• Min-Hee Ryu, Won Ki Kang, Yung-Jue Bang, Kyung Hee Lee, Dong Bok Shin, Baek-Yeol Ryoo, Jae Kyung Roh, Jin-Hyoung Kang, Hyoungnam Lee, Tae Won Kim, Heung Moon Chang, Joon Oh Park, Young Suk Park, Tae-You Kim, Min Kyoung Kim, Woon Kee Lee, Hye Jin Kang, and Yoon-Koo Kang.
• Department of Internal Medicine, Division of Oncology, Asan Medical Center, Songpa-Gu, Seoul, Korea.
• Oncology. 2009 Jan 1; 76 (5): 326-32.

ObjectivesThis prospective, multicenter, phase 2 study evaluated the efficacy and safety of imatinib mesylate and assessed KIT and PDGFRA gene mutation status in Korean patients with gastrointestinal stromal tumors (GISTs).MethodsForty-seven patients with pathologically proven KIT-positive metastatic or unresectable GISTs were accrued from eight institutions in Korea. Imatinib was administered orally at 400 mg once daily. In case of disease progression, the dose was escalated to 600 mg once daily, then 400 mg twice daily. KIT and PDGFRA mutations were analyzed in 29 of the 47 patients.ResultsImatinib produced partial responses in 30 patients (63.8%; 95% confidence interval, 50.1-77.6%) and stable disease in 13 patients (27.7%). The median time to response was 2.6 months (range, 1.0-6.2 months). With a median follow-up of 62 months (range, 32-67 months), 4-year progression-free survival and overall survival rates were 50 and 65%, respectively. The most common adverse events were anemia, neutropenia, edema, and skin rash (predominantly of grade 1-2). There were no treatment-related deaths. In the subset evaluated for mutational status, 24 patients (82.8%) had KIT exon 11 mutations and 1 (3.4%) had a KIT exon 9 mutation.ConclusionsImatinib is effective and safe in Korean patients with metastatic or unresectable GIST.Copyright 2009 S. Karger AG, Basel.

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