An open label, multicenter, phase II study of dovitinib in advanced thyroid cancer. Issue 12 (August 2015)

• Record Type: Journal Article
• Authors: Lim, Sun Min; Chung, Woong Youn; Nam, Kee-Hyun; Kang, Sang-Wook; Lim, Jae Yun; Kim, Hoon-Gu; Shin, Seong Hoon; Sun, Jong-Mu; Kim, Seong-Geun; Kim, Joo-Hang; Kang, Chan Woo; Kim, Hye Ryun; Cho, Byoung Chul
• Is Part Of: European journal of cancer. Volume 51:Issue 12(2015:Aug.)
• Page Start: 1588
• Page End: 1595
• Publication Date: 2015-08
• Subjects: Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2015.05.020
• Languages: English
• ISSNs: 0959-8049

Abstract

<abstract xml:lang="en" abstract-type="author" id="ab005"> <title id="st005">Abstract</title> <sec> <title id="st010">Background</title> <p id="sp0005">This phase 2 study investigated the efficacy and safety of dovitinib (TKI258), a receptor tyrosine kinase inhibitor with potent activity against fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR), in locally advanced or metastatic thyroid cancer patients.</p> </sec> <sec> <title id="st015">Patients and methods</title> <p id="sp0010">Patients with advanced thyroid cancer that was refractory or not appropriate for <sup>131</sup>I received dovitinib orally, 500 mg once daily for five consecutive days, followed by a 2-day rest every week. The primary end-point was objective response rate. Secondary end-points were progression-free survival (PFS), overall survival (OS), duration of response, changes in tumour markers and safety.</p> </sec> <sec> <title id="st020">Results</title> <p id="sp0015">Between January 2013 and October 2014, a total of 40 patients were enrolled. There were 23 (57.5%) papillary thyroid cancer, 12 (30%) medullary thyroid cancer and 5 (12.5%) follicular thyroid cancer patients. One patient had withdrawn consent before the administration of dovitinib. The overall response rate was 20.5% (8/39) and disease control rate was 69.1% (26/39). Median PFS was 5.4 months (95% confidence interval (CI), 2.0–8.8) and median OS was not reached with 8.4 months follow-up duration. Common treatment-related adverse events were diarrhoea (53.8%), anorexia (35.8%), vomiting (25.6%), fatigue (23%) and nausea (20.5%), most of which were grade 1 or 2. There were no grade 4 events or treatment-related deaths. Dose interruption occurred in 12 (30.7%) patients, and 19 (48.7%) patients experienced dose reduction due to adverse events.</p> </sec> <sec> <title id="st025">Conclusions</title> <p id="sp0020">Dovitinib has a modest activity with manageable toxicity in locally advanced or metastatic thyroid cancer.</p> </sec> </abstract>