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Volumn 24, Issue 19, 2018, Pages 4650-4661

Phase II studies with refametinib or refametinib plus sorafenib in patients with RAS-mutated hepatocellular Carcinoma

(27)  Lim, Ho Yeong a,ac   Merle, Philippe b   Weiss, Karl Heinz c   Yau, Thomas d   Ross, Paul e   Mazzaferro, Vincenzo f   Blanc, Jean Fredèric g   Ma, Yuk Ting h   Yen, Chia Jui i   Kocsis, Judit j   Choo, Su Pin k   Sukeepaisarnjaroen, Wattana l   Gerolami, Rene m   Dufour, Jean François n   Gane, Edward J o   Ryoo, Baek Yeol p   Peck Radosavljevic, Markus q,ab   Dao, Thong r   Yeo, Winnie s   Lamlertthon, Wisut t   more..


Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BETA CATENIN; CIRCULATING TUMOR DNA; CTNNB1 PROTEIN, HUMAN; DIPHENYLAMINE; MITOGEN ACTIVATED PROTEIN KINASE KINASE KINASE; N-(3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)-6-METHOXYPHENYL)-1-(2,3-DIHYDROXYPROPYL)CYCLOPROPANE-1-SULFONAMIDE; PROTEIN KINASE INHIBITOR; PROTEIN P53; RAS PROTEIN; SORAFENIB; SULFONAMIDE; TELOMERASE; TERT PROTEIN, HUMAN; TP53 PROTEIN, HUMAN;

EID: 85053740236     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-17-3588     Document Type: Article
Times cited : (65)

References (42)
  • 3
    • 84858658381 scopus 로고    scopus 로고
    • EASL-EORTC clinical practice guidelines: Management of hepatocellular carcinoma
    • European Association for the Study of the Liver, European Organisation for Research and Treatment of Cancer
    • European Association for the Study of the Liver, European Organisation for Research and Treatment of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol 2012; 56:908-43.
    • (2012) J Hepatol , vol.56 , pp. 908-943
  • 4
    • 84984586846 scopus 로고    scopus 로고
    • Asian pacific association for the study of the liver consensus recommendations on hepatocellular carcinoma
    • Omata M, Lesmana LA, Tateishi R, Chen PJ, Lin SM, Yoshida H, et al. Asian Pacific Association for the Study of the Liver consensus recommendations on hepatocellular carcinoma. Hepatol Int 2010;4:439-74.
    • (2010) Hepatol Int , vol.4 , pp. 439-474
    • Omata, M.1    Lesmana, L.A.2    Tateishi, R.3    Chen, P.J.4    Lin, S.M.5    Yoshida, H.6
  • 5
    • 79952231921 scopus 로고    scopus 로고
    • Management of hepatocellular carcinoma: An update
    • Bruix J, Sherman M. Management of hepatocellular carcinoma: an update. Hepatology 2011;53:1020-2.
    • (2011) Hepatology , vol.53 , pp. 1020-1022
    • Bruix, J.1    Sherman, M.2
  • 6
    • 85042855944 scopus 로고    scopus 로고
    • Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: A randomised phase 3 non-inferiority trial
    • Epub ahead of print
    • Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet 2018;[Epub ahead of print].
    • (2018) Lancet
    • Kudo, M.1    Finn, R.S.2    Qin, S.3    Han, K.H.4    Ikeda, K.5    Piscaglia, F.6
  • 7
    • 85007560261 scopus 로고    scopus 로고
    • Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): A randomised, double-blind, placebo-controlled, phase 3 trial
    • Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, 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;389:56-66.
    • (2017) Lancet , vol.389 , pp. 56-66
    • Bruix, J.1    Qin, S.2    Merle, P.3    Granito, A.4    Huang, Y.H.5    Bodoky, G.6
  • 8
    • 85042883711 scopus 로고    scopus 로고
    • Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: Results from the randomized phase III CELESTIAL trial
    • abstr
    • Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, et al. Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: results from the randomized phase III CELESTIAL trial. J Clin Oncol 2018;36:abstr 207.
