THURSDAY, March 19 (HealthDay News) -- A phase III trial of imatinib mesylate adjuvant therapy has shown that the drug is safe and increases the odds of recurrence-free survival after primary gastrointestinal stromal tumor resection, according to study findings published online March 19 in The Lancet.
Ronald P. DeMatteo, M.D., of Memorial Sloan-Kettering Cancer Center in New York City, and colleagues conducted a double-blind, placebo-controlled multicenter trial of 713 patients who had a primary gastrointestinal stromal tumor at least 3 cm in size and had undergone complete gross tumor resection, of whom 359 were randomized to receive 400 mg of imatinib every day for one year, while 354 received placebo. Patients in the control group who had a tumor recurrence were eligible to switch to the treatment group.
After a median 19.7 months of follow-up, 30 (8 percent) of the treatment group had a tumor recurrence or died, versus 70 (20 percent) of the placebo group, the investigators found. The rate of recurrence-free survival at one year was 98 percent for imatinib versus 83 percent for placebo, the researchers report. Imatinib was well-tolerated, with side effects including dermatitis (affecting 3 percent of the patients treated), abdominal pain (3 percent) and diarrhea (2 percent).
"Our findings will affect the management of patients with primary gastrointestinal stromal tumor and could have relevance to the adjuvant use of other molecular agents for cancer," the authors write.
The study was partially funded by Novartis Pharmaceuticals, maker of Gleevec (imatinib mesylate), and several authors report receiving honoraria from and serving on advisory boards for Novartis.
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