectal Cancer

摘要: PURPOSE: To study how adding oxaliplatin (l-OHP) to chronomodulated fluorouracil (5-FU)–leucovorin (LV) affected the objective response rate, as first-line treatment of metastatic colorectal cancer. PATIENTS AND METHODS: Two hundred patients from 15 institutions in four countries were randomly assigned receive a 5-day course 5-FU and LV (700 300 mg/m2/d, respectively; peak delivery rate at 0400 hours) with or without l-OHP on first day each (125 mg/m2, 6-hour infusion). Each was repeated every 21 days. Response assessed by extramural review computed tomography scans. RESULTS: Grade 3 4 toxicity 5-FU–LV occurred ≤ 5% (≤ 1% courses). diarrhea 43% given (10% courses), less than 2% had severe hematotoxicity. Thirteen percent moderate functional impairment peripheral sensory neuropathy. Sixteen rec...