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

 Bhumsuk Keam  ;  Sung-Bae Kim  ;  Seong Hoon Shin  ;  Byoung Chul Cho  ;  Keun-Wook Lee  ;  Min Kyoung Kim  ;  Hwan-Jung Yun  ;  Se-Hoon Lee  ;  Dok Hyun Yoon  ;  Yung-Jue Bang 
 CANCER, Vol.121(15) : 2612-2617, 2015 
Journal Title
Issue Date
Adult ; Aged ; Antineoplastic Agents/therapeutic use* ; Benzimidazoles/therapeutic use* ; Carcinoma, Adenoid Cystic/drug therapy* ; Carcinoma, Adenoid Cystic/mortality ; Carcinoma, Adenoid Cystic/pathology ; Female ; Head and Neck Neoplasms/drug therapy* ; Head and Neck Neoplasms/mortality ; Head and Neck Neoplasms/pathology ; Humans ; Male ; Middle Aged ; Neoplasm Metastasis ; Quinolones/therapeutic use* ; Republic of Korea/epidemiology ; Salivary Gland Neoplasms/drug therapy ; Salivary Gland Neoplasms/mortality ; Salivary Gland Neoplasms/pathology ; Treatment Outcome ; Young Adult
adenoid cystic carcinoma ; clinical trial ; dovitinib ; dovitinib (TKI258) ; fibroblast growth factor receptor (FGFR)
BACKGROUND: The objective of this study was to evaluate the efficacy and safety of dovitinib in patients with adenoid cystic carcinoma (ACC).

METHODS: ACC 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.

RESULTS: Between 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%).

CONCLUSIONS: Dovitinib shows modest antitumor activity in the treatment of ACC.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
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