Lenvatinib as a therapy for unresectable hepatocellular carcinoma

References

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2017. CA Cancer J Clin. 2017;67(1):7–30.
   PubMed Web of Science ®Google Scholar
• El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012;142(6):1264–1273 e1261.
   PubMed Web of Science ®Google Scholar
• Morgan TR, Mandayam S, Jamal MM. Alcohol and hepatocellular carcinoma. Gastroenterology. 2004;127(5 Suppl 1):S87–96.
   PubMed Web of Science ®Google Scholar
• Chang MH, You SL, Chen CJ, et al. Long-term effects of hepatitis B immunization of infants in preventing liver cancer. Gastroenterology. 2016;151(3):472–480 e471.
   PubMed Web of Science ®Google Scholar
• Morgan RL, Baack B, Smith BD, et al. Eradication of hepatitis C virus infection and the development of hepatocellular carcinoma: a meta-analysis of observational studies. Ann Intern Med. 2013;158(5 Pt 1):329–337.
   PubMed Web of Science ®Google Scholar
• Singal AG, Mittal S, Yerokun OA, et al. Hepatocellular carcinoma screening associated with early tumor detection and improved survival among patients with cirrhosis in the US. Am J Med. 2017;130(9):1099–1106 e1091.
   PubMed Web of Science ®Google Scholar
• Salem R, Gordon AC, Mouli S, et al. Y90 radioembolization significantly prolongs time to progression compared with chemoembolization in patients with hepatocellular carcinoma. Gastroenterology. 2016;151(6):1155–1163 e1152.
   PubMed Web of Science ®Google Scholar
• Kalogeridi MA, Zygogianni A, Kyrgias G, et al. Role of radiotherapy in the management of hepatocellular carcinoma: a systematic review. World J Hepatol. 2015;7(1):101–112.
   PubMedGoogle Scholar
• Brown KT, Do RK, Gonen M, et al. Randomized trial of hepatic artery embolization for hepatocellular carcinoma using doxorubicin-eluting microspheres compared with embolization with microspheres alone. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2016;34(17):2046–2053.
   PubMed Web of Science ®Google Scholar
• Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359(4):378–390.
   PubMed Web of Science ®Google Scholar
• Bruix J, Qin S, Merle P, et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389(10064):56–66.
   PubMed Web of Science ®Google Scholar
• Abou-Alfa GK, Meyer T, Cheng A-L, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med. 2018;379(1):54–63.
   PubMed Web of Science ®Google Scholar
• Kudo M, Finn RS, Qin S, et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018;391:1163-1173.
   PubMed Web of Science ®Google Scholar
• Cheng AL, Kang YK, 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(1):25–34.
   PubMed Web of Science ®Google Scholar
• Cheng AL, Kang YK, Lin DY, et al. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2013;31(32):4067–4075.
   PubMed Web of Science ®Google Scholar
• Johnson PJ, Qin S, Park JW, et al. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2013;31(28):3517–3524.
   PubMed Web of Science ®Google Scholar
• Cainap C, Qin S, Huang WT, et al. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2015;33(2):172–179.
   PubMed Web of Science ®Google Scholar
• Zhu AX, Rosmorduc O, Evans TR, et al. SEARCH: a phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with advanced hepatocellular carcinoma. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2015;33(6):559–566.
   PubMed Web of Science ®Google Scholar
• Chow PK, Gandhi M, Gebski V. The SIRveNIB and SARAH trials and the role of SIR-Spheres(R) Y-90 resin microspheres in the management of hepatocellular carcinoma. Future Oncology. 2017;13(25):2213–2216.
   PubMed Web of Science ®Google Scholar
• Sangro B, Gomez-Martin C, de la Mata M, et al. A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C. J Hepatol. 2013;59(1):81–88.
   PubMed Web of Science ®Google Scholar
• El-Khoueiry AB, Sangro B, Yau T, et al. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017;389(10088):2492–2502.
   PubMed Web of Science ®Google Scholar
• Yamamoto Y, Matsui J, Matsushima T, et al. Lenvatinib, an angiogenesis inhibitor targeting VEGFR/FGFR, shows broad antitumor activity in human tumor xenograft models associated with microvessel density and pericyte coverage. Vasc Cell. 2014;6:18.
   PubMedGoogle Scholar
• Yamada K, Yamamoto N, Yamada Y, et al. Phase I dose-escalation study and biomarker analysis of E7080 in patients with advanced solid tumors. Clin Cancer Res: J American Asso Cancer Research. 2011;17(8):2528–2537.
