Immunotherapy in prostate cancer: Emerging strategies against a formidable foe

Vaccine

Volumn 29, Issue 38, 2011, Pages 6485-6497

  Bilusic, Marijo ^a   Heery, Christopher ^a   Madan, Ravi A ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

Cancer vaccines; Immune checkpoint inhibitors; Immunotherapy; Prostate cancer

Indexed keywords

ACID PHOSPHATASE PROSTATE ISOENZYME; BLP 25 LIPOSOME VACCINE; BUDESONIDE; CANCER VACCINE; CYCLIC AMP DEPENDENT PROTEIN KINASE ANCHORING PROTEIN; CYCLIC AMP DEPENDENT PROTEIN KINASE ANCHORING PROTEIN 4; CYCLOPHOSPHAMIDE; DNA VACCINE; DOCETAXEL; FLUTAMIDE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR VACCINE; IPILIMUMAB; L BLP 25; MONTANIDE ISA 51; MUCIN 1; NEW GENE EXPRESSED IN PROSTATE; PLACEBO; PLASMID DNA; PREDNISONE; PROSTATE SPECIFIC ANTIGEN; PROSTATE SPECIFIC MEMBRANE ANTIGEN; PROSTATE STEM CELL ANTIGEN; PROSTVAC; PROVENGE; PSA TRICOM VACCINE; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; SIX TRANSMEMBRANE EPITHELIAL ANTIGEN OF THE PROSTATE; STIMUVAX; T LYMPHOCYTE RECEPTOR GAMMA CHAIN; T LYMPHOCYTE RECEPTOR GAMMA CHAIN ALTERNATE READING FRAME PROTEIN; TUMOR ANTIGEN; TUMOR MARKER; UNCLASSIFIED DRUG;

AUTOIMMUNE DISEASE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER HORMONE THERAPY; CANCER IMMUNIZATION; CANCER RADIOTHERAPY; CANCER SURVIVAL; COLITIS; CORTICOSTEROID THERAPY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG INDUCED DISEASE; DRUG MECHANISM; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; FEVER; HUMAN; IMMUNOSTIMULATION; INJECTION SITE REACTION; LIPOSOMAL DELIVERY; MULTIPLE CYCLE TREATMENT; NONHUMAN; OVERALL SURVIVAL; PATIENT SELECTION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; PROTEIN EXPRESSION; PROTEIN LOCALIZATION; REVIEW; SINGLE DRUG DOSE; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

CANCER VACCINES; CLINICAL TRIALS AS TOPIC; DRUG THERAPY, COMBINATION; HUMANS; IMMUNOTHERAPY; MALE; PROSTATIC NEOPLASMS; TREATMENT OUTCOME;

EID: 80051664956     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.06.088     Document Type: Review

References (150)

1. Jemal A., Siegel R., Xu J., Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010, 60:277-300.
2. Roehl K.A, Han M., Ramos C.G., Antenor J.A., Catalona W.J. Cancer progression and survival rates following anatomical radical retropubic prostatectomy in 3,478 consecutive patients: long-term results. J Urol 2004, 172:910-914.
3. Tanaka K., Tanahashi N., Tsurumi C., Yokota K.Y., Shimbara N. Proteasomes and antigen processing. Adv Immunol 1997, 64:1-38.
4. Hammer G.E., Kanaseki T., Shastri N. The final touches make perfect the peptide-MHC class I repertoire. Immunity 2007, 26:397-406.
5. Cheever M.A., Allison J.P., Ferris A.S., Finn O.J., Hastings B.M., Hecht T.T., et al. The prioritization of cancer antigens: a national cancer institute pilot project for the acceleration of translational research. Clin Cancer Res 2009, 15:5323-5337.
6. Freedland S.J., Hotaling J.M., Fitzsimons N.J., Presti J.C., Kane C.J., Terris M.K., et al. PSA in the new millennium: a powerful predictor of prostate cancer prognosis and radical prostatectomy outcomes-results from the SEARCH database. Eur Urol 2008, 53:758-764. [65-6; discussion].
7. Madan R.A., Arlen P.M., Mohebtash M., Hodge J.W., Gulley J.L. Prostvac-V.F: a vector-based vaccine targeting PSA in prostate cancer. Expert Opin Investig Drugs 2009, 18:1001-1011.
8. Fishman M. A changing world for DCvax: a PSMA loaded autologous dendritic cell vaccine for prostate cancer. Expert Opin Biol Ther 2009, 9:1565-1575.
9. Becker J.T., Olson B.M., Johnson L.E., Davies J.G., Dunphy E.J., McNeel D.G. DNA vaccine encoding prostatic acid phosphatase (PAP) elicits long-term T-cell responses in patients with recurrent prostate cancer. J Immunother 2010, 33:639-647.
