Thirty studies (n=2,902) were included in the review: 25 phase 2 studies with 32 samples (n=1,894 participants) and five phase 3 studies with six samples (n=1,008).
Phase 2 trials: Disease control rate ranged from 26% to 73% (32 samples). Twenty-three samples reported a rate of at least 50%. Median time to progression ranged from 2.7 to 6.0 months (25 samples). Median overall survival ranged from 6.6 to 16.1 months (30 samples). Severe adverse events included severe diarrhoea (range 5% to 39%; 27 samples), nausea (range 1% to 24%; 16 to 24 samples), vomiting (range 2% to 22%; 19 to 27 samples), anorexia (range zero to 12%; nine samples), constipation (range zero to 6%; eight samples), mucositis (range zero to 3%; 12 samples), severe asthenia (range zero to 31%; 18 samples) and alopecia (range 32% to 100%; 16 samples). Treatment-related mortality of 2% was reported in two samples; the other 13 samples reported no treatment-related mortality. Quality of life scores were related to tumour response.
Phase 3 trials: Disease control rate ranged from 42.4% to 54.9% (two samples). Median time to progression ranged from 3.0 to 4.3 months (three samples). Median overall survival rate was greater than nine months in all six samples. Severe adverse events included diarrhoea (range 15% to 36%; six samples), nausea (range 5% to 14%; four to six samples), vomiting (range 6% to 14%; four to six samples), severe asthenia (range 4% to 21%; six samples), alopecia (86%; one sample) and treatment-related mortality (range zero to 5%; five samples). There was no evidence of a difference in quality of life between irinotecan and 5-fluorouracil. Patients who had irinotecan had better quality of life scores than patients who had supportive care (no figures reported). Quality of life scores on the weekly schedule of irinotecan were similar to scores on the three-weekly schedule (no figures reported).