Annals of Oncology 14:1106-1114, 2003
© 2003 European Society for Medical Oncology
Original Paper |
A randomized phase II trial of irinotecan in combination with infusional or two different bolus 5-fluorouracil and folinic acid regimens as first-line therapy for advanced colorectal cancer
1 EHS Centre Pierre et Marie Curie, Algiers, Algeria; 2 Institue Salah Azaiz Bab Saadoun, Tunis, Tunisia; 3 Regionalne Centrum Oncologii, Bydgoszcz, Poland; 4 Pandy K Bekescountry County Hospital, Gyula, Hungary; 5 Oncology Center of Latvia, Riga, Latvia; 6 Clinicum of the University of Tartu, Tartu, Estonia; 7 National Cancer Institute, Cairo, Egypt; 8 Oncology Dispanser, Omsk, Russia; 9 Global Medical Affairs Oncology, Aventis Pharma, Antony, France
Received 18 October 2002; revised 13 February 2003; accepted 17 March 2003
Background:
Three different therapeutic regimens of irinotecan (CPT-11) in combination with 5-fluorouracil (5-FU) and folinic acid (FA) were evaluated for efficacy and safety in the first-line therapy of advanced colorectal cancer.
Patients and methods:
Patients were randomly assigned to receive intravenously either: CPT-11 125 mg/m2, FA 20 mg/m2 followed by 5-FU 500 mg/m2 bolus, weekly for 4 weeks (arm A, Saltz regimen); or CPT-11 180 mg/m2 day 1 then FA 200 mg/m2 over 2 h and 5-FU 400 mg/m2 bolus and 5-FU 600 mg/m2 22-h infusion on days 1 and 2, every 2 weeks (arm B, Douillard regimen); or CPT-11 350 mg/m2 (days 1 and 43) alternating with FA 20 mg/m2/day followed by 5-FU bolus 425 mg/m2/day during 5 days (days 22–26) (arm C, Mayo Clinic regimen).
Results:
A total of 154 patients were included in the study (arm A, 51 patients; arm B, 53; arm C, 50). Overall response rates for the intention-to-treat populations were 33% [95% confidence interval (CI) 21% to 48%], 42% (95% CI 28% to 56%) and 30% (95% CI 18% to 45%) for arms A, B and C, respectively. Median times to progression were 6, 8 and 7 months for arms A, B and C, respectively. Median survival times were 15, 12 and 17 months for arms A, B and C, respectively. Overall response rates for the evaluable patient populations were 40% (95% CI 24% to 58%) in arm A, 44% (95% CI 29% to 60%) in arm B and 31% (95% CI 17% to 47%) in arm C. Neutropenia was the main serious adverse event in arms A (30% of patients) and C (22% of patients) but occurred in only 8% of patients in arm B. Delayed diarrhea was the main severe adverse event for the three regimens, from 15% to 22%.
Conclusion:
All three regimens were highly active. The biweekly combination of CPT-11 and 5-FU/FA (arm B) was notable for its low incidence of grade 3/4 neutropenia. The incidence of grade 3/4 delayed diarrhea was equivalent for the three treatment arms.
Key words: colorectal cancer, first-line, 5-fluorouracil/folinic acid, irinotecan
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