Cancer immunotherapy: Sipuleucel-T and beyond

Pharmacotherapy

Volumn 31, Issue 8, 2011, Pages 813-828

  Hammerstrom, Aimee E ^a   Cauley, Diana H ^a   Atkinson, Bradley J ^a   Sharma, Padmanee ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Advanced prostate cancer; Anticancer vaccines; Immunotherapy; Sipuleucel T; Tumor immunology

Indexed keywords

BEVACIZUMAB; BIOVAXID; CABAZITAXEL; CANCER VACCINE; CORTICOSTEROID; DCVAX; DENDRITIC CELL VACCINE; DOCETAXEL; GLYCOPROTEIN 100; GONADORELIN AGONIST; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR VACCINE; HEAT SHOCK PROTEIN; IPILIMUMAB; MDX 101; MDX 1106; NILUTAMIDE; OPIATE; PA 2024; PLACEBO; PREDNISONE; PROSTATE SPECIFIC ANTIGEN; PROSTATE SPECIFIC MEMBRANE ANTIGEN; PROSTATIC ACID; PROSTVAC VF; PROVENGE; TICILIMUMAB; TUMOR ANTIGEN; TUMOR CELL VACCINE; UNCLASSIFIED DRUG; UNINDEXED DRUG; VIRUS VECTOR; VITESPEN;

ABLATION THERAPY; ADAPTIVE IMMUNITY; ADVANCED CANCER; ANTIGEN PRESENTING CELL; ARTHRALGIA; B LYMPHOCYTE; BACKACHE; BLEEDING; BONE PAIN; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CANCER IMMUNOTHERAPY; CANCER PAIN; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; CEREBROVASCULAR DISEASE; CHILL; COLITIS; COMBINATION CHEMOTHERAPY; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DRUG COST; DRUG CYTOTOXICITY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; ENDOCRINE DISEASE; FATIGUE; GENE THERAPY; GLIOBLASTOMA; HELPER CELL; HORMONE REFRACTORY PROSTATE CANCER; HUMAN; HUMORAL IMMUNITY; IMMUNE RESPONSE; IMMUNE SYSTEM; IMMUNOSTIMULATION; INNATE IMMUNITY; KIDNEY CARCINOMA; LYMPHOCYTE PROLIFERATION; MELANOMA; METASTASIS; METASTASIS POTENTIAL; MONOTHERAPY; NAUSEA; NONHODGKIN LYMPHOMA; ORCHIECTOMY; OVERALL SURVIVAL; POXVIRUS; PROSTATE CANCER; QUALITY ADJUSTED LIFE YEAR; REGULATORY T LYMPHOCYTE; REVIEW; SKIN DISEASE; SOLID TUMOR; T LYMPHOCYTE; T LYMPHOCYTE ACTIVATION; TREATMENT DURATION; TUMOR IMMUNOLOGY; VIRAL GENE DELIVERY SYSTEM; VISCERAL METASTASIS;

ANIMALS; ANTIGENS, NEOPLASM; CANCER VACCINES; HUMANS; IMMUNOTHERAPY; MALE; NEOPLASM STAGING; NEOPLASMS; PROSTATIC NEOPLASMS; T-LYMPHOCYTES; TISSUE EXTRACTS;

EID: 79961109805     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.31.8.813     Document Type: Review

References (77)

