Annotation Detail

Information
Associated Genes
KIT
Associated Variants
KIT EXON 9 MUTATION
KIT EXON 9 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 9 mutations (n=15) treated with regorafenib were associated with a similarly favorable progression free survival (HR: 0.239), as compared to patients with treated with placebo.
Variant Origin
somatic
Variant Origin
Somatic
Evidence URL
https://civic.genome.wustl.edu/links/evidence_items/4628
Gene URL
https://civic.genome.wustl.edu/links/genes/29
Variant URL
https://civic.genome.wustl.edu/links/variants/509
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