Toxicity of irinotecan in patients with colorectal cancer.

To the Editor: The early deaths reported by Sargent et al. (July 12 issue)1 among patients with colorectal cancer who were enrolled in trials N9741 and C89803 have aroused concern regarding the use of irinotecan in combination with fluorouracil and leucovorin. In these trials, a weekly bolus regimen of fluorouracil and leucovorin was combined with irinotecan. A different regimen of infusional fluorouracil and leucovorin, with or without irinotecan,2 is being used in three large, ongoing European trials. The Pan-European Trials in Adjuvant Colon Cancer 3 randomly assigned 1668 patients with stage III colon cancer to receive infusional fluorouracil and leucovorin . . .