Final Scope: Appraisal of Capecitabine and tegafur with uracil for metastatic colorectal cancer

Objective: To establish the clinical and cost-effectiveness of capecitabine and tegafur with uracil for metastatic colorectal cancer in relation to their licensed indications, in order to produce guidance to the NHS in England and Wales.

Background: Colorectal cancer is the second most common cancer with an annual incidence of 57 cases per 100,000. In 2000, colorectal cancer caused approximately 15,000 deaths in England and Wales in the same year. Colorectal cancer occurs in about the same proportion of men as women and is rare in people aged under 40 years.

The technologies: Capecitabine and tegafur are orally administered fluoropyrimidine prodrugs of 5-fluorouracil (5FU). Tegafur is combined with uracil, which competitively inhibits 5FU degradation, and is given in conjunction with calcium folinate (FA).



Capecitabine is indicated for first line monotherapy for metastatic colorectal cancer. Tegafur with uracil is indicated for first-line treatment of metastatic colorectal cancer in combination with calcium folinate.


People with metastatic colorectal cancer.

Current standard treatments (comparators)

5-FU/FA containing regimens

Other considerations

Outcomes should include:

  • Survival
  • Progression-free survival
  • Tumour response
  • Time to treatment failure
  • Adverse events \ toxicity
  • Quality-of-life

The infusional regimen used to deliver 5-FU and folinic acid should be stated for each study.

Patient preference and impact of using oral instead of intravenous treatment.

Cost-effectiveness should be expressed in terms of cost per quality-adjusted life-year gained.

The evidence base may also contain studies in which comparators other than 5FU/FA have been used. Where available these will be used to inform the committee's considerations.

1The Department of Health remit to the Institute is "To advise on the clinical and cost-effectiveness of capecitabine and tegafur uracil in their licensed indications for the treatment of advanced and metastatic colorectal cancer, either as monotherapy or as combination therapy."


This page was last updated: 30 March 2010