10. Maeda H., Nagata S., Wolfgang C.D., Bratthauer G.L., Bera T.K., Pastan I. The T cell receptor gamma chain alternate reading frame protein (TARP), a prostate-specific protein localized in mitochondria. J Biol Chem 2004, 279:24561-24568.
11. Epel M., Carmi I., Soueid-Baumgarten S., Oh S.K., Bera T., Pastan I., et al. Targeting TARP, a novel breast and prostate tumor-associated antigen, with T cell receptor-like human recombinant antibodies. Eur J Immunol 2008, 38:1706-1720.
12. Cereda V., Poole D.J., Palena C., Das S., Bera T.K., Remondo C., et al. New gene expressed in prostate: a potential target for T cell-mediated prostate cancer immunotherapy. Cancer Immunol Immunother 2010, 59:63-71.
13. Raff A.B., Gray A., Kast W.M. Prostate stem cell antigen: a prospective therapeutic and diagnostic target. Cancer Lett 2009, 277:126-132.
14. Garcia-Hernandez M., de L., Gray A., Hubby B., Kast W.M. In vivo effects of vaccination with six-transmembrane epithelial antigen of the prostate: a candidate antigen for treating prostate cancer. Cancer Res 2007, 67:1344-1351.
15. Sabbisetti V.S., Chirugupati S., Thomas S., Vaidya K.S., Reardon D., Chiriva-Internati M., et al. Calcitonin increases invasiveness of prostate cancer cells: role for cyclic AMP-dependent protein kinase A in calcitonin action. Int J Cancer 2005, 117:551-560.
16. Chiriva-Internati M., Yu Y., Mirandola L., D'Cunha N., Hardwicke F., Cannon M.J., et al. Identification of AKAP-4 as a new cancer/testis antigen for detection and immunotherapy of prostate cancer. Prostate 2011.
17. Finn O.J., Jerome K.R., Henderson R.A., Pecher G., Domenech N., Magarian-Blander J., et al. MUC-1 epithelial tumor mucin-based immunity and cancer vaccines. Immunol Rev 1995, 145:61-89.
18. Cozzi P.J., Wang J., Delprado W., Perkins A.C., Allen B.J., Russell P.J., et al. MUC1, MUC2, MUC4, MUC5AC and MUC6 expression in the progression of prostate cancer. Clin Exp Metastasis 2005, 22:565-573.
19. Parmiani G., Russo V., Marrari A., Cutolo G., Casati C., Pilla L., et al. Universal and stemness-related tumor antigens: potential use in cancer immunotherapy. Clin Cancer Res 2007, 13:5675-5679.
20. Fu T., Shen Y., Fujimoto S. Tumor-specific CD4(+) suppressor T-cell clone capable of inhibiting rejection of syngeneic sarcoma in A/J mice. Int J Cancer 2000, 87:680-687.
21. Ghiringhelli F., Larmonier N., Schmitt E., Parcellier A., Cathelin D., Garrido C., et al. CD4+CD25+ regulatory T cells suppress tumor immunity but are sensitive to cyclophosphamide which allows immunotherapy of established tumors to be curative. Eur J Immunol 2004, 34:336-344.
22. Teicher B.A. Transforming growth factor-beta and the immune response to malignant disease. Clin Cancer Res 2007, 13:6247-6251.
23. Muller A.J., Prendergast G.C. Indoleamine 2,3-dioxygenase in immune suppression and cancer. Curr Cancer Drug Targets 2007, 7:31-40.
24. Gulley J.L., Arlen P.M., Madan R.A., Tsang K.Y., Pazdur M.P., Skarupa L., 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, 59:663-674.
25. Halabi S., Small E.J., Kantoff P.W., Kattan M.W., Kaplan E.B., Dawson N.A., et al. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol 2003, 21:1232-1237.
26. Peshwa M.V., Shi J.D., Ruegg C., Laus R., van Schooten W.C. Induction of prostate tumor-specific CD8+ cytotoxic T-lymphocytes in vitro using antigen-presenting cells pulsed with prostatic acid phosphatase peptide. Prostate 1998, 36:129-138.
27. Small E.J., Fratesi P., Reese D.M., Strang G., Laus R., Peshwa M.V., et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol 2000, 18:3894-3903.
28. Burch P.A., Breen J.K., Buckner J.C., Gastineau D.A., Kaur J.A., Laus R.L., et al. Priming tissue-specific cellular immunity in a phase I trial of autologous dendritic cells for prostate cancer. Clin Cancer Res 2000, 6:2175-2182.
