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A randomised comparison between 6 months of bolus fluorouracil/leucovorin and 12 weeks of protracted venous infusion fluorouracil as adjuvant treatment in colorectal cancer

Record type: Article

Background: We performed a multicentre randomised trial to compare the efficacy and toxicity of 12 weeks of protracted venous infusion (PVI) 5-fluorouracil (5-FU) against the standard bolus monthly regimen of 5-FU/leucovorin (LV) given for 6 months as adjuvant treatment in colorectal cancer (CRC).
Patients and methods: Patients with curatively resected stage II and III CRC were randomly assigned to 5-FU/LV [5-FU 425 mg/m2 intravenously (i.v.) and LV 20 mg/m2 i.v. bolus days 1–5 every 28 days for 6 months] or to PVI 5-FU (300 mg/m2/day for 12 weeks).
Results: Between 1993 and 2003, 801 eligible patients were randomised to 5-FU/LV (n=404) or PVI 5-FU (n=397). With a median follow-up of 5.3 years, 231 relapses and 220 deaths have been observed. Five-year relapse-free survival (RFS) was 66.7% [95% confidence interval (CI) 61.6% to 71.3%] and 73.3% (95% CI 68.4% to 77.6%) with bolus 5-FU/LV and PVI 5-FU, respectively [hazard ratio (HR) 0.8; 95% CI 0.62–1.04; P=0.10]. Five-year overall survival (OS) was 71.5% (95% CI 66.4% to 75.9%) and 75.7% (95% CI 70.8% to 79.9%) with bolus 5-FU/LV and PVI 5-FU, respectively (HR 0.79; 95% CI 0.61–1.03; P=0.083). There was a significant survival advantage for patients starting adjuvant chemotherapy within 8 weeks (P=0.044). Significantly less diarrhoea, stomatitis, nausea and vomiting, alopecia, lethargy, and neutropenia (all with P <0.0001) were seen with PVI 5-FU.
Conclusions: There was no OS difference between the two arms, although PVI 5-FU was associated with a trend towards better RFS and OS compared with bolus 5-FU/LV, as well as significantly less toxicity. Based on our results, the probability of 12 weeks of PVI 5-FU being inferior to 6 months of bolus 5-FU/LV is extremely low (P <0.005), and therefore shorter duration of adjuvant treatment should be explored further.

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Citation

Chau, I., Norman, A.R., Cunningham, D., Tait, D., Ross, P.J., Iveson, T., Hill, M., Hickish, T., Lofts, F., Jodrell, D., Webb, A. and Oates, J.R. (2005) A randomised comparison between 6 months of bolus fluorouracil/leucovorin and 12 weeks of protracted venous infusion fluorouracil as adjuvant treatment in colorectal cancer Annals of Oncology, 16, (4), pp. 549-557. (doi:10.1093/annonc/mdi116).

More information

Published date: April 2005
Keywords: adjuvant therapy, colorectal cancer, fluorouracil
Organisations: Cancer Sciences

Identifiers

Local EPrints ID: 26243
URI: http://eprints.soton.ac.uk/id/eprint/26243
ISSN: 0923-7534
PURE UUID: f3f40b04-ab76-4a93-9823-7e3f42c27912

Catalogue record

Date deposited: 07 Apr 2006
Last modified: 17 Jul 2017 16:08

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Contributors

Author: I. Chau
Author: A.R. Norman
Author: D. Cunningham
Author: D. Tait
Author: P.J. Ross
Author: T. Iveson
Author: M. Hill
Author: T. Hickish
Author: F. Lofts
Author: D. Jodrell
Author: A. Webb
Author: J.R. Oates

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