FDA Updates Use of Gleevec for Gastrointestinal Stromal Tumors

In changes approved by the US Food and Drug Administration (FDA), the prescribing information for Gleevec® (imatinib) now notes that three years of adjuvant (post-surgery) treatment results in better survival than one year of adjuvant treatment among patients with high-risk gastrointestinal stromal tumors (GIST).[1]

GIST is a type of soft tissue sarcoma that develops in the stomach, small intestine, or other parts of the gastrointestinal tract. Treatment of early GIST often involves surgery followed by adjuvant treatment with Gleevec. Gleevec is a type of targeted therapy that inhibits a specific protein that is overactive in the majority of GIST cells. Adjuvant treatment has typically been given for one year, but the optimal duration of treatment has been uncertain.

A comparison between one and three years of adjuvant treatment was conducted by researchers in Scandinavia and Germany. The study included patients with early GIST who were at a high risk of recurrence. Following surgery, one group was treated with Gleevec for three years while the other group was treated with Gleevec for one year. Longer treatment with Gleevec improved survival: five-year survival was 92 percent among patients treated with three years of Gleevec, compared with 82 percent among patients treated with one year of Gleevec.[2]

Side effects of Gleevec include swelling, nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.

Patients with high-risk GIST may wish to talk with their doctor about the duration of Gleevec that’s best for them. Three years of treatment produces better outcomes than one year of treatment in this group of patients, but the optimal duration remains uncertain.


[1] FDA News Release. FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer. January 31, 2012.

[2] Joensuu H, Eriksson M, Hatrmann J, et al. Twelve versus 36 months of adjuvant imatinib (IM) as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). Paper presented at: 2011 Annual Meeting of the American Society of Clinical Oncology; June 3-7, 2011;Chicago,IL. Abstract LBA1.

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