Clinical Features of Regorafenib-induced Liver Injury in Japanese Patients From Postmarketing Experience

Wilhelm, 2011, Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity, Int J Cancer, 129, 245, 10.1002/ijc.25864 Grothey, 2013, Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial, Lancet, 381, 303, 10.1016/S0140-6736(12)61900-X Yoshino, 2015, Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations, Invest New Drugs, 33, 740, 10.1007/s10637-014-0154-x European Medicines Agency Srivastava, 2010, Role of reactive metabolites in drug-induced hepatotoxicity, Handb Exp Pharmacol, 196, 165, 10.1007/978-3-642-00663-0_7 Han, 2010, Signal transduction pathways involved in drug-induced liver injury, Handb Exp Pharmacol, 196, 267, 10.1007/978-3-642-00663-0_10 Pessayre, 2012, Central role of mitochondria in drug-induced liver injury, Drug Metab Rev, 44, 34, 10.3109/03602532.2011.604086 Shah, 2013, Hepatotoxicity of tyrosine kinase inhibitors: clinical and regulatory perspectives, Drug Saf, 36, 491, 10.1007/s40264-013-0048-4 Rauben, 2004, Hy's law, Hepatology, 39, 574, 10.1002/hep.20081 US Food and Drug Administration International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2014 Food and Drug Administration Abboud, 2007, Drug-induced liver injury, Drug Saf, 30, 277, 10.2165/00002018-200730040-00001 2009 Bernstein, 1998, Fulminant hepatic failure, Crit Care Clin, 14, 181, 10.1016/S0749-0704(05)70391-2 Sunakawa, 2014, Regorafenib in Japanese patients with solid tumors: phase I study of safety, efficacy, and pharmacokinetics, Invest New Drugs, 32, 104, 10.1007/s10637-013-9953-8 Health Canada Takikawa, 2005, A proposal of the diagnostic scale of drug-induced liver injury, Hepatol Res, 32, 250, 10.1016/j.hepres.2005.05.007 Takikawa, 2009, Recent status of drug-induced liver injury, Hepatol Res, 39, 1, 10.1111/j.1872-034X.2008.00400.x Danan, 1993, Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries, J Clin Epidemiol, 46, 1323, 10.1016/0895-4356(93)90101-6 Benicho, 1993, Causality assessment of adverse reactions to drugs—II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge, J Clin Epidemiol, 46, 1331, 10.1016/0895-4356(93)90102-7 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 Powles, 2015, Characterisation of liver chemistry abnormalities associated with pazopanib monotherapy: a systematic review and meta-analysis of clinical trials in advanced cancer patients, Eur J Cancer, 51, 1293, 10.1016/j.ejca.2015.03.019 Toffoli, 2006, The role of UGT1A1*28 polymorphism in the pharmacodynamics and pharmacokinetics of irinotecan in patients with metastatic colorectal cancer, J Clin Oncol, 24, 3061, 10.1200/JCO.2005.05.5400 Spraggs, 2011, HLA-DQA1*02:01 is a major risk factor for lapatinib-induced hepatotoxicity in women with advanced breast cancer, J Clin Oncol, 29, 667, 10.1200/JCO.2010.31.3197