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The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.

Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials

Open access
Cutsem, E Van, Hoff, P M, Harper, P, Bukowski, R M, Cunningham, D, Dufour, P, Graeven, U, Lokich, J, Madajewicz, S, Maroun, J A, Marshall, J L, Mitchell, E P, Perez-Manga, G, Rougier, P, Schmiegel, W, Schoelmerich, J, Sobrero, A, Schilsky, R L·2004·British Journal of Cancer

Abstract

This study evaluates the efficacy of capecitabine using data from a large, well-characterised population of patients with metastatic colorectal cancer (mCRC) treated in two identically designed phase III studies. A total of 1207 patients with previously untreated mCRC were randomised to either oral capecitabine (1250 mg m(-2) twice daily, days 1-14 every 21 days; n=603) or intravenous (i.v.) bolus 5-fluorouracil/leucovorin (5-FU/LV; Mayo Clinic regimen; n=604). Capecitabine demonstrated a statistically significant superior response rate compared with 5-FU/LV (26 vs 17%; P<0.0002). Subgroup analysis demonstrated that capecitabine consistently resulted in superior response rates (P<0.05), even in patient subgroups with poor prognostic indicators. The median time to response and duration of response were similar and time to progression (TTP) was equivalent in the two arms (hazard ratio (HR) 0.997, 95% confidence interval (CI) 0.885-1.123, P=0.95; median 4.6 vs 4.7 months with capecitabine and 5-FU/LV, respectively). Multivariate Cox regression analysis identified younger age, liver metastases, multiple metastases and poor Karnofsky Performance Status as independent prognostic indicators for poor TTP. Overall survival was equivalent in the two arms (HR 0.95, 95% CI 0.84-1.06, P=0.48; median 12.9 vs 12.8 months, respectively). Capecitabine results in superior response rate, equivalent TTP and overall survival, an improved safety profile and improved convenience compared with i.v. 5-FU/LV as first-line treatment for MCRC. For patients in whom fluoropyrimidine monotherapy is indicated, capecitabine should be strongly considered. Following encouraging results from phase I and II trials, randomised trials are evaluating capecitabine in combination with irinotecan, oxaliplatin and radiotherapy. Capecitabine is a suitable replacement for i.v. 5-FU as the backbone of colorectal cancer therapy.

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Metadata

Authors
Cutsem, E. V., Hoff, P. M., Harper, P., Bukowski, R. M., Cunningham, D., Dufour, P., Graeven, U., Lokich, J., Madajewicz, S., Maroun, J. A., Marshall, J. L., Mitchell, E. P., Perez-Manga, G., Rougier, P., Schmiegel, W., Schoelmerich, J., Sobrero, A., & Schilsky, R. L.
Venue
British Journal of Cancer
Published
2004-02-24
Volume
90
Issue
6
Pages
1190-1197
ISSN
  • 0007-0920 (ISSN-L)
  • 1532-1827
OpenAlex
W2084330540
Cited by
401
References
28
FWCI
18.21
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. https://app.cochat.ai/papers/10.1038/sj.bjc.6601676
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Cutsem, E. V., Hoff, P. M., Harper, P., Bukowski, R. M., Cunningham, D., Dufour, P., Graeven, U., Lokich, J., Madajewicz, S., Maroun, J. A., Marshall, J. L., Mitchell, E. P., Perez-Manga, G., Rougier, P., Schmiegel, W., Schoelmerich, J., Sobrero, A., & Schilsky, R. L. (2004). Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. British Journal of Cancer. https://doi.org/10.1038/sj.bjc.6601676

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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