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Perspective

From clinical trials to clinical practice: therapeutic cancer vaccines for the treatment of prostate cancer

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Pages 743-753 | Published online: 09 Jan 2014

References

  • Huggins C, Bergenstal DM. Inhibition of human mammary and prostatic cancers by adrenalectomy. Cancer Res.12(2), 134–141 (1952).
  • Sharifi N, Gulley JL, Dahut WL. Androgen deprivation therapy for prostate cancer. JAMA294(2), 238–244 (2005).
  • Tannock IF, de Wit R, Berry WR et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N. Engl. J. Med.351(15), 1502–1512 (2004).
  • 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.351(15), 1513–1520 (2004).
  • Tran C, Ouk S, Clegg NJ et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science324(5928), 787–790 (2009).
  • Madan RA, Arlen PM. Abiraterone. Cougar Biotechnology. IDrugs9(1), 49–55 (2006).
  • De Bono J, Logothetis C, Fizazi K et al. Abiraterone acetate (AA) plus low dose prednisone (P) improves overall survival (OS) in patients (PTS) with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after docetaxel-based chemotherapy (chemo): results of COU-AA-301, a randomized double-blind placebo-controlled Phase III study. Ann. Oncol.21(Suppl. 8), VIII1–VIII12 (2010) (Abstract).
  • Kantoff PW, Higano CS, Shore ND et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N. Engl. J. Med.363(5), 411–422 (2010).
  • Hodi FS, O’Day SJ, McDermott DF et al. Improved survival with ipilimumab in patients with metastatic melanoma. N. Engl. J. Med.363(8), 711–723 (2010).
  • 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.28(7), 1099–1105 (2010).
  • Rini BI. Technology evaluation: APC-8015, Dendreon. Curr. Opin. Mol. Ther.4(1), 76–79 (2002).
  • Patel PH, Kockler DR. Sipuleucel-T: a vaccine for metastatic, asymptomatic, androgen-independent prostate cancer. Ann. Pharmacother.42(1), 91–98 (2008).
  • 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.6(6), 2175–2182 (2000).
  • Small EJ, Fratesi P, Reese DM et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J. Clin. Oncol.18(23), 3894–3903 (2000).
  • 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.24(19), 3089–3094 (2006).
  • Madan RA, Arlen PM, Mohebtash M, Hodge JW, Gulley JL. Prostvac-VF: a vector-based vaccine targeting PSA in prostate cancer. Expert Opin. Investig. Drugs18(7), 1001–1011 (2009).
  • Essajee S, Kaufman HL. Poxvirus vaccines for cancer and HIV therapy. Expert Opin. Biol. Ther.4(4), 575–588 (2004).
  • Kaufman H, 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.22(11), 2122–2132 (2004).
  • Hodge JW, Sabzevari H, Yafal AG, Gritz L, Lorenz MG, Schlom J. A triad of costimulatory molecules synergize to amplify T-cell activation. Cancer Res.59(22), 5800–5807 (1999).
  • Aarts WM, Schlom J, Hodge JW. Vector-based vaccine/cytokine combination therapy to enhance induction of immune responses to a self-antigen and antitumor activity. Cancer Res.62(20), 5770–5777 (2002).
  • Grosenbach DW, Barrientos JC, Schlom J, Hodge JW. Synergy of vaccine strategies to amplify antigen-specific immune responses and antitumor effects. Cancer Res.61(11), 4497–4505 (2001).
  • Arlen PM, Skarupa L, Pazdur M et al. Clinical safety of a viral vector based prostate cancer vaccine strategy. J. Urol.178(4 Pt 1), 1515–1520 (2007).
  • Gulley JL, Arlen PM, Madan RA 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.59(5), 663–674 (2010).
  • Schlom J, Gulley JL, Arlen PM. Paradigm shifts in cancer vaccine therapy. Exp. Biol. Med.233(5), 522–534 (2008).
  • Zitvogel L, Apetoh L, Ghiringhelli F, Kroemer G. Immunological aspects of cancer chemotherapy. Nat. Rev. Immunol.8(1), 59–73 (2008).
  • Galetto A, Buttiglieri S, Forno S, Moro F, Mussa A, Matera L. Drug- and cell-mediated antitumor cytotoxicities modulate cross-presentation of tumor antigens by myeloid dendritic cells. Anticancer Drugs14(10), 833–843 (2003).
  • Suzuki E, Kapoor V, Jassar AS, Kaiser LR, Albelda SM. Gemcitabine selectively eliminates splenic Gr-1+/CD11b+ myeloid suppressor cells in tumor-bearing animals and enhances antitumor immune activity. Clin. Cancer Res.11(18), 6713–6721 (2005).
  • Weber JS, O’Day S, Urba W et al. Phase I/II study of ipilimumab for patients with metastatic melanoma. J. Clin. Oncol.26(36), 5950–5956 (2008).
  • Phan GQ, Yang JC, Sherry RM et al. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc. Natl Acad. Sci. USA100(14), 8372–8377 (2003).
  • Stein WD, Figg WD, Dahut W 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. Oncologist13(10), 1046–1054 (2008).
