Immunotherapy for prostate cancer using antigen-loaded antigen-presenting cells: APC8015 (Provenge^®)

• JEMAL A, SIEGEL R, WARD E, MURRAY T, XU J, THN MJ: Cancer statistics, 2007. CA Cancer J. Clin. (2007) 57(1):43-66.
   PubMed Web of Science ®Google Scholar
• 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(15):1513-1520.
   PubMed Web of Science ®Google Scholar
• TANNOCK IF, DEWIT R, BERRY WR et al.: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N. Engl. J. Med. (2004) 351(15):1502-1512.
   PubMed Web of Science ®Google Scholar
• STEINMAN RM, WITMER-PACK M, INABA K: Dendritic cells: antigen presentation, accessory function and clinical relevance. Adv. Exp. Med. Biol. (1993) 329:1-9.
   PubMedGoogle Scholar
• ALMAND B, RESSER JR, LINDMAN B et al.: Clinical significance of defective dendritic cell differentiation in cancer. Clin. Cancer Res. (2000) 6(5):1755-1766.
   PubMed Web of Science ®Google Scholar
• GABRILOVICH DI, CORAK J, CIERNIK IF, KAVANAUGH D, CARBONE DP: Decreased antigen presentation by dendritic cells in patients with breast cancer. Clin. Cancer Res. (1997) 3(3):483-490.
   PubMed Web of Science ®Google Scholar
• LAM KW, LI CY, YAM LT, SUN T, LEE G, ZIESMER S: Improved immunohistochemical detection of prostatic acid phosphatase by a monoclonal antibody. Prostate (1989) 15(1):13-21.
   PubMed Web of Science ®Google Scholar
• SOLIN T, KONTTURI M, POHLANN R, VIHKO P: Gene expression and prostate specificity of human prostatic acid phosphatase (PAP): evaluation by RNA blot analyses. Biochim. Biophys. Acta (1990) 1048(1):72-77.
   PubMed Web of Science ®Google Scholar
• FONG L, RUEGG CL, BROCKSTEDT D, ENGLEMAN EG, LAUS R: Induction of tissue-specific autoimmne prostatitis with prostatic acid phosphatase immunization: implications for immunotherapy of prostate cancer. J. Immunol. (1997) 159(7):3113-3117.
   PubMed Web of Science ®Google Scholar
• SMALL EJ, FRATESI P, REESE DM et al.: Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J. Clin. Oncol. (2000) 18(23):3894-3903.
   PubMed Web of Science ®Google Scholar
• RINI B: Technology evaluation: APC-8015, Dendreon. Curr. Opin. Mol. Ther. (2002) 4(1):76-79.
   PubMed Web of Science ®Google Scholar
• BURCH PA, BREEN J, 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(6):2175-2182.
   PubMed Web of Science ®Google Scholar
• BEINART G, RINI BI, WEINBERG V, SMALL EJ: Antigen-presenting cells 8015 (Provenge) in patients with androgen-dependent, biochemically relapsed prostate cancer. Clin. Prostate Cancer (2005) 4(1):55-60.
   PubMedGoogle Scholar
• RINI BI, WEINBERG V, BOK R, SMALL EJ: Prostate-specific antigen kinetics as a measure of the biologic effect of granulocyte-macrophage colony-stimulating factor in patients with serologic progression of prostate cancer. J. Clin. Oncol. (2003) 21(1):99-105.
   PubMed Web of Science ®Google Scholar
• LIN AM, RINI BI, WEINBERG V et al.: A Phase II trial of imatinib mesylate in patients with biochemical relapse of prostate cancer after definitive local therapy. BJU Int. (2006) 98(4):763-769.
   PubMed Web of Science ®Google Scholar
• RINI B, WEINBERG V, FONG L, SMALL E: A Phase II study of prostate acid phosphatase-pulsed dendritic cells (APC8015; Provenge) in combination with bevacizumab in patients with serologic progression of prostate cancer following local therapy. Proc. Am. Soc. Clin. Oncol. Multidisciplinary Prostate Cancer Symposium. Orlando, USA (2005).
   Google Scholar
• BURCH PA, BREEN JC, BRUCKNER 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(6):2175-2182.
   PubMed Web of Science ®Google Scholar
• TAKAUE YTR, TOBISU K, KAKIZOE T et al.: Antigen-pulsed dendritic cell therapy for the treatment of hormone-refractry prostate cancer: a Phase I trial of APC8015. Proc. Am. Soc. Clin. Oncol. (2002) 21:B18(Abstract #181).
   Google Scholar
• 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 II trial. Prostate (2004) 60(3):197-204.
   PubMed Web of Science ®Google Scholar
• 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(19):3089-3094.
   PubMed Web of Science ®Google Scholar
• SIPULEUCEL-T: APC 8015, APC-8015, prostate cancer vaccine–Dendreon. Drugs R D (2006) 7(3):197-201.
   Google Scholar
• POUND CR, PARTIN AW, EISENBERGER MA, CHAN DW, PEARSON JD, WALSH PC: Natural history of progression after PSA elevation following radical prostatectomy. JAMA (1999) 281(17):1591-1597.
   PubMed Web of Science ®Google Scholar
• KUDO-SAITO C, SCHLOM J, CAMPHAUSEN K, COLEMAN CN, HODGE JW: The requirement of multimodal therapy (vaccine, local tumor radiation, and reduction of suppressor cells) to eliminate established tumors. Clin. Cancer Res. (2005) 11(12):4533-4544.
   PubMed Web of Science ®Google Scholar
• RODEN AC, MOSER MT, TRI SF et al.: Augmentation of T cell levels and responses induced by androgen deprivation. J. Immunol. (2004) 173(10):6098-6108.
   PubMed Web of Science ®Google Scholar

Website

• http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4291B1_01.pdf Cellular, Tissue and Gene Therapies Advisory Committee Sipuleucel-T Briefing Document (2007).
   Google Scholar