    • (2018) J Clin Oncol , vol.36 , pp. 207
    • Abou-Alfa, G.K.1    Meyer, T.2    Cheng, A.L.3    El-Khoueiry, A.B.4    Rimassa, L.5    Ryoo, B.Y.6
  • 9
    • 85018660134 scopus 로고    scopus 로고
    • Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): An open-label, non-comparative, phase 1/2 dose escalation and expansion trial
    • El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, 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;389:2492-502.
    • (2017) Lancet , vol.389 , pp. 2492-2502
    • El-Khoueiry, A.B.1    Sangro, B.2    Yau, T.3    Crocenzi, T.S.4    Kudo, M.5    Hsu, C.6
  • 10
    • 84937523736 scopus 로고    scopus 로고
    • Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): A randomised, double-blind, multicentre, phase 3 trial
    • Zhu AX, Park JO, Ryoo BY, Yen CJ, Poon R, Pastorelli D, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol 2015;16:859-70.
    • (2015) Lancet Oncol , vol.16 , pp. 859-870
    • Zhu, A.X.1    Park, J.O.2    Ryoo, B.Y.3    Yen, C.J.4    Poon, R.5    Pastorelli, D.6
  • 11
    • 70149119899 scopus 로고    scopus 로고
    • RDEA119/BAY 869766: A potent, selective, allosteric inhibitor of MEK1/ 2 for the treatment of cancer
    • Iverson C, Larson G, Lai C, Yeh LT, Dadson C, Weingarten P, et al. RDEA119/BAY 869766: a potent, selective, allosteric inhibitor of MEK1/ 2 for the treatment of cancer. Cancer Res 2009;69:6839-47.
    • (2009) Cancer Res , vol.69 , pp. 6839-6847
    • Iverson, C.1    Larson, G.2    Lai, C.3    Yeh, L.T.4    Dadson, C.5    Weingarten, P.6
  • 12
    • 84968719045 scopus 로고    scopus 로고
    • A Phase I study of the safety, pharmacokinetics, and pharmacodynamics of combination therapy with refametinib plus sorafenib in patients with advanced cancer
    • Adjei AA, Richards DA, El-Khoueiry A, Braiteh F, Becerra CHR, Stephenson JJ, et al. A Phase I study of the safety, pharmacokinetics, and pharmacodynamics of combination therapy with refametinib plus sorafenib in patients with advanced cancer. Clin Cancer Res 2016;22:2368-76.
    • (2016) Clin Cancer Res , vol.22 , pp. 2368-2376
    • Adjei, A.A.1    Richards, D.A.2    El-Khoueiry, A.3    Braiteh, F.4    Becerra, C.H.R.5    Stephenson, J.J.6
  • 13
    • 84938055998 scopus 로고    scopus 로고
    • Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: A retrospective, exploratory analysis of the CORRECT trial
    • Tabernero J, Lenz HJ, Siena S, Sobrero A, Falcone A, Ychou M, et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol 2015;16:937-48.
    • (2015) Lancet Oncol , vol.16 , pp. 937-948
    • Tabernero, J.1    Lenz, H.J.2    Siena, S.3    Sobrero, A.4    Falcone, A.5    Ychou, M.6
  • 14
    • 84898476658 scopus 로고    scopus 로고
    • Clinical validation of the detection of KRAS and BRAF mutations from circulating tumor DNA
    • Thierry AR, Mouliere F, El Messaoudi S, Mollevi C, Lopez-Crapez E, Rolet F, et al. Clinical validation of the detection of KRAS and BRAF mutations from circulating tumor DNA. Nat Med 2014;20:430-5.
    • (2014) Nat Med , vol.20 , pp. 430-435
    • Thierry, A.R.1    Mouliere, F.2    El Messaoudi, S.3    Mollevi, C.4    Lopez-Crapez, E.5    Rolet, F.6
  • 16
  • 17
    • 84918777261 scopus 로고    scopus 로고
    • A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma
    • Lim HY, Heo J, Choi HJ, Lin CY, Yoon JH, Hsu C, et al. A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. Clin Cancer Res 2014;20:5976-85.
    • (2014) Clin Cancer Res , vol.20 , pp. 5976-5985
    • Lim, H.Y.1    Heo, J.2    Choi, H.J.3    Lin, C.Y.4    Yoon, J.H.5    Hsu, C.6
  • 18
    • 77349102071 scopus 로고    scopus 로고
    • Modified RECIST (mRECIST) assessment for hepatocellular carcinoma
    • Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis 2010;30:52-60.
