NEW YORKResponse and overall survival were significantly
improved with use of irinotecan (Camptosar), fluorouracil, and
leucovorin, compared with fluorouracil/leucovorin alone, in a
randomized study involving 683 patients with previously untreated
metastatic colorectal cancer.
Leonard B. Saltz, MD, of Memorial Sloan-Kettering Cancer Center,
reported the results for the Irinotecan Study Group at the 36th
Annual Meeting of the American Society of Clinical Oncology, and the
full data have now been published (N Engl J Med 343:905-914, 2000).
Patients received bolus fluorouracil 500 mg/m² plus leucovorin
20 mg/m² plus irinotecan 125 mg/m² weekly for 4 weeks or
the Mayo Clinic bolus fluorouracil/leucovorin regimen.
Dr. Saltz reported a confirmed response rate of 39% for patients
receiving irinotecan therapy vs 21% for those assigned to
fluorouracil/leucovorin (P < .001). Median progression-free
survival was 7 months for those on irinotecan vs 4.3 months for those
on fluorouracil/leucovorin alone (P = .004). Median overall
survival was 14.8 months for the irinotecan group vs 12.6 months for
fluorouracil/leucovorin (P = .04). Analysis of quality-of-life
data showed no significant differences between the groups.
The irinotecan combination is now being compared with a weekly
regimen of fluorouracil/leucovorin as adjuvant therapy for patients
with stage III colon cancer to determine whether it will
increase rates of cure in patients with an earlier stage of the
disease, Dr. Saltz said.