Irinotecan is a promising new agent which appears to produce small survival gains among people with advanced colorectal cancer. The evidence in its support comes from two phase III randomised controlled trials, both of which, have some methodological problems. The Committee noted that the evidence refers only to the first twelve months of follow up, which means that the average survival gain figures estimated in the report may be an underestimate. On the other hand, the Committee was concerned that the extra survival might be at the expense of a poor quality of life.
The Committee noted that the trial had not included patients aged 75 and over, although nearly half of people with colorectal cancer fall into this category. In addition, although the manufacturers recommend the use of irinotecan in patients with less severe disease, the Committee noted the potential for diffusion of irinotecan use to more advanced cases where benefits appear even smaller and more uncertain. The possible use of irinotecan needs therefore to be discussed carefully with patients and their carers with a clear account of its possibilities and limitations.