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dc.contributor.authorAnn Lii Chengen_US
dc.contributor.authorSumitra Thongpraserten_US
dc.contributor.authorHo Yeong Limen_US
dc.contributor.authorWattana Sukeepaisarnjaroenen_US
dc.contributor.authorTsai Shen Yangen_US
dc.contributor.authorCheng Chung Wuen_US
dc.contributor.authorYee Chaoen_US
dc.contributor.authorStephen L. Chanen_US
dc.contributor.authorMasatoshi Kudoen_US
dc.contributor.authorMasafumi Ikedaen_US
dc.contributor.authorYoon Koo Kangen_US
dc.contributor.authorHongming Panen_US
dc.contributor.authorKazushi Numataen_US
dc.contributor.authorGuohong Hanen_US
dc.contributor.authorBinaifer Balsaraen_US
dc.contributor.authorYong Zhangen_US
dc.contributor.authorAna Marie Rodriguezen_US
dc.contributor.authorYi Zhangen_US
dc.contributor.authorYongyu Wangen_US
dc.contributor.authorRonnie T.P. Poonen_US
dc.description.abstract© 2016 by the American Association for the Study of Liver Diseases Angiogenesis inhibition by the vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) inhibitor sorafenib provides survival benefit in hepatocellular carcinoma (HCC); however, angiogenic escape from sorafenib may occur due to angiogenesis-associated fibroblast growth factor receptor (FGFR) pathway activation. In addition to VEGFR and PDGFR, dovitinib inhibits FGFR. Frontline oral dovitinib (500 mg/day, 5 days on, 2 days off; n = 82) versus sorafenib (400 mg twice daily; n = 83) was evaluated in an open-label, randomized phase 2 study of Asian-Pacific patients with advanced HCC. The primary and key secondary endpoints were overall survival (OS) and time to tumor progression (TTP) as determined by a local investigator, respectively. Patients included in the study were ineligible for surgical and/or locoregional therapies or had disease progression after receiving these therapies. The median OS (95% confidence interval [CI]) was 8.0 (6.6-9.1) months for dovitinib and 8.4 (5.4-11.3) months for sorafenib. The median TTP (95% CI) per investigator assessment was 4.1 (2.8-4.2) months and 4.1 (2.8-4.3) months for dovitinib and sorafenib, respectively. Common any-cause adverse events included diarrhea (62%), decreased appetite (43%), nausea (41%), vomiting (41%), fatigue (35%), rash (34%), and pyrexia (30%) for dovitinib and palmar-plantar erythrodysesthesia syndrome (66%) and decreased appetite (31%) for sorafenib. Subgroup analysis revealed a significantly higher median OS for patients in the dovitinib arm who had baseline plasma soluble VEGFR1 (sVEGFR1) and hepatocyte growth factor (HGF) below median levels versus at or above the median levels (median OS [95% CI]: sVEGFR1, 11.2 [9.0-13.8] and 5.7 [4.3-7.0] months, respectively [P =.0002]; HGF, 11.2 [8.9-13.8] and 5.9 [5.0-7.6] months, respectively [P = 0.0002]). Conclusion: Dovitinib was well tolerated, but activity was not greater than sorafenib as a frontline systemic therapy for HCC. Based on these data, no subsequent phase 3 study has been planned. (Hepatology 2016;64:774-784).en_US
dc.titleRandomized, open-label phase 2 study comparing frontline dovitinib versus sorafenib in patients with advanced hepatocellular carcinomaen_US
article.volume64en_US Taiwan University Hospitalen_US Mai Universityen_US Medical Center, Sungkyunkwan Universityen_US hospitalen_US Gung Memorial Hospitalen_US General Hospital-Taichung Taiwanen_US General Hospital-Taipeien_US University of Hong Kongen_US University School of Medicineen_US Cancer Center Hospital Easten_US Medical Centeren_US Universityen_US City University Hospitalen_US Hospitalen_US Pharmaceuticals Corporationen_US International AGen_US Mary Hospital Hong Kongen_US
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