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JAMA. 2002;287:1103.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved imatinib mesylate capsules (Gleevec, Novartis Pharmaceutical Corp, East Hanover, NJ), an approved treatment for chronic myeloid leukemia, for the treatment of patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).

The new indication was approved on the basis of an open-label, randomized study in 147 patients with unresectable or metastatic malignant GIST who were randomized to receive either 400 mg or 600 mg of the drug daily for up to 24 months. Primary evidence of efficacy was based on objective response rates.

At the time of interim analysis, partial response was achieved by 56 (38%) patients. There were no significant differences in response rates between the two dosage groups. No complete responses were observed.

In the trial, four patients in the 600-mg dosage group and three in the 400-mg group (total 5%) were reported to have had gastrointestinal or intratumoral bleeds. Most suspected adverse drug . . . [Full Text of this Article]