The study met its primary endpoint of increasing recurrence-free survival. However, there was no difference in overall survival for patients on the two treatment arms. Researchers found that approximately 97% of patients in the study who received one year of Gleevec after surgery did not have a recurrence of their cancer, compared to 83% of patients who received one year of placebo. In addition, Gleevec therapy was well tolerated by most patients enrolled in the study.
“These results have major implications for patients with primary GIST,” said Ronald DeMatteo from New York’s Memorial Sloan-Kettering Cancer Center, who was the principal investigator on the study.
“Conventional chemotherapy agents have been notoriously ineffective in GIST. This study for the first time demonstrated that targeted molecular therapy reduces the rate of recurrence after complete removal of a primary GIST.”
Gleevec was approved by the FDA in 2002 for the treatment of unresectable or metastatic GIST.