Regorafenib in advanced hepatocellular carcinoma (HCC): considerations for treatment

Kyung Kim1, Reena Jha2, Petra Prins1,3, Hongkun Wang4, Monica Chacha1, Marion L. Hartley5, Aiwu Ruth He5
1Georgetown University Hospital, Washington, DC, USA
2Department of Radiology, Georgetown University Hospital, Washington, DC, USA
3The Ruesch Center for the Cure of Gastrointestinal Cancers, Washington, DC, USA
4Georgetown University Hospital, 3800 Reservoir Road, N.W., Washington, DC, 20007, USA
5The Ruesch Center for the Cure of Gastrointestinal Cancers, 3800 Reservoir Road, Washington, DC, 20007, USA

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Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal JA (2015) Global cancer statistics, 2012. CA: A Cancer J Clin 65:87–108. doi: 10.3322/caac.21262

Llovet JM, Burroughs A, Bruix J (2003) Hepatocellular carcinoma. Lancet 362(9399):1907–1917. doi: 10.1016/S0140-6736(03)14964-1

Llovet JM, Ricci S, Mazzaferro V, SHARP Investigators Study Group et al (2008) Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 359(4):378–390. doi: 10.1056/NEJMoa0708857

Cheng AL, Kang YK, Chen Z et al (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(1):25–34. doi: 10.1016/S1470-2045(08)70285-7

Cheng AL, Kang YK, Lin DY et al (2013) Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol 31(32):4067–4075. doi: 10.1200/JCO.2012.45.8372

Johnson PJ, Qin S, Park JW et al (2013) Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol 31(28):3517–3524. doi: 10.1200/JCO.2012.48.4410

Cainap C, Qin S, Huang WT et al (2015) Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol 33(2):172–179. doi: 10.1200/JCO.2013.54.3298

Zhu AX, Rosmorduc O, Evans TR et al (2015) SEARCH: a phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with advanced hepatocellular carcinoma. J Clin Oncol 33(6):559–566. doi: 10.1200/JCO.2013.53.7746

Abou-Alfa GK, Niedzwieski D, Knox JJ et al (2016) Phase III randomized study of sorafenib plus doxorubicin versus sorafenib in patients with advanced hepatocellular carcinoma (HCC): CALGB 80802 (Alliance). J Clin Oncol 34(4S):192–192

Llovet JM, Decaens T, Raoul JL et al (2013) Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol 31:3509–3516. doi: 10.1200/JCO.2012.47.3009

Zhu AX, Kudo M, Assenat E et al (2014) Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial. JAMA 312:57–67. doi: 10.1001/jama.2014.7189

Zhu AX, Park JO, Ryoo BY et al (2015) Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomized, double-blind, multicentre, phase 3 trial. Lancet Oncol 16:859–870. doi: 10.1016/S1470-2045(15)00050-9

Bruix J, Qin S, Merle P et al (2017) Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet 389(10064):56–66. doi: 10.1016/S0140-6736(16)32453-9

Wilhelm SM, Dumas J, Adnane L et al (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(1):245–255. doi: 10.1002/ijc.25864

Lencioni R, Llovet JM (2010) Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis 30(1):52–60. doi: 10.1055/s-0030-1247132

Bruix J, Tak WY, Gasbarrini A et al (2013) Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study. Eur J Cancer 49(16):3412–3419. doi: 10.1016/j.ejca.2013.05.028

Drug safety labeling changes. US food and drug administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203085s007lbl.pdf . Accessed on 23 May 2017

Tabchi S, Ghosn M (2015) Regorafenib: start low and go slow. Target Oncol 10(3):445–447

de’ Angelis N, Landi F, Nencioni M et al (2016) Role of sorafenib in patients with recurrent hepatocellular carcinoma after liver transplantation. Prog Transplant 26(4):348–355. doi: 10.1177/1526924816664083

Staufer K, Fischer L, Seegers B, Vettorazzi E, Nashan B, Sterneck M (2012) High toxicity of sorafenib for recurrent hepatocellular carcinoma after liver transplantation. Transpl Int 25(11):1158–1164. doi: 10.1111/j.1432-2277.2012.01540.x

Ketter TA, Frye MA, Cora-Locatelli G, Kimbrell TA, Post RM (1999) Metabolism and excretion of mood stabilizers and new anticonvulsants. Cell Mol Neurobiol 19(4):511–514

Finn RS (2017) Outcomes with sorafenib (SOR) followed by regorafenib (REG) or placebo (PBO) for hepatocellular carcinoma (HCC): Results of the international, randomized phase 3 RESORCE trial. J Clin Oncol 35(4S):344–344. doi: 10.1200/JCO.2017.35.4_suppl.344

Belum VR, Wu S, Lacouture ME (2013) Risk of hand-foot skin reaction with the novel multikinase inhibitor regorafenib: a meta-analysis. Invest New Drugs 31(4):1078–1086. doi: 10.1007/s10637-013-9977-0

Grothey A, Sobrero AF, Siena S et al (2013) Time profile of adverse events (AEs) from regorafenib (REG) treatment for metastatic colorectal cancer (mCRC) in the phase III CORRECT study. J Clin Oncol 31:3637–3637. doi: 10.1200/jco.2013.31.15_suppl.3637

Mross K, Frost A, Steinbild S et al (2012) A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res 18(9):2658–2667. doi: 10.1158/1078-0432.CCR-11-1900

Ducreux M, Öhler L, Scheithauer W et al (2017) Safety and effectiveness of regorafenib (REG) in patients with metastatic colorectal cancer (mCRC) in routine clinical practice: an interim analysis (IA) from the prospective, observational CORRELATE study. J Clin Oncol 35(4S):700–700. doi: 10.1200/JCO.2017.35.4_suppl.700