  • Fojo A, Stein W, Wilkerson J, Bates S. Kinetic analysis of breast tumor decay and growth following ixabepilone plus capecitabine (IXA + CAP) versus capecitabine alone (CAP) to discern whether the superiority of the combination is a result of slower growth, enhanced tumor cell kill, or both. J. Clin. Oncol.28(15s), 1096 (2010) (Abstract).
  • Wilkerson J, Stein W, Kim S et al. Validation of a kinetic analysis of renal cancer regression and growth following treatment with sunitinib and interferon-α (IFN-α): Analysis of the pivotal randomized trial. J. Clin. Oncol.28(15s), 4597 (2010) (Abstract).
  • Stein WD, Gulley J, Schlom J et al. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials. The growth rate as an indicator of therapeutic efficacy. Clin. Cancer Res.17(4), 907–917 (2010).
  • Gulley J, Stein W, Schlom J et al. A retrospective analysis of intramural NCI prostate cancer trials: progress made and insights gleaned. J. Clin. Oncol.28(15s), 4657 (2010) (Abstract).
  • Lucas A, Petrylak DP. The case for early chemotherapy for the treatment of metastatic disease. J. Urol.176(6 Pt 2), S72–S75 (2006).
  • Yagoda A, Petrylak D. Cytotoxic chemotherapy for advanced hormone-resistant prostate cancer. Cancer71(Suppl. 3), 1098–1109 (1993).
  • Scher H, Chi K, De Wit R et al. Docetaxel (D) plus high-dose calcitriol versus D plus prednisone (P) for patients (pts) with progressive castration-resistant prostate cancer (CRPC): results from the Phase III ASCENT2 trial. J. Clin. Oncol.28(15s), (2010) (Abstract 4509).
  • Kelly W, Halabi S, Carducci M et al. A randomized, double-blind, placebo-controlled Phase III trial comparing docetaxel, prednisone, and placebo with docetaxel, prednisone, and bevacizumab in men with metastatic castration-resistant prostate cancer (mCRPC): survival results of CALGB 90401. J. Clin. Oncol.28(18s), (2010) (Abstract LBA4511).
  • Small E, Demkow T, Gerritsen W 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). Program and Abstracts of the Genitourinary Cancers Symposium. Orlando, FL, USA (2009) (Abstract 7).
  • Sartor A, Oudard S, Ozguroglu M et al. Cabazitaxel or mitoxantrone with prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: final results of a multinational Phase III trial (TROPIC). Program and Abstracts of the Genitourinary Cancers Symposium. San Francisco, CA, USA (2010) (Abstract 9).
  • Attard G, Reid AH, Yap TA et al. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J. Clin. Oncol.26(28), 4563–4571 (2008).
  • Danila DC, Morris MJ, de Bono JS et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. J. Clin. Oncol.28(9), 1496–1501 (2010).
  • Shah S, Ryan C. Abiraterone acetate for castration resistant prostate cancer. Expert Opin. Investig. Drugs19(4), 563–570 (2010).
  • Halabi S, Small EJ, Kantoff PW et al. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J. Clin. Oncol.21(7), 1232–1237 (2003).
  • Madan RA, Mohebtash M, Schlom J, Gulley JL. Therapeutic vaccines in metastatic castration-resistant prostate cancer: principles in clinical trial design. Expert Opin. Biol. Ther.10(1), 19–28 (2010).
  • 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. Cancer113(5), 975–984 (2008).
  • 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. Cancer87(5), 680–687 (2000).
  • Ghiringhelli F, Larmonier N, Schmitt E 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.34(2), 336–344 (2004).
  • Curiel TJ, Coukos G, Zou L et al. Specific recruitment of regulatory T cells in ovarian carcinoma fosters immune privilege and predicts reduced survival. Nat. Med.10(9), 942–949 (2004).
  • Sato E, Olson SH, Ahn J et al. Intraepithelial CD8+ tumor-infiltrating lymphocytes and a high CD8+/regulatory T cell ratio are associated with favorable prognosis in ovarian cancer. Proc. Natl Acad. Sci. USA102(51), 18538–18543 (2005).
  • Kawaida H, Kono K, Takahashi A et al. Distribution of CD4+CD25high regulatory T-cells in tumor-draining lymph nodes in patients with gastric cancer. J. Surg. Res.124(1), 151–157 (2005).
  • Woo EY, Chu CS, Goletz TJ et al. Regulatory CD4(+)CD25(+) T cells in tumors from patients with early-stage non-small cell lung cancer and late-stage ovarian cancer. Cancer Res.61(12), 4766–4772 (2001).
  • Piccirillo CA, Shevach EM. Cutting edge: control of CD8+ T cell activation by CD4+CD25+ immunoregulatory cells. J. Immunol.167(3), 1137–1140 (2001).
  • Woo EY, Yeh H, Chu CS et al. Cutting edge: regulatory T cells from lung cancer patients directly inhibit autologous T cell proliferation. J. Immunol.168(9), 4272–4276 (2002).
