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Positive Results Prompt US National Cancer Institute to Make,Gleevec Available To Patients in Post-Surgical Gist Study

ators on a submission to gain regulatory approval for Gleevec as adjuvant treatment for GIST."

Following the recommendation of a data monitoring committee, the study will be closed and patients in the study who are currently being treated with placebo may choose to receive one year of Gleevec.

In the study, patients were randomized to one of two treatment arms. Neither the patients nor physicians knew which treatment the patients were receiving. One patient group received Gleevec at a dose of 400 milligrams per day for one year, while the second group received placebo for one year. According to the study design, patients who developed a recurrence of their cancer while on a study therapy were unblinded to their treatment assignment. Those receiving placebo subsequently received Gleevec, while those already given Gleevec continued with this therapy but at a higher dose. Study results will be presented at a forthcoming scientific meeting.

Gastrointestinal stromal tumors (GIST) belong to a group of cancers known as soft tissue sarcomas that usually arise from the intestinal tract, with the most common site being the stomach followed by the small intestine. The incidence of GIST is estimated to be 4,500-6,000 new cases per year in the US (15-20 cases per million population), of which more than 90% are kit-positive.

Investigators in the NCI study reported that Gleevec therapy was well tolerated by most patients, with side effects similar to those observed in other clinical trials with Gleevec. These include nausea, diarrhea and swelling (edema). Information on more than 600 patients enrolled in the study was used in the analysis.

About Gleevec

Gleevec(R) (imatinib mesylate) is indicated for the treatment of patients with Kit (CD117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). The effectiveness of Gleevec in GIST is based on objective response rate. There are no controlled trials demon
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