A phase II study of FOLFIRI-3 (double infusion of irinotecan combined with LV5FU) after FOLFOX in advanced colorectal cancer patients
Open Access
- 11 April 2006
- journal article
- research article
- Published by Springer Science and Business Media LLC in British Journal of Cancer
- Vol. 94 (9), 1287-1292
- https://doi.org/10.1038/sj.bjc.6603095
Abstract
In advanced colorectal cancer previously treated with oxaliplatin, efficacy of irinotecan-based chemotherapy is poor and the best regimen is not defined. We designed FOLFIRI-3 and conducted a phase II study to establish its efficacy and safety in advanced colorectal cancer patients previously treated with FOLFOX. FOLFIRI-3 consisted of irinotecan 100 mg m-2 as a 60-min infusion on day 1, running concurrently with leucovorin 200 mg m-2 as a 2-h infusion on day 1, followed by 46-h continuous infusion of 5-fluorouracil (5FU) 2000 mg m-2, and irinotecan 100 mg m-2 repeated on day 3, at the end of the 5FU infusion, every 2 weeks. Sixty-five patients entered the study. The intent-to-treat objective response rate was 23% (95% CI 13-33%). Disease was stable in 37% of patients, progressed in 26% and was not assessable in 14%. From the start of FOLFIRI-3, median progression-free survival was 4.7 months and median survival 10.5 months. Main toxicities (% of patients) were grade 3-4 diarrhoea 23% and grade 4 neutropenia 11%. FOLFIRI-3 is a promising regimen achieving high response rate and progression-free survival in patients previously treated with FOLFOX with a moderate toxicity.Keywords
This publication has 28 references indexed in Scilit:
- FOLFIRI Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: A Randomized GERCOR StudyJournal of Clinical Oncology, 2004
- A Randomized Controlled Trial of Fluorouracil Plus Leucovorin, Irinotecan, and Oxaliplatin Combinations in Patients With Previously Untreated Metastatic Colorectal CancerJournal of Clinical Oncology, 2004
- Scheduling of Fluorouracil: A Forget-Me-Not in the Jungle of DoubletsJournal of Clinical Oncology, 2004
- Prospective Phase II Trial of Irinotecan, 5-Fluorouracil, and Leucovorin in Combination as Salvage Therapy for Advanced Colorectal CancerAmerican Journal of Clinical Oncology, 2001
- Irinotecan plus Fluorouracil and Leucovorin for Metastatic Colorectal CancerThe New England Journal of Medicine, 2000
- New Guidelines to Evaluate the Response to Treatment in Solid TumorsJNCI Journal of the National Cancer Institute, 2000
- CPT-11 (Irinotecan) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancerEuropean Journal of Cancer, 1999
- Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancerThe Lancet, 1998
- Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancerThe Lancet, 1998
- Nonparametric Estimation from Incomplete ObservationsJournal of the American Statistical Association, 1958