29. Burch P.A., Croghan G.A., Gastineau D.A., Jones L.A., Kaur J.S., Kylstra J.W., et al. Immunotherapy (APC8015, Provenge) targeting prostatic acid phosphatase can induce durable remission of metastatic androgen-independent prostate cancer: a phase 2 trial. Prostate 2004, 60:197-204.
30. Kantoff P.W., Higano C.S., Shore N.D., Berger E.R., Small E.J., Penson D.F., et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010, 363:411-422.
31. Small E.J., Schellhammer P.F., Higano C.S., Redfern C.H., Nemunaitis J.J., Valone F.H., 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, 24:3089-3094.
32. Higano C.S., Schellhammer P.F., Small E.J., Burch P.A., Nemunaitis J., Yuh L., 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, 115:3670-3679.
33. Beer T.M., Bernstein G.T., Corman J.M., Glode M., Hall S.J., Poll W.L., et al. Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. Clin Cancer Res 2011.
34. Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer (NeoACT). [June 2011]; Available from: http://clinicaltrials.gov/ct2/show/NCT00715104.
35. Arlen P.M., Kaufman H.L., DiPaola R.S. Pox viral vaccine approaches. Semin Oncol 2005, 32:549-555.
36. Kantoff P.W., Schuetz T.J., Blumenstein B.A., Glode L.M., Bilhartz D.L., Wyand M., 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, 28:1099-1105.
37. Kaufman H.L., Wang W., Manola J., DiPaola R.S., Ko Y.J., Sweeney C., 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, 22:2122-2132.
38. Harrington L.E., Most Rv R., Whitton J.L., Ahmed R. Recombinant vaccinia virus-induced T-cell immunity: quantitation of the response to the virus vector and the foreign epitope. J Virol 2002, 76:3329-3337.
39. Arlen P.M., Skarupa L., Pazdur M., Seetharam M., Tsang K.Y., Grosenbach D.W., et al. Clinical safety of a viral vector-based prostate cancer vaccine strategy. J Urol 2007, 178:1515-1520.
40. DiPaola R, Chen Y, Bubley G, Hahn N, Stein M, Schlom J, et al. A phase II study of PROSTVAC-V (vaccinia)/TRICOM and PROSTVAC-F (fowlpox)/TRICOM with GM-CSF in patients with PSA progression after local therapy for prostate cancer: results of ECOG 9802 [abstract]. ASCO Genitourinary Cancers Symposium 2009:108.
41. Gulley J., Chen A.P., Dahut W., Arlen P.M., Bastian A., Steinberg S.M., et al. Phase I study of a vaccine using recombinant vaccinia virus expressing PSA (rV-PSA) in patients with metastatic androgen-independent prostate cancer. Prostate 2002, 53:109-117.
42. Gulley J.L., Arlen P.M., Bastian A., Morin S., Marte J., Beetham P., et al. Combining a recombinant cancer vaccine with standard definitive radiotherapy in patients with localized prostate cancer. Clin Cancer Res 2005, 11:3353-3362.
43. Arlen P.M., Gulley J.L., Todd N., Lieberman R., Steinberg S.M., Morin S., et al. Antiandrogen, vaccine and combination therapy in patients with nonmetastatic hormone refractory prostate cancer. J Urol 2005, 174:539-546.
44. Eder J.P., Kantoff P.W., Roper K., Xu G.X., Bubley G.J., Boyden J., et al. A phase I trial of a recombinant vaccinia virus expressing prostate-specific antigen in advanced prostate cancer. Clin Cancer Res 2000, 6:1632-1638.
45. Sanda M.G., Smith D.C., Charles L.G., Hwang C., Pienta K.J., Schlom J., et al. Recombinant vaccinia-PSA (PROSTVAC) can induce a prostate-specific immune response in androgen-modulated human prostate cancer. Urology 1999, 53:260-266.
46. Sahin U., Tureci O., Pfreundschuh M. Serological identification of human tumor antigens. Curr Opin Immunol 1997, 9:709-716.
47. Melero I., Hervas-Stubbs S., Glennie M., Pardoll D.M., Chen L. Immunostimulatory monoclonal antibodies for cancer therapy. Nat Rev Cancer 2007, 7:95-106.
48. Fong L., Small E.J. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J Clin Oncol 2008, 26:5275-5283.
49. O'Day S.J., Hamid O., Urba W.J. Targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4): a novel strategy for the treatment of melanoma and other malignancies. Cancer 2007, 110:2614-2627.
50. Small E.J., Tchekmedyian N.S., Rini B.I., Fong L., Lowy I., Allison J.P. A pilot trial of CTLA-4 blockade with human anti-CTLA-4 in patients with hormone-refractory prostate cancer. Clin Cancer Res 2007, 13:1810-1815.
