A new recommendation by the UK’s National Institute for Health and Clinical Excellence (NICE), which provides guidance to the National Health Service (NHS), endorses the use of
capecitabine following surgery (as adjuvant treatment) for colon cancer. In addition to being at least as effective as intravenous 5-fluorouracil (5-FU), capecitabine produces fewer severe side effects and is extremely cost-effective. NICE estimate that the NHS may save around £3320 per patient with early colon cancer who is treated with capecitabine rather than 5-FU. These new recommendations put patients in England and Wales on an equal footing with their counterparts in Scotland, who are already benefiting from adjuvant capecitabine in this setting.

The recommendations by NICE follow approval of capecitabine for adjuvant treatment of colon cancer by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) regulatory authorities. The new indication is a result of the landmark clinical trial, ‘Xeloda in adjuvant colon cancer therapy (X-ACT)’,<1> which showed the benefits of capecitabine in terms of anti-tumour effectiveness, safety and convenience. Capecitabine was shown to produce less hair loss, nausea, vomiting and diarrhoea than 5-FU,<2> and on average, patients needed only eight hospital visits when treated with capecitabine compared with 30 visits with 5-FU.<3, 4>

Capecitabine has a broad indication in Europe for use following surgery for colon cancer, due to submission of data demonstrating its safety profile in combination with intravenous oxaliplatin. This means that it can be used alone or as a part of combination treatment. Adjuvant treatment with capecitabine will enable more patients with early colon cancer to have the freedom of an effective and well-tolerated oral chemotherapy that may provide a better chance of a cancer-free life and a less intrusive side-effect profile compared with the old standard, 5-FU.

1. Twelves C, Wong A, Nowacki MP et al. Capecitabine as adjuvant treatment for stage III colon cancer. New England Journal of Medicine 2005; 352: 2696–2704.

2. Scheithauer W, McKendrick J, Begbie S et al. Oral capecitabine as an alternative to i.v. 5-fluourouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial. Annals of Oncology 2003; 14: 1735–1743.

3. McKendrick JJ, Cassidy J et al. Capecitabine (x) is resource saving compared with i.v. bolus 5-FU/LV in adjuvant chemotherapy for Dukes’ C colon cancer patients: Medical resource utilization (MRU) data from large phase III trial (X-ACT). Journal of Clinical Oncology 2004; 22 (July suppl): 264s (Abstract 3578).

4. Douillard JY, Twelves C, McKendrick JJ et al. Pharmacoeconomic analysis of oral capecitabine in the adjuvant setting. Results from the X-ACT trial comparing capecitabine with i.v. 5-FU/LV in patients with Dukes’ C colon cancer. Annals of Oncology 2004; 15 (Suppl 2): iii73 (Abstract 274).