A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C

Journal of Hepatology

Volumn 59, Issue 1, 2013, Pages 81-88

  Sangro, Bruno ^a,b   Gomez Martin, Carlos ^c   De La Mata, Manuel ^b,d,e   Iñarrairaegui, Mercedes ^a,b   Garralda, Elena ^c   Barrera, Pilar ^b,d   Riezu Boj, Jose Ignacio ^f   Larrea, Esther ^f   Alfaro, Carlos ^a   Sarobe, Pablo ^f   Lasarte, Juan José ^f   Pérez Gracia, Jose L ^a   Melero, Ignacio ^a,f   Prieto, Jesús ^a,b,f  

^a UNIVERSITY CLINIC OF NAVARRA   (Spain)

^b INSTITUTO DE SALUD CARLOS III   (Spain)

^c HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^d HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^e Instituto de Salud Carlos III   (Spain)

^f UNIVERSITY OF NAVARRA   (Spain)

Author keywords

CTLA 4; Immunotherapy; Liver cancer; Treg

Indexed keywords

AMINOTRANSFERASE; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; TICILIMUMAB;

ABDOMINAL PAIN; ACUTE KIDNEY FAILURE; ADULT; AGED; ALOPECIA; ANOREXIA; ARTHRITIS; ARTICLE; ASCITES; BLEEDING; BRAIN DISEASE; CHOLANGITIS; CLINICAL ARTICLE; DEPRESSION; DIARRHEA; DISEASE CONTROL; DISEASE SEVERITY; DIVERTICULITIS; DRUG WITHDRAWAL; EDEMA; FAINTNESS; FATIGUE; FEMALE; HEPATITIS C; HERPES ZOSTER; HUMAN; HYPOTHYROIDISM; IMMUNE RESPONSE; INSOMNIA; LIVER CELL CARCINOMA; LIVER CIRRHOSIS; LIVER FUNCTION; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OPHTHALMIC ZOSTER; PATIENT SAFETY; PILOT STUDY; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; RASH; RESPIRATORY TRACT INFECTION; THRUSH; TUMOR GROWTH; URINARY TRACT INFECTION; VIRUS LOAD;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ANTIVIRAL AGENTS; CARCINOMA, HEPATOCELLULAR; CTLA-4 ANTIGEN; FEMALE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; LIVER CIRRHOSIS; LIVER NEOPLASMS; MALE; MIDDLE AGED; PILOT PROJECTS; VIRAL LOAD;

EID: 84879141840     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jhep.2013.02.022     Document Type: Article

References (33)

