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Sub-category:
GIST
Category:
Sarcoma
Meeting:
2010 ASCO Annual Meeting
Session Type and Session Title:
Trials in Progress Poster Session, Trials in Progress Poster Session
Abstract No:
TPS332^
Citation:
J Clin Oncol 28:15s, 2010 (suppl; abstr TPS332^)
Author(s):
P. G. Casali, H. Joensuu, J. Martin Broto, X. Garcia del Muro, J. Blay, C. May, A. Pustowka, P. Reichardt; Istituto Nazionale dei Tumori, Milano, Italy; Helsinki University Central Hospital, Helsinki, Finland; Hospital Son Dureta, Palma de Mallorca, Spain; Instituto Catalan d'Oncologia, Barcelona, Spain; Université Claude Bernard Lyon I, Lyon, France; Novartis Pharmaceuticals Corporation, Nuernberg, Germany; HELIOS Klinikum Bad Saarow, Berlin, Germany
Abstract:
Background: Nilotinib (N) is a novel tyrosine kinase inhibitor (TKI) of KIT, PDGFRA, and BCR-AbL that has been shown to inhibit the proliferation of imatinib (I)-resistant GIST cell lines. Preliminary studies with N have shown that it can provide clinical activity in patients (pts) who have failed first- and second-line therapies and is safe in pts with advanced GIST. This Phase II study was conducted to investigate the efficacy of N as first-line treatment. Methods: The multicenter, single-arm trial evaluated the efficacy of N in newly diagnosed pts with unresectable or metastatic GIST or with recurrent GIST post adjuvant treatment. Pts were given N 400 mg bid until disease progression, unacceptable toxicity, or discontinuation for another reason. Primary endpoint was PFS at 6 months determined by RECIST; secondary endpoints included objective tumor response (RECIST), time to overall response, duration of response, progression-free survival, overall survival, and safety. Results: As of December 2009, a total of 21 pts were enrolled, 14 of whom had completed 6 months of treatment and were included in the efficacy analysis. Median follow-up was 176 days (range: 1-367). The study included 19 pts with metastatic GIST; there were 11 male and 8 female pts, with median age 60 years (range: 35-78). Best overall response included 6 pts with partial responses (42.9%), 6 with stable disease (42.9%), and 2 with progressive disease (14.3%). Rate of progression-free pts at 6 mo is 85.7%. Adverse events (AEs) were experienced by 57.9% of pts, including gastrointestinal disorders such as nausea, vomiting, diarrhea (42.1%) and eyelid edema (10.5%). Most AEs were grade 1 or 2 (CTCEAv3.0). No deaths occurred during the study period. Mutational data will be presented. Conclusions: In the early analysis of this pilot study, N displayed substantial clinical benefit and a favorable safety profile in the first-line treatment of patients with metastatic or unresectable GIST. Updated data will be presented.
Abstract Disclosures
Faculty & Discussant Disclosures
Annual Meeting Planning Committee Disclosures
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):
Other Abstracts in this Sub-Category:
Abstracts by P. G. Casali:
Presentations by P. G. Casali:
Educational Book Manuscripts by P. G. Casali:
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