352
Views
3
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

Clinical Efficacy and Safety of an Immune Checkpoint Inhibitor in Combination with Regorafenib Therapy as Second-Line Regimen for Patients with Unresectable Hepatocellular Carcinoma

, , , &
Pages 329-339 | Received 09 Dec 2022, Accepted 19 Mar 2023, Published online: 05 Apr 2023

References

  • Rimassa L, Wörns M-A. Navigating the new landscape of second-line treatment in advanced hepatocellular carcinoma. Liver Int. 2020;40:1800–1811.
  • Llovet JM, Ricci S, Mazzaferro V, et al; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359(4):378–390. doi:10.1056/NEJMoa0708857
  • 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(10126):1163–1173. doi:10.1016/S0140-6736(18)30207-1
  • 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. doi:10.1016/S0140-6736(16)32453-9
  • Elseud YA, Shaaban A, Mohanty A, Albarrak J. Safety and tolerability of regorafenib: a real-life experience. J Gastrointest Cancer. 2022;53(1):187–191. doi:10.1007/s12029-020-00570-1
  • Lee MJ, Chang SW, Kim JH, et al. Real-world systemic sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Korea. Invest New Drugs. 2021;39(1):260–268. doi:10.1007/s10637-020-00977-4
  • Vogel A, Cervantes A, Chau I, et al. Hepatocellular carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29:iv238–iv255. doi:10.1093/annonc/mdy308
  • Bruix J, Chan SL, Galle PR, Rimassa L, Sangro B. Systemic treatment of hepatocellular carcinoma: an EASL position paper. J Hepatol. 2021;75:960–974. doi:10.1016/j.jhep.2021.07.004
  • Shigeta K, Matsui A, Kikuchi H, et al. Regorafenib combined with PD1 blockade increases CD8 T-cell infiltration by inducing CXCL10 expression in hepatocellular carcinoma. J Immunother Cancer. 2020;8(2):e001435. doi:10.1136/jitc-2020-001435
  • Tai WT, Chu PY, Shiau CW, et al. STAT3 mediates regorafenib-induced apoptosis in hepatocellular carcinoma. Clin Cancer Res. 2014;20(22):5768–5776. doi:10.1158/1078-0432.CCR-14-0725
  • Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247. doi:10.1016/j.ejca.2008.10.026
  • Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010;30(1):52–60. doi:10.1055/s-0030-1247132
  • National Cancer Institute. Common terminology criteria for adverse events, version 5.0; 2017.
  • Qin S, Bi F, Gu S, et al. Donafenib versus sorafenib in first-line treatment of unresectable or metastatic hepatocellular carcinoma: a randomized, open-label, parallel-controlled Phase II–III trial. J Clin Oncol. 2021;39(27):3002–3011. doi:10.1200/JCO.21.00163
  • Liu Z, Lin Y, Zhang J, et al. Molecular targeted and immune checkpoint therapy for advanced hepatocellular carcinoma. J Exp Clin Cancer Res. 2019;38(1):447. doi:10.1186/s13046-019-1412-8
  • El-Khoueiry AB, Sangro B, Yau T, et al. Nivolumab in patients with advanced hepatocel-lular carcinoma (CheckMate 040): an open-label, non- comparative, Phase 1/2 dose escalation and expansion trial. Lancet. 2017;389(10088):2492–2502. doi:10.1016/S0140-6736(17)31046-2
  • Zhu AX, Finn RS, Edeline J, et al. Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): anon-randomised, open-label Phase 2 trial. Lancet Oncol. 2018;19:940–952. doi:10.1016/S1470-2045(18)30351-6
  • Finn RS, Qin S, Ikeda M, et al. Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. N Engl J Med. 2020;382(20):1894–1905. doi:10.1056/NEJMoa1915745
  • Finn RS, Ikeda M, Zhu AX, et al. Phase ib study of lenvatinib plus pembrolizumab in patients with unresectable hepatocellular carcinoma. J Clin Oncol. 2020;8(26):2960–2970. doi:10.1200/JCO.20.00808
  • Mei K, Qin S, Chen Z, Liu Y, Wang L, Zou J. Camrelizumab in combination with apatinib in second-line or above therapy for advanced primary liver cancer: cohort a report in a multicenter phase Ib/II trial. J Immunother Cancer. 2021;9(3):e002191. doi:10.1136/jitc-2020-002191
  • Aspriţoiu VM, Stoica I, Bleotu C, Diaconu CC. Epigenetic regulation of angiogenesis in development and tumors progression: potential implications for cancer treatment. Front Cell Dev Biol. 2021;9:689962. doi:10.3389/fcell.2021.689962
  • Xu F, Jin T, Zhu Y, Dai C. Immune checkpoint therapy in liver cancer. J Exp Clin Cancer Res. 2018;37(1):110. doi:10.1186/s13046-018-0777-4
  • Gabrilovich DI, Nagaraj S. Myeloid-derived suppressor cells as regulators of the immune system. Nat Rev Immunol. 2009;9(3):162–174. doi:10.1038/nri2506
  • Wang YK, Bi XY, Li ZY, et al. A new prognostic score system of hepatocellular carcinoma following hepatectomy. Zhonghua Zhong Liu Za Zhi. 2017;39:903–909. doi:10.3760/cma.j.issn.0253-3766.2017.12.005
  • Samstein RM, Lee C-H, Shoushtari AN, et al. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nat Genet. 2019;51:202–206. doi:10.1038/s41588-018-0312-8
  • Kim HD, Bang Y, Lee MA, et al. Regorafenib in patients with advanced Child-Pugh B hepatocellular carcinoma: a multicentre retrospective study. Liver Int. 2020;40(10):2544–2552. doi:10.1111/liv.14573
  • Casadei Gardini A, Frassineti GL, Foschi FG, et al. Sorafenib and regorafenib in HBV- or HCV-positive hepatocellular carcinoma patients: analysis of RESORCE and SHARP trials. Dig Liver Dis. 2017;49(8):943–944. doi:10.1016/j.dld.2017.04.022
  • Kudo M, Matilla A, Santoro A, et al. CheckMate 040 cohort 5: a phase I/II study of nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh B cirrhosis. J Hepatol. 2021;75(3):600–609. doi:10.1016/j.jhep.2021.04.047
  • Huang J, Guo Y, Huang W, et al. Regorafenib combined with PD-1 blockade immunotherapy versus regorafenib as second-line treatment for advanced hepatocellular carcinoma: a multicenter retrospective study. J Hepatocell Carcinoma. 2022;9:157–170. doi:10.2147/JHC.S353956
  • Yoo C, Park JW, Kim YJ, et al. Multicenter retrospective analysis of the safety and efficacy of regorafenib after progression on sorafenib in Korean patients with hepatocellular carcinoma. Invest New Drugs. 2019;37:567–572. doi:10.1007/s10637-018-0707-5
  • Ogasawara S, Ooka Y, Itokawa N, et al. Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan. Invest New Drugs. 2020;38:172–180. doi:10.1007/s10637-019-00801-8
  • Ren Z, Xu J, Bai Y, et al; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2–3 study. Lancet Oncol. 2021;22(7):977–990. doi:10.1016/S1470-2045(21)00252-7