1. J.M. Llovet, S. Ricci, V. Mazzaferro, P. Hilgard, E. Gane, and J.-F. Blanc Sorafenib in advanced hepatocellular carcinoma N Engl J Med 359 2008 378 390
2. 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 56 2012 908 943
3. A. Villanueva, and J.M. Llovet Targeted therapies for hepatocellular carcinoma Gastroenterology 140 2011 1410 1426
4. S. Oquiñena, M. Iñarrairaegui, J.J. Vila, F. Alegre, J.M. Zozaya, and B. Sangro Spontaneous regression of hepatocellular carcinoma: three case reports and a categorized review of the literature Dig Dis Sci 54 2008 1147 1153
5. D.H. Palmer, R.S. Midgley, N. Mirza, E.E. Torr, F. Ahmed, and J.C. Steele A phase II study of adoptive immunotherapy using dendritic cells pulsed with tumor lysate in patients with hepatocellular carcinoma Hepatology 49 2008 124 132
6. T. Takayama, T. Sekine, M. Makuuchi, S. Yamasaki, T. Kosuge, and J. Yamamoto Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial Lancet 356 2000 802 807
7. C.A. Chambers, M.S. Kuhns, J.G. Egen, and J.P. Allison CTLA-4-mediated inhibition in regulation of T cell responses: mechanisms and manipulation in tumor immunotherapy Annu Rev Immunol 19 2001 565 594
8. C.E. Rudd The reverse stop-signal model for CTLA4 function Nat Rev Immunol 8 2008 153 160
9. L.E. Marengère, P. Waterhouse, G.S. Duncan, H.W. Mittrücker, G.S. Feng, and T.W. Mak Regulation of T cell receptor signaling by tyrosine phosphatase SYP association with CTLA-4 Science 272 1996 1170 1173
10. K.M. Lee, E. Chuang, M. Griffin, R. Khattri, D.K. Hong, and W. Zhang Molecular basis of T cell inactivation by CTLA-4 Science 282 1998 2263 2266
11. D.M. Pardoll The blockade of immune checkpoints in cancer immunotherapy Nat Rev Cancer 12 2012 252 264
12. L.S.K. Walker, and D.M. Sansom The emerging role of CTLA4 as a cell-extrinsic regulator of T cell responses Nat Rev Immunol 11 2011 852 863
13. J.M. Kirkwood, P. Lorigan, P. Hersey, A. Hauschild, C. Robert, and D. McDermott Phase II trial of tremelimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma Clin Cancer Res 16 2010 1042 1048
14. L.H. Camacho, S. Antonia, J. Sosman, J.M. Kirkwood, T.F. Gajewski, and B. Redman Phase I/II trial of tremelimumab in patients with metastatic melanoma J Clin Oncol 27 2009 1075 1081
15. K.Y. Chung, I. Gore, L. Fong, A. Venook, S.B. Beck, and P. Dorazio Phase II study of the anti-cytotoxic T-lymphocyte-associated antigen 4 monoclonal antibody, tremelimumab, in patients with refractory metastatic colorectal cancer J Clin Oncol 28 2010 3485 3490
16. F.S. Hodi, S.J. O'Day, D.F. McDermott, R.W. Weber, J.A. Sosman, and J.B. Haanen Improved survival with ipilimumab in patients with metastatic melanoma N Engl J Med 363 2010 711 723
17. I. Melero, S. Hervás-Stubbs, M. Glennie, D.M. Pardoll, and L. Chen Immunostimulatory monoclonal antibodies for cancer therapy Nat Rev Cancer 7 2007 95 106
18. J. Bruix, M. Sherman, J. Llovet, M. Beaugrand, R. Lencioni, and A.K. Burroughs Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver J Hepatol 35 2001 421 430
19. P. Therasse, S.G. Arbuck, E.A. Eisenhauer, J. Wanders, R.S. Kaplan, and L. Rubinstein New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada J Natl Cancer Inst 92 2000 205 216
20. A.V. Maker, P. Attia, and S.A. Rosenberg Analysis of the cellular mechanism of antitumor responses and autoimmunity in patients treated with CTLA-4 blockade J Immunol 175 2005 7746 7754
21. B. Kavanagh, S. O'Brien, D. Lee, Y. Hou, V. Weinberg, and B. Rini CTLA4 blockade expands FoxP3+ regulatory and activated effector CD4+ T cells in a dose-dependent fashion Blood 112 2008 1175 1183
22. C. Ralph, E. Elkord, D.J. Burt, J.F. O'Dwyer, E.B. Austin, and P.L. Stern Modulation of lymphocyte regulation for cancer therapy: a phase II trial of tremelimumab in advanced gastric and esophageal adenocarcinoma Clin Cancer Res 16 2010 1662 1672
23. B.I. Rini, M. Stein, P. Shannon, S. Eddy, A. Tyler, and J.J. Stephenson Phase 1 dose-escalation trial of tremelimumab plus sunitinib in patients with metastatic renal cell carcinoma Cancer 117 2011 758 767
24. A.A. Tarhini, J. Cherian, S.J. Moschos, H.A. Tawbi, Y. Shuai, and W.E. Gooding Safety and efficacy of combination immunotherapy with interferon alfa-2b and tremelimumab in patients with stage IV melanoma J Clin Oncol 30 2012 322 328
25. A.X. Zhu, T.A. Abrams, R. Miksad, L.S. Blaszkowsky, J.A. Meyerhardt, and H. Zheng Phase 1/2 study of everolimus in advanced hepatocellular carcinoma Cancer 117 2011 5094 5102
26. J.-W. Park, R.S. Finn, J.S. Kim, M. Karwal, R.K. Li, and F. Ismail Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma Clin Cancer Res 17 2011 1973 1983
27. E. Larrea, J.I. Riezu-Boj, L. Gil-Guerrero, N. Casares, R. Aldabe, and P. Sarobe Upregulation of indoleamine 2,3-dioxygenase in hepatitis C virus infection J Virol 81 2007 3662 3666
28. J.-I. Riezu-Boj, E. Larrea, R. Aldabe, L. Guembe, N. Casares, and E. Galeano Hepatitis C virus induces the expression of CCL17 and CCL22 chemokines that attract regulatory T cells to the site of infection J Hepatol 54 2011 422 431
29. N. Nakamoto, H. Cho, A. Shaked, K. Olthoff, M.E. Valiga, and M. Kaminski Synergistic reversal of intrahepatic HCV-specific CD8 T cell exhaustion by combined PD-1/CTLA-4 blockade PLoS Pathog 5 2009 e1000313
30. N. Nakamoto, D.E. Kaplan, J. Coleclough, Y. Li, M.E. Valiga, and M. Kaminski Functional restoration of HCV-specific CD8 T cells by PD-1 blockade is defined by PD-1 expression and compartmentalization Gastroenterology 134 2008 1927 1937 e1-2
31. R. Cabrera, M. Ararat, Y. Xu, T. Brusko, C. Wasserfall, and M.A. Atkinson Immune modulation of effector CD4+ and regulatory T cell function by sorafenib in patients with hepatocellular carcinoma Cancer Immunol Immunother 2012 10.1007/s0026-012-1380-8
32. H. Nagai, T. Mukozu, D. Matsui, T. Kanekawa, M. Kanayama, and N. Wakui Sorafenib prevents escape from host immunity in liver cirrhosis patients with advanced hepatocellular carcinoma Clin Dev Immunol 2012 2012 607851
33. M.K. Callahan, J.D. Wolchok, and J.P. Allison Anti-CTLA-4 antibody therapy: immune monitoring during clinical development of a novel immunotherapy Semin Oncol 37 2010 473 484