51. Hersh E.M., O'Day S.J., Powderly J., Khan K.D., Pavlick A.C., Cranmer L.D., et al. A phase II multicenter study of ipilimumab with or without dacarbazine in chemotherapy-naive patients with advanced melanoma. Invest New Drugs 2010 Jan 16, [Epub ahead of print].
52. O'Day S.J., Maio M., Chiarion-Sileni V., Gajewski T.F., Pehamberger H., Bondarenko I.N., et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol 2010, 21:1712-1717.
53. Wolchok J.D., Neyns B., Linette G., Negrier S., Lutzky J., Thomas L., et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol 2010, 11:155-164.
54. Fong L., Kwek S.S., O'Brien S., Kavanagh B., McNeel D.G., Weinberg V., et al. Potentiating endogenous antitumor immunity to prostate cancer through combination immunotherapy with CTLA4 blockade and GM-CSF. Cancer Res 2009, 69:609-615.
55. Ansell S.M., Hurvitz S.A., Koenig P.A., LaPlant B.R., Kabat B.F., Fernando D., et al. Phase I study of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with relapsed and refractory B-cell non-Hodgkin lymphoma. Clin Cancer Res 2009, 15:6446-6453.
56. Yang J.C., Hughes M., Kammula U., Royal R., Sherry R.M., Topalian S.L., et al. Ipilimumab (anti-CTLA4 antibody) causes regression of metastatic renal cell cancer associated with enteritis and hypophysitis. J Immunother 2007, 30:825-830.
57. Beck K.E., Blansfield J.A., Tran K.Q., Feldman A.L., Hughes M.S., Royal R.E., et al. Enterocolitis in patients with cancer after antibody blockade of cytotoxic T-lymphocyte-associated antigen 4. J Clin Oncol 2006, 24:2283-2289.
58. Hodi F.S., O'Day S.J., McDermott D.F., Weber R.W., Sosman J.A., Haanen J.B., et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010, 363:711-723.
59. Beer T., Slovin S., Higano C., Tejwani S., Dorff T., Stankevich E., et al. Phase I trial of ipilimumab (IPI) alone and in combination with radiotherapy (XRT) in patients with metastatic castration resistant prostate cancer (mCRPC) [abstract]. J Clin Oncol 2008, 26(15S):5004.
60. Weber J. Ipilimumab: controversies in its development, utility and autoimmune adverse events. Cancer Immunol Immunother 2009, 58:823-830.
61. Weber J., Thompson J.A., Hamid O., Minor D., Amin A., Ron I., et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res 2009, 15:5591-5598.
62. Chen Y.T., Gure A.O., Tsang S., Stockert E., Jager E., Knuth A., et al. Identification of multiple cancer/testis antigens by allogeneic antibody screening of a melanoma cell line library. Proc Natl Acad Sci U S A 1998, 95:6919-6923.
63. Scanlan M.J., Chen Y.T., Williamson B., Gure A.O., Stockert E., Gordan J.D., et al. Characterization of human colon cancer antigens recognized by autologous antibodies. Int J Cancer 1998, 76:652-658.
64. Ward J.E., McNeel D.G. GVAX: an allogeneic, whole-cell, GM-CSF-secreting cellular immunotherapy for the treatment of prostate cancer. Expert Opin Biol Ther 2007, 7:1893-1902.
65. Small E, Demkow T, Gerritsen W, Rolland F, Hoskin P, Smith D, 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) [abstract]. ASCO Genitourinary Cancers Symposium 2009:7.
66. Higano C, Saad F, Somer B, Curti B, Petrylak D, Drake C, et al. A phase III trial of GVAX immunotherapy for prostate cancer versus docetaxel plus prednisone in asymptomatic, castration-resistant prostate cancer (CRPC) [abstract]. ASCO Genitourinary Cancers Symposium 2009:LBA150.
67. Higano C.S., Corman J.M., Smith D.C., Centeno A.S., Steidle C.P., Gittleman M., et al. Phase 1/2 dose-escalation study of a GM-CSF-secreting, allogeneic, cellular immunotherapy for metastatic hormone-refractory prostate cancer. Cancer 2008, 113:975-984.
68. Lakatos E. Sample sizes based on the log-rank statistic in complex clinical trials. Biometrics 1988, 44:229-241.
69. Rice J., Ottensmeier C.H., Stevenson F.K. DNA vaccines: precision tools for activating effective immunity against cancer. Nat Rev Cancer 2008, 8:108-120.
70. Tsen S.W., Paik A.H., Hung C.F., Wu T.C. Enhancing DNA vaccine potency by modifying the properties of antigen-presenting cells. Expert Rev Vaccines 2007, 6:227-239.
