References
- Rosenberg SA, Lotze MT, Yang JC et al. Experience with the use of high-dose interleukin-2 in the treatment of 652 cancer patients. Ann. Surg.210(4), 474–484; discussion 484–475 (1989).
- Holdener EE, Emmons RP, Brunda M, Evans L, Levitt D. Interferon-α and interleukin-2 in the treatment of renal cell cancer. Prog. Clin. Biol. Res.348, 61–69 (1990).
- Ressing ME, Offringa R, Toes RE et al. Immunotherapy of cancer by peptide-based vaccines for the induction of tumor-specific T cell immunity. Immunotechnology2(4), 241–251 (1996).
- Chakraborty NG, Stevens RL, Mehrotra S et al. Recognition of PSA-derived peptide antigens by T cells from prostate cancer patients without any prior stimulation. Cancer Immunol. Immunother.52(8), 497–505 (2003).
- Coffey DS, Isaacs JT. Prostate tumor biology and cell kinetics – theory. Urology17(Suppl. 3), 40–53 (1981).
- Rhodes DR, Barrette TR, Rubin MA, Ghosh D, Chinnaiyan AM. Meta-analysis of microarrays: interstudy validation of gene expression profiles reveals pathway dysregulation in prostate cancer. Cancer Res.62(15), 4427–4433 (2002).
- Fong L, Small EJ. Immunotherapy for prostate cancer. Semin. Oncol.30(5), 649–658 (2003).
- Cereda V, Poole DJ, Palena C et al. New gene expressed in prostate: a potential target for T cell-mediated prostate cancer immunotherapy. Cancer Immunol. Immunother.59(1), 63–71 (2010).
- Oesterling JE. Prostate specific antigen: a critical assessment of the most useful tumor marker for adenocarcinoma of the prostate. J. Urol.145(5), 907–923 (1991).
- Gulley JL, Arlen PM, Bastian A et al. Combining a recombinant cancer vaccine with standard deflnitive radiotherapy in patients with localized prostate cancer. Clin. Cancer Res.11(9), 3353–3362 (2005).
- Disis ML, Goodell V, Schiffman K, Knutson KL. Humoral epitope-spreading following immunization with a HER-2/neu peptide based vaccine in cancer patients. J. Clin. lmmunol.24(5), 571–578 (2000).
- 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).
- So-Rosillo R, Small EJ. Sipuleucel-T (APC8015) for prostate cancer. Expert Rev. Anticancer Ther.6(9), 1163–1167 (2006).
- Tao MH, Levy R. Idiotype/granulocyte-macrophage colony-stimulating factor fusion protein as a vaccine for B-cell lymphoma. Nature362(6422), 755–758 (1993).
- Sharifi N, Gulley JL, Dahut WL. Androgen deprivation therapy for prostate cancer. JAMA294(2), 238–244 (2005).
- 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).
- 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. Prostate60(3), 197–204 (2004).
- 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).
- 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. Cancer115(16), 3670–3679 (2009).
- Small E, Rini B, Higano C et al. A randomized, placebo-controlled Phase III trial of APC8015 in patients with androgen-independent prostate cancer (AiPCa) [abstract]. Proc. Am. Soc. Clin. Oncol.22, 1534 (2003).
- 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).
- Sheikh N, Jones L. CD54 is a surrogate marker of antigen presenting cell activation. Cancer Immunol. Immunother.57(9), 1381–1390 (2008).
- Stewart F, dela Rosa C, Sheikh N et al. Correlation between product parameters and overall survival in three trials of sipuleucel-T, an autologous active cellular immunotherapy for the treatment of prostate cancer [abstract]. J. Clin. Oncol.28(15S), 4552 (2010).
- Frohlich M, Sheikh N, Xu Y, Whitmore J, Poehlein C, Urdal D. Sipuleucel-T immune parameters and correlation with overall survival. Presented at: iSBTC 25th Annual Scientific Meeting. Washington, DC, USA, 30 September–4 October 2010.
- 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).
- Moore MJ, Osoba D, Murphy K et al. Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer. J. Clin. Oncol.12(4), 689–694 (1994).
- 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 [abstract]. J. Clin. Oncol.28(18s), LBA4511 (2010).
- Huggins C, Bergenstal DM. Inhibition of human mammary and prostatic cancers by adrenalectomy. Cancer Res.12(2), 134–141 (1952).
- Furr BJ. “Casodex” (ICI 176,334) – a new, pure, peripherally-selective anti-androgen: preclinical studies. Horm. Res.32(Suppl. 1), 69–76 (1989).
- Madan RA, Arlen PM. Abiraterone. Cougar Biotechnology. IDrugs9(1), 49–55 (2006).
- 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).
- Attard G, Reid AH, A’Hern R et al. Selective inhibition of CYP17 with abiraterone acetate is highly active in the treatment of castration-resistant prostate cancer. J. Clin. Oncol.27(23), 3742–3748 (2009).
