In a Phase III clinical trial, three years of adjuvant (post-surgery) treatment with Gleevec® (imatinib) resulted in better survival than one year of adjuvant treatment among patients with high-risk gastrointestinal stromal tumors (GIST). These results were published in the Journal of the American Medical Association.
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 longer treatment now appears to be beneficial.
To evaluate the safety and efficacy of three years of Gleevec, an international group of researchers conducted a Phase III clinical trial among 400 patients with early, KIT-positive GIST. All patients had a high risk of recurrence. After surgery, half the patients were treated with Gleevec for three years and half were treated with Gleevec for one year.
- Five-year survival without a recurrence was 66 percent among patients who took Gleevec for three years, compared with 48 percent for patients who took Gleevec for only one year.
- Five-year overall survival was 92 percent among patients who took Gleevec for three years, compared with 82 percent for patients who took Gleevec for only one year.
These results indicate that longer treatment with Gleevec improves outcomes among patients with early, high-risk GIST. This information has been added to the FDA-approved prescribing information for Gleevec.
Reference: Joensuu H, Eriksson M, Sundby Hall K et al. One vs Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor. JAMA. 2012;307(12):1265-1272.
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