Are we SHARP enough? The importance of adequate patient selection in sorafenib treatment for hepatocellular carcinoma

References

• Cheng A-L, Kang Y-K, Chen Z, et al. 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. 2009;10:25–34.
   PubMed Web of Science ®Google Scholar
• Llovet J, Ricci S, Mazzaferro V. Sorafenib in advanced hepatocellular carcinoma N Engl J Med. 2008;359:378–390.
   Web of Science ®Google Scholar
• EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012;56:908–943.
   PubMed Web of Science ®Google Scholar
• Bruix J, Sherman M. Management of hepatocellular carcinoma: an update. Hepatology. 2011;53:1020–1022.
   PubMed Web of Science ®Google Scholar
• Bayer Schering Pharma AG. EU Summary of Product Characteristics for Nexavar, 21 July 2011, Germany.
   Google Scholar
• Bruix J, Reig M, Sherman M. Evidence-based diagnosis, staging, and treatment of patients with hepatocellular carcinoma. Gastroenterology. 2016;150:835–853.
   PubMed Web of Science ®Google Scholar
• Abou-Alfa GK, Amadori D, Santoro A, et al. Safety and efficacy of sorafenib in patients with hepatocellular carcinoma (HCC) and Child-Pugh A versus B cirrhosis. Gastrointest Cancer Res. 2011;4:40–44.
   PubMedGoogle Scholar
• Edeline J, Blanc JF, Johnson P, et al. A multicentre comparison between Child Pugh and albumin-bilirubin scores in patients treated with sorafenib for hepatocellular carcinoma. Liver Int. 2016;36:1821–1828.
   PubMed Web of Science ®Google Scholar
• Hollebecque A, Cattan S, Romano O, et al. Safety and efficacy of sorafenib in hepatocellular carcinoma: the impact of the Child-Pugh score. Aliment Pharmacol Ther. 2011;34:1193–1201.
   PubMed Web of Science ®Google Scholar
• Iavarone M, Cabibbo G, Piscaglia F, et al. Field-practice study of sorafenib therapy for hepatocellular carcinoma: a prospective multicenter study in Italy. Hepatology. 2011;54:2055–2063.
   PubMed Web of Science ®Google Scholar
• DAF LG, Barroso-Sousa R, Bento AD, et al. Safety and efficacy of sorafenib in patients with Child-Pugh B advanced hepatocellular carcinoma. Mol Clin Oncol. 2015;3:793–796.
   PubMedGoogle Scholar
• Marrero JA, Kudo M, Venook AP, et al. Observational registry of sorafenib use in clinical practice across Child-Pugh subgroups: the GIDEON study. J Hepatol. 2016;65:1140–1147.
   PubMed Web of Science ®Google Scholar
• Ogasawara S, Chiba T, Ooka Y, et al. Sorafenib treatment in Child-Pugh A and B patients with advanced hepatocellular carcinoma: safety, efficacy and prognostic factors. Invest New Drugs. 2015;33:729–739.
   PubMed Web of Science ®Google Scholar
• Pinter M, Sieghart W, Graziadei I, et al. Sorafenib in unresectable hepatocellular carcinoma from mild to advanced stage liver cirrhosis. Oncologist. 2009;14:70–76.
   PubMed Web of Science ®Google Scholar
• Pressiani T, Boni C, Rimassa L, et al. Sorafenib in patients with Child-Pugh class A and B advanced hepatocellular carcinoma: a prospective feasibility analysis. Ann Oncol. 2013;24:406–411.
   PubMed Web of Science ®Google Scholar
• Worns MA, Weinmann A, Pfingst K, et al. Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma in consideration of concomitant stage of liver cirrhosis. J Clin Gastroenterol. 2009;43:489–495.
   PubMed Web of Science ®Google Scholar
• Mol L, Koopman M, van Gils CW, et al. Comparison of treatment outcome in metastatic colorectal cancer patients included in a clinical trial versus daily practice in the Netherlands. Acta Oncol. 2013;52:950.
   PubMed Web of Science ®Google Scholar
• Templeton AJ, Vera-Badillo FE, Wang L, et al. Translating clinical trials to clinical practice: outcomes of men with metastatic castration resistant prostate cancer treated with docetaxel and prednisone in and out of clinical trials. Ann Oncol. 2013;24:2972–2977.
   PubMed Web of Science ®Google Scholar
• Dierks J, Gaspersz MP, Belkouz A, et al. Translating the ABC-02 trial into daily practice: outcome of palliative treatment in patients with unresectable biliary tract cancer treated with gemcitabine and cisplatin. Acta Oncol. 2018;57:807–812.
   PubMed Web of Science ®Google Scholar
• Evaluation of sorafenib in combination with local micro-therapy guided by Gd-EOB-DTPA enhanced MRI in patients with inoperable hepatocellular carcinoma. J Clin Oncol. 2011;29:28023040.
   Web of Science ®Google Scholar
• Bruix J, Sherman M. Management of hepatocellular carcinoma. Hepatology. 2005;42:1208–1236.
   PubMed Web of Science ®Google Scholar
• Mittal S, El-Serag HB, Sada YH, et al. Hepatocellular carcinoma in the absence of cirrhosis in United States veterans is associated with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2016;14:124–131.e1.
   PubMed Web of Science ®Google Scholar
• Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–216.
   PubMed Web of Science ®Google Scholar
• Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. US Department of Health and Human Services, 2010 [cited2018Jun7]. Available from: https://evs.nci.nih.gov/ftp1/CTCAE/About.html
   Google Scholar
• Cabibbo G, Enea M, Attanasio M, et al. A meta-analysis of survival rates of untreated patients in randomized clinical trials of hepatocellular carcinoma. Hepatology. 2010;51:1274–1283.
   PubMed Web of Science ®Google Scholar
• Sorafenib in first-line treatment of advanced B Child Hepatocellular Carcinoma (BOOST) [Internet]. U.S. National Library of Medicine (NLM) at the National Institutes of Health (NIH); [cited 2018 Jun 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT01405573?term=Boost+trial+HCC&rank=1
   Google Scholar
• Camma C, Cabibbo G, Petta S, et al. Cost-effectiveness of sorafenib treatment in field practice for patients with hepatocellular carcinoma. Hepatology. 2013;57:1046–1054.
   PubMed Web of Science ®Google Scholar
• Parikh ND, Marshall VD, Singal AG, et al. Survival and cost-effectiveness of sorafenib therapy in advanced hepatocellular carcinoma: an analysis of the SEER-Medicare database. Hepatology. 2017;65:122–133.
   PubMed Web of Science ®Google Scholar
• Johnson PJ, Berhane S, Kagebayashi C, et al. Assessment of liver function in patients with hepatocellular carcinoma: a new evidence-based approach-the ALBI grade. J Clin Oncol. 2015;33:550–558.
   PubMed Web of Science ®Google Scholar