Sunitinib as a second-line therapy for advanced GISTs after failure of imatinib: Relationship between efficacy and tumor genotype in Korean patients

Background: To assess the efficacy and safety of sunitinib with regards to primary genotypes of tumor in Korean patients with advanced gastrointestinal stromal tumors (GISTs) who failed an initial therapy of imatinib. Methods: Clinical data were collected from 88 consecutive patients with metastatic/unresectable GISTs treated with sunitinib at the Asan Medical Center. Results: The median time-to-progression (TTP) and overall survival (OS) times were 7.1 months and 17.6 months, respectively. Of the 74 patients tested for KIT (exons 9, 11, 13, 17) and PDGFRA (exons 12 and 18), patients with KIT exon 9 mutant GIST (n=11, 14.9%) showed numerically better clinical benefit (objective response or stable disease ≥24 weeks) rate (63.6% vs 46.8%, p=0.504) and TTP (median 13.6 mo vs 6.9 mo, p=0.631) than those with KIT exon 11 mutant GIST (n=47, 63.5%). The most common grade 3/4 adverse events included neutropenia (34.1%), thrombocytopenia (33.0%) and hand-foot skin reaction (25.0%). Conclusions: Sunitinib is an effective and safe second-line therapy for Korean patients with advanced GIST. The superior efficacy of sunitinib against GISTs with KIT exon 9 mutations appears to be similar in Korean patients to Western experience although statistical significance was not secured.