71. McNeel D.G., Dunphy E.J., Davies J.G., Frye T.P., Johnson L.E., Staab M.J., 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, 27:4047-4054.
72. Madan R.A., Mohebtash M., Schlom J., Gulley J.L. Therapeutic vaccines in metastatic castration-resistant prostate cancer: principles in clinical trial design. Expert Opin Biol Ther 2010, 10:19-28.
73. Essand M., Vasmatzis G., Brinkmann U., Duray P., Lee B., Pastan I. High expression of a specific T-cell receptor gamma transcript in epithelial cells of the prostate. Proc Natl Acad Sci U S A 1999, 96:9287-9292.
74. Wolfgang C.D., Essand M., Lee B., Pastan I. T-cell receptor gamma chain alternate reading frame protein (TARP) expression in prostate cancer cells leads to an increased growth rate and induction of caveolins and amphiregulin. Cancer Res 2001, 61:8122-8126.
75. Kirschenbaum A., Itzkowitz S.H., Wang J.P., Yao S., Eliashvili M., Levine A.C. MUC1 expression in prostate carcinoma: correlation with grade and stage. Mol Urol 1999, 3:163-168.
76. Butts C., Murray N., Maksymiuk A., Goss G., Marshall E., Soulieres D., et al. Randomized phase IIB trial of BLP25 liposome vaccine in stage IIIB and IV non-small-cell lung cancer. J Clin Oncol 2005, 23:6674-6681.
77. North S.A., Graham K., Bodnar D., Venner P. A pilot study of the liposomal MUC1 vaccine BLP25 in prostate specific antigen failures after radical prostatectomy. J Urol 2006, 176:91-95.
78. Gulley J.L., Madan R.A., Arlen P.M. Enhancing efficacy of therapeutic vaccinations by combination with other modalities. Vaccine 2007, 25(Suppl. 2):B89-B96.
79. Ozoren N., El-Deiry W.S. Cell surface death receptor signaling in normal and cancer cells. Semin Cancer Biol 2003, 13:135-147.
80. Piccirillo C.A., Shevach E.M. Cutting edge: control of CD8+ T cell activation by CD4+CD25+ immunoregulatory cells. J Immunol 2001, 167:1137-1140.
81. Woo E.Y., Yeh H., Chu C.S., Schlienger K., Carroll R.G., Riley J.L., et al. Cutting edge: regulatory T cells from lung cancer patients directly inhibit autologous T cell proliferation. J Immunol 2002, 168:4272-4276.
82. Sakaguchi S. Regulatory T cells: key controllers of immunologic self-tolerance. Cell 2000, 101:455-458.
83. Mule J.J., Schwarz S.L., Roberts A.B., Sporn M.B., Rosenberg S.A. Transforming growth factor-beta inhibits the in vitro generation of lymphokine-activated killer cells and cytotoxic T cells. Cancer Immunol Immunother 1988, 26:95-100.
84. Farsaci B., Sabzevari H., Higgins J.P., Di Bari M.G., Takai S., Schlom J., et al. Effect of a small molecule BCL-2 inhibitor on immune function and use with a recombinant vaccine. Int J Cancer 2010, 127:1603-1613.
85. Chakraborty M., Abrams S.I., Camphausen K., Liu K., Scott T., Coleman C.N., et al. Irradiation of tumor cells up-regulates Fas and enhances CTL lytic activity and CTL adoptive immunotherapy. J Immunol 2003, 170:6338-6347.
86. Ferrara T.A., Hodge J.W., Gulley J.L. Combining radiation and immunotherapy for synergistic antitumor therapy. Curr Opin Mol Ther 2009, 11:37-42.
87. Chakraborty M., Abrams S.I., Coleman C.N., Camphausen K., Schlom J., Hodge J.W. External beam radiation of tumors alters phenotype of tumor cells to render them susceptible to vaccine-mediated T-cell killing. Cancer Res 2004, 64:4328-4337.
88. Nesslinger N.J., Ng A., Tsang K.Y., Ferrara T., Schlom J., Gulley J.L., et al. A viral vaccine encoding prostate-specific antigen induces antigen spreading to a common set of self-proteins in prostate cancer patients. Clin Cancer Res 2010, 16:4046-4056.
89. Garnett C.T., Schlom J., Hodge J.W. Combination of docetaxel and recombinant vaccine enhances T-cell responses and antitumor activity: effects of docetaxel on immune enhancement. Clin Cancer Res 2008, 14:3536-3544.
90. Arlen P.M., Gulley J.L., Parker C., Skarupa L., Pazdur M., Panicali D., 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, 12:1260-1269.
