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Phase II Trial of Nilotinib in Patients With Metastatic Malignant Melanoma Harboring KIT Gene Aberration: A Multicenter Trial of Korean Cancer Study Group (UN10-06)

Title
Phase II Trial of Nilotinib in Patients With Metastatic Malignant Melanoma Harboring KIT Gene Aberration: A Multicenter Trial of Korean Cancer Study Group (UN10-06)
Authors
Lee, Su JinKim, Tae MinKim, Yu JungJang, Kee-TaekLee, Hyo JinLee, Soon NamAhn, Mi SunHwang, In GyuLee, SueeLee, Moon-HeeLee, Jeeyun
Ewha Authors
이순남
SCOPUS Author ID
이순남scopus
Issue Date
2015
Journal Title
ONCOLOGIST
ISSN
1083-7159JCR Link1549-490XJCR Link
Citation
vol. 20, no. 11, pp. 1312 - 1319
Keywords
NilotinibMelanomaKIT mutationKIT amplification
Publisher
ALPHAMED PRESS
Indexed
SCIE; SCOPUS WOS scopus
Abstract
Background. KIT has been suggested to be a potential therapeutic target for malignant melanoma. We evaluated the antitumor activity and safety of the KIT inhibitor nilotinib in metastatic melanoma patients harboring KIT gene mutations or amplifications. Methods. We conducted a phase II multicenter trial of nilotinib in metastatic malignant melanoma with KIT mutations or amplifications. Patients received 400 mg oral nilotinib twice daily. The primary endpoint was response rate, and if seven or more responders were observed from the cumulative 36 patients, nilotinib would be considered worthy of further testing in this study population. Results. Between October 2009 and June 2013, 176 patients underwent molecular screening for KIT gene aberrations, and 42 patients harboring KIT gene mutations and/or amplification were enrolled in the study. Overall, 25 (59.5%), 15 (35.7%), and 2(4.8%) patients had KIT mutations, KIT amplifications, and both KIT mutations and amplification, respectively. Of the 42 enrolled patients, 1 patient achieved complete response, 6 patients achieved partial response, and 17 patients achieved stable disease, resulting in an overall response rate of 16.7% (95% confidence interval [CI]: 5.4%-28.0%) and a disease control rate of 57.1% (95% CI: 42.1%-72.1%). The median duration of response was 34 weeks (range: 5-55 weeks). Of the 7 responders, 6 patients had KIT mutations (exon 11: 5 patients; exon 17: 1 patient), and 1 patient had KIT amplification only. Conclusion. Although this study did not meet its primary endpoint of response rate, nilotinib showed durable response in a subset of metastatic melanoma patients with specific KIT mutations.
DOI
10.1634/theoncologist.2015-0161
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의학전문대학원 > 의학과 > Journal papers
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