Tivantinib, a new option for second-line treatment of advanced hepatocellular carcinoma? the experience of Italian centers

Tumori

Volumn 101, Issue 2, 2015, Pages 139-143

  Rimassa, Lorenza ^a   Santoro, Armando ^a   Daniele, Bruno ^b   Germano, Domenico ^b   Gasbarrini, Antonio ^c   Salvagni, Stefania ^d   Masi, Gianluca ^e   Abbadessa, Giovanni ^f   Lamar, Maria ^f   Goldberg, Terri ^g   Porta, Camillo ^h  

^a HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

^b G RUMMO HOSPITAL   (Italy)

^c CATHOLIC UNIVERSITY   (Italy)

^d UNIVERSITY HOSPITAL OF PARMA   (Italy)

^e UNIVERSITY HOSPITAL OF PISA   (Italy)

^f ARQULE INC   (United States)

^g DAIICHI SANKYO INC   (United States)

^h FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

Author keywords

Hepatocellular carcinoma; MET; Second line treatment; Tivantinib

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; MITOGEN ACTIVATED PROTEIN KINASE; PLACEBO; SCATTER FACTOR; SCATTER FACTOR RECEPTOR; SOMATOMEDIN B; SORAFENIB; TIVANTINIB; TRANSFORMING GROWTH FACTOR BETA; VASCULOTROPIN; 2 PYRROLIDONE DERIVATIVE; ANTINEOPLASTIC AGENT; CARBANILAMIDE DERIVATIVE; NICOTINAMIDE; QUINOLINE DERIVATIVE;

ANTINEOPLASTIC ACTIVITY; APOPTOSIS; ARTICLE; CANCER PROGNOSIS; CANCER SURVIVAL; CELL MIGRATION; CELL PROLIFERATION; CELL VIABILITY; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MECHANISM; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; DRUG SELECTIVITY; DRUG TOLERABILITY; HUMAN; LIVER CELL CARCINOMA; MET GENE; NEUTROPENIA; NONHUMAN; ONCOGENE; OVERALL SURVIVAL; PATHOGENESIS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; PROTEIN FUNCTION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SURVIVAL RATE; ADULT; AGED; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; CARCINOMA, HEPATOCELLULAR; CLINICAL TRIAL; CONTROLLED STUDY; EPIDEMIOLOGY; FEMALE; GENE EXPRESSION REGULATION; ITALY; KAPLAN MEIER METHOD; LIVER NEOPLASMS; MALE; METABOLISM; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT FAILURE; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, HEPATOCELLULAR; FEMALE; GENE EXPRESSION REGULATION, NEOPLASTIC; HUMANS; ITALY; KAPLAN-MEIER ESTIMATE; LIVER NEOPLASMS; MALE; MIDDLE AGED; NIACINAMIDE; PHENYLUREA COMPOUNDS; PROTO-ONCOGENE PROTEINS C-MET; PYRROLIDINONES; QUINOLINES; TREATMENT FAILURE; TREATMENT OUTCOME;

EID: 84930581374     PISSN: 03008916     EISSN: 20382529     Source Type: Journal    
DOI: 10.5301/tj.5000217     Document Type: Article

References (38)

