Post-Surgery Preventive Imatinib

Currently the FDA has not yet approved use of imatinib (Gleevec) after complete resection of a primary gastrointestinal stromal tumor (GIST).  Trials are underway to determine whether administering imatinib (Gleevec) for some period of time after complete resection (1, 2, or 3 years) will reduce the percentage of patients who develop recurrences of GIST.  This is called adjuvant treatment.

Data are fairly clear that patients in the very-low and low-risk groups do not need adjuvant Gleevec.  The question is whether patients with intermediate-risk or high-risk GISTs will benefit.

Ongoing trials include the following: 

Z9001 trial:  In the USA the ACOSOG has completed recruitment of patients for this trial studying one year of adjuvant imatinib (Gleevec).  An interim analysis was done in spring 2007; please link here to our summary by the principal investigator, Ronald DeMatteo, MD.

Adjuvant Imatinib in High-Risk GIST With c-Kit Mutation, Asan Medical Center, South Korea

Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor, European sites

Study Comparing 12 Months Versus 36 Months of Imatinib in the Treatment of Gastrointestinal Stromal Tumor (GIST), Scandinavian sites