Observational registry of sorafenib use in clinical practice across Child-Pugh subgroups: The GIDEON study

Journal of Hepatology - Tập 65 Số 6 - Trang 1140-1147 - 2016
Jorge A. Marrero1, Masatoshi Kudo2, Alan P. Venook3, Sheng-Long Ye4, Jean‐Pierre Bronowicki5, Xiao‐Ping Chen6, Lucy Dagher7, Junji Furuse8, Jean-François H. Geschwind9, Laura Ladrón de Guevara10, Christos N. Papandreou11, Tadatoshi Takayama12, Arun J. Sanyal13, Seung Kew Yoon14, Keiko Nakajima15, Robert Lehr16, Stephanie Heldner17, Riccardo Lencioni18
1Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA
2Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka, Japan
3Medical Oncology and Translational Research, University of California, San Francisco, CA, USA
4Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
5University Henri Poincaré by University of Lorraine, Nancy, France
6Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
7Policlínica Metropolitana, Caracas, Venezuela
8Kyorin University School of Medicine, Mitaka, Tokyo, Japan
9Vascular and Interventional Radiology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
10Hospital Angeles Clínica Londres, Mexico City, Mexico
11University Hospital of Larissa, Larissa, Greece
12Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan
13Virginia Commonwealth University Medical Center Richmond, VA, USA
14The Catholic University of Korea, Seoul, Republic of Korea
15Global Medical Affairs, Bayer HealthCare Pharmaceuticals, Inc., Montville, NJ, USA
16Clinical Statistics, Bayer HealthCare Pharmaceuticals, Inc., Montville, NJ, USA
17Global Medical Affairs and Pharmacovigilance, Bayer HealthCare Pharmaceuticals, Inc., Berlin, Germany
18Division of Diagnostic Imaging and Intervention, Pisa University Hospital and School of Medicine, Pisa, Italy

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Torre, 2015, Global cancer statistics, 2012, CA Cancer J Clin, 65, 87, 10.3322/caac.21262

Monsour, 2013, Hepatocellular carcinoma: the rising tide from east to west—review of epidemiology, screening and tumor markers, Transl Cancer Res, 2, 492

Singal, 2015, Hepatocellular carcinoma from epidemiology to prevention: translating knowledge into practice, Clin Gastroenterol Hepatol, 13, 2140, 10.1016/j.cgh.2015.08.014

Samuel, 2009, Neoadjuvant and adjuvant therapy for surgical resection of hepatocellular carcinoma, Cochrane Database Syst Rev, 10.1002/14651858.CD001199.pub2

Schlachterman, 2015, Current and future treatments for hepatocellular carcinoma, World J Gastroenterol, 21, 8478, 10.3748/wjg.v21.i28.8478

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

Bruix, 2011, Management of hepatocellular carcinoma: an update, Hepatology, 53, 1020, 10.1002/hep.24199

Peck-Radosavljevic, 2010, Consensus on the current use of sorafenib for the treatment of hepatocellular carcinoma, Eur J Gastroenterol Hepatol, 22, 391, 10.1097/MEG.0b013e328333df23

Lencioni, 2010, Design and rationale for the non-interventional Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib (GIDEON) study, Int J Clin Pract, 64, 1034, 10.1111/j.1742-1241.2010.02414.x

European Medicines Agency. EUDRALEX: The rules governing medicinal products in the European Union. Available from: http://ec.europa.eu/enterprise/newsroom/cf/itemdetail.cfm?&item_id=897. Accessed 5 November 2015.