1. Dendreon Inc. Provenge (sipuleucel-T) package insert. Seattle, WA; 2010.
2. Starnes CO. Coley's toxins in perspective. Nature 1992;357:11-12.
3. Delves PJ, Roitt IM. The immune system: first of two parts. N Engl J Med 2000;343:37-49. (Pubitemid 30447991)
4. Delves PJ, Roitt IM. The immune system: second of two parts. N Engl J Med 2000;343:108-17.
5. Quezada SA, Simpson TR, Peggs KS, et al. Tumor-reactive CD4(+) T cells develop cytotoxic activity and eradicate large established melanoma after transfer into lymphopenic hosts. J Exp Med 2010;207:637-50.
6. Liu Y, Ng K, Lillehei KO. Cell-mediated immunotherapy: a new approach to the treatment of malignant glioma. Cancer Control 2003;10:138-47. (Pubitemid 36437820)
7. Harding FA, McArthur JG, Gross JA, Raulet DH, Allison JP. CD28-mediated signaling costimulates murine T cells and prevents induction of anergy in T cell clones. Nature 1992;356:607-9.
8. Mueller DL, Jenkins MK, Schwartz RH. Clonal expansion versus functional clonal inactivation: a costimulatory signaling pathway determines the outcome of T cell antigen receptor occupancy. Annu Rev Immunol 1989;7:445-80. (Pubitemid 19138020)
9. Brunet JF, Denizot F, Luciani MF, et al. A new member of the immunoglobulin superfamily: CTLA-4. Nature 1987;328:267-70. (Pubitemid 17108278)
10. Ishida Y, Agata Y, Shibahara K, Honjo T. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J 1992;11:3887-95.
11. + T cells. J Immunol 2000;165:5062-8.
12. Krummel MF, Allison JP. CD28 and CTLA-4 have opposing effects on the response of T cells to stimulation. J Exp Med 1995;182:459-65.
13. Butte MJ, Keir ME, Phamduy TB, Sharpe AH, Freeman GJ. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T cell responses. Immunity 2007;27:111-22. (Pubitemid 47089023)
14. Curiel TJ. Regulatory T cell development: is Foxp3 the decider? Nat Med 2007;13:250-3. (Pubitemid 46376657)
15. + regulatory T cells for immunologic self-tolerance and negative control of immune responses. Annu Rev Immunol 2004;22:531-62.
16. reg: mode, stability, and role in specific tolerance. J Clin Immunol 2008;28:619-24.
17. Jonuleit H, Schmitt E, Schuler G, Knop J, Enk AH. Induction of interleukin 10-producing, nonproliferating CD4(+) T cells with regulatory properties by repetitive stimulation with allogeneic immature human dendritic cells. J Exp Med 2000;192:1213-22.
18. Dunn GP, Bruce AT, Ikeda H, Old LJ, Schreiber RD. Cancer immunoediting: from immunosurveillance to tumor escape. Nat Immunol 2002;3:991-8. (Pubitemid 35363648)
19. Schwartz RH. T cell anergy. Annu Rev Immunol 2003;21:305-34. (Pubitemid 37174534)
20. Campoli M, Chang CC, Ferrone S. HLA class I antigen loss, tumor immune escape and immune selection. Vaccine 2002;20(suppl 4):A40-5. (Pubitemid 35449404)
21. Whiteside TL. The tumor microenvironment and its role in promoting tumor growth. Oncogene 2008;27:5904-12.
22. Kawamura K, Bahar R, Natsume W, Sakiyama S, Tagawa M. Secretion of interleukin-10 from murine colon carcinoma cells suppresses systemic antitumor immunity and impairs protective immunity induced against the tumors. Cancer gene Ther 2002;9:109-15. (Pubitemid 34052860)
23. + regulatory T cells by TgF-beta induction of transcription factor Foxp3. J Exp Med 2003;198:1875-86.
24. Gabrilovich DI, Chen HL, Girgis KR, et al. Production of vascular endothelial growth factor by human tumors inhibits the functional maturation of dendritic cells. Nat Med 1996;2:1096-103. (Pubitemid 26338628)
25. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010;60:277-300.
26. National Comprehensive Cancer Network. The NCCN clinical practice guidelines in oncology prostate cancer, version 1.2011, 2010. Available from www.NCCN.org. Accessed December 28, 2010.
27. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502-12. (Pubitemid 39315317)
28. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513-20. (Pubitemid 39315318)
29. De Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet 2010;376:1147-54.
30. Drake CG. Immunotherapy for prostate cancer: walk, don't run. J Clin Oncol 2009;27:4035-7.
