Multiple-target chemotherapy (LV-modulated 5-FU bolus and continuous infusion, oxaliplatin, CPT- 11) in advanced 5-FU-refractory colorectal cancer: MTD definition and efficacy evaluation. A phase I-II study.

摘要: Aims and background: To identify the maximum tolerated doses to define activity of a regimen incorporating leucovorin (LV)-modulated 5-fluorouracil (5-FU) bolus continuous infusion, oxaliplatin (I-OHP) irinotecan (CPT-11) in patients with advanced, 5-FU-refractory colorectal cancer (CRC). Patients methods: Starting doses: LV 100 mg/m 2 as 2-hour infusion followed by 5-FU 300 administration 500 mg//m 22-hour on days 1 2; I-OHP 65 concomitantly day 1; CPT-11 90 2. Planned cycle interval: weeks. Results: Two hundred twenty-six cycles were administered 27 patients. Recommended , protracted 1-OHP 75 150 . Among 25 evaluable for response we observed 13 disease stabilizations (52%; 95% Cl: 33-71%), 6 instances progression responses (24%; 7-41%). Median time overall survival 24 60 weeks, respectively. A delay >3 was 134/199 (67%). Conclusions: This study confirms feasibility triplet chemotherapy advanced CRC.