1,284
Views
13
CrossRef citations to date
0
Altmetric
Special Focus Review

Sipuleucel-T for the treatment of metastatic prostate cancer

Promise and challenges

&
Pages 509-519 | Published online: 01 Apr 2012

References

  • Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin 2010; 60:277 - 300; http://dx.doi.org/10.3322/caac.20073; PMID: 20610543
  • Antonarakis ES, Feng Z, Trock BJ, Humphreys EB, Carducci MA, Partin AW, et al. The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up. BJU Int 2012; 109:32 - 9; http://dx.doi.org/10.1111/j.1464-410X.2011.10422.x; PMID: 21777360
  • Uchio EM, Aslan M, Wells CK, Calderone J, Concato J. Impact of biochemical recurrence in prostate cancer among US veterans. Arch Intern Med 2010; 170:1390 - 5; http://dx.doi.org/10.1001/archinternmed.2010.262; PMID: 20696967
  • Antonarakis ES, Chen Y, Elsamanoudi SI, Brassell SA, Da Rocha MV, Eisenberger MA, et al. Long-term overall survival and metastasis-free survival for men with prostate-specific antigen-recurrent prostate cancer after prostatectomy: analysis of the Center for Prostate Disease Research National Database. BJU Int 2011; 108:378 - 85; http://dx.doi.org/10.1111/j.1464-410X.2010.09878.x; PMID: 21091976
  • D’Amico AV, Cote K, Loffredo M, Renshaw AA, Schultz D. Determinants of prostate cancer-specific survival after radiation therapy for patients with clinically localized prostate cancer. J Clin Oncol 2002; 20:4567 - 73; http://dx.doi.org/10.1200/JCO.2002.03.061; PMID: 12454114
  • Oh WK, Kantoff PW. Management of hormone refractory prostate cancer: current standards and future prospects. J Urol 1998; 160:1220 - 9; http://dx.doi.org/10.1016/S0022-5347(01)62501-1; PMID: 9751323
  • Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet 2011; 377:813 - 22; http://dx.doi.org/10.1016/S0140-6736(10)62344-6; PMID: 21353695
  • de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al, TROPIC Investigators. 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; http://dx.doi.org/10.1016/S0140-6736(10)61389-X; PMID: 20888992
  • de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, et al, COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011; 364:1995 - 2005; http://dx.doi.org/10.1056/NEJMoa1014618; PMID: 21612468
  • Antonarakis ES, Eisenberger MA. Expanding treatment options for metastatic prostate cancer. N Engl J Med 2011; 364:2055 - 8; http://dx.doi.org/10.1056/NEJMe1102758; PMID: 21612475
  • Coffey DS, Isaacs JT. Control of prostate growth. Urology 1981; 17:Suppl 3 17 - 24; PMID: 6163242
  • Wang X, Yu J, Sreekumar A, Varambally S, Shen R, Giacherio D, et al. Autoantibody signatures in prostate cancer. N Engl J Med 2005; 353:1224 - 35; http://dx.doi.org/10.1056/NEJMoa051931; PMID: 16177248
  • Taylor BS, Varambally S, Chinnaiyan AM. Differential proteomic alterations between localised and metastatic prostate cancer. Br J Cancer 2006; 95:425 - 30; http://dx.doi.org/10.1038/sj.bjc.6603274; PMID: 16880794
  • 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 2002; 62:4427 - 33; PMID: 12154050
  • Arlen PM, Mohebtash M, Madan RA, Gulley JL. