Phase II study of the GPC3-derived peptide vaccine as an adjuvant therapy for hepatocellular carcinoma patients

OncoImmunology

Volumn 5, Issue 5, 2016, Pages

  Sawada, Yu ^a,b   Yoshikawa, Toshiaki ^a   Ofuji, Kazuya ^a   Yoshimura, Mayuko ^a   Tsuchiya, Nobuhiro ^a,b   Takahashi, Mari ^a   Nobuoka, Daisuke ^a,c   Gotohda, Naoto ^d   Takahashi, Shinichiro ^d   Kato, Yuichiro ^d   Konishi, Masaru ^d   Kinoshita, Taira ^e   Ikeda, Masafumi ^d   Nakachi, Kohei ^d   Yamazaki, Naoya ^f   Mizuno, Shoichi ^a   Takayama, Tadatoshi ^g   Yamao, Kenji ^e   Uesaka, Katsuhiko ^h   Furuse, Junji ⁱ   Endo, Itaru ^b   Nakatsura, Tetsuya ^a   more..

^a NATIONAL CANCER CENTER   (Japan)

^b YOKOHAMA CITY UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c OKAYAMA UNIVERSITY   (Japan)

^d NATIONAL CANCER CENTER HOSPITAL EAST   (Japan)

^e AICHI CANCER CENTER HOSPITAL   (Japan)

^f NATIONAL CANCER CENTER HOSPITAL   (Japan)

^g NIHON UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^h SHIZUOKA CANCER CENTER   (Japan)

ⁱ KYORIN UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Adjuvant therapy; CTL; Glypican 3; HCC; Peptide vaccine

Indexed keywords

GAMMA INTERFERON; GLYPICAN 3; GLYPICAN 3 PEPTIDE VACCINE; PEPTIDE VACCINE; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ARTICLE; BRAIN HEMORRHAGE; CANCER ADJUVANT THERAPY; CANCER IMMUNIZATION; CANCER RECURRENCE; CANCER SURGERY; CASE CONTROL STUDY; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG FEVER; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; FOLLOW UP; HEPATITIS B; HEPATITIS C; HUMAN; HYPERBILIRUBINEMIA; HYPERKALEMIA; HYPOALBUMINEMIA; HYPONATREMIA; IMMUNOHISTOCHEMISTRY; LEUKOPENIA; LIVER CELL CARCINOMA; LYMPHOCYTOPENIA; MALE; NEUTROPENIA; NUCLEAR MAGNETIC RESONANCE IMAGING; OVERALL SURVIVAL; PERIPHERAL BLOOD MONONUCLEAR CELL; PHASE 2 CLINICAL TRIAL; PRIMARY TUMOR; PROTEIN EXPRESSION; PROTEINURIA; PRURITUS; RADIOFREQUENCY ABLATION; RECURRENCE FREE SURVIVAL; SINGLE BLIND PROCEDURE; THROMBOCYTOPENIA;

EID: 84975807216     PISSN: 21624011     EISSN: 2162402X     Source Type: Journal    
DOI: 10.1080/2162402X.2015.1129483     Document Type: Article

References (32)

