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• W2890554588 abstract "9501 Background: Pre-clinical studies report a critical role of c-KIT mutations in some mucosal, acral, solar, and vulvovaginal melanomas. Clinical trials of KIT-directed therapy with imatinib and sunitinib demonstrated activity in these subtypes. Unlike other TKIs, dasatinib has activity in melanoma cell lines with the most common KIT mutation at exon 11L576P. E2607 assessed the efficacy of dasatinib in treatment-naïve or previously-treated patients (pts) with unresectable melanoma of these subtypes. Methods: Pts were assigned to receive dasatinib 70 mg PO twice daily with adjustment for toxicity. The primary objective for this two-stage phase II trial was response rate (RR: RECIST). Stage I was open to KIT mutated (KIT+) and wild-type (KIT-) tumors with mucosal, acral, and solar melanomas (n = 57). Depending upon the interim analysis, stage II would be for pts with KIT+ (n = 30) tumors; to enrich for KIT+, vulvovaginal was added and solar melanomas removed. Secondary objectives included progression-free survival (PFS), overall survival (OS), and safety. Results: From May 2009 to Dec 2010, 57 pts were accrued to stage I. These data were presented at ASCO 2012. Three pts had KIT+ tumors, with 13.2+ months (mo) as the longest OS. Stage II opened in Nov 2011, accrued 24 pts with KIT+ tumors, and closed in Dec 2015 due to slow accrual. Six pts had mucosal (25%), 9 acral (37.5%), and 9 vulvovaginal melanomas (37.5%). As of Jan 2016, 16/24 have progressed (median PFS: 4.0 mo, 95% CI: 1.3-25.0) and 14/24 died (median OS: 12.3 mo, 4.5-29.7). Among 10 surviving pts, median follow-up is 15.2 mo (0.5-36.1 mo). Of 17 pts from stage II with mature response data, 4 had partial response (PR: 23.5%), 6 stable disease (35%), 5 progression (29.5%), and 2 were unevaluable (12%). Grade III (11/23: 48%) treatment-related toxicities were fatigue, (5 pts), anemia (3 pts) and dyspnea (2 pts). One pt had grade IV dyspnea. Conclusions: E2607 is closed to accrual, and finalized results, including type of KIT mutation and durations of disease control from stages I and II will be presented. Among pts with these KIT+ melanoma subtypes, dasatinib is an active agent. Clinical trial information: NCT00700882." @default.
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• W2890554588 date "2016-05-20" @default.
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• W2890554588 title "A phase II trial of dasatinib in patients with unresectable locally advanced or stage IV mucosal, acral, and vulvovaginal melanomas: A trial of the ECOG-ACRIN Cancer Research Group (E2607)." @default.
• W2890554588 doi "https://doi.org/10.1200/jco.2016.34.15_suppl.9501" @default.
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