91. von Mehren M., Arlen P., Tsang K.Y., Rogatko A., Meropol N., Cooper H.S., et al. Pilot study of a dual gene recombinant avipox vaccine containing both carcinoembryonic antigen (CEA) and B7.1 transgenes in patients with recurrent CEA-expressing adenocarcinomas. Clin Cancer Res 2000, 6:2219-2228.
92. Matzinger P. The danger model: a renewed sense of self. Science 2002, 296:301-305.
93. Zitvogel L., Apetoh L., Ghiringhelli F., Andre F., Tesniere A., Kroemer G. The anticancer immune response: indispensable for therapeutic success?. J Clin Invest 2008, 118:1991-2001.
94. Aymeric L., Apetoh L., Ghiringhelli F., Tesniere A., Martins I., Kroemer G., et al. Tumor cell death and ATP release prime dendritic cells and efficient anticancer immunity. Cancer Res 2010, 70:855-858.
95. 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, 12:4957-4971.
96. Mercader M., Bodner B.K., Moser M.T., Kwon P.S., Park E.S., Manecke R.G., 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, 98:14565-14570.
97. Goldberg G.L., Sutherland J.S., Hammet M.V., Milton M.K., Heng T.S., Chidgey A.P., et al. Sex steroid ablation enhances lymphoid recovery following autologous hematopoietic stem cell transplantation. Transplantation 2005, 80:1604-1613.
98. Drake C.G., Doody A.D., Mihalyo M.A., Huang C.T., Kelleher E., Ravi S., et al. Androgen ablation mitigates tolerance to a prostate/prostate cancer-restricted antigen. Cancer Cell 2005, 7:239-249.
99. Sutherland J.S., Goldberg G.L., Hammett M.V., Uldrich A.P., Berzins S.P., Heng T.S., et al. Activation of thymic regeneration in mice and humans following androgen blockade. J Immunol 2005, 175:2741-2753.
100. Wang J., Zhang Q., Jin S., Feng M., Kang X., Zhao S., et al. Immoderate inhibition of estrogen by anastrozole enhances the severity of experimental polyarthritis. Exp Gerontol 2009, 44:398-405.
101. Koh Y.T., Gray A., Higgins S.A., Hubby B., Kast W.M. Androgen ablation augments prostate cancer vaccine immunogenicity only when applied after immunization. Prostate 2009, 69:571-584.
102. Madan R.A., Gulley J.L., Schlom J., Steinberg S.M., Liewehr D.J., Dahut W.L., et al. Analysis of overall survival in patients with nonmetastatic castration-resistant prostate cancer treated with vaccine, nilutamide, and combination therapy. Clin Cancer Res 2008, 14:4526-4531.
103. Bilusic M., Gulley J., Heery C., Apolo A., Arlen P., Rauckhorst M., et al. A randomized phase II study of flutamide with or without PSA-TRICOM in nonmetastatic castration-resistant prostate cancer (CRPC) [abstract]. J Clin Oncol 2011, 29(7S):163.
104. Yokokawa J., Cereda V., Remondo C., Gulley J.L., Arlen P.M., Schlom J., et al. Enhanced functionality of CD4+CD25(high)FoxP3+ regulatory T cells in the peripheral blood of patients with prostate cancer. Clin Cancer Res 2008, 14:1032-1040.
105. Gray A., Raff A.B., Chiriva-Internati M., Chen S.Y., Kast W.M. A paradigm shift in therapeutic vaccination of cancer patients: the need to apply therapeutic vaccination strategies in the preventive setting. Immunol Rev 2008, 222:316-327.
106. Garcia-Hernandez M., de L., Gray A., Hubby B., Klinger O.J., Kast W.M. Prostate stem cell antigen vaccination induces a long-term protective immune response against prostate cancer in the absence of autoimmunity. Cancer Res 2008, 68:861-869.
107. Gray A., Yan L., Kast W.M. Prevention is better than cure: the case for clinical trials of therapeutic cancer vaccines in the prophylactic setting. Mol Interv 2010, 10:197-203.
108. Gray A., de la Luz Garcia-Hernandez M., van West M., Kanodia S., Hubby B., Kast W.M. Prostate cancer immunotherapy yields superior long-term survival in TRAMP mice when administered at an early stage of carcinogenesis prior to the establishment of tumor-associated immunosuppression at later stages. Vaccine 2009, 27(Suppl. 6):G52-G59.
109. Kudo-Saito C., Schlom J., Hodge J.W. Induction of an antigen cascade by diversified subcutaneous/intratumoral vaccination is associated with antitumor responses. Clin Cancer Res 2005, 11:2416-2426.