Pugh, 1973, Transection of the oesophagus for bleeding oesophageal varices, Br J Surg, 60, 646, 10.1002/bjs.1800600817

Ozenne, 2010, Tolerance and outcome of patients with unresectable hepatocellular carcinoma treated with sorafenib, Eur J Gastroenterol Hepatol, 22, 1106, 10.1097/MEG.0b013e3283386053

Hollebecque, 2011, Safety and efficacy of sorafenib in hepatocellular carcinoma: the impact of the Child-Pugh score, Aliment Pharmacol Ther, 34, 1193, 10.1111/j.1365-2036.2011.04860.x

Kim, 2011, Sorafenib for hepatocellular carcinoma according to Child-Pugh class of liver function, Cancer Chemother Pharmacol, 68, 1285, 10.1007/s00280-011-1616-x

Al-Rajabi, 2015, Comparative dosing and efficacy of sorafenib in hepatocellular cancer patients with varying liver dysfunction, J Gastrointest Oncol, 6, 259

da Fonseca, 2015, Safety and efficacy of sorafenib in patients with Child-Pugh B advanced hepatocellular carcinoma, Mol Clin Oncol, 3, 793, 10.3892/mco.2015.536

Brose, 2014, Management of sorafenib-related adverse events: a clinician’s perspective, Semin Oncol, 41, S1, 10.1053/j.seminoncol.2014.01.001

Abou-Alfa, 2011, Safety and efficacy of sorafenib in patients with hepatocellular carcinoma (HCC) and Child-Pugh A vs. B cirrhosis, Gastrointest Cancer Res, 4, 40

Miller, 2009, Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301, J Clin Oncol, 27, 1800, 10.1200/JCO.2008.20.0931

Lettieri, 2011, Effect of hepatic impairment on sorafenib pharmacokinetics: results of a multicenter, open-label, single-dose, phase I trial, J Clin Oncol, 29, abs2580, 10.1200/jco.2011.29.15_suppl.2580

Mitchell DY, Prins K, Ploeger B, Grevel J, Lettieri J, Meinhardt G, et al. Impact of Child-Pugh status (A, B, or C) and duration of treatment on sorafenib exposure in patients with advanced hepatocellular carcinoma in the Phase IV HATT trial: a population pharmacokinetic analysis (abstract O-030). International Liver Cancer Association, Kyoto, Japan, 5–7 September, 2014.

Bayer Pharma AG. Nexavar® (sorafenib). Summary of product characteristics. Available from: http://www.nexavar.com/scripts/pages/en/home//pdf/Nexavar_SmPC_June_2014.pdf. Accessed 5 November 2015.

Pressiani, 2013, Sorafenib in patients with Child-Pugh class A and B advanced hepatocellular carcinoma: a prospective feasibility analysis, Ann Oncol, 24, 406, 10.1093/annonc/mds343

Di Marco, 2013, Sorafenib: from literature to clinical practice, Ann Oncol, 24, ii30, 10.1093/annonc/mdt055

Chiu, 2011, The use of single-agent sorafenib in the treatment of patients with advanced hepatocellular carcinoma with underlying Child-Pugh B liver cirrhosis, J Clin Oncol, 29, abs4083, 10.1200/jco.2011.29.15_suppl.4083

Ji, 2014, Sorafenib in liver function impaired advanced hepatocellular carcinoma, Chin Med Sci J, 29, 7, 10.1016/S1001-9294(14)60017-1

Johnson, 2015, Assessment of liver function in patients with hepatocellular carcinoma: a new evidence-based approach – the ALBI grade, J Clin Oncol, 33, 550, 10.1200/JCO.2014.57.9151

Otsuka, 2012, Skin toxicities and survival in advanced hepatocellular carcinoma patients treated with sorafenib, Hepatol Res, 42, 879, 10.1111/j.1872-034X.2012.00991.x

Shin, 2013, Correlation of skin toxicity and hypertension with clinical benefit in advanced hepatocellular carcinoma patients treated with sorafenib, Int J Clin Pharmacol Ther, 51, 837, 10.5414/CP201907

Shomura, 2014, Skin toxicity predicts efficacy to sorafenib in patients with advanced hepatocellular carcinoma, World J Hepatol, 6, 670, 10.4254/wjh.v6.i9.670

Bettinger, 2012, Diarrhea predicts a positive response to sorafenib in patients with advanced hepatocellular carcinoma, Hepatology, 56, 789, 10.1002/hep.25637