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Efficacy and safety of dovitinib in pretreated patients with advanced squamous non-small cell lung cancer with FGFR1 amplification: A single-arm, phase 2 study

 Sung Hee Lim  ;  Jong-Mu Sun  ;  Yoon-La Choi  ;  Hye Ryun Kim  ;  Soomin Ahn  ;  Ji Yun Lee  ;  Se-Hoon Lee  ;  Jin Seok Ahn  ;  Keunchil Park  ;  Joo Hang Kim  ;  Byoung Chul Cho  ;  Myung-Ju Ahn 
 CANCER, Vol.122(19) : 3024-3031, 2016 
Journal Title
Issue Date
Aged ; Aged, 80 and over ; Benzimidazoles/therapeutic use* ; Carcinoma, Non-Small-Cell Lung/drug therapy* ; Carcinoma, Non-Small-Cell Lung/genetics ; Carcinoma, Non-Small-Cell Lung/secondary ; Carcinoma, Squamous Cell/drug therapy* ; Carcinoma, Squamous Cell/genetics ; Carcinoma, Squamous Cell/secondary ; Female ; Follow-Up Studies ; Gene Amplification* ; Humans ; Lung Neoplasms/drug therapy* ; Lung Neoplasms/genetics ; Lung Neoplasms/pathology ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Staging ; Prognosis ; Quinolones/therapeutic use* ; Receptor, Fibroblast Growth Factor, Type 1/genetics* ; Survival Rate
FGFR messenger RNA (mRNA) ; biomarker ; dovitinib ; fibroblast growth factor receptor 1 (FGFR1) amplification ; squamous cell lung cancer
BACKGROUND: Fibroblast growth factor receptor 1 (FGFR1) amplification is a potential driving oncogene in squamous cell cancer (SCC) of the lung. The current phase 2 study evaluated the efficacy and tolerability of dovitinib, an FGFR inhibitor, in patients with advanced SCC of the lung.

METHODS: Patients with pretreated advanced SCC of the lung whose tumors demonstrated FGFR1 amplification of?>?5 copies by fluorescence in situ hybridization were enrolled. Dovitinib at a dose of 500?mg was administered orally, once daily, on days 1 to 5 of every week, followed by 2 days off. The primary endpoint was overall response. Secondary endpoints were progression-free survival, overall survival, and toxicity.

RESULTS: All 26 patients were men with a median age of 68 years (range, 52-80 years). The majority of patients were ever-smokers. The median duration of dovitinib administration (28 days per cycle) was 2.5 months (range, 0.7-8.6 months). The overall response rate was 11.5% (95% confidence interval [95% CI], 0.8%-23.8%) and the disease control rate was 50% (95% CI, 30.8%-69.2%), with 3 patients achieving partial responses. Response durations for the patients with partial responses were ≥4.5 months,?≥?5.1 months, and 6.1 months, respectively. After a median follow-up of 15.7 months (range, 1.2-25.6 months), the median overall survival was 5.0 months (95% CI, 3.6-6.4 months) and the median progression-free survival was 2.9 months (95% CI, 1.5-4.3 months). The most common grade 3 or higher adverse events were fatigue (19.2%), anorexia (11.5%), and hyponatremia (11.5%) (event severity was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]).

CONCLUSIONS: Treatment with dovitinib demonstrated modest efficacy in patients with advanced SCC with FGFR1 amplification. Further studies to evaluate other biomarkers correlated with the efficacy of dovitinib in patients with SCC are warranted.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
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