Orantinib versus placebo combined with transcatheter arterial chemoembolisation in patients with unresectable hepatocellular carcinoma (ORIENTAL): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study

The Lancet Gastroenterology & Hepatology - Tập 3 - Trang 37-46 - 2018
Masatoshi Kudo1, Ann-Lii Cheng2, Joong-Won Park3, Jae Hyung Park4,5, Po-Chin Liang6, Hisashi Hidaka7, Namiki Izumi8, Jeong Heo9, Youn Jae Lee10, I-Shyan Sheen11, Chang-Fang Chiu12, Hitoshi Arioka13, Satoshi Morita14, Yasuaki Arai15
1Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan
2Department of Oncology, National Taiwan University Hospital, Taipei City, Taiwan
3Center for Liver Cancer, National Cancer Center Korea, Gyeonggi-do, South Korea
4Department of Radiology, Seoul National University Hospital, Seoul, South Korea
5Department of Radiology, Myongji Hospital, Gyeonggi-do, South Korea
6Division of Abdomen Radiology, National Taiwan University Hospital, Taipei City, Taiwan
7Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Kanagawa, Japan
8Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan
9Department of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, South Korea
10Division of Gastroenterology, Inje University Busan Paik Hospital, Busan, South Korea
11Department of Hepato-gastroenterology, Chang Gung Memorial Hospital—Linkou, Taoyuan County, Taiwan
12Division of Hematology/Oncology, China Medical University Hospital, Taichung City, Taiwan
13Department of Medical Oncology, Yokohama Rosai Hospital, Kanagawa, Japan
14Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan
15Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan

Tài liệu tham khảo

Jemal, 2011, Global cancer statistics, CA Cancer J Clin, 61, 69, 10.3322/caac.20107 Llovet, 2008, Sorafenib in advanced hepatocellular carcinoma, N Engl J Med, 359, 378, 10.1056/NEJMoa0708857 Cheng, 2009, Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial, Lancet Oncol, 10, 25, 10.1016/S1470-2045(08)70285-7 Llovet, 2014, Hepatocellular carcinoma: reasons for phase III failure and novel perspectives on trial design, Clin Cancer Res, 20, 2072, 10.1158/1078-0432.CCR-13-0547 Bruix, 2017, Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial, Lancet, 389, 56, 10.1016/S0140-6736(16)32453-9 Llovet, 2002, Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial, Lancet, 359, 1734, 10.1016/S0140-6736(02)08649-X Lo, 2002, Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma, Hepatology, 35, 1164, 10.1053/jhep.2002.33156 Takayasu, 2012, Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese guidelines, J Hepatol, 56, 886, 10.1016/j.jhep.2011.10.021 Lammer, 2010, Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study, Cardiovasc Intervent Radiol, 33, 41, 10.1007/s00270-009-9711-7 El-Assal, 1998, Clinical significance of microvessel density and vascular endothelial growth factor expression in hepatocellular carcinoma and surrounding liver: possible involvement of vascular endothelial growth factor in the angiogenesis of cirrhotic liver, Hepatology, 27, 1554, 10.1002/hep.510270613 Yamaguchi, 1998, Expression of vascular endothelial growth factor in human hepatocellular carcinoma, Hepatology, 28, 68, 10.1002/hep.510280111 Miura, 1997, Increased expression of vascular endothelial growth factor in human hepatocellular carcinoma, J Hepatol, 27, 854, 10.1016/S0168-8278(97)80323-6 Poon, 2003, Tissue factor expression correlates with tumor angiogenesis and invasiveness in human hepatocellular carcinoma, Clin Cancer Res, 9, 5339 Schmitt, 2004, Disruption of hepatocellular tight junctions by vascular endothelial growth factor (VEGF): a novel mechanism for tumor invasion, J Hepatol, 41, 274, 10.1016/j.jhep.2004.04.035 Suzuki, 1999, Serum vascular endothelial growth factor in the course of transcatheter arterial embolization of hepatocellular carcinoma, Int J Oncol, 14, 1087 Hsu, 2012, Perspectives on the design of clinical trials combining transarterial chemoembolization and molecular targeted therapy, Liver Cancer, 1, 168, 10.1159/000343830 Lencioni, 2016, Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: the SPACE trial, J Hepatol, 64, 1090, 10.1016/j.jhep.2016.01.012 Kudo, 2014, Brivanib as adjuvant therapy to transarterial chemoembolization in patients with hepatocellular carcinoma: a randomized phase III trial, Hepatology, 60, 1697, 10.1002/hep.27290 Meyer, 2017, Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial, Lancet Gastroenterol Hepatol, 2, 565, 10.1016/S2468-1253(17)30156-5 Laird, 2000, SU6668 is a potent antiangiogenic and antitumor agent that induces regression of established tumors, Cancer Res, 60, 4152 Solorzano, 2001, In vivo intracellular signaling as a marker of antiangiogenic activity, Cancer Res, 61, 7048 Kuenen, 2005, Dose-finding study of the multitargeted tyrosine kinase inhibitor SU6668 in patients with advanced malignancies, Clin Cancer Res, 11, 6240, 10.1158/1078-0432.CCR-04-2466 Kanai, 2011, A phase I/II trial of the oral antiangiogenic agent TSU-68 in patients with advanced hepatocellular carcinoma, Cancer Chemother Pharmacol, 67, 315, 10.1007/s00280-010-1320-2 Ikeda, 2014, Phase I study on the safety, pharmacokinetic profile, and efficacy of the combination of TSU-68, an oral antiangiogenic agent, and S-1 in patients with advanced hepatocellular carcinoma, Invest New Drugs, 32, 928, 10.1007/s10637-014-0109-2 Inaba, 2013, A randomised phase II study of TSU-68 in patients with hepatocellular carcinoma treated by transarterial chemoembolisation, Eur J Cancer, 49, 2832, 10.1016/j.ejca.2013.05.011 2012, EASL-EORTC Clinical Practice Guidelines: management of hepatocellular carcinoma, J Hepatol, 56, 908, 10.1016/j.jhep.2011.12.001 Bruix, 2011, Management of hepatocellular carcinoma: an update, Hepatology, 53, 1020, 10.1002/hep.24199 Cheng, 2014, Re-evaluating transarterial chemoembolization for the treatment of hepatocellular carcinoma: consensus recommendations and review by an International Expert Panel, Liver Int, 34, 174, 10.1111/liv.12314 Raoul, 2011, Evolving strategies for the management of intermediate-stage hepatocellular carcinoma: available evidence and expert opinion on the use of transarterial chemoembolization, Cancer Treat Rev, 37, 212, 10.1016/j.ctrv.2010.07.006 Marelli, 2007, Transarterial therapy for hepatocellular carcinoma: which technique is more effective? A systematic review of cohort and randomized studies, Cardiovasc Intervent Radiol, 30, 6, 10.1007/s00270-006-0062-3 Rini, 2008, Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma, J Clin Oncol, 26, 3743, 10.1200/JCO.2007.15.5416