Annotation Detail

Information
Associated Genes
KIT
Associated Variants
KIT EXON 11 MUTATION
KIT EXON 11 MUTATION
Associated Disease
gastrointestinal stromal tumor
Source Database
CIViC Evidence
Description
This international, placebo controlled prospective phase 3 clinical trial (NCT01271712) examined safety and efficacy of regorafenib in patients with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) who failed previous treatments with at least imatinib or sunitinib. Progression free survival was measured for 199 patients treated with either daily 160mg regorafenib (n=133) or a matching placebo (n= 66). Overall, median PFS was 7.4 months in the regorafenib group and 1.7 months in the placebo group (HR= .22, P <.001). Patients with KIT exon 11 mutations (n=51) treated with regorafenib were associated with similarly favorable progression free survival (HR: 0.212), as compared to patients with treated with placebo.
Variant Origin
somatic
Variant Origin
Somatic
Evidence URL
https://civic.genome.wustl.edu/links/evidence_items/4599
Gene URL
https://civic.genome.wustl.edu/links/genes/29
Variant URL
https://civic.genome.wustl.edu/links/variants/66
Rating
2
Evidence Type
Predictive
Disease
Gastrointestinal Stromal Tumor
Evidence Direction
Supports
Drug
Regorafenib
Evidence Level
B
Clinical Significance
Sensitivity/Response
Pubmed
23177515
Drugs
Drug NameSensitivitySupported
RegorafenibSensitivitytrue