31. Drake CG. Prostate cancer as a model for tumour immunotherapy. Nat Rev Immunol 2010;10:580-93.
32. Sfanos KS, Bruno TC, Maris CH, et al. Phenotypic analysis of prostate-infiltrating lymphocytes reveals TH17 and Treg skewing. Clin Cancer Res 2008;14:3254-61.
33. +CD25 high T cells are enriched in the tumor and peripheral blood of prostate cancer patients. J Immunol 2006;177:7398-405.
34. Hurwitz AA, Yanover P, Markowitz M, Allison JP, Kwon ED. Prostate cancer: advances in immunotherapy. BioDrugs 2003;17:131-8. (Pubitemid 36433994)
35. Small EJ, Fratesi P, Reese DM, et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol 2000;18:3894-903.
36. Burch PA, Croghan GA, Gastineau DA, 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. (Pubitemid 38971831)
37. Burch PA, Breen JK, Buckner JC, et al. Priming tissue-specific cellular immunity in a phase I trial of autologous dendritic cells for prostate cancer. Clin Cancer Res 2000;6:2175-82. (Pubitemid 30399182)
38. Small EJ, Schellhammer PF, Higano CS, 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;24:3089-94. (Pubitemid 46638945)
39. Higano CS, Schellhammer PF, Small EJ, 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;115:3670-9.
40. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010;363:411-22.
41. Longo DL. New therapies for castration-resistant prostate cancer. N Engl J Med 2010;363:479-81.
42. Madan RA, Gulley JL, Fojo T, Dahut WL. Therapeutic cancer vaccines in prostate cancer: the paradox of improved survival without changes in time to progression. Oncologist 2010;15:969-75.
43. Wolchok JD, Hoos A, O'Day S, et al. guidelines for the evaluation of immune therapy activity in solid tumors: immunerelated response criteria. Clin Cancer Res 2009;15:7412-20.
44. Gulley JL, Stein WD, Schlom J, et al. A retrospective analysis of intramural NCI prostate cancer trials: progress made and insights gleaned [abstract]. J Clin Oncol 2010;28(suppl 15):abstract 4657.
45. U.S. Food and Drug Administration. Approval letter: Provenge. Available from www.fda.gov/BiologicsBlood Vaccines/CellulargeneTherapyProducts/ ApprovedProducts/ucm210215.htm. Accessed October 18, 2010.
46. Brower V. Approval of Provenge seen as first step for cancer treatment vaccines. J Natl Cancer Inst 2010;102:1108-10.
47. Alemayehu B, Buysman E, Parry D, Becker L, Nathan F. Economic burden and healthcare utilization associated with castration-resistant prostate cancer in a commercial and Medicare Advantage U.S. patient population. J Med Econ 2010;21:315-61.
48. Greenberg D, Earle C, Fang C-H, Eldar-Lissai A, Neumann PJ. When is cancer care cost-effective? A systematic overview of cost-utility analysis in oncology. J Natl Cancer Inst 2010;102:82-8.
49. Centers for Medicare and Medicaid Services. Proposed decision memo for autologous celllular immunotherapy treatment of metastatic prostate cancer (CAg-00422N). Available from http://www.cms.gov/medicare-coverage-database/ details/nca-proposed-decision-memo.aspx?NCAId=247&ver=8&NcaName= Autologous+Cellular+Immunotherapy+Treatment+of+Metastatic+Prostate+Cancer& bc=BEAAAAAAEAAA. Accessed May 23, 2011.
50. Dendreon Inc. Products: manufacturing. Available from www.dendreon.com/products/provenge/manufacturing. Accessed October 18, 2010.
51. Gulley JL, Arlen PM, Bastian A, et al . Combining a recombinant cancer vaccine with standard definitive radiotherapy in patients with localized prostate cancer. Clin Cancer Res 2005;11:3353-62. (Pubitemid 40627887)
52. Mercader M, Bodner BK, Moser MT, 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;98:14565-70. (Pubitemid 33121432)
53. Sutherland JS, Goldberg GL, Hammett MV, et al. Activation of thymic regeneration in mice and humans following androgen blockade. J Immunol 2005;175:2741-53. (Pubitemid 41113891)
54. Arlen PM, Gulley JL, Todd N, et al. Antiandrogen, vaccine and combination therapy in patients with nonmetastatic hormone refractory prostate cancer. J Urol 2005;174:539-46. (Pubitemid 40981596)
55. Madan RA, Gulley JL, Schlom J, 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;14:4526-31.