  • Sakaguchi S, Sakaguchi N, Asano M, Itoh M, Toda M. Immunologic self-tolerance maintained by activated T cells expressing IL-2 receptor α-chains (CD25). Breakdown of a single mechanism of self-tolerance causes various autoimmune diseases. J. Immunol.155(3), 1151–1164 (1995).
  • Morse MA, Clay TM, Mosca P, Lyerly HK. Immunoregulatory T cells in cancer immunotherapy. Expert Opin. Biol. Ther.2(8), 827–834 (2002).
  • Sakaguchi S. Regulatory T cells: key controllers of immunologic self-tolerance. Cell101(5), 455–458 (2000).
  • Madan R, Vergati M, Cereda V et al. Changes in regulatory T cell function and overall survival in metastatic castration resistant prostate cancer (mCRPC) patients treated with a vector-based vaccine. Presented at: AACR Annual Meeting. Denver, CO, USA, 18–22 April 2009 (Poster 726).
  • Vergati M, Cereda V, Madan RA et al. Analysis of circulating regulatory T cells in patients with metastatic prostate cancer pre- versus post-vaccination. Cancer Immunol. Immunother.60(2), 197–206 (2010).
  • Halabi S, Vogelzang NJ, Kornblith AB et al. Pain predicts overall survival in men with metastatic castration-refractory prostate cancer. J. Clin. Oncol.26(15), 2544–2549 (2008).
  • Higano C, Saad F, Somer B et al. A Phase III trial of GVAX immunotherapy for prostate cancer versus docetaxel plus prednisone in asymptomatic, castration-resistant prostate cancer (CRPC). Program and Abstracts of the Genitourinary Cancers Symposium. Orlando, FL, USA (2009) (Abstract LBA150).
  • von Mehren M, Arlen P, Gulley J et al. The influence of granulocyte macrophage colony-stimulating factor and prior chemotherapy on the immunological response to a vaccine (ALVAC-CEA B7.1) in patients with metastatic carcinoma. Clin. Cancer Res.7(5), 1181–1191 (2001).
  • Armstrong AJ, Garrett-Mayer ES, Yang YC, de Wit R, Tannock IF, Eisenberger M. A contemporary prognostic nomogram for men with hormone-refractory metastatic prostate cancer: a TAX327 study analysis. Clin. Cancer Res.13(21), 6396–6403 (2007).
  • Scher HI, Halabi S, Tannock I et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J. Clin. Oncol.26(7), 1148–1159 (2008).
  • 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.14(14), 4526–4531 (2008).
  • Longo DL. New therapies for castration-resistant prostate cancer. N. Engl. J. Med.363(5), 479–481 (2010).
  • Boehm AL, Higgins J, Franzusoff A, Schlom J, Hodge JW. Concurrent vaccination with two distinct vaccine platforms targeting the same antigen generates phenotypically and functionally distinct T-cell populations. Cancer Immunol. Immunother.59(3), 397–408 (2010).
  • McNeel DG, Dunphy EJ, Davies JG et al. Safety and immunological efficacy of a DNA vaccine encoding prostatic acid phosphatase in patients with stage D0 prostate cancer. J. Clin. Oncol.27(25), 4047–4054 (2009).
  • Su Z, Dannull J, Yang BK et al. Telomerase mRNA-transfected dendritic cells stimulate antigen-specific CD8+ and CD4+ T cell responses in patients with metastatic prostate cancer. J. Immunol.174(6), 3798–3807 (2005).
  • Aragon-Ching JB, Williams KM, Gulley JL. Impact of androgen-deprivation therapy on the immune system: implications for combination therapy of prostate cancer. Front. Biosci.12, 4957–4971 (2007).
  • Drake CG, Doody AD, Mihalyo MA et al. Androgen ablation mitigates tolerance to a prostate/prostate cancer-restricted antigen. Cancer Cell7(3), 239–249 (2005).
  • 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.14(11), 3536–3544 (2008).
  • Chakraborty M, Abrams SI, Coleman CN, Camphausen K, Schlom J, Hodge JW. External beam radiation of tumors alters phenotype of tumor cells to render them susceptible to vaccine-mediated T-cell killing. Cancer Res.64(12), 4328–4337 (2004).
  • Hoos A, Eggermont AM, Janetzki S et al. Improved endpoints for cancer immunotherapy trials. J. Natl Cancer Inst.102(18), 1388–1397 (2010).
  • Palanisamy N, Ateeq B, Kalyana-Sundaram S et al. Rearrangements of the RAF kinase pathway in prostate cancer, gastric cancer and melanoma. Nat. Med.16(7), 793–798 (2010).
  • Sharifi N, Hamada A, Sissung T et al. A polymorphism in a transporter of testosterone is a determinant of androgen independence in prostate cancer. BJU Int.102(5), 617–621 (2008).
  • Kantoff P, Higano CS, Berger ER. Updated survival results of the IMPACT trial of sipuleucel-T for metastatic castration-resistant prostate cancer (CRPC). Programs and Abstracts of the 2010 Genitourinary Cancers Symposium. San Francisco, CA, USA (2010) (Abstract).

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