Immunotherapy for Castration-Resistant Prostate Cancer

Urologic Clinics of North America

Volumn 39, Issue 4, 2012, Pages 465-481

  Sonpavde, Guru ^a   Kantoff, Philip W ^b  

^a University of Alabama at Birmingham   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Castration resistant; Immune response; Immunotherapy; Overall survival; Prostate cancer; PROSTVAC VF TRICOM; Sipuleucel T, CTLA 4

Indexed keywords

ABIRATERONE ACETATE; ADENOVIRUS VECTOR; BEVACIZUMAB; CPG OLIGODEOXYNUCLEOTIDE; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; DEXAMETHASONE; DNA VACCINE; DOCETAXEL; ESTRAMUSTINE PHOSPHATE; FLUTAMIDE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR VACCINE; HLA ANTIGEN; HYDROCORTISONE; INTERLEUKIN 2; IPILIMUMAB; KETOCONAZOLE; LISTERIOLYSIN O; LUTETIUM 177; MONOCLONAL ANTIBODY J591; NY ESO 1 ANTIGEN; PEPTIDE VACCINE; PLACEBO; PREDNISONE; PROGRAMMED DEATH 1 RECEPTOR; PROSTATE SPECIFIC ANTIGEN; PROSTVAC VF TRICOM; RILIMOGENE GALVACIREPVEC; SIPULEUCEL T; UNCLASSIFIED DRUG; UNINDEXED DRUG; YTTRIUM 90;

ANTIGEN PRESENTING CELL; BRAIN HEMORRHAGE; CANCER IMMUNOTHERAPY; CANCER RADIOTHERAPY; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CHILL; COLITIS; CONTINUOUS INFUSION; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; ENDOCRINE DISEASE; FEVER; GASTROINTESTINAL DISEASE; GLEASON SCORE; HEPATITIS; HUMAN; IMMUNE RESPONSE; LISTERIA; LIVER DISEASE; LOW DRUG DOSE; MALE; METASTASIS POTENTIAL; NONHUMAN; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POXVIRUS; PREDICTION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSTATECTOMY; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; T LYMPHOCYTE; TREATMENT OUTCOME; VIRAL GENE DELIVERY SYSTEM;

ACID PHOSPHATASE; CANCER VACCINES; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; IMMUNOTHERAPY; LISTERIA MONOCYTOGENES; MALE; NEOPLASMS, HORMONE-DEPENDENT; PROSTATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT FUSION PROTEINS; TISSUE EXTRACTS; TUMOR MARKERS, BIOLOGICAL;

EID: 84867666752     PISSN: 00940143     EISSN: 1558318X     Source Type: Journal    
DOI: 10.1016/j.ucl.2012.07.004     Document Type: Review

References (110)

