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Ref Type Journal Article
PMID (21690468)
Authors Guo J, Si L, Kong Y, Flaherty KT, Xu X, Zhu Y, Corless CL, Li L, Li H, Sheng X, Cui C, Chi Z, Li S, Han M, Mao L, Lin X, Du N, Zhang X, Li J, Wang B, Qin S
Title Phase II, open-label, single-arm trial of imatinib mesylate in patients with metastatic melanoma harboring c-Kit mutation or amplification.
Journal Vol Issue Date Pages Journal Short Title
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 29 21 2011 Jul 20 2904-9 J Clin Oncol
URL
Abstract Text Melanomas harbor aberrations in the c-Kit gene. We tested the efficiency of the tyrosine kinase inhibitor imatinib in selected patients with metastatic melanoma harboring c-Kit mutations or amplifications.Forty-three patients with metastatic melanoma harboring c-Kit aberrations were enrolled on this phase II trial. Each patient received a continuous dose of imatinib 400 mg/d unless intolerable toxicities or disease progression occurred. Fifteen patients who experienced progression of disease were allowed to escalate the dose to 800 mg/d.Forty-three patients were eligible for evaluation, and the median follow-up time was 12.0 months. The median progression-free survival (PFS) was 3.5 months, and the 6-month PFS rate was 36.6%. Rate of total disease control was 53.5%: 10 patients (23.3%; 95% CI, 10.2% to 36.4%) and 13 patients (30.2%; 95% CI, 16.0% to 44.4%) achieved partial response (PR) and stable disease (SD), respectively. Eighteen patients (41.9%) demonstrated regression of tumor mass. Notably, nine of the 10 PRs were observed in patients with mutations in exons 11 or 13. The 1-year overall survival (OS) rate was 51.0%. The median PFS and OS times for patients who had PR or SD versus disease progression were 9.0 months versus 1.5 months (P < .001) and 15.0 months versus 9.0 months (P = .036), respectively. Imatinib 400 mg/d was well tolerated, and only one of the 15 patients who received dose escalation to 800 mg/d achieved SD.Imatinib demonstrated significant activity in patients with metastatic melanoma harboring genetic c-Kit aberrations, with an overall response rate of 23.3%. Escalation to 800 mg/d could not restore disease control.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
KIT I653T missense unknown KIT I653T lies within the protein kinase domain (exon 13) of the Kit protein (UniProt.org). I653T has been identified in the scientific literature (PMID: 21690468), but has not been been biochemically characterized and therefore, its effect on Kit protein function is unknown (PubMed, Nov 2024).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KIT exon11 melanoma predicted - sensitive Imatinib Phase II Actionable In a Phase II trial, Gleevec (imatinib) treatment resulted in a 6-month progression-free survival (PFS) rate of 36.6%, a median PFS of 3.5 months, a median overall survival (OS) of 14.0 mo, a 1-year OS rate of 51.0%, partial responses (PR) in 23.3% (10/43) and stable disease in 30.2% of metastatic melanoma patients harboring KIT mutations, 9 of the 10 responders harbored KIT exon 11/ 13 mutations (PMID: 21690468; NCT00881049). 21690468
KIT exon13 melanoma predicted - sensitive Imatinib Phase II Actionable In a Phase II trial, Gleevec (imatinib) treatment resulted in a 6-month progression-free survival (PFS) rate of 36.6%, a median PFS of 3.5 months, a median overall survival (OS) of 14.0 mo, a 1-year OS rate of 51.0%, partial responses (PR) in 23.3% (10/43) and stable disease in 30.2% of metastatic melanoma patients harboring KIT mutations, 9 of the 10 responders harbored KIT exon 11/ 13 mutations (PMID: 21690468; NCT00881049). 21690468