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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
National Cancer Center
Goyang, South Korea
Asan Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul Samsung Medical Center
Seoul, South Korea
2-year Relapse Free Survival Rate
Time frame: 2 years
2-year Overall Survival Rate
Time frame: 2 years
Toxicity Profile
Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of adjuvant imatinib
Time frame: Monitoring of adverse events will be continued for at least 28days following the last dose of study treatment, up to 3 years.
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