- 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).
- 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).
- Scher HI, Beer TM, Higano CS et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a Phase 1–2 study. Lancet375(9724), 1437–1446 (2010).
- 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). Presented at: ASCO Genitourinary Cancers Symposium. San Francisco, CA, USA, 5–7 March 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).
- 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).
- Longo DL. New therapies for castration-resistant prostate cancer. N. Engl. J. Med.363(5), 479–481 (2010).
- 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).
- Gulley J, Chen AP, Dahut W et al. Phase I study of a vaccine using recombinant vaccinia virus expressing PSA (rV-PSA) in patients with metastatic androgen-independent prostate cancer. Prostate53(2), 109–117 (2002).
- Kaufman HL, 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).
- 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).
- DiPaola R, Chen Y, Bubley G 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. Presented at: ASCO Genitourinary Cancers Symposium. Orlando, FL, USA, 26–28 February 2009.
- 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).
- 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).
- Baghdadi R. Dendreon vs CMS: why the Provenge coverage controversy is bigger than just one product. Oncology24(10), 881–883 (2010).
- Fojo T, Grady C. How much is life worth: cetuximab, non-small cell lung cancer, and the $440 billion question. J. Natl Cancer Inst.101(15), 1044–1048 (2009).
- Cancer patients receiving chemotherapy: opportunities for better management. Milliman Client Report. Milliman Inc., NY, USA, 1–30 (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).
- 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. Oncologist15(9), 969–975 (2010).
- 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. DOI: 10.1158/1078-0432.CCR-10-1762 (2010) (Epub ahead of print).
- 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, 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).
- 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).
- Zlotocha S, Staab MJ, Horvath D et al. A Phase I study of a DNA vaccine targeting prostatic acid phosphatase in patients with stage D0 prostate cancer. Clin. Genitourin. Cancer4(3), 215–218 (2005).
- Arlen PM, Gulley JL, Todd N et al. Antiandrogen, vaccine and combination therapy in patients with nonmetastatic hormone refractory prostate cancer. J. Urol.174(2), 539–546 (2005).
- 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.11(9), 3353–3362 (2005).
- 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.12(4), 1260–1269 (2006).
- Tseng CW, Trimble C, Zeng Q et al. Low-dose radiation enhances therapeutic HPV DNA vaccination in tumor-bearing hosts. Cancer Immunol. Immunother.58(5), 737–748 (2009).
- Newcomb EW, Demaria S, Lukyanov Y et al. The combination of ionizing radiation and peripheral vaccination produces long-term survival of mice bearing established invasive GL261 gliomas. Clin. Cancer Res.12(15), 4730–4737 (2006).
- Garnett CT, Palena C, Chakraborty M, Tsang KY, Schlom J, Hodge JW. Sublethal irradiation of human tumor cells modulates phenotype resulting in enhanced killing by cytotoxic T lymphocytes. Cancer Res.64(21), 7985–7994 (2004).
- 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).
- 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. USA98(25), 14565–14570 (2001).
- 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).
- Waterhouse P, Penninger JM, Timms E et al. Lymphoproliferative disorders with early lethality in mice deficient in CTLA-4. Science270(5238), 985–988 (1995).
- Egen JG, Kuhns MS, Allison JP. CTLA-4: new insights into its biological function and use in tumor immunotherapy. Nat. Immunol.3(7), 611–618 (2002).
- Allison JP, Chambers C, Hurwitz A et al. A role for CTLA-4-mediated inhibitory signals in peripheral T cell tolerance? Novartis Found. Symp.215, 92–98; discussion 98–102, 186–190 (1998).
- Hodge JW, Chakraborty M, Kudo-Saito C, Garnett CT, Schlom J. Multiple costimulatory modalities enhance CTL avidity. J. Immunol.174(10), 5994–6004 (2005).
- 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).
Websites
- FDA Prescribing Information for Provenge. PROVENGE® Package Insert www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf
- FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer. FDA Press Release www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm
- Study of Investigational Agent Abiraterone Acetate for Metastatic Advanced Prostate Cancer Unblinded After Meeting Pre-Determined Criteria. Cougar Biotechnology Press Release, 9 September 2010 www.prnewswire.com/news-releases/study-of-investigational-agent-abiraterone-acetate-for-metastatic-advanced-prostate-cancer-unblinded-after-meeting-pre-determined-criteria-102576469.html
- Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer. NIH Clinical Trials, updated 21 May 2010 http://clinicaltrials.gov/ct2/show/NCT00887198?term=abiraterone&rank=10
- Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM). NIH Clinical Trials, updated 22 September 2010 http://clinicaltrials.gov/ct2/show/NCT00974311?term=MDV3100&rank=3
- Cabazitaxel. FDA Press Release, 17 June 2010 www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216214.htm