1. A.Jemal, F.Bray, M.M.Center, J.Ferlay, E.Ward, D.Forman. Global cancer statistics. CA Cancer J Clin 2011; 61:69-90; PMID:21296855; http://dx.doi.org/10.3322/caac.20107
2. H.B.El-Serag, K.L.Rudolph. Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology 2007; 132:2557-76; PMID:17570226; http://dx.doi.org/10.1053/j.gastro.2007.04.061
3. K.Hanazaki, S.Kajikawa, N.Shimozawa, M.Mihara, K.Shimada, M.Hiraguri, N.Koide, W.Adachi, J.Amano. Survival and recurrence after hepatic resection of 386 consecutive patients with hepatocellular carcinoma. J Am Coll Surg 2000; 191:381-8; PMID:11030243; http://dx.doi.org/10.1016/S1072-7515(00)00700-6
4. S.Shiina, R.Tateishi, T.Arano, K.Uchino, K.Enooku, H.Nakagawa, Y.Asaoka, T.Sato, R.Masuzaki, Y.Kondo Radiofrequency Ablation for Hepatocellular Carcinoma: 10-Year Outcome and Prognostic Factors. Am J Gastroenterol 2012; 107:569-77; PMID:22158026; http://dx.doi.org/10.1038/ajg.2011.425
5. T.Kumada, S.Nakano, I.Takeda, K.Sugiyama, T.Osada, S.Kiriyama, Y.Sone, H.Toyoda, S.Shimada, M.Takahashi Patterns of recurrence after initial treatment in patients with small hepatocellular carcinoma. Hepatology 1997; 25:87-92; PMID:8985270; http://dx.doi.org/10.1002/hep.510250116
6. J.Bruix, T.Takayama, V.Mazzaferro, G.Y.Chau, J.Yang, M.Kudo, J.Cai, R.T.Poon, K.H.Han, W.Y.Tak Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015; 16(13):1344-54; PMID:26361969; http://dx.doi.org/10.1016/S1470-2045(15)00198-9
7. D.Habu, S.Shiomi, A.Tamori, T.Takeda, T.Tanaka, S.Kubo, S.Nishiguchi. Role of vitamin K2 in the development of hepatocellular carcinoma in women with viral cirrhosis of the liver. JAMA 2004; 292:358-61; PMID:15265851; http://dx.doi.org/10.1001/jama.292.3.358
8. Y.Muto, H.Moriwaki, M.Ninomiya, S.Adachi, A.Saito, K.T.Takasaki, T.Tanaka, K.Tsurumi, M.Okuno, E.Tomita Prevention of second primary tumors by an acyclic retinoid, polyprenoic acid, in patients with hepatocellular carcinoma. Hepatoma Prevention Study Group. N Engl J Med 1996; 334:1561-7; PMID:8628336; http://dx.doi.org/10.1056/NEJM199606133342402
9. K.Ikeda, Y.Arase, S.Saitoh, M.Kobayashi, Y.Suzuki, F.Suzuki, A.Tsubota, K.Chayama, N.Murashima, H.Kumada. Interferon beta prevents recurrence of hepatocellular carcinoma after complete resection or ablation of the primary tumor-A prospective randomized study of hepatitis C virus-related liver cancer. Hepatology 2000; 32:228-32; PMID:10915728; http://dx.doi.org/10.1053/jhep.2000.9409
10. T.Takayama, T.Sekine, M.Makuuchi, S.Yamasaki, T.Kosuge, J.Yamamoto, K.Shimada, M.Sakamoto, S.Hirohashi, Y.Ohashi Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial. Lancet 2000; 356:802-7; PMID:11022927; http://dx.doi.org/10.1016/S0140-6736(00)02654-4
11. M.Kuang, B.G.Peng, M.D.Lu, L.J.Liang, J.F.Huang, Q.He, Y.P.Hua, S.Totsuka, S.Q.Liu, K.W.Leong Phase II randomized trial of autologous formalin-fixed tumor vaccine for postsurgical recurrence of hepatocellular carcinoma. Clin Cancer Res 2004; 10:1574-9; PMID:15014006; http://dx.doi.org/10.1158/1078-0432.CCR-03-0071
