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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.

Author information

1
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
2
Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
3
Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
4
Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.
5
Department of Internal Medicine, Yonsei University College of Medicine, Yonsei Cancer Center, Seoul, Republic of Korea.
6
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
7
Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.
8
Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, Republic of Korea.

Abstract

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.

KEYWORDS:

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

PMID:
25903089
DOI:
10.1002/cncr.29401
[Indexed for MEDLINE]
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