1. Blades R.A., Keating P.J., McWilliam L.J., et al. Loss of HLA class I expression in prostate cancer: implications for immunotherapy. Urology 1995, 46:681.
2. Miller A.M., Pisa P. Tumor escape mechanisms in prostate cancer. Cancer Immunol Immunother 2007, 56:81.
3. Zhang H., Melamed J., Wei P., et al. Concordant down-regulation of proto-oncogene PML and major histocompatibility antigen HLA class I expression in high-grade prostate cancer. Cancer Immun 2003, 3:2.
4. Badawi A.F. The role of prostaglandin synthesis in prostate cancer. BJU Int 2000, 85:451.
5. Barach Y.S., Lee J.S., Zang X. T cell coinhibition in prostate cancer: new immune evasion pathways and emerging therapeutics. Trends Mol Med 2010, [Epub ahead of print].
6. Elsasser-Beile U., Gierschner D., Jantscheff P., et al. Different basal expression of type T1 and T2 cytokines in peripheral lymphocytes of patients with adenocarcinomas and benign hyperplasia of the prostate. Anticancer Res 2003, 23:4027.
7. Filella X., Alcover J., Zarco M.A., et al. Analysis of type T1 and T2 cytokines in patients with prostate cancer. Prostate 2000, 44:271.
8. Katz J.B., Muller A.J., Prendergast G.C. Indoleamine 2,3-dioxygenase in T-cell tolerance and tumoral immune escape. Immunol Rev 2008, 222:206.
9. Kusmartsev S., Vieweg J. Enhancing the efficacy of cancer vaccines in urologic oncology: new directions. Nat Rev Urol 2009, 6:540.
10. Mantovani A., Allavena P., Sica A., et al. Cancer-related inflammation. Nature 2008, 454:436.
11. Murdoch C., Muthana M., Coffelt S.B., et al. The role of myeloid cells in the promotion of tumour angiogenesis. Nat Rev Cancer 2008, 8:618.
12. Sanda M.G., Restifo N.P., Walsh J.C., et al. Molecular characterization of defective antigen processing in human prostate cancer. J Natl Cancer Inst 1995, 87:280.
13. Wang D., Dubois R.N. Prostaglandins and cancer. Gut 2006, 55(1):115-122.
14. Kantoff P.W., Higano C.S., Shore N.D., et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010, 363:411.
15. Small E.J., Schellhammer P.F., Higano C.S., et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol 2006, 24:3089.
16. Kantoff P.W., Schuetz T.J., Blumenstein B.A., et al. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol 2010, 28:1099.
17. Kaufman H.L., Wang W., Manola J., et al. Phase II randomized study of vaccine treatment of advanced prostate cancer (E7897): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol 2004, 22:2122.
18. Gulley J.L., Arlen P.M., Madan R.A., et al. Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer. Cancer Immunol Immunother 2010, 59:663.
19. Arlen P.M., Gulley J.L., Parker C., et al. A randomized phase II study of concurrent docetaxel plus vaccine versus vaccine alone in metastatic androgen-independent prostate cancer. Clin Cancer Res 2006, 12:1260.
20. Noguchi M., Kakuma T., Uemura H., et al. A randomized phase II trial of personalized peptide vaccine plus low dose estramustine phosphate (EMP) versus standard dose EMP in patients with castration resistant prostate cancer. Cancer Immunol Immunother 2010, 59:1001.
21. Higano CS, Saad F, Curti BD, et al. A phase III trial of GVAX immunotherapy for prostate cancer versus docetaxel plus prednisone in asymptomatic, castration-resistant prostate cancer (CRPC). Genitourinary Cancers Symposium [abstract LBA150]. Orlando (FL): February 26-28, 2009.
22. Small E, Demkow, T, Gerritsen, WR, et al. A phase III trial of GVAX immunotherapy for prostate cancer in combination with docetaxel versus docetaxel plus prednisone in symptomatic, castration-resistant prostate cancer (CRPC). Proceedings Genitourinary Cancer Symposium [abstract 7]. Orlando (FL): 2009.
23. Higano C.S., Schellhammer P.F., Small E.J., et al. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer 2009, 115:3670.
24. Small E.J., Higano C.S., Kantoff P.W., et al. Time to disease-related pain after sipuleucel-T in asymptomatic patients with metastatic castrate-resistant prostate cancer (mCRPC): results from three randomized phase III trials. J Clin Oncol 2011, 29(Suppl). [abstract: 4661].
