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Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma

Cited 43 time in Web of Science Cited 44 time in Scopus
Issue Date
2015-08
Citation
Cancer, Vol.121 No.15, pp.2612-2617
Keywords
adenoid cystic carcinomadovitinibclinical trialfibroblast growth factor receptor (FGFR)dovitinib (TKI258)
Abstract
BACKGROUNDThe objective of this study was to evaluate the efficacy and safety of dovitinib in patients with adenoid cystic carcinoma (ACC). METHODSACC patients with documented disease progression within the past 12 months were eligible. Patients received oral dovitinib (500 mg once daily for 5 consecutive days followed by a 2-day rest every week) until disease progression or unacceptable toxicities. The primary endpoint was the probability of 4-month progression-free survival (PFS). Metabolic response was evaluated with positron emission tomography (PET)/computed tomography (CT) scans performed at the baseline and after 8 weeks of treatment. RESULTSBetween September 2011 and April 2013, 32 patients with metastatic and/or unresectable ACC were enrolled in this prospective, multicenter trial. The 4-month PFS probability was 80.4%, and the median PFS was 6.0 months (95% confidence interval, 4.4-7.6 months). Tumor shrinkage was observed in 22 patients (68.8%), and 1 patient had a confirmed partial response. The disease control rate was 96.9%. Among 26 patients with PET/CT scans both before and after treatment (at 8 weeks), the metabolic activity of ACC was reduced in 13 patients (50.0%), and 5 patients (19.2%) achieved a metabolic partial response, which was defined as a 25% reduction in maximum standardized uptake values. Common grade 3 and 4 adverse events were asthenia (50.0%) and neutropenia (25.0%). CONCLUSIONSDovitinib shows modest antitumor activity in the treatment of ACC. Cancer 2015;121:2612-2617. (c) 2015 American Cancer Society. Dovitinib shows promising antitumor activity in the treatment of adenoid cystic carcinoma.
ISSN
0008-543X
URI
https://hdl.handle.net/10371/173014
DOI
https://doi.org/10.1002/cncr.29401
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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