Twelve weeks of protracted venous infusion of fluorouracil (5-FU) is as effective as 6 months of bolus 5-FU and folinic ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2003-06-10

AUTHORS

A Saini, A R Norman, D Cunningham, I Chau, M Hill, D Tait, T Hickish, T Iveson, F Lofts, D Jodrell, P J Ross, J Oates

ABSTRACT

We performed a multicentre randomised trial to compare the efficacy and toxicity of 12 weeks of 5-fluorouracil (5-FU) delivered by protracted intravenous infusion (PVI 5-FU) against the standard bolus regimen of 5-FU and folinic acid (5-FU/FA) given for 6 months as adjuvant treatment in colorectal cancer. A total of 716 patients with curatively resected Dukes' B or C colorectal cancer were randomised to 5-FU/FA (5-FU 425 mg m−2 i.v. and FA 20 mg m−2 i.v. bolus days 1–5 every 28 days for 6 months) or to PVI 5-FU alone (300 mg m−2 day for 12 weeks). With a median follow-up of 19.8 months, 133 relapses and 77 deaths have been observed. Overall survival did not differ significantly (log rank P=0.764) between patients receiving 5-FU/FA and PVI 5-FU (3-year survival 83.2 vs 87.9%, respectively). Patients in the 5-FU/FA group had significantly worse relapse-free survival (RFS, log rank P=0.023) compared to those receiving PVI 5-FU (3-year RFS, 68.6 vs 80%, respectively). Grades 3–4 neutropenia, diarrhoea, stomatitis and severe alopecia were significantly less (P<0.0001) and global quality of life scores significantly better (P<0.001) for patients in the PVI 5-FU treatment arm. In conclusion, infused 5-FU given over 12 weeks resulted in similar survival to bolus 5-FU and FA over a 6 month period, but with significantly less toxicity. More... »

PAGES

1859-1865

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/sj.bjc.6600995

DOI

http://dx.doi.org/10.1038/sj.bjc.6600995

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1027975231

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/12799627


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