25. Nabhan C., Gomella L.G., DeVries T., et al. An analysis to quantify the overall survival (OS) benefit of sipuleucel-T accounting for the crossover in the control arm of the IMPACT study. J Clin Oncol 2012, 30(Suppl 5). [abstract: 144].
26. Sheikh N.A., Wesley J.D., Chadwick E., et al. Characterization of antigen-specific T-cell activation and cytokine expression induced by sipuleucel-T. J Clin Oncol 2011, 29(Suppl 7). [abstract: 155].
27. Beer T.M., Bernstein G.T., Corman J.M., et al. Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen dependent prostate cancer. Clin Cancer Res 2011, 17:4558.
28. Beer T.M., Schellhammer P.F., Corman J.M., et al. Quality-of-life assessment in a randomized, double-blind study of sipuleucel-T in men with androgen-dependent prostate cancer. J Clin Oncol 2011, 29(Suppl). [abstract: 4648].
29. Rini B.I., Weinberg V., Fong L., et al. Combination immunotherapy with prostatic acid phosphatase pulsed antigen-presenting cells (Provenge) plus bevacizumab in patients with serologic progression of prostate cancer after definitive local therapy. Cancer 2006, 107:67.
30. Fong L., Weinberg V.K., Corman J.M., et al. Immune responses in prostate tumor tissue following neoadjuvant sipuleucel-T in patients with localized prostate cancer. J Clin Oncol 2012, 30(Suppl 5). [abstract: 181].
31. Hanks B.A., Jiang J., Singh R.A., et al. Re-engineered CD40 receptor enables potent pharmacological activation of dendritic-cell cancer vaccines in vivo. Nat Med 2005, 11:130.
32. Lapteva N., Seethammagari M.R., Hanks B.A., et al. Enhanced activation of human dendritic cells by inducible CD40 and Toll-like receptor-4 ligation. Cancer Res 2007, 67:10528.
33. Iuliucci J.D., Oliver S.D., Morley S., et al. Intravenous safety and pharmacokinetics of a novel dimerizer drug, AP1903, in healthy volunteers. J Clin Pharmacol 2001, 41:870.
34. Sonpavde G., McMannis J., Bai Y., et al. Results of a phase I/II clinical trial of BPX-101, a novel drug-activated dendritic cell (DC) vaccine for metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 2011, 29(Suppl 7). [abstract: 132].
35. Arlen P.M., Kaufman H.L., DiPaola R.S. Pox viral vaccine approaches. Semin Oncol 2005, 32:549.
36. Drake C.G. Prostate cancer as a model for tumour immunotherapy. Nat Rev Immunol 2010, 10:580.
37. Harrington L.E., Most Rv R., Whitton J.L., et al. Recombinant vaccinia virus-induced T-cell immunity: quantitation of the response to the virus vector and the foreign epitope. J Virol 2002, 76:3329.
38. Fakih M., Johnson C.S., Trump D.L. Glucocorticoids and treatment of prostate cancer: a preclinical and clinical review. Urology 2002, 60:553.
39. Antonia S.J., Mirza N., Fricke I., et al. Combination of p53 cancer vaccine with chemotherapy in patients with extensive stage small cell lung cancer. Clin Cancer Res 2006, 12:878.
40. Audia S., Nicolas A., Cathelin D., et al. Increase of CD4+ CD25+ regulatory T cells in the peripheral blood of patients with metastatic carcinoma: a Phase I clinical trial using cyclophosphamide and immunotherapy to eliminate CD4+ CD25+ T lymphocytes. Clin Exp Immunol 2007, 150:523.
41. Wada S., Yoshimura K., Hipkiss E.L., et al. Cyclophosphamide augments antitumor immunity: studies in an autochthonous prostate cancer model. Cancer Res 2009, 69:4309.
42. Arlen P.M., Gulley J.L., Todd N., et al. Antiandrogen, vaccine and combination therapy in patients with nonmetastatic hormone refractory prostate cancer. J Urol 2005, 174:539.
43. Koh Y.T., Gray A., Higgins S.A., et al. Androgen ablation augments prostate cancer vaccine immunogenicity only when applied after immunization. Prostate 2009, 69:571.
44. Madan R.A., Mohebtash M., Arlen P.M., et al. Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol 2012, 13:501.
45. Dreicer R., Stadler W.M., Ahmann F.R., et al. MVA-MUC1-IL2 vaccine immunotherapy (TG4010) improves PSA doubling time in patients with prostate cancer with biochemical failure. Invest New Drugs 2009, 27:379.
