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An open label, multicenter, phase II study of dovitinib in advanced thyroid cancer

 Sun Min Lim  ;  Woong Youn Chung  ;  Kee-Hyun Nam  ;  Sang-Wook Kang  ;  Jae Yun Lim  ;  Hoon-Gu Kim  ;  Seong Hoon Shin  ;  Jong-Mu Sun  ;  Seong-Geun Kim  ;  Joo-Hang Kim  ;  Chan Woo Kang  ;  Hye Ryun Kim  ;  Byoung Chul Cho 
 EUROPEAN JOURNAL OF CANCER, Vol.51(12) : 1588-1595, 2015 
Journal Title
Issue Date
Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/therapeutic use* ; Benzimidazoles/therapeutic use* ; Biomarkers, Tumor/metabolism ; Female ; Humans ; Male ; Middle Aged ; Protein Kinase Inhibitors/therapeutic use* ; Quinolones/therapeutic use* ; Receptors, Vascular Endothelial Growth Factor/antagonists & inhibitors ; Survival Analysis ; Thyroid Neoplasms/drug therapy* ; Thyroid Neoplasms/metabolism ; Vascular Endothelial Growth Factor A/antagonists & inhibitors
Dovitinib ; Efficacy ; Phase 2 ; Safety ; Thyroid cancer
BACKGROUND: 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. PATIENTS AND METHODS: Patients with advanced thyroid cancer that was refractory or not appropriate for (131)I received dovitinib orally, 500mg 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. RESULTS: 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 One patient had withdrawn consent before the administration of dovitinib.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. CONCLUSIONS: Dovitinib has a modest activity with manageable toxicity in locally advanced or metastatic thyroid cancer.
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Yonsei Biomedical Research Center (연세의생명연구원) > 1. Journal Papers
Yonsei Authors
Kang, Sang Wook(강상욱) ORCID logo https://orcid.org/0000-0001-5355-833X
Kang, Chan Woo(강찬우)
Kim, Joo Hang(김주항)
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
Nam, Kee Hyun(남기현) ORCID logo https://orcid.org/0000-0002-6852-1190
Lim, Sun Min(임선민)
Lim, Jae Yun(임재윤)
Chung, Woung Youn(정웅윤)
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
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