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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
Author(s) -
Lim Sung Hee,
Sun JongMu,
Choi YoonLa,
Kim Hye Ryun,
Ahn Soomin,
Lee Ji Yun,
Lee SeHoon,
Ahn Jin Seok,
Park Keunchil,
Kim Joo Hang,
Cho Byoung Chul,
Ahn MyungJu
Publication year - 2016
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.30135
Subject(s) - medicine , tolerability , gastroenterology , lung cancer , clinical endpoint , phases of clinical research , surgery , confidence interval , adverse effect , toxicity , randomized controlled trial
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. Cancer 2016;122:3024‐3031 . © 2016 American Cancer Society .