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Annals of Oncology Advance Access published online on February 2, 2005
Annals of Oncology, doi:10.1093/annonc/mdi116
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© 2005 European Society for Medical Oncology
Received October 20, 2004
Revised November 12, 2004
Accepted November 15, 2004

Original article

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

I. Chau 1, A. R. Norman 1, D. Cunningham 1*, D. Tait 1, P. J. Ross 1, T. Iveson 2, M. Hill 3, T. Hickish 4, F. Lofts 5, D. Jodrell 6, A. Webb 7, and J. R. Oates 1

1 Royal Marsden Hospital, London and Surrey, UK
2 Southampton General Hospital, Southampton and Salisbury District Hospital, Salisbury, UK
3 Kent Oncology Centre, Maidstone, UK
4 Royal Bournemouth and Poole Hospitals, Dorset, UK
5 St George's Hospital, London, UK
6 Western General Hospital, Edinburgh, UK
7 Brighton and Sussex University Hospital, Brighton, UK

* To whom correspondence should be addressed.
D. Cunningham, E-mail: david.cunningham{at}icr.ac.uk


  Abstract

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.

Keywords: adjuvant therapy; colorectal cancer; fluorouracil.
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