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Phase II Study of Dovitinib in Patients with Castration-Resistant Prostate Cancer (KCSG-GU11-05)

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Author(s)
Yoon Ji ChoiHye Sook KimSe Hoon ParkBong-Seog KimKyoung Ha KimHyo Jin LeeHong Suk SongDong-Yeop ShinHa Young LeeHoon-Gu KimKyung Hee LeeJae Lyun LeeKyong Hwa Park
Keimyung Author(s)
Song, Hong Suk
Department
Dept. of Internal Medicine (내과학)
Journal Title
Cancer Res Treat
Issued Date
2018
Volume
50
Issue
4
Keyword
DovitinibCastration-resistant prostatic neoplasmBiomarkers
Abstract
Purpose
Fibroblast growth factor (FGF) signals are important in carcinogenesis and progression of prostate cancer. Dovitinib is an oral, pan-class inhibitor of vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor, and fibroblast growth factor receptor (FGFR). We evaluated the efficacy and toxicity of dovitinib in men with metastatic castration resistant prostate cancer (mCRPC).

Materials and Methods
This study was a single-arm, phase II, open-label, multicenter trial of dovitinib 500 mg/day (5-days-on/2-days-off schedule). The primary endpoint was 16-week progression-free survival (PFS). Secondary endpoints were overall survival (OS), toxicity and prostate-specific antigen
(PSA) response rate. Biomarker analyses for VEGFR2, FGF23, and FGFR2 using multiplex enzyme-linked immunosorbent assay was performed.

Results
Forty-four men were accrued from 11 hospitals. Eighty percent were post-docetaxel. Median PSA was 100 ng/dL, median age was 69, 82% had bone metastases, and 23% had liver metastases. Median cycles of dovitinib was 2 (range, 0 to 33). Median PFS was 3.67 months (95% confidence interval [CI], 1.36 to 5.98) and median OS was 13.70 months (95% CI, 0 to 27.41). Chemotherapy-naïve patients had longer PFS (17.90 months; 95% CI, 9.23 to 28.57) compared with docetaxel-treated patients (2.07 months; 95% CI, 1.73 to 2.41; p=0.001) and the patients with high serum VEGFR2 level over median level (7,800 pg/mL) showed longer PFS compared with others (6.03 months [95% CI, 4.26 to 7.80] vs. 1.97 months [95% CI, 1.79 to 2.15], p=0.023). Grade 3 related adverse events were seen in 40.9% of patients. Grade 1-2 nausea, diarrhea, fatigue, anorexia, and all grade thrombocytopenia are common.

Conclusion
Dovitinib showed modest antitumor activity with manageable toxicities in men with mCRPC. Especially, patients who were chemo-naïve benefitted from dovitinib.
Keimyung Author(s)(Kor)
송홍석
Publisher
School of Medicine (의과대학)
Citation
Yoon Ji Choi et al. (2018). Phase II Study of Dovitinib in Patients with Castration-Resistant Prostate Cancer (KCSG-GU11-05). Cancer Res Treat, 50(4), 1252–1259. doi: 10.4143/crt.2017.438
Type
Article
ISSN
2005-9256
Source
https://www.e-crt.org/journal/view.php?doi=10.4143/crt.2017.438#
DOI
10.4143/crt.2017.438
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41690
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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