Journal article
Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Advanced Colorectal Cancer Meta-Analysis Project
Journal of clinical oncology, Vol.10(6), pp.896-903
06/01/1992
DOI: 10.1200/JCO.1992.10.6.896
PMID: 1534121
Abstract
PURPOSEA meta-analysis was performed on nine randomized clinical trials that compared fluorouracil (5-FU) with 5-FU plus intravenous (IV) leucovorin (LV) for the treatment of advanced colorectal cancer.DESIGNThe analysis was based on the most recently updated individual patient data from all trials. The end points of interest were tumor response and overall survival.RESULTSTherapy with 5-FU plus LV administered either as weekly or monthly regimens showed a highly significant benefit over single-agent 5-FU in terms of tumor response rate (23% v 11%; response odds ratio (OR), 0.45; P less than 10(-7)). This increase in response did not result in a discernable improvement of overall survival (survival OR, 0.97; P = .57). The large number of patients who did not respond to treatment in both groups, and cross-overs from 5-FU alone to 5-FU plus LV are discussed as plausible explanations for the lack of a survival difference.CONCLUSIONThese results confirm the advantage of 5-FU plus leucovorin over 5-FU alone in terms of objective tumor response. They also suggest that in planning future trials, tumor response should not be considered a valid surrogate end point for survival in patients with advanced colorectal cancer.
Details
- Title: Subtitle
- Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Advanced Colorectal Cancer Meta-Analysis Project
- Creators
- P. Piedbois - Intl. Institute for Drug DevelopmentN. Petrelli - Intl. Institute for Drug DevelopmentM. Buyse - International Drug DevelopmentY. Rustum - Intl. Institute for Drug DevelopmentD. Machover - Intl. Institute for Drug DevelopmentC. Erlichman - Medical OncologyR.W. Carlson - Intl. Institute for Drug DevelopmentF. Valone - Intl. Institute for Drug DevelopmentR. Labianca - Intl. Institute for Drug DevelopmentJ.H. Doroshow - Intl. Institute for Drug Development
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.10(6), pp.896-903
- DOI
- 10.1200/JCO.1992.10.6.896
- PMID
- 1534121
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 06/01/1992
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359798102771
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