12. T.Nakatsura, Y.Yoshitake, S.Senju, M.Monji, H.Komori, Y.Motomura, S.Hosaka, T.Beppu, T.Ishiko, H.Kamohara Glypican-3, overexpressed specifically in human hepatocellular carcinoma, is a novel tumor marker. Biochem Biophys Res Commun 2003; 306:16-25; PMID:12788060; http://dx.doi.org/10.1016/S0006-291X(03)00908-2
13. M.Capurro, I.R.Wanless, M.Sherman, G.Deboer, W.Shi, E.Miyoshi, J.Filmus. Glypican-3: a novel serum and histochemical marker for hepatocellular carcinoma. Gastroenterology 2003; 125:89-97; PMID:12851874; http://dx.doi.org/10.1016/S0016-5085(03)00689-9
14. H.Shirakawa, H.Suzuki, M.Shimomura, M.Kojima, N.Gotohda, S.Takahashi, T.Nakagohri, M.Konishi, N.Kobayashi, T.Kinoshita Glypican-3 expression is correlated with poor prognosis in hepatocellular carcinoma. Cancer Sci 2009; 100:1403-7; PMID:19496787; http://dx.doi.org/10.1111/j.1349-7006.2009.01206.x
15. Y.Sawada, T.Yoshikawa, D.Nobuoka, H.Shirakawa, T.Kuronuma, Y.Motomura, S.Mizuno, H.Ishii, K.Nakachi, M.Konishi Phase I trial of a glypican-3-derived peptide vaccine for advanced hepatocellular carcinoma: immunologic evidence and potential for improving overall survival. Clin Cancer Res 2012; 18:3686-96; PMID:22577059; http://dx.doi.org/10.1158/1078-0432.CCR-11-3044
16. Y.Sawada, T.Yoshikawa, S.Fujii, S.Mitsunaga, D.Nobuoka, S.Mizuno, M.Takahashi, C.Yamauchi, I.Endo, T.Nakatsura. Remarkable tumor lysis in a hepatocellular carcinoma patient immediately following glypican-3-derived peptide vaccination: An autopsy case. Human Vaccines and Immunotherapeutics. 2013; 9(7):1228-1233; PMID:23466818; http://dx.doi.org/10.4161/hv.24179
17. S.Suzuki, K.Shibata, F.Kikkawa, T.Nakatsura. Significant clinical response of progressive recurrent ovarian clear cell carcinoma to glypican-3-derived peptide vaccine therapy: two case reports. Hum Vaccin Immunother 2013; 19:10(2):338–343; PMID: 24252799; http://dx.doi.org/10.4161/hv.27217
18. A.Zerbini, M.Pilli, A.Penna, G.Pelosi, C.Schianchi, A.Molinari, S.Schivazappa, C.Zibera, F.F.Fagnoni, C.Ferrari Radiofrequency thermal ablation of hepatocellular carcinoma liver nodules can activate and enhance tumor-specific T-cell responses. Cancer Res 2006; 66:1139-46; PMID:16424051; http://dx.doi.org/10.1158/0008-5472.CAN-05-2244
19. E.Mizukoshi, T.Yamashita, K.Arai, H.Sunagozaka, T.Ueda, F.Arihara, T.Kagaya, T.Yamashita, K.Fushimi, S.Kaneko. Enhancement of tumor-associated antigen-specific T cell responses by radiofrequency ablation of hepatocellular carcinoma Hepatology 2013; 57(4):1448-57; PMID:23174905; http://dx.doi.org/10.1002/hep.26153
20. D.Nobuoka, Y.Motomura, H.Shirakawa, T.Yoshikawa, T.Kuronuma, M.Takahashi, K.Nakachi, H.Ishii, J.Furuse, N.Gotohda Radiofrequency ablation for hepatocellular carcinoma induces glypican-3 peptide-specific cytotoxic T lymphocytes. Int J Oncol 2012; 40:63–70; PMID:21922136; http://dx.doi.org/10.3892/ijo.2011.1202
21. T.Yoshikawa, M.Nakatsugawa, S.Suzuki, H.Shirakawa, D.Nobuoka, N.Sakemura, Y.Motomura, Y.Tanaka, S.Hayashi, T.Nakatsura. HLA-A2-restricted glypican-3 peptide-specific CTL clones induced by peptide vaccine show high avidity and antigen-specific killing activity against tumor cells. Cancer Sci 2011; 102:918-25; PMID:21281401; http://dx.doi.org/10.1111/j.1349-7006.2011.01896.x