    • (2010) Semin Liver Dis , vol.30 , pp. 52-60
    • Lencioni, R.1    Llovet, J.M.2
  • 21
    • 84924283696 scopus 로고    scopus 로고
    • Tumour pharmacodynamics and circulating cell free DNA in patients with refractory colorectal carcinoma treated with regorafenib
    • Wong ALA, Lim JSJ, Sinha A, Gopinathan A, Lim R, Tan CS, et al. Tumour pharmacodynamics and circulating cell free DNA in patients with refractory colorectal carcinoma treated with regorafenib. J Transl Med 2015; 13:57.
    • (2015) J Transl Med , vol.13 , pp. 57
    • Wong, A.L.A.1    Lim, J.S.J.2    Sinha, A.3    Gopinathan, A.4    Lim, R.5    Tan, C.S.6
  • 22
    • 84904258206 scopus 로고    scopus 로고
    • Mutation analysis of key genes in RAS/RAF and PI3K/PTEN pathways in Chinese patients with hepatocellular carcinoma
    • Hou W, Liu J, Chen P, Wang H, Ye BC, Qiang F. Mutation analysis of key genes in RAS/RAF and PI3K/PTEN pathways in Chinese patients with hepatocellular carcinoma. Oncol Lett 2014;8:1249-54.
    • (2014) Oncol Lett , vol.8 , pp. 1249-1254
    • Hou, W.1    Liu, J.2    Chen, P.3    Wang, H.4    Ye, B.C.5    Qiang, F.6
  • 23
    • 85054421926 scopus 로고    scopus 로고
    • Prevalence of K-Ras mutations in hepatocellular carcinoma: A Turkish oncology group pilot study
    • Turhal NS, Savaş B, Coşkun O, Baş E, Karabulut B, Nart D, et al. Prevalence of K-Ras mutations in hepatocellular carcinoma: a Turkish oncology group pilot study. Mol Clin Oncol 2015;3:1275-9.
    • (2015) Mol Clin Oncol , vol.3 , pp. 1275-1279
    • Turhal, N.S.1    Savaş, B.2    Coşkun, O.3    Baş, E.4    Karabulut, B.5    Nart, D.6
  • 24
    • 84966747233 scopus 로고    scopus 로고
    • Molecular alterations in hepatocellular carcinoma associated with hepatitis B and hepatitis C infections
    • Tornesello ML, Buonaguro L, Izzo F, Buonaguro FM. Molecular alterations in hepatocellular carcinoma associated with hepatitis B and hepatitis C infections. Oncotarget 2016;7:25087-102.
    • (2016) Oncotarget , vol.7 , pp. 25087-25102
    • Tornesello, M.L.1    Buonaguro, L.2    Izzo, F.3    Buonaguro, F.M.4
  • 25
    • 84895901513 scopus 로고    scopus 로고
    • Liver cancer in 2013: Mutational landscape of HCC - The end of the beginning
    • Villanueva A, Llovet JM. Liver cancer in 2013: mutational landscape of HCC - the end of the beginning. Nat Rev Clin Oncol 2014;11:73-4.
    • (2014) Nat Rev Clin Oncol , vol.11 , pp. 73-74
    • Villanueva, A.1    Llovet, J.M.2
  • 26
    • 84875211731 scopus 로고    scopus 로고
    • Cancer heterogeneity: Implications for targeted therapeutics
    • Fisher R, Pusztai L, Swanton C. Cancer heterogeneity: implications for targeted therapeutics. Br J Cancer 2013;108:479-85.
    • (2013) Br J Cancer , vol.108 , pp. 479-485
    • Fisher, R.1    Pusztai, L.2    Swanton, C.3
  • 27
    • 84885587718 scopus 로고    scopus 로고
    • 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
    • Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, et al. 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 2013;31:3509-16.
