Journal article
Single-agent irinotecan or 5-fluorouracil and leucovorin (FOLFIRI) as second-line chemotherapy for advanced colorectal cancer; Results of a randomised phase II study (DaVINCI) and meta-analysis
SJ Clarke, S Yip, C Brown, GA Van Hazel, DT Ransom, D Goldstein, GM Jeffrey, NC Tebbutt, M Buck, RM Lowenthal, A Boland, V Gebski, J Zalcberg, RJ Simes
European Journal of Cancer | ELSEVIER SCI LTD | Published : 2011
Abstract
Background: Second-line treatment with irinotecan for advanced or metastatic colorectal cancer prolongs survival. It is uncertain whether irinotecan is better administered with 5-fluorouracil or alone in patients previously treated with a fluoropyrimidine. We compared toxicity (particularly diarrhoea), quality of life, and efficacy of combination chemotherapy and irinotecan in these patients. Methods: In DaVINCI, a randomised phase II trial, patients with advanced colorectal cancer were randomly allocated to: Combination therapy (FOLFIRI), irinotecan (180 mg/m2 IV over 90 min, day 1), 5-fluorouracil (400 mg/m2 IV bolus and 2400 mg/m2 by 46-hour infusion from day 1) and folinic acid (20 mg/m2..
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Funding Acknowledgements
AGITG was the sponsor responsible for undertaking the DaVinci trial, and the NHMRC Clinical Trials Centre was the coordinating centre responsible for performing the trial under the auspices of AGITG. The trial was supported by an educational grant from Pfizer Australia Pty Ltd.