https://scholars.lib.ntu.edu.tw/handle/123456789/568463
標題: | Phase 2 trial of linifanib (ABT-869) in patients with unresectable or metastatic hepatocellular carcinoma | 作者: | Toh H.C. PEI-JER CHEN Carr B.I. Knox J.J. Gill S. Ansell P. McKeegan E.M. Dowell B. Pedersen M. Qin Q. Qian J. Scappaticci F.A. Ricker J.L. Carlson D.M. Yong W.P. |
關鍵字: | angiogenesis; hepatocellular carcinoma (HCC); linifanib; platelet-derived growth factor receptor (PDGFR); sorafenib; vascular endothelial growth factor receptor (VEGFR) | 公開日期: | 2013 | 出版社: | John Wiley and Sons Inc. | 卷: | 119 | 期: | 2 | 起(迄)頁: | 380-387 | 來源出版物: | Cancer | 摘要: | Background: The efficacy and safety of linifanib (ABT-869), a selective inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptor tyrosine kinases, were assessed in this phase 2, single-arm, open-label, multicenter trial. Methods: Eligible patients had unresectable or metastatic hepatocellular carcinoma and had received ? 1 prior systemic therapy. Patients received oral linifanib at a fasting dose of 0.25 mg/kg,. The primary endpoint was the progression-free rate at 16 weeks. Tumor response was assessed every 8 weeks. Secondary endpoints included the time to disease progression, overall survival, and objective response rate. Safety was also assessed. Results: Of the 44 patients enrolled, the majority were Asian (89%), had received no prior systemic therapy (82%), had Child-Pugh class A hepatic function (86%), and had hepatitis B virus infection (61%). The estimated progression-free rate at 16 weeks was 31.8% (34.2% for patients with Child-Pugh class A hepatic function), the estimated objective response rate was 9.1% (10.5% for patients with Child-Pugh class A hepatic function), the median time to disease progression was 3.7 months (3.7 months for patients with Child-Pugh class A hepatic function), and the median overall survival was 9.7 months (10.4 months for patients with Child-Pugh class A hepatic function). The most common linifanib-related adverse events were diarrhea (55%) and fatigue (52%). The most common linifanib-related grade 3/4 adverse events were hypertension (25%) and fatigue (14%). Serum levels of biomarkers cancer antigen (CA) 125, cytokeratin fragment (CYFRA)21.1, and protein induced by vitamin K absence or antagonist II (PIVKA) demonstrated potential as prognostic indicators of patient response or outcome. Conclusions: Single-agent linifanib was found to be clinically active in patients with advanced hepatocellular carcinoma, with an acceptable safety profile. ? 2012 American Cancer Society. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84984559340&doi=10.1002%2fcncr.27758&partnerID=40&md5=a8533cccd756583660928ef796714434 https://scholars.lib.ntu.edu.tw/handle/123456789/568463 |
ISSN: | 0008-543X | DOI: | 10.1002/cncr.27758 | SDG/關鍵字: | CA 125 antigen; cytokeratin fragment 21.1; decarboxyprothrombin; keratin; linifanib; tumor marker; unclassified drug; adult; aged; alanine aminotransferase blood level; anemia; article; Asian; aspartate aminotransferase blood level; bedtime dosage; bilirubin blood level; cancer growth; cancer prognosis; cancer survival; Child Pugh score; clinical article; decreased appetite; diarrhea; drug efficacy; drug eruption; drug safety; fatigue; female; hand foot syndrome; human; hypertension; leukopenia; liver cell carcinoma; liver function; male; metastasis potential; multicenter study; neutropenia; open study; overall survival; phase 2 clinical trial; priority journal; progression free survival; protein blood level; proteinuria; side effect; systemic therapy; thrombocytopenia; treatment response; vomiting |
顯示於: | 臨床醫學研究所 |
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