    • (2013) J Clin Oncol , vol.31 , pp. 3509-3516
    • Llovet, J.M.1    Decaens, T.2    Raoul, J.L.3    Boucher, E.4    Kudo, M.5    Chang, C.6
  • 28
    • 85010444964 scopus 로고    scopus 로고
    • Efficacy and safety of regorafenib versus placebo in patients with hepatocellular carcinoma (HCC) progressing on sorafenib: Results of the international, randomized phase 3 RESORCE trial
    • Bruix J, Merle P, Granito A, Huang YH, Bodoky G, Yokosuka O, et al. Efficacy and safety of regorafenib versus placebo in patients with hepatocellular carcinoma (HCC) progressing on sorafenib: results of the international, randomized phase 3 RESORCE trial. Ann Oncol 2016; 27:ii140-ii1.
    • (2016) Ann Oncol , vol.27 , pp. ii140-ii141
    • Bruix, J.1    Merle, P.2    Granito, A.3    Huang, Y.H.4    Bodoky, G.5    Yokosuka, O.6
  • 30
    • 79960051265 scopus 로고    scopus 로고
    • Therapeutic strategies for targeting ras proteins
    • Gysin S, Salt M, Young A, McCormick F. Therapeutic strategies for targeting ras proteins. Genes Cancer 2011;2:359-72.
    • (2011) Genes Cancer , vol.2 , pp. 359-372
    • Gysin, S.1    Salt, M.2    Young, A.3    McCormick, F.4
  • 31
    • 84865717657 scopus 로고    scopus 로고
    • Safety, pharmacokinetics, and pharmacodynamics results from a phase I trial of BAY 86-9766 (RDEA119), a MEK inhibitor, in patients with advanced cancer
    • Gore L, Lewis K, Von Hoff DD, Weiss GJ, Ramanathan RK, Adjei AA, et al. Safety, pharmacokinetics, and pharmacodynamics results from a phase I trial of BAY 86-9766 (RDEA119), a MEK inhibitor, in patients with advanced cancer. J Clin Oncol (Meeting Abstracts). 2011;29.
    • (2011) J Clin Oncol (Meeting Abstracts) , vol.29
    • Gore, L.1    Lewis, K.2    Von Hoff, D.D.3    Weiss, G.J.4    Ramanathan, R.K.5    Adjei, A.A.6
  • 33
    • 84903537320 scopus 로고    scopus 로고
    • The clinical development of MEK inhibitors
    • Zhao Y, Adjei AA. The clinical development of MEK inhibitors. Nat Rev Clin Oncol 2014;11:385-400.
    • (2014) Nat Rev Clin Oncol , vol.11 , pp. 385-400
    • Zhao, Y.1    Adjei, A.A.2
  • 34
    • 84865749357 scopus 로고    scopus 로고
    • First-in-human, phase I dose-escalation study of the safety, pharmacokinetics, and pharmacodynamics of RO5126766, a first-in-class dual MEK/RAF inhibitor in patients with solid tumors
    • Martinez-Garcia M, Banerji U, Albanell J, Bahleda R, Dolly S, Kraeber-Bodere F, et al. First-in-human, phase I dose-escalation study of the safety, pharmacokinetics, and pharmacodynamics of RO5126766, a first-in-class dual MEK/RAF inhibitor in patients with solid tumors. Clin Cancer Res 2012;18:4806-19.
    • (2012) Clin Cancer Res , vol.18 , pp. 4806-4819
    • Martinez-Garcia, M.1    Banerji, U.2    Albanell, J.3    Bahleda, R.4    Dolly, S.5    Kraeber-Bodere, F.6
  • 35
    • 84995810964 scopus 로고    scopus 로고
    • Role of transarterial chemoembolization in relation with sorafenib for patients with advanced hepatocellular carcinoma
    • Ha Y, Lee D, Shim JH, Lim YS, Lee HC, Chung YH, et al. Role of transarterial chemoembolization in relation with sorafenib for patients with advanced hepatocellular carcinoma. Oncotarget 2016;7:74303-13.
    • (2016) Oncotarget , vol.7 , pp. 74303-74313
    • Ha, Y.1    Lee, D.2    Shim, J.H.3    Lim, Y.S.4    Lee, H.C.5    Chung, Y.H.6
  • 36
    • 84929129284 scopus 로고    scopus 로고
    • Exome sequencing of hepatocellular carcinomas identifies new mutational signatures and potential therapeutic targets
    • Schulze K, Imbeaud S, Letouze E, Alexandrov LB, Calderaro J, Rebouissou S, et al. Exome sequencing of hepatocellular carcinomas identifies new mutational signatures and potential therapeutic targets. Nat Genet 2015; 47:505-11.