46. van Luijn M.M., Chamuleau M.E., Ressing M.E., et al. Alternative Ii-independent antigen-processing pathway in leukemic blasts involves TAP-dependent peptide loading of HLA class II complexes. Cancer Immunol Immunother 2010, 59:1825.
47. Hirano F., Kaneko K., Tamura H., et al. Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity. Cancer Res 2005, 65:1089.
48. Iwai Y., Terawaki S., Honjo T. PD-1 blockade inhibits hematogenous spread of poorly immunogenic tumor cells by enhanced recruitment of effector T cells. Int Immunol 2005, 17:133.
49. Smith-Garvin J.E., Koretzky G.A., Jordan M.S. T cell activation. Annu Rev Immunol 2009, 27:591.
50. Hodi F.S., O'Day S.J., McDermott D.F., et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010, 363:711.
51. Langer L.F., Clay T.M., Morse M.A. Update on anti-CTLA-4 antibodies in clinical trials. Expert Opin Biol Ther 2007, 7:1245.
52. O'Mahony D., Morris J.C., Quinn C., et al. A pilot study of CTLA-4 blockade after cancer vaccine failure in patients with advanced malignancy. Clin Cancer Res 2007, 13:958.
53. Slovin S.F., Beer T.M., Higano C.S., et al. Initial phase II experience of ipilimumab (IPI) alone and in combination with radiotherapy (XRT) in patients with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 2009, 27(Suppl):15s. [abstract: 5138].
54. Chakraborty M., Abrams S.I., Camphausen K., et al. Irradiation of tumor cells up-regulates Fas and enhances CTL lytic activity and CTL adoptive immunotherapy. J Immunol 2003, 170:6338.
55. Demaria S., Kawashima N., Yang A.M., et al. Immune-mediated inhibition of metastases after treatment with local radiation and CTLA-4 blockade in a mouse model of breast cancer. Clin Cancer Res 2005, 11:728.
56. Garnett C.T., Palena C., Chakraborty M., et al. Sublethal irradiation of human tumor cells modulates phenotype resulting in enhanced killing by cytotoxic T lymphocytes. Cancer Res 2004, 64:7985.
57. Harris T.J., Hipkiss E.L., Borzillary S., et al. Radiotherapy augments the immune response to prostate cancer in a time-dependent manner. Prostate 2008, 68:1319.
58. Apetoh L., Ghiringhelli F., Tesniere A., et al. Toll-like receptor 4-dependent contribution of the immune system to anticancer chemotherapy and radiotherapy. Nat Med 2007, 13:1050.
59. Chakraborty M., Abrams S.I., Coleman C.N., et al. External beam radiation of tumors alters phenotype of tumor cells to render them susceptible to vaccine-mediated T-cell killing. Cancer Res 2004, 64:4328.
60. van den Eertwegh A.J., Versluis J., van den Berg H.P., et al. Combined immunotherapy with granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells and ipilimumab in patients with metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol 2012, 13:509.
61. Zang X., Allison J.P. The B7 family and cancer therapy: costimulation and coinhibition. Clin Cancer Res 2007, 13:5271.
62. Nishimura H., Okazaki T., Tanaka Y., et al. Autoimmune dilated cardiomyopathy in PD-1 receptor-deficient mice. Science 2001, 291:319.
63. Brahmer J.R., Drake C.G., Wollner I., et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol 2010, 28:3167.
64. Brahmer J.R., Tykodi S.S., Chow L.Q., et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med 2012, 366:2455.
65. Topalian S.L., Hodi F.S., Brahmer J.R., et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012, 366:2443.
66. Morris M.J., Divgi C.R., Pandit-Taskar N., et al. Pilot trial of unlabeled and indium-111-labeled anti-prostate-specific membrane antigen antibody J591 for castrate metastatic prostate cancer. Clin Cancer Res 2005, 11:7454.
67. Milowsky M.I., Nanus D.M., Kostakoglu L., et al. Vascular targeted therapy with anti-prostate-specific membrane antigen monoclonal antibody J591 in advanced solid tumors. J Clin Oncol 2007, 25:540.
68. Jeske S.J., Milowsky M.I., Smith C.R., et al. Phase II trial of the anti-prostate specific membrane antigen (PSMA) monoclonal antibody (mAb) J591 plus low-dose interleukin-2 (IL-2) in patients (pts) with recurrent prostate cancer (PC). J Clin Oncol 2007, 25(Suppl 18). ASCO Annual Meeting Proceedings Part I, [abstract: 15558].
