title: Irinotecan combined or alternated with bolus 5-fluorouracil and folinic acid versus the Mayo Clinic regimen in the first-line therapy of advanced colorectal cancer.
abstract: The objective of this study was to assess the efficacy and safety of two regimens of irinotecan, combined or alternated with bolus 5-fluorouracil (5-FU) and folinic acid (FA), and the Mayo Clinic regimen as first-line therapy for colorectal cancer (CRC). A total of 152 patients with advanced CRC were randomised, and 149 patients were treated intravenously by irinotecan 125 mg/m2, FA 20 mg/m2 followed by 5-FU 500 mg/m2 bolus, weekly for 4 weeks (arm A, Saltz regimen; n=46), or irinotecan 350 mg/m2 alternating with FA 20 mg/m2/day followed by 5-FU bolus 425 mg/m2/day for 5 days (arm B; n=53), or FA 20 mg/m2/ day followed by 5-FU bolus 425 mg/m2/day over 5 days every 4 weeks (arm C, Mayo Clinic regimen; n=50). Patients were analyzed for tumor response, time to progression, overall survival, safety and quality of life. The overall response rate for evaluable patients in arm A was 33% [95% confidence interval (CI), 17-49%], in arm B was 32% (95% CI, 16-49%) and in arm C was 26% (95% CI, 12-40%). Median times to progression were 7.9, 7.0 and 6.9 months and median survival times were 22.2, 17.0 and 18.2 months for arms A, B and C, respectively, in the intention-to-treat population. The main grade 3-4 adverse events were neutropenia (7%, 39% and 12%) and diarrhea (6%, 21% and 18%). In conclusion, both regimens containing irinotecan were active and well tolerated in patients with advanced CRC.
authors.affiliation: Medezinische Universitätsklinik, Knappschafts-Krankenhaus, Bochum, Germany. innere1@mariahilf.de
authors.forename: Ullrich
authors.initials: U
authors.lastname: Graeven
authors.forename: Karsten
authors.initials: K
authors.lastname: Ridwelski
authors.forename: Maja
authors.initials: M
authors.lastname: Artandi
authors.forename: Pilar
authors.initials: P
authors.lastname: Espana
authors.forename: Jürgen
authors.initials: J
authors.lastname: Schölmerich
authors.forename: Adolfo M
authors.initials: AM
authors.lastname: Rosales
authors.forename: Göran
authors.initials: G
authors.lastname: Carlsson
authors.forename: Markus
authors.initials: M
authors.lastname: Borner
authors.forename: Blandine
authors.initials: B
authors.lastname: Boussard
authors.forename: Wolff
authors.initials: W
authors.lastname: Schmiegel
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin