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Sub-category:
Gastrointestinal Stromal Tumors
Category:
Sarcoma
Meeting:
2009 ASCO Annual Meeting
Session Type and Session Title:
Oral Presentation, Sarcoma
Abstract No:
10507
Citation:
J Clin Oncol 27:15s, 2009 (suppl; abstr 10507)
Author(s):
A. Le Cesne, J. Blay, N. B. Bui, O. Bouché, A. Adenis, J. Domont, A. Cioffi, A. Moussy, O. Hermine; Institut Gustave Roussy, Villejuif, France; Centre Léon Bérard, Lyon, France; Institut Bergonié, Bordeaux, France; Hopital Robert Debré, Reims, France; Centre Oscar Lambret, Lille, France; AB Science, Paris, France; Hopital Necker, Paris, France
Abstract:
Background: Masitinib mesylate (AB1010, AB Science, Paris, France) is a novel protein tyrosine kinase inhibitor which, in vitro, has greater activity and selectivity than imatinib mesylate against bith wild-type c-Kit receptor and its mutated form in the juxtamembrane region. Masatinib also inhibits PDGFR and FGFR3. This multicenter phase II study evaluated the efficacy and safety of masatinib as a first-line treatment of advanced GIST. Methods: Imatinib-naïve patients with inoperable, locally advanced or metastatic GIST received oral masatinib (7.5 mg/kg/day) until progression, refusal or toxicity. A Simon "minimax two stage" design was used. Efficacy variables included response rate at two months, best response according to RECIST, disease control rate (DCR), metabolic response rate and progression free survival (PFS). Results: 30 patients with a median age of 58 years (60% of males) were included from June 2005 to April 2007 in five French institutions. The most frequent relevant grade 3 toxicities were rash (10%), neutropenia (7%) and abdominal pain (7%). One patient presented a grade 4 skin exfoliation. Three patients discontinued treatment due to suspected toxicity. At two months, the response rate was 20% (6/30 patients) according to RECIST (DCR of 98.7%, 29/30 patients) and 84.6% (11/13 evaluable patients) according to FDG-PET response criteria. After a median follow-up of 23.7 months, there were 6.7% of CR, 43.3% of PR, 46.7% of SD and 3.3% of PD as best response (DCR of 96.7%). Mean time to response was 5.7 months (0.8 to 23.3 months). The median PFS was 27.2 months with PFS rates of 68.8% at 1 year and 60.2% at 2 years. Up to date, all but one patient are alive (one patient died of post-surgical complications, unrelated to treatment). Mutational analyses of the patients'tumors are ongoing. Conclusions: The results observed with masatinib compare favorably with those reported with imatinib in front-line treatment of advanced GIST both in term of safety and efficacy and support the initiation of a phase III randomized clinical trial.
Abstract Disclosures
Faculty and Discussant Disclosures
Annual Meeting Planning Committee Disclosures
2009 Annual Meeting Proceedings Part I Errata
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
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1. Masatinib mesylate in imatinib-naive locally advanced or metastatic gastrointestinal stromal tumor (GIST): Results of the French Sarcoma Group phase II trial.
Meeting:
2009 ASCO Annual Meeting
Presenter:
Axel Le Cesne, MD
Session:
Sarcoma
(Oral Presentation)
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Other Abstracts in this Sub-Category:
Abstracts by A. Le Cesne:
Presentations by A. Le Cesne:
Educational Book Manuscripts by A. Le Cesne:
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