22. K.Pan, Y.Q.Li, W.Wang, L.Xu, Y.J.Zhang, H.X.Zheng, J.J.Zhao, H.J.Qiu, D.S.Weng, J.J.Li The efficacy of cytokine-induced killer cell infusion as an adjuvant therapy for postoperative hepatocellular carcinoma patients. Ann Surg Oncol 2013; 20:4305-11; PMID:23892527; http://dx.doi.org/10.1245/s10434-013-3144-x
23. Y.Sawada, K.Ofuji, M.Sakai, T.Nakatsura. Immunotherapy for hepatocellular carcinoma: current status and future perspectives. In: Reeves H, Manas DM, Lochan R, eds. editors Liver Tumors - Epidemiology, Diagnosis, Prevention and Treatment. Rijeka: Intech, 2013. 59-90 p; http://dx.doi.org/10.5772/54594
24. J.M.Llovert, J.Bruix. Novel advancements in the management of hepatocellular carcinoma in 2008. Journal of Hepatology 2008; 48:S20-S37; PMID:18304676; http://dx.doi.org/10.1016/j.jhep.2008.01.022
25. F.Wang, E.Bade, C.Kuniyoshi, L.Spears, G.Jeffery, V.Marty, S.Groshen, J.Weber. Phase I trial of a MART-1 peptide vaccine with incomplete freund’s adjuvant for resected high-risk melanoma. Clin Cancer Res 1999; 5:2756-65; PMID:10537339
26. C.L.SlingluffJr, S.Lee, F.Zhao, K.A.Chianese-Bullock, W.C.Olson, L.H.Butterfield, T.L.Whiteside, P.D.Leming, J.M.Kirkwood. A randomized phase II trial of multiepitope vaccination with melanoma peptides for cytotoxic T cells and helper T cells for patients with metastatic melanoma (E1602). Clin Cancer Res 2013; 19:4228-38; PMID:23653149; http://dx.doi.org/10.1158/1078-0432.CCR-13-0002
27. J.Fourcade, Z.Sun, O.Pagliano, J.M.Chauvin, C.Sander, B.Janjic, A.A.Tarhini, H.A.Tawbi, J.M.Kirkwood, S.Moschos PD-1 and Tim-3 regulate the expansion of tumor antigen-specific CD8+ T cellsinduced by melanoma vaccines. Cancer Res 2014; 74(4):1045-55; PMID:24343228; http://dx.doi.org/10.1158/0008-5472.CAN-13-2908
28. Y.Hailemichael, Z.Dai, N.Jaffarzad, Y.Ye, M.A.Medina, X.F.Huang, S.M.Dorta-Estremera, N.R.Greeley, G.Nitti, W.Peng Persistent antigen at vaccination sites induces tumor-specific CD8(+) T cell sequestration, dysfunction and deletion. Nat Med 2013; 19:465-72; PMID:23455713; http://dx.doi.org/10.1038/nm.3105
29. E.P.Salerno, S.M.Shea, W.C.Olson, G.R.Petroni, M.E.Smolkin, C.McSkimming, K.A.Chianese-Bullock, C.L.SlingluffJr. Activation, dissfunction and retention of T cell in vaccine sites after injection of incomplete Freund’s adjuvant, with or without peptide. Cancer Immunol Immunother 2013; 62:1149-59; PMID:23657629; http://dx.doi.org/10.1007/s00262-013-1435-5
30. S.A.Rosenberg, R.M.Sherry, K.E.Morton, W.J.Scharfman, J.C.Yang, S.L.Topalian, R.E.Royal, U.Kammula, N.P.Restifo, M.S.Hughes Tumor progression can occur despite the induction of very high levels of self/tumor antigen-specific CD8+ T cells in patients with melanoma. J Immunol 2005; 175:6169-76; PMID:16237114; http://dx.doi.org/10.4049/jimmunol.175.9.6169
31. J.M.Kirkwood, L.H.Butterfield, A.A.Tarhini, H.Zarour, P.Kalinski, S.Ferrone. Immunotherapy of cancer in 2012. CA Cancer J Clin 2012; 62:309-335; PMID:22576456; http://dx.doi.org/10.3322/caac.20132
32. Y.Sawada, T.Yoshikawa, M.Shimomura, T.Iwama, I.Endo, T.Nakatsura. Programmed death-1 blockade enhances the antitumor effects of peptide vaccine-induced peptide-specific cytotoxic T lymphocytes. Int J Oncol 2015; 46:28-36; PMID:25354479; http://dx.doi.org/10.3892/ijo.2014.2737