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From the Food and Drug Administration
July 5, 2000

New First-Line Therapy for Colorectal Cancer

JAMA. 2000;284(1):33. doi:10-1001/pubs.JAMA-ISSN-0098-7484-284-1-jfd00005

The FDA has approved a new indication for irinotecan hydrochloride injection (Camptosar; Pharmacia & Upjohn Inc, Kalamazoo, Mich) as first-line therapy in combination with 5-fluorouracil and leucovorin to treat metastatic colorectal cancer. The approval was based on the results of two multicenter, randomized controlled trials in patients with metastatic cancer of the colon or rectum.

One study was conducted in Europe with 385 patients who were randomized to receive 5-fluorouracil and leucovorin with or without irinotecan. One regimen consisted of leucovorin, 200 mg/m2 given over 2 hours, and 5-fluorouracil as a 400 mg/m2 bolus followed by 600 mg/m2, administered intravenously over 22 hours, given every 2 weeks. Patients randomized to the irinotecan group also received 180 mg/m2 of irinotecan before receiving leucovorin on the first day of each 14-day cycle. The study demonstrated statistically significant improvement in survival in the irinotecan group (median, 17.4 vs 14.1 months, P<.05).