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

• Published in: Cancer Vol. 121; no. 15; pp. 2612 - 2617
• Main Authors: Keam, Bhumsuk, Kim, Sung‐Bae, Shin, Seong Hoon, Cho, Byoung Chul, Lee, Keun‐Wook, Kim, Min Kyoung, Yun, Hwan‐Jung, Lee, Se‐Hoon, Yoon, Dok Hyun, Bang, Yung‐Jue
• Format: Journal Article
• Language: English
• Published: United States 01-08-2015
• Subjects: adenoid cystic carcinoma; Adult; Aged; Antineoplastic Agents - therapeutic use; Benzimidazoles - therapeutic use; Carcinoma, Adenoid Cystic - drug therapy; Carcinoma, Adenoid Cystic - mortality; Carcinoma, Adenoid Cystic - pathology; clinical trial; dovitinib; dovitinib (TKI258); Female; fibroblast growth factor receptor (FGFR); 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; Republic of Korea; clinical trial; dovitinib (TKI258); dovitinib; fibroblast growth factor receptor (FGFR); adenoid cystic carcinoma
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.29401

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. Cancer 2015;121:2612–2617. © 2015 American Cancer Society.
Dovitinib shows promising antitumor activity in the treatment of adenoid cystic carcinoma.