title: Systematic review of benefits and risks of second-line irinotecan monotherapy for advanced colorectal cancer.
abstract: This study was performed to obtain a comprehensive overview of the benefits and risks of second-line irinotecan monotherapy for advanced colorectal cancer. The literature was systematically reviewed to identify phase II and phase III trials that investigated the effect of second-line monotherapy with irinotecan. Thirty studies were included in this review: 25 phase II studies including 32 samples and five phase III studies including six samples. A disease control rate of greater than or equal to 50% was found in 23 out of 32 phase II samples, and one out of two phase III samples that reported disease control rate. Median time to progression was 2.7-6.0 months in phase II samples and 3.0-4.3 months in phase III samples. Median overall survival ranged from 6.6 to 16.1 months in phase II samples and 9.1-10.8 months in phase III samples. The most important severe adverse event in both phase II and phase III trials was diarrhea (5-39 and 15-36%, respectively), followed by nausea (1-24 and 5-14%), vomiting (2-22 and 6-14%), and asthenia (0-31 and 4-21%). Treatment-related mortality was 0-2% in phase II samples and 0-5% in phase III samples. Quality-of-life scores in phase II studies were associated with tumor response. In phase III studies, the quality of life while on treatment with irinotecan was similar to that of 5-fluorouracil, but better than supportive care alone. The quality of life on the weekly schedule was similar to the 3-weekly schedule. This study provides a comprehensive overview of the benefits and risks of second-line irinotecan. In general, second-line treatment with irinotecan is beneficial to patients.
authors.affiliation: Department of Epidemiology, Radboud University Nijmegen Medical Center, The Netherlands. l.oostendorp@ebh.umcn.nl
authors.forename: Linda J M
authors.initials: LJ
authors.lastname: Oostendorp
authors.forename: Peep F
authors.initials: PF
authors.lastname: Stalmeier
authors.forename: Pieternel C
authors.initials: PC
authors.lastname: Pasker-de Jong
authors.forename: Winette T
authors.initials: WT
authors.lastname: Van der Graaf
authors.forename: Petronella B
authors.initials: PB
authors.lastname: Ottevanger
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000378:metabolism*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D015201:Meta-Analysis as Topic; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002166:Camptothecin