110. Kudo-Saito C., Schlom J., Hodge J.W. Intratumoral vaccination and diversified subcutaneous/intratumoral vaccination with recombinant poxviruses encoding a tumor antigen and multiple costimulatory molecules. Clin Cancer Res 2004, 10:1090-1099.
111. Heery C., Pinto P., Schlom J., Tsang K., Madan R., Poole D., et al. Intraprostatic vaccine administration in patients with locally recurrent prostate cancer [abstract]. J Clin Oncol 2011, 29(7S):141.
112. Ferro M.A., Gillatt D., Symes M.O., Smith P.J. High-dose intravenous estrogen therapy in advanced prostatic carcinoma. Use of serum prostate-specific antigen to monitor response. Urology 1989, 34:134-138.
113. Figg W.D., Ammerman K., Patronas N., Steinberg S.M., Walls R.G., Dawson N., et al. Lack of correlation between prostate-specific antigen and the presence of measurable soft tissue metastases in hormone-refractory prostate cancer. Cancer Invest 1996, 14:513-517.
114. Smith D.C., Dunn R.L., Strawderman M.S., Pienta K.J. Change in serum prostate-specific antigen as a marker of response to cytotoxic therapy for hormone-refractory prostate cancer. J Clin Oncol 1998, 16:1835-1843.
115. Kelly W.K., Scher H.I., Mazumdar M., Vlamis V., Schwartz M., Fossa S.D. Prostate-specific antigen as a measure of disease outcome in metastatic hormone-refractory prostate cancer. J Clin Oncol 1993, 11:607-615.
116. Scher H.I., Kelly W.M., Zhang Z.F., Ouyang P., Sun M., Schwartz M., et al. Post-therapy serum prostate-specific antigen level and survival in patients with androgen-independent prostate cancer. J Natl Cancer Inst 1999, 91:244-251.
117. Stein W.D., Yang J., Bates S.E., Fojo T. Bevacizumab reduces the growth rate constants of renal carcinomas: a novel algorithm suggests early discontinuation of bevacizumab resulted in a lack of survival advantage. Oncologist 2008, 13:1055-1062.
118. Stein W.D., Figg W.D., Dahut W., Stein A.D., Hoshen M.B., Price D., et al. Tumor growth rates derived from data for patients in a clinical trial correlate strongly with patient survival: a novel strategy for evaluation of clinical trial data. Oncologist 2008, 13:1046-1054.
119. Stein W.D., Gulley J.L., Schlom J., Madan R.A., Dahut W., Figg W.D., et al. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy. Clin Cancer Res 2011, 17:907-917.
120. Tang P.A., Bentzen S.M., Chen E.X., Siu L.L. Surrogate end points for median overall survival in metastatic colorectal cancer: literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol 2007, 25:4562-4568.
121. Panageas K.S., Ben-Porat L., Dickler M.N., Chapman P.B., Schrag D. When you look matters: the effect of assessment schedule on progression-free survival. J Natl Cancer Inst 2007, 99:428-432.
122. Therasse P., Eisenhauer E.A., Verweij J. RECIST revisited: a review of validation studies on tumour assessment. Eur J Cancer 2006, 42:1031-1039.
123. Schlom J., Arlen P.M., Gulley J.L. Cancer vaccines: moving beyond current paradigms. Clin Cancer Res 2007, 13:3776-3782.
124. Madan R.A., Gulley J.L., Fojo T., Dahut W.L. Therapeutic cancer vaccines in prostate cancer: the paradox of improved survival without changes in time to progression. Oncologist 2010, 15:969-975.
125. Hoos A. Proposal of a clinical development paradigm for cancer immunotherapy: novel endpoints. Presented at ASCO 2008 Annual Meeting, June 2, Chicago, IL. [June 2011]; Available from: http://www.asco.org/ascov2/MultiMedia/Virtual+Meeting%3F%26vmview=vm_session_presentations_view%26confID=55%26sessionID=2624.
126. Fine G.D. Consequences of delayed treatment effects on analysis of time-to-event endpoints. Drug Inf J 2007, 41:535-539.
127. Sposto R., Stablein D., Carter-Campbell S. A partially grouped logrank test. Stat Med 1997, 16:695-704.
128. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. 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 2000, 92:205-216.
129. Gulley J.L., Arlen P.M., Tsang K.Y., Yokokawa J., Palena C., Poole D.J., et al. Pilot study of vaccination with recombinant CEA-MUC-1-TRICOM poxviral-based vaccines in patients with metastatic carcinoma. Clin Cancer Res 2008, 14:3060-3069.
130. Jones R.L., Cunningham D., Cook G., Ell P.J. Tumour vaccine associated lymphadenopathy and false positive positron emission tomography scan changes. Br J Radiol 2004, 77:74-75.