69. Galsky M.D., Eisenberger M., Moore-Cooper S., et al. Phase I trial of the prostate-specific membrane antigen-directed immunoconjugate MLN2704 in patients with progressive metastatic castration-resistant prostate cancer. J Clin Oncol 2008, 26:2147.
70. Bander N.H., Milowsky M.I., Nanus D.M., et al. Phase I trial of 177lutetium-labeled J591, a monoclonal antibody to prostate-specific membrane antigen, in patients with androgen-independent prostate cancer. J Clin Oncol 2005, 23:4591.
71. Milowsky M.I., Nanus D.M., Kostakoglu L., et al. Phase I trial of yttrium-90-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 for androgen-independent prostate cancer. J Clin Oncol 2004, 22:2522.
72. Tagawa S.T., Milowsky M.I., Morris M., et al. Phase II trial of 177Lutetium radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 (177Lu-J591) in patients (pts) with metastatic castrate-resistant prostate cancer (metCRPC). J Clin Oncol 2008, 26(Suppl 15):284s. [abstract: 5140].
73. Tagawa S.T., Vallabhajosula S., Osborne J., et al. Phase I trial of fractionated-dose 177lutetium radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 (177Lu-J591) in patients (pts) with metastatic castration-resistant prostate cancer (metCRPC). J Clin Oncol 2010, 28(Suppl 15). [abstract: 4667].
74. McNeel D.G., Dunphy E.J., Davies J.G., et al. Safety and immunological efficacy of a DNA vaccine encoding prostatic acid phosphatase in patients with stage D0 prostate cancer. J Clin Oncol 2009, 27:4047.
75. Pavlenko M., Roos A.K., Lundqvist A., et al. A phase I trial of DNA vaccination with a plasmid expressing prostate-specific antigen in patients with hormone-refractory prostate cancer. Br J Cancer 2004, 91:688.
76. Becker J.T., Olson B.M., Johnson L.E., et al. DNA vaccine encoding prostatic acid phosphatase (PAP) elicits long-term T-cell responses in patients with recurrent prostate cancer. J Immunother 2010, 33:639.
77. Higano C.S., Corman J.M., Smith D.C., et al. Phase 1/2 dose-escalation study of a GM-CSF-secreting, allogeneic, cellular immunotherapy for metastatic hormone-refractory prostate cancer. Cancer 2008, 113:975.
78. Small E.J., Sacks N., Nemunaitis J., et al. Granulocyte macrophage colony-stimulating factor-secreting allogeneic cellular immunotherapy for hormone-refractory prostate cancer. Clin Cancer Res 2007, 13:3883.
79. Cell Genesys Halts VITAL-2 GVAX Trial in Advanced Prostate Cancer. Available at: Accessed January 3, 2010. http://phx.corporate-ir.net/phoenix.zhtml%3Fc=98399%26p=irol-newsArticle%26ID=1191052.
80. Eaton J.D., Perry M.J., Nicholson S., et al. Allogeneic whole-cell vaccine: a phase I/II study in men with hormone-refractory prostate cancer. BJU Int 2002, 89:19.
81. Noguchi M., Mine T., Komatsu N., et al. Assessment of immunological biomarkers in patients with advanced cancer treated by personalized peptide vaccination. Cancer Biol Ther 2011, 10:1266.
82. Nakada T., Noguchi Y., Satoh S., et al. NY-ESO-1 mRNA expression and immunogenicity in advanced prostate cancer. Cancer Immun 2003, 3:10.
83. Zeng G., Li Y., El-Gamil M., et al. Generation of NY-ESO-1-specific CD4+ and CD8+ T cells by a single peptide with dual MHC class I and class II specificities: a new strategy for vaccine design. Cancer Res 2002, 62:3630.
84. Zeng G., Wang X., Robbins P.F., et al. CD4(+) T cell recognition of MHC class II-restricted epitopes from NY-ESO-1 presented by a prevalent HLA DP4 allele: association with NY-ESO-1 antibody production. Proc Natl Acad Sci U S A 2001, 98:3964.
85. Komatsu N., Matsueda S., Tashiro K., et al. Gene expression profiles in peripheral blood as a biomarker in cancer patients receiving peptide vaccination. Cancer 2012, 118:3208.
86. Elzey B.D., Siemens D.R., Ratliff T.L., et al. Immunization with type 5 adenovirus recombinant for a tumor antigen in combination with recombinant canarypox virus (ALVAC) cytokine gene delivery induces destruction of established prostate tumors. Int J Cancer 2001, 94:842.
87. Siemens D.R., Elzey B.D., Lubaroff D.M., et al. Cutting edge: restoration of the ability to generate CTL in mice immune to adenovirus by delivery of virus in a collagen-based matrix. J Immunol 2001, 166:731.
