Irinotecan as first-line treatment of colorectal cancer: new indication. A modest advantage.

(1) The reference treatment for colorectal cancer is surgery. In advanced cases, the first-line drug regimen is fluorouracil combined with calcium folinate. (2) The indications for irinotecan, a cytotoxic agent, have recently been extended in France to cover first-line treatment of advanced-stage colorectal cancer, in combination with fluorouracil and calcium folinate. (3) The clinical file on irinotecan in this indication mainly contains two unblinded trials comparing irinotecan + fluorouracil + calcium folinate with fluorouracil + calcium folinate. Only one of these trials is interpretable. (4) In this trial adding irinotecan increased survival by 4.4 months and delayed deterioration of daily performance by 1.3 months (median values). (5) 44% of patients developed severe diarrhoea, 7% severe fatigue, 29% severe neutropenia and 20% severe leukopenia while on irinotecan. (6) In practice, the reference treatment in this setting remains fluorouracil. Combination with irinotecan should be discussed with the individual patient.