    • (2015) Nat Genet , vol.47 , pp. 505-511
    • Schulze, K.1    Imbeaud, S.2    Letouze, E.3    Alexandrov, L.B.4    Calderaro, J.5    Rebouissou, S.6
  • 37
    • 85003443874 scopus 로고    scopus 로고
    • Mutational landscape of combined hepatocellular carcinoma and cholangiocarcinoma, and its clinicopatho-logical significance
    • Sasaki M, Sato Y, Nakanuma Y. Mutational landscape of combined hepatocellular carcinoma and cholangiocarcinoma, and its clinicopatho-logical significance. Histopathology 2016;70:423-34.
    • (2016) Histopathology , vol.70 , pp. 423-434
    • Sasaki, M.1    Sato, Y.2    Nakanuma, Y.3
  • 38
    • 84994314579 scopus 로고    scopus 로고
    • Frequent somatic TERT promoter mutations and CTNNB1 mutations in hepatocellular carcinoma
    • Lee SE, Chang SH, Kim WY, Lim SD, Kim WS, Hwang TS, et al. Frequent somatic TERT promoter mutations and CTNNB1 mutations in hepatocellular carcinoma. Oncotarget 2016;7:69267-75.
    • (2016) Oncotarget , vol.7 , pp. 69267-69275
    • Lee, S.E.1    Chang, S.H.2    Kim, W.Y.3    Lim, S.D.4    Kim, W.S.5    Hwang, T.S.6
  • 39
    • 84897670620 scopus 로고    scopus 로고
    • Worse outcome of sorafenib therapy associated with ascites and Child-Pugh score in advanced hepatocellular carcinoma
    • Kim HY, Park JW, Joo J, Kim H, Woo SM, Lee WJ, et al. Worse outcome of sorafenib therapy associated with ascites and Child-Pugh score in advanced hepatocellular carcinoma. J Gastroenterol Hepatol 2013;28: 1756-61.
    • (2013) J Gastroenterol Hepatol , vol.28 , pp. 1756-1761
    • Kim, H.Y.1    Park, J.W.2    Joo, J.3    Kim, H.4    Woo, S.M.5    Lee, W.J.6
  • 40
    • 84956655233 scopus 로고    scopus 로고
    • The prognostic value of alpha-fetoprotein response for advanced-stage hepatocellular carcinoma treated with sorafenib combined with transarterial chemoembolization
    • Liu L, Zhao Y, Jia J, Chen H, Bai W, Yang M, et al. The prognostic value of alpha-fetoprotein response for advanced-stage hepatocellular carcinoma treated with sorafenib combined with transarterial chemoembolization. Sci Rep 2016;6:19851.
    • (2016) Sci Rep , vol.6 , pp. 19851
    • Liu, L.1    Zhao, Y.2    Jia, J.3    Chen, H.4    Bai, W.5    Yang, M.6
  • 41
    • 85028033098 scopus 로고    scopus 로고
    • Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: Analysis of two phase III studies
    • Bruix J, Cheng AL, Meinhardt G, Nakajima K, De Sanctis Y, Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: analysis of two phase III studies. J Hepatol 2017;67:999-1008.
    • (2017) J Hepatol , vol.67 , pp. 999-1008
    • Bruix, J.1    Cheng, A.L.2    Meinhardt, G.3    Nakajima, K.4    De Sanctis, Y.5    Llovet, J.6
  • 42
    • 31744435976 scopus 로고    scopus 로고
    • BEAMing up for detection and quantification of rare sequence variants
    • Li M, Diehl F, Dressman D, Vogelstein B, Kinzler KW. BEAMing up for detection and quantification of rare sequence variants. Nat Methods 2006;3:95-7.
    • (2006) Nat Methods , vol.3 , pp. 95-97
    • Li, M.1    Diehl, F.2    Dressman, D.3    Vogelstein, B.4    Kinzler, K.W.5


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