56. Gulley JL, Madan RA, Arlen PM. Enhancing efficacy of therapeutic vaccinations by combination with other modalities. Vaccine 2007;25(suppl 2):B89-96. (Pubitemid 47488548)
57. Emens LA, Machiels JP, Reilly RT, Jaffee EM. Chemotherapy: friend or foe to cancer vaccines? Curr Opin Mol Ther 2001;3:77-84. (Pubitemid 32177972)
58. Garnett CT, Schlom J, Hodge JW. Combination of docetaxel and recombinant vaccine enhances T cell responses and antitumor activity: effects of docetaxel on immune enhancement. Clin Cancer Res 2008;14:3536-44.
59. Arlen PM, Gulley JL, 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;12:1260-9. (Pubitemid 43342517)
60. Gribben JG, Ryan DP, Boyajian R, et al. Unexpected association between induction of immunity to the universal tumor antigen CYP1B1 and response to next therapy. Clin Cancer Res 2005;11:4430-6. (Pubitemid 40825633)
61. Antonia SJ, 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(3 pt 1):878-87. (Pubitemid 43259871)
62. Petrylak D. Defining the optimal role of immunotherapy and chemotherapy: advanced prostate cancer patients who receive sipuleucel-T followed by docetaxel derive the greatest survival benefit. Presented at the Chemotherapy Symposium 14th annual meeting, New York, NY, November 8-11, 2006.
63. Rini BI, Weinberg V, Fong L, Conry S, Hershberg RM, Small EJ. 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;107:67-74. (Pubitemid 43939032)
64. Wood C, Srivastava P, Bukowski R, et al. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet 2008;372:145-54.
65. Testori A, Richards J, Whitman E, et al. Phase III comparison of vitespen, an autologous tumor-derived heat shock protein gp96 peptide complex vaccine, with physician's choice of treatment for stage IV melanoma: the C-100-21 study group. J Clin Oncol 2008;26:955-62. (Pubitemid 351398090)
66. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711-23.
67. Higano CS, Corman JM, Smith DC, et al. Phase 1-2 dose-escalation study of a gM-CSF-secreting, allogeneic, cellular immunotherapy for metastatic hormone-refractory prostate cancer. Cancer 2008;113:975-84.
68. Fishman M. A changing world for DCVax: a PSMA loaded autologous dendritic cell vaccine for prostate cancer. Expert Opin Biol Ther 2009;9:1565-75.
69. Northwest Biotherapeutics. DCVax Brain: phase II clinical trial. Available from www.nwbio.com/clinical-dcvax-brain.php. Accessed October 18, 2010.
70. Madan RA, Arlen PM, Mohebtash M, Hodge JW, Gulley JL. Prostvac-VF: a vector-based vaccine targeting PSA in prostate cancer. Expert Opin Investig Drugs 2009;18:1001-11.
71. Kantoff PW, Schuetz TJ, Blumenstein BA, 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;28:1099-105.
72. Reinis M. BiovaxID, a personalized therapeutic vaccine against B-cell lymphomas. Curr Opin Mol Ther 2008;10:526-34.
73. Schuster SJ, Neelapu SS, Guase BL, et al. Idiotype vaccine therapy (Biovax ID) in follicular lymphoma in first complete remission: phase III clinical trial results [abstract]. J Clin Oncol 2009;27(suppl 18):abstract 2.
74. Mittendorf EA, Sharma P. Mechanisms of T cell inhibition: implications for cancer immunotherapy. Expert Rev Vaccines 2010;9:89-105.
75. Hurwitz AA, Yu TF, Leach DR, Allison JP. CTLA-4 blockade synergizes with tumor-derived granulocyte-macrophage colony-stimulating factor for treatment of an experimental mammary carcinoma. Proc Natl Acad Sci U S A 1998;95:10067-71. (Pubitemid 28415295)
76. Tollefson MK, Karnes RJ, Thompson RH, et al. A randomized phase II study of ipilimumab with androgen ablation compared with androgen ablation alone in patients with advanced prostate cancer [abstract 168]. Presented at the American Society of Clinical Oncology 2010 genitourinary cancers symposium, San Francisco, California, March 5-7, 2010.
77. Brahmer JR, Topalian SL, Powderly J, et al . Phase II experience with MDX-1106 (Ono-4538), an anti-PD-1 monoclonal antibody, in patients with selected refractory or relapsed malignancies [abstract]. J Clin Oncol 2009;27(suppl 15):abstract 3018.