   PubMed Web of Science ®Google Scholar
• Shumaker R, Aluri J, Fan J, et al. Influence of hepatic impairment on lenvatinib pharmacokinetics following single-dose oral administration. J Clin Pharmacol. 2015;55(3):317–327.
   PubMed Web of Science ®Google Scholar
• Okamoto K, Ikemori-Kawada M, Jestel A, et al. Distinct binding mode of multikinase inhibitor lenvatinib revealed by biochemical characterization. ACS Med Chem Lett. 2015;6(1):89–94.
   PubMed Web of Science ®Google Scholar
• Koyama N, Saito K, Nishioka Y, et al. Pharmacodynamic change in plasma angiogenic proteins: a dose-escalation phase 1 study of the multi-kinase inhibitor lenvatinib. BMC Cancer. 2014;14:530.
   PubMed Web of Science ®Google Scholar
• Boss DS, Glen H, Beijnen JH, et al. A phase I study of E7080, a multitargeted tyrosine kinase inhibitor, in patients with advanced solid tumours. Br J Cancer. 2012;106(10):1598–1604.
   PubMed Web of Science ®Google Scholar
• Dubbelman AC, Rosing H, Thijssen B, et al. Development and validation of LC-MS/MS assays for the quantification of E7080 and metabolites in various human biological matrices. J Chromatogr B Analyt Technol Biomed Life Sci. 2012;887–888:25–34.
   PubMed Web of Science ®Google Scholar
• Dubbelman AC, Rosing H, Nijenhuis C, et al. Pharmacokinetics and excretion of (14)C-lenvatinib in patients with advanced solid tumors or lymphomas. Invest New Drugs. 2015;33(1):233–240.
   PubMed Web of Science ®Google Scholar
• Shumaker R, Aluri J, Fan J, et al. Effects of Ketoconazole on the pharmacokinetics of Lenvatinib (E7080) in healthy participants. Clini Pharma Drug Deve. 2015;4(2):155–160.
   PubMed Web of Science ®Google Scholar
• Shumaker RC, Aluri J, Fan J, et al. Effect of rifampicin on the pharmacokinetics of lenvatinib in healthy adults. Clin Drug Investig. 2014;34(9):651–659.
   PubMed Web of Science ®Google Scholar
• Gupta A, Jarzab B, Capdevila J, et al. Population pharmacokinetic analysis of lenvatinib in healthy subjects and patients with cancer. Br J Clin Pharmacol. 2016;81(6):1124–1133.
   PubMed Web of Science ®Google Scholar
• Ikeda M, Okusaka T, Mitsunaga S, et al. Safety and pharmacokinetics of Lenvatinib in patients with advanced hepatocellular carcinoma. Clin Cancer Res: J American Asso Cancer Research. 2016;22(6):1385–1394.
   PubMed Web of Science ®Google Scholar
• Ikeda K, Kudo M, Kawazoe S, et al. Phase 2 study of lenvatinib in patients with advanced hepatocellular carcinoma. J Gastroenterol. 2017;52(4):512–519.
   PubMed Web of Science ®Google Scholar
• Tamai T, Hayato S, Hojo S, et al. Dose finding of Lenvatinib in subjects with advanced hepatocellular carcinoma based on population pharmacokinetic and exposure-response analyses. J Clin Pharmacol. 2017;57(9):1138–1147.
   PubMed Web of Science ®Google Scholar
• Nakamichi S, Nokihara H, Yamamoto N, et al. A phase 1 study of lenvatinib, multiple receptor tyrosine kinase inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015;76(6):1153–1161.
   PubMed Web of Science ®Google Scholar
• Hong DS, Kurzrock R, Wheler JJ, et al. Phase I dose-escalation study of the multikinase inhibitor Lenvatinib in patients with advanced solid tumors and in an expanded cohort of patients with melanoma. Clin Cancer Res: J American Asso Cancer Research. 2015;21(21):4801–4810.
   PubMed Web of Science ®Google Scholar
• Furuse J, Ishii H, Nakachi K, et al. Phase I study of sorafenib in Japanese patients with hepatocellular carcinoma. Cancer Sci. 2008;99(1):159–165.
   PubMed Web of Science ®Google Scholar
• Abou-Alfa GK, Schwartz L, Ricci S, et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2006;24(26):4293–4300.
   PubMed Web of Science ®Google 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(6):1140–1147.
   PubMed Web of Science ®Google Scholar