Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
The presence of c-kit mutation is an independent poor prognostic factor for relapse in
addition to large size (> 5 cm) and high mitotic rate (> 5/50 high power field [HPF]) in
localized gastrointestinal stromal tumor (GIST) patients who underwent complete surgical
resection. In addition, the localized GIST which had exon 11 c-kit mutation and features of
high-risk for relapse according to National Institute of Health (NIH) consensus guideline
(tumor size > 10 cm or mitotic count > 10/50 HPF) also have high-risk of relapse. Until
recently, there has been no effective therapy for advanced, unresectable GISTs. However, a
new agent, imatinib mesylate, has shown promise in the metastatic setting, and c-kit exon 11
mutation is the strongest prognostic factor for better response and survival. It is
reasonable to try imatinib in an earlier and minimal residual status especially for patients
at higher risk of relapse and a higher probability of response to imatinib.