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In phase II trials, irinotecan is active in patients with advanced colorectal cancer, but the survival and clinical benefit of irinotecan compared with secondline fluorouracil by continuous infusion is not known. 267 patients who had failed to respond to firstline fluorouracil, or whose disease had progressed after treatment with first-line fluorouracil were randomly allocated irinotecan 300–350 mg/m 2 infused once every 3 weeks or fluorouracil by continuous infusion. Treatment was given until disease progression, unacceptable toxic effects, or the patient refused to continue treatment. The primary endpoint was survival, while progression-free survival, response rate, symptom-free survival, adverse events, and quality of life (QoL) were secondary endpoints. 133 patients were randomly allocated irinotecan and 134 were allocated fluorouracil by continuous infusion. Patients treated with irinotecan lived for significantly longer than patients on fluorouracil (p=0·035). Survival at 1 year was increased from 32% in the fluorouracil group to 45% in the irinotecan group. Median survival was 10·8 months in the irinotecan group and 8·5 months in the fluorouracil group. Median progression-free survival was longer with irinotecan (4·2 vs 2·9 months for irinotecan vs fluorouracil, respectively; p=0·030). The median pain-free survival was 10·3 months and 8·5 months (p=0·06) for irinotecan and fluorouracil, respectively. Both treatments were equally well tolerated. QoL was similar in both groups. Compared with fluorouracil by continuous infusion second-line irinotecan significantly improved survival in patients with advanced colorectal cancer.

In phase II studies, irinotecan is active in metastatic colorectal cancer, but the overall benefit has not been assessed in a randomised clinical trial. Patients with proven metastatic colorectal cancer, which had progressed within 6 months of treatment with fluorouracil, were randomly assigned either 300–350 mg/m 2 irinotecan every 3 weeks with supportive care or supportive care alone, in a 2:1 ratio. 189 patients were allocated irinotecan and supportive care and 90 supportive care alone. The mean age of the participants was 58·8 years; 181 (65%) were men and 98 (35%) were women. WHO performance status was 0 in 79 (42%) patients, 1 in 77 (41%) patients, and 2 in 32 (17%) patients. Tumour-related symptoms were present in 134 (71%) patients and weight loss of more than 5% was seen in 15 (8%) patients. With a median follow-up of 13 months, the overall survival was significantly better in the irinotecan group (p=0·0001), with 36·2% 1-year survival in the irinotecan group versus 13·8% in the supportive-care group. The survival benefit, adjusted for prognostic factors in a multivariate analysis, remained significant (p=0·001). Survival without performance-status deterioration (p=0·0001), without weight loss of more than 5% (p=0·018), and pain-free survival (p=0·003) were significantly better in the patients given irinotecan. In a quality-of-life analysis, all significant differences, except on diarrhoea score, were in favour of the irinotecan group. Our study shows that despite the sideeffects of treatment, patients who have metastatic colorectal cancer, and for whom fluorouracil has failed, have a longer survival, fewer tumour-related symptoms, and a better quality of life when treated with irinotecan than with supportive care alone.