1. Robbins SL, Kumar V, Cotran RS. Robbins and Cotran pathologic basis of disease. 8th ed. 2010, Philadelphia, PA. Saunders/Elsevier. xiv, 1450 p.
2. Schwartz M, Roayaie S, Konstadoulakis M. Strategies for the management of hepatocellular carcinoma. Nat Clin Pract Oncol. 2007;4(7):424-432.
3. Llovet JM, Bruix J. Novel advancements in the management of hepatocellular carcinoma in 2008. J Hepatol. 2008;48(Suppl 1): S20-S37.
4. Di Maio M, De Maio E, Perrone F, Pignata S, Daniele B. Hepatocellular carcinoma: systemic treatments. J Clin Gastroenterol. 2002;35(5 Suppl 2):S109-S114.
5. Kato A, Miyazaki M, Ambiru S, et al. Multidrug resistance gene (MDR-1) expression as a useful prognostic factor in patients with human hepatocellular carcinoma after surgical resection. J Surg Oncol. 2001;78(2):110-115.
6. Höpfner M, Schuppan D, Scherübl H. Growth factor receptors and related signalling pathways as targets for novel treatment strategies of hepatocellular cancer. World J Gastroenterol. 2008; 14(1):1-14.
7. Thorgeirsson SS, Grisham JW. Molecular pathogenesis of human hepatocellular carcinoma. Nat Genet. 2002;31(4):339-346.
8. Abou-Alfa GK, Schwartz L, Ricci S, et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006;24(26):4293-4300.
9. 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.
10. 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.
11. Cecchi F, Rabe DC, Bottaro DP. Targeting the HGF/Met signaling pathway in cancer therapy. Expert Opin Ther Targets. 2012;16(6):553-572.
12. Takayama H, LaRochelle WJ, Sharp R, et al. Diverse tumorigenesis associated with aberrant development in mice overexpressing hepatocyte growth factor/scatter factor. Proc Natl Acad Sci USA. 1997;94(2):701-706.
13. Gordin M, Tesio M, Cohen S, et al. c-Met and its ligand hepatocyte growth factor/scatter factor regulate mature B cell survival in a pathway induced by CD74. J Immunol. 2010;185(4):2020-2031.
14. Pennacchietti S, Michieli P, Galluzzo M, Mazzone M, Giordano S, Comoglio PM. Hypoxia promotes invasive growth by transcriptional activation of the met protooncogene. Cancer Cell. 2003;3(4):347-361.
15. Jahangiri A, De Lay M, Miller LM, et al. Gene expression profile identifies tyrosine kinase c-Met as a targetable mediator of antiangiogenic therapy resistance. Clin Cancer Res. 2013; 19(7):1773-1783.
16. Rapisarda A, Melillo G. Overcoming disappointing results with antiangiogenic therapy by targeting hypoxia. Nat Rev Clin Oncol. 2012;9(7):378-390.
17. Jeay S, Munshi N, Hill J, et al. ARQ 197, a highly selective small molecule inhibitor of MET, with selective anti-tumor properties in a broad spectrum of human cancer cells. Presented at 98th AACR Annual Meeting, April 14-18, 2007, Los Angeles, CA, USA; abstr. 2369.
18. Katayama R, Aoyama A, Yamori T, et al. Cytotoxic activity of tivantinib (ARQ 197) is not due solely to c-MET inhibition. Cancer Res. 2013;73(10):3087-3096.
19. Lu S, Rizzani A, Kolligs FT, Gallmeier E, Arena S. Anti-proliferative mechanisms downstream of MET of the kinase inhibitor tivantinib (ARQ 197). Presented at AASLD Annual Meeting, November 1-5, 2013, Washington DC, USA; abstr. 1818.
20. Zhou Y, Zhao C, Gery S, et al. Off-target effects of c-MET inhibitors on thyroid cancer cells. Mol Cancer Ther. 2014;13(1): 134-143.
21. Remsing Rix LL, Kuenzi BM, Luo Y, et al. GSK3 alpha and beta are new functionally relevant targets of tivantinib in lung cancer cells. ACS Chem Biol. 2014;9(2):353-358.
22. Basilico C, Pennacchietti S, Vigna E, et al. Tivantinib (ARQ197) displays cytotoxic activity that is independent of its ability to bind MET. Clin Cancer Res. 2013;19(9):2381-2392.
23. Rimassa L, Bruix J, Broggini M, Santoro A. Tivantinib (ARQ197) displays cytotoxic activity that is independent of its ability to bind MET-letter. Clin Cancer Res. 2013;19(15):4290.
24. Santoro A, Rimassa L, Borbath I, et al. Tivantinib for second-line treatment of advanced hepatocellular carcinoma: A randomised, placebo-controlled phase 2 study. Lancet Oncol. 2013;14(1):55-63.
25. Scagliotti G, Novello S, Ramlau R, et al. Marquee: A randomized, double-blind, placebo-controlled, phase 3 trial of tivantinib (ARQ 197) plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, non-squamous, non-small-cell lung cancer (NSCLC). Presented at 17th ECCO-38th ESMO-32nd ESTRO European Cancer Congress, Sep 27-Oct 1, 2013, Amsterdam; abstr E17-1821.
26. Eng C, Hart LL, Severtsev A, et al. A randomized, placebocontrolled, phase I/II study of tivantinib (ARQ 197) in combination with cetuximab and irinotecan in patients (pts) with KRAS wild-type (WT) metastatic colorectal cancer (CRC) who had received previous front-line systemic therapy. J Clin Oncol. 2013;31(Suppl):abstr 3508.
27. Yap TA, Olmos D, Brunetto AT, et al. Phase I trial of a selective MET inhibitor ARQ 197 incorporating proof of mechanism pharmacodynamic studies. J Clin Oncol. 2011;29(10):1271-1279.
28. Santoro A, Simonelli M, Rodriguez-Lope C, et al. A phase-1b study of tivantinib (ARQ 197) in adult patients with hepatocellular carcinoma and cirrhosis. Br J Cancer. 2013;108(1):21-24.
29. Rimassa L, Porta C, Borbath I, et al. Tivantinib in MET-high hepatocellular carcinoma patients and the ongoing phase III clinical trial. Hepatic Oncol. 2014;1(2):181-188.
30. Cheng AL, Kang YK, Lin DY, et al. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013;31(32):4067-4075.
31. 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 Clin Oncol. 2013;31(28):3517-3524.
32. 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 Clin Oncol. 2015;33(2):172-179.
33. 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 Clin Oncol. 2015;33(6):559-566.
34. Llovet JM, Decaens T, Raoul JL, 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(28): 3509-3516.
35. Zhu AX, Kudo M, Assenat E, et al. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: The EVOLVE-1 randomized clinical trial. JAMA. 2014; 312(1):57-67.
36. Zhu AX, Ryoo BY, Yen CJ, et al. Ramucirumab (RAM) as secondline treatment in patients (pts) with advanced hepatocellular carcinoma (HCC) following first-line therapy with sorafenib: results from the randomized phase III REACH study. Presented at 38th ESMO Congress, Sept 26-30, 2014, Madrid, Spain; abstr LBA16.
37. Finn RS. Survival after sorafenib: expect the unexpected. J Hepatol. 2014;60(2):243-244.
38. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. 2014; 32(12):1277-1280.