Saini, A., Norman, A.R., Cunningham, D., Chau, I., Hill, M. E.E., Tait, D., Hickish, T. F., Iveson, T. J., Lofts, F., Jodrell, D., Ross, P. J. and Oates, J. R., 2003. Twelve weeks of protracted venous infusion of fluorouracil (5-FU) is as effective as 6 months of bolus 5-FU and folinic acid as adjuvant treatment in colorectal cancer. British Journal Of Cancer, 88 (12), pp. 1859-1866.
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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[SUP-2] i.v. and FA 20 mg m[SUP-2] i.v. bolus days 1-5 every 28 days for 6 months) or to PVI 5-FU alone (300 mg m[SUP-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.
|Subjects:||Technology > Medicine and Health|
|Group:||School of Health and Social Care > Centre for Postgraduate Medical Research and Education|
|Deposited By:||INVALID USER|
|Deposited On:||21 Oct 2008 21:55|
|Last Modified:||07 Mar 2013 14:51|
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