Phase III trial of irinotecan plus infusional 5-fluorouracil/folinic acid versus irinotecan plus oxaliplatin as first-line treatment of advanced colorectal cancer.

摘要: Abstract Purpose To determine whether irinotecan plus oxaliplatin (mIROX) is superior to infusional 5-fluorouracil, leucovorin (FUFIRI) as first-line therapy of patients with metastatic colorectal cancer (mCRC). Patients and methods A phase III, randomised, open-label multicentre study compared standard treatment FUFIRI (irinotecan 80 mg/m2, 5-fluorouracil 2000 mg/m2, folinic acid 500 mg/m2 weekly times 6) mIROX using an identical schedule 85 mg/m2 applied on days 1, 15 29 a 7-week cycle. The primary end-point was progression-free survival (PFS). Results total 479 eligible were randomly assigned. Progression-free 7.2 months in the arm 8.2 months [hazard ratio = 1.14; 95% confidence interval (CI) 0.94–1.37; P = 0.178]. Comparable results also obtained for overall time 19 months mIROX-arm 22 months FUFIRI-arm (hazard ratio = 1.08, P = 0.276). Both regimens induced objective response rate (ORR) 41%, but disease control (ORR stable disease) significantly greater group (81% versus 68%, P = 0.001). Most frequent grades 1–4 side-effects nausea (80% 73%) delayed diarrhoea (79% 68%). Grades 3–4 toxicities generally below 10%, except which more (19% 30%, P = 0.006) Conclusion failed show activity high-dose 5-FU/folinic irinotecan. Due better tolerability combination remains care cancer.