Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial

摘要: Summary Background Irinotecan is active against colorectal cancer in patients whose disease refractory to fluorouracil. We investigated the efficacy of these two agents combined for first-line treatment metastatic cancer. Methods 387 previously untreated with chemotherapy (other than adjuvant) advanced were randomly assigned open-label irinotecan plus fluorouracil and calcium folinate (irinotecan group, n=199) or alone (no-irinotecan n=188). Infusion schedules once weekly every 2 weeks, chosen by each centre. assessed response rates time progression, also duration, survival, quality life. Analyses done on intention-to-treat population evaluable patients. Findings The rate was significantly higher group those no-irinotecan (49 vs 31%, p 22%, 4·4 months, 14·1 p=0·031). Some grade 3 4 toxic effects more frequent but predictible, reversible, non-cumulative, manageable. Interpretation well-tolerated increased rate, a later deterioration This combination should be considered as reference