88. Lubaroff D.M., Konety B.R., Link B., et al. Phase I clinical trial of an adenovirus/prostate-specific antigen vaccine for prostate cancer: safety and immunologic results. Clin Cancer Res 2009, 15:7375.
89. Aragon-Ching J.B., Williams K.M., Gulley J.L. Impact of androgen-deprivation therapy on the immune system: implications for combination therapy of prostate cancer. Front Biosci 2007, 12:4957.
90. Drake C.G., Doody A.D., Mihalyo M.A., et al. Androgen ablation mitigates tolerance to a prostate/prostate cancer-restricted antigen. Cancer Cell 2005, 7:239.
91. Mercader M., Bodner B.K., Moser M.T., et al. T cell infiltration of the prostate induced by androgen withdrawal in patients with prostate cancer. Proc Natl Acad Sci U S A 2001, 98:14565.
92. Roden A.C., Moser M.T., Tri S.D., et al. Augmentation of T cell levels and responses induced by androgen deprivation. J Immunol 2004, 173:6098.
93. Sutherland J.S., Goldberg G.L., Hammett M.V., et al. Activation of thymic regeneration in mice and humans following androgen blockade. J Immunol 2005, 175:2741.
94. Geary S.M., Lemke C.D., Lubaroff D.M., et al. Tumor immunotherapy using adenovirus vaccines in combination with intratumoral doses of CpG ODN. Cancer Immunol Immunother 2011, 60:1309.
95. Pamer E.G. Immune responses to Listeria monocytogenes. Nat Rev Immunol 2004, 4:812.
96. Shahabi V., Reyes-Reyes M., Wallecha A., et al. Development of a Listeria monocytogenes based vaccine against prostate cancer. Cancer Immunol Immunother 2008, 57:1301.
97. Maciag P.C., Radulovic S., Rothman J. The first clinical use of a live-attenuated Listeria monocytogenes vaccine: a phase I safety study of Lm-LLO-E7 in patients with advanced carcinoma of the cervix. Vaccine 2009, 27:3975.
98. Le D.T., Brockstedt D.G., Nir-Paz R., et al. A live-attenuated Listeria vaccine (ANZ-100) and a live-attenuated Listeria vaccine expressing mesothelin (CRS-207) for advanced cancers: phase i studies of safety and immune induction. Clin Cancer Res 2012, 18:858.
99. Eisenhauer E.A., Therasse P., Bogaerts J., et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228.
100. Arlen P.M., Bianco F., Dahut W.L., et al. Prostate Specific Antigen Working Group guidelines on prostate specific antigen doubling time. J Urol 2008, 179:2181.
101. de Bono J.S., Scher H.I., Montgomery R.B., et al. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res 2008, 14:6302.
102. Hoos A., Eggermont A.M., Janetzki S., et al. Improved endpoints for cancer immunotherapy trials. J Natl Cancer Inst 2010, 102:1388.
103. Wolchok J.D., Hoos A., O'Day S., et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009, 15:7412.
104. Arlen P., Tsang K.Y., Marshall J.L., et al. The use of a rapid ELISPOT assay to analyze peptide-specific immune responses in carcinoma patients to peptide vs. recombinant poxvirus vaccines. Cancer Immunol Immunother 2000, 49:517.
105. Kreher C.R., Dittrich M.T., Guerkov R., et al. CD4+ and CD8+ cells in cryopreserved human PBMC maintain full functionality in cytokine ELISPOT assays. J Immunol Methods 2003, 278:79.
106. Whiteside T.L. Immunologic monitoring of clinical trials in patients with cancer: technology versus common sense. Immunol Invest 2000, 29:149.
107. Bilusic M., Gulley J.L. Endpoints, patient selection, and biomarkers in the design of clinical trials for cancer vaccines. Cancer Immunol Immunother 2012, 61:109.
108. Chang M.H., You S.L., Chen C.J., et al. Decreased incidence of hepatocellular carcinoma in hepatitis B vaccinees: a 20-year follow-up study. J Natl Cancer Inst 2009, 101:1348.
109. Garland S.M., Hernandez-Avila M., Wheeler C.M., et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med 2007, 356:1928.
110. Sonpavde G., Thompson T.C., Jain R.K., et al. GLIPR1 tumor suppressor gene expressed by adenoviral vector as neoadjuvant intraprostatic injection for localized intermediate or high-risk prostate cancer preceding radical prostatectomy. Clin Cancer Res 2011, 17:7174.