131. Loveland B.E., Zhao A., White S., Gan H., Hamilton K., Xing P.X., et al. Mannan-MUC1-pulsed dendritic cell immunotherapy: a phase I trial in patients with adenocarcinoma. Clin Cancer Res 2006, 12:869-877.
132. Saenger Y.M., Wolchok J.D. The heterogeneity of the kinetics of response to ipilimumab in metastatic melanoma: patient cases. Cancer Immun 2008, 8:1.
133. Wolchok J.D., Hoos A., O'Day S., Weber J.S., Hamid O., Lebbe C., et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009, 15:7412-7420.
134. Czerkinsky C., Andersson G., Ekre H.P., Nilsson L.A., Klareskog L., Ouchterlony O. Reverse ELISPOT assay for clonal analysis of cytokine production I. Enumeration of gamma-interferon-secreting cells. J Immunol Methods 1988, 110:29-36.
135. Ryan J.E., Ovsyannikova I.G., Dhiman N., Pinsky N.A., Vierkant R.A., Jacobson R.M., et al. Inter-operator variation in ELISPOT analysis of measles virus-specific IFN-gamma-secreting T cells. Scand J Clin Lab Invest 2005, 65:681-689.
136. Cox J.H., Ferrari G., Kalams S.A., Lopaczynski W., Oden N., D'Souza M.P. Results of an ELISPOT proficiency panel conducted in 11 laboratories participating in international human immunodeficiency virus type 1 vaccine trials. AIDS Res Hum Retroviruses 2005, 21:68-81.
137. Hernandez-Fuentes M.P., Warrens A.N., Lechler R.I. Immunologic monitoring. Immunol Rev 2003, 196:247-264.
138. Scher H.I., Heller G., Molina A., Kheoh T., Attard G., Moreira J., et al. Evaluation of circulating tumor cell (CTC) enumeration as an efficacy response biomarker of overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC): Planned final analysis (FA) of COU-AA-301, a randomized double-blind, placebo-controlled phase III study of abiraterone acetate (AA) plus low-dose prednisone (P) post docetaxel [abstract]. J Clin Oncol 2011, 29:LB4517.
139. Sahin U., Tureci O., Schmitt H., Cochlovius B., Johannes T., Schmits R., et al. Human neoplasms elicit multiple specific immune responses in the autologous host. Proc Natl Acad Sci U S A 1995, 92:11810-11813.
140. de Bono J., Ashworth A. Translating cancer research into targeted therapeutics. Nature 2010, 467:543-549.
141. Cheever M.A., Schlom J., Weiner L.M., Lyerly H.K., Disis M.L., Greenwood A., et al. Translational Research Working Group developmental pathway for immune response modifiers. Clin Cancer Res 2008, 14:5692-5699.
142. Britten C.M., Janetzki S., van der Burg S.H., Gouttefangeas C., Hoos A. Toward the harmonization of immune monitoring in clinical trials: quo vadis?. Cancer Immunol Immunother 2008, 57:285-288.
143. Hoos A., Parmiani G., Hege K., Sznol M., Loibner H., Eggermont A., et al. A clinical development paradigm for cancer vaccines and related biologics. J Immunother 2007, 30:1-15.
144. Janetzki S., Panageas K.S., Ben-Porat L., Boyer J., Britten C.M., Clay T.M., et al. Results and harmonization guidelines from two large-scale international ELISPOT proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI). Cancer Immunol Immunother 2008, 57:303-315.
145. Boehm A.L., Higgins J., Franzusoff A., Schlom J., Hodge J.W. Concurrent vaccination with two distinct vaccine platforms targeting the same antigen generates phenotypically and functionally distinct T-cell populations. Cancer Immunol Immunother 2010, 59:397-408.
146. Rappuoli R., Aderem A. A 2020 vision for vaccines against HIV, tuberculosis and malaria. Nature 2011, 473:463-469.
147. Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer. [April 2011]; Available from: http://www.clinicaltrials.gov/ct2/show/NCT01057810%3Fterm=NCT01057810%26rank=1.
148. Study of Immunotherapy to Treat Advanced Prostate Cancer. [April 2011]; Available from: http://www.clinicaltrials.gov/ct2/show/NCT00861614%3Fterm=NCT00861614%26rank=1.
149. Bavarian Nordic Receives Special Protocol Assessment Agreement from the FDA for Phase 3 Trial of PROSTVAC®. Accessed: April 2011; Available from: http://www.bavarian-nordic.com/investor/announcements/2010-40.aspx.
150. BioSante Pharmaceuticals: Cancer Vaccines. Accessed: March 2011; Available from: http://www.biosantepharma.com/Cancer-Vaccines.php.