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

Graeven, Ullrich and Ridwelski, Karsten and Artandi, Maja and Espana, Pilar and Scholmerich, Juergen and Rosales, Adolfo M. and Carlsson, Göran and Borner, Markus and Boussard, Blandine and Schmiegel, Wolff (2005) 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. ONCOLOGY REPORTS, 13 (4). pp. 681-688. ISSN 1021-335X, 1791-2431

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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/m(2), FA 20 mg/m(2) followed by 5-FU 500 mg/m(2) bolus, weekly for 4 weeks (arm A, Saltz regimen; n=46), or irinotecan 350 mg/m(2) alternating with FA 20 mg/m(2)/day followed by 5-FU bolus 425 mg/m(2)/day for 5 days (arm B; n=53), or FA 20 mg/m(2)/day followed by 5-FU bolus 425 mg/ml/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.

Item Type: Article
Uncontrolled Keywords: PHASE-II TRIAL; HIGH-DOSE LEUCOVORIN; CONTINUOUS-INFUSION FLUOROURACIL; RANDOMIZED-TRIAL; BIOCHEMICAL MODULATION; WEEKLY SCHEDULE; CHEMOTHERAPY; CARCINOMA; COMBINATION; INHIBITORS; colorectal cancer; first-line; 5-fluorouracil; folinic acid; irinotecan
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin I
Depositing User: Dr. Gernot Deinzer
Date Deposited: 18 May 2021 09:20
Last Modified: 18 May 2021 09:20
URI: https://pred.uni-regensburg.de/id/eprint/36328

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