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Cancer. 2015 Aug 1;121(15):2612-7. doi: 10.1002/cncr.29401. Epub 2015 Apr 22.

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

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Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.
Department of Internal Medicine, Yonsei University College of Medicine, Yonsei Cancer Center, Seoul, Republic of Korea.
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.
Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Republic of Korea.



The objective of this study was to evaluate the efficacy and safety of dovitinib in patients with adenoid cystic carcinoma (ACC).


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.


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%).


Dovitinib shows modest antitumor activity in the treatment of ACC.


adenoid cystic carcinoma; clinical trial; dovitinib; dovitinib (TKI258); fibroblast growth factor receptor (FGFR)

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