Single-agent irinotecan or FOLFIRI as second-line chemotherapy for advanced colorectal cancer; results of a randomised phase II study (DaVINCI) and meta-analysis
Field | Value | Language |
dc.contributor.author | Clarke, Stephen | |
dc.contributor.author | Yip, Sonia | |
dc.contributor.author | Brown, Chris | |
dc.contributor.author | Van Hazel, Guy | |
dc.contributor.author | Ransom, David T | |
dc.contributor.author | Goldstein, David | |
dc.contributor.author | Jeffrey, G Mark | |
dc.contributor.author | Tebbutt, Niall C | |
dc.contributor.author | Buck, Martin | |
dc.contributor.author | Lowenthal, Raymond M | |
dc.contributor.author | Boland, Amy | |
dc.contributor.author | Gebski, Val | |
dc.contributor.author | Zalcberg, John | |
dc.contributor.author | Simes, R John | |
dc.date.accessioned | 2016-07-12 | |
dc.date.available | 2016-07-12 | |
dc.date.issued | 2011-06-10 | |
dc.identifier.citation | Clarke S, Yip S, Brown C, van Hazel G, Ransom D, Goldstein D, Jeffrey G, Tebbut N, Buck M, Lowenthal R, Boland A, Gebski V, Zalcberg J, Simes R, on behalf of the Australasian Gastro-Intestinal Trials Group. Single-agent irinotecan or FOLFIRI as second-line chemotherapy for advanced colorectal cancer; results of a randomised phase II study (DaVINCI) and meta-analysis [Correction: European Journal of Cancer 2012; 48(3): 407]. European Journal of Cancer 2011; 47(12): 1826–1836. | en_AU |
dc.identifier.uri | http://hdl.handle.net/2123/15324 | |
dc.description.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 IV bolus, day 1), 2-weekly; or single-agent, irinotecan (350 mg/m2 IV over 90 min), 3-weekly. Toxicity was evaluated every treatment cycle; QOL and response 6 weekly. Analysis was by intention to treat. Results were also combined with those of other trials. Findings We randomised 44 patients to combination and 45 to single-agent. The most common toxicity was complete alopecia (single-agent 37%, combination 14%, P<0.02). Eight patients in the irinotecan arm and 4 in the combination arm had grade 3–4 diarrhoea (P=0.24). The treatment groups did not differ significantly in overall QOL changes, response rate, or progression free or overall survival. In a systematic review of 29 trials of second-line irinotecan-based treatment, single-agent irinotecan was associated with more diarrhoea and alopecia than the combination, but efficacy was similar. Interpretation Combination treatment compared with single-agent irinotecan appears to reduce the rateof complete alopecia and diarrhoea without compromising efficacy on clinical outcomes. | en_AU |
dc.description.sponsorship | Australasian Gastro-Intestinal Trials Group | en_AU |
dc.language.iso | en | en_AU |
dc.publisher | Elsevier | en_AU |
dc.relation | Pfizer Australia educational grant | en_AU |
dc.subject | colorectal cancer | en_AU |
dc.subject | chemotherapy | en_AU |
dc.subject | phase 2 trial | en_AU |
dc.subject | drug toxicity | en_AU |
dc.subject | irinitecan | en_AU |
dc.title | Single-agent irinotecan or FOLFIRI as second-line chemotherapy for advanced colorectal cancer; results of a randomised phase II study (DaVINCI) and meta-analysis | en_AU |
dc.title.alternative | Irinotecan or FOLFIRI for 2nd line colorectal | en_AU |
dc.type | Article | en_AU |
dc.type.pubtype | Post-print | en_AU |
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