Preliminary results from a large, randomized, placebo-controlled clinical trial for patients with primary gastrointestinal stromal tumor ( GIST ), a type of tumor usually found in the stomach or small intestine, showed that patients who received Imatinib ( Glivec / Gleevec ) after complete removal of their tumor were significantly less likely to have a recurrence of their cancer compared to those who did not receive Imatinib.
The clinical trial was sponsored by the National Cancer Institute ( NCI ), part of the National Institutes of Health ( NIH ), and conducted by a network of researchers led by the American College of Surgeons Oncology Group ( ACOSOG ).
Researchers found that approximately 97 per cent of patients in the study who received one year of Imatinib after surgery did not have a recurrence of their cancer compared to 83 percent of patients who received one year of placebo. In addition, Imatinib therapy was well tolerated by most patients enrolled in the study. The types of side effects observed in this trial were similar to those observed in other clinical trials with Imatinib, and included nausea, diarrhea, and swelling.
“ These results have major implications for patients with primary GIST,” noted the principal investigator of the study, Ronald DeMatteo, Memorial Sloan-Kettering Cancer Center, New York, N.Y. “ 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. ” Information on over 600 patients enrolled on this study was used in the analysis. Patients participated through one of five NCI-sponsored North American Cooperative Oncology Groups, led by ACOSOG and including Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, Southwest Oncology Group, and the National Cancer Institute of Canada, Clinical Trials Group.
Patients with primary tumors three centimeters or larger that had been completely removed with surgery were enrolled in the trial between June 2002 and April 2007. Patients were randomized to one of two treatment arms. One patient group received Imatinib at a dose of 400 milligrams per day for one year. The second group received placebo for one year.
Those patients who had been on placebo subsequently received Imatinib and those who had been on Imatinib continued their Imatinib therapy, but at a higher dose.
There was no difference in overall survival for patients on the two treatment arms.
Gastrointestinal stromal tumor ( GIST ) is a sarcoma, that arises within the gastrointestinal tract. It is estimated that approximately 5,000 to 6,000 new patients are diagnosed with GIST each year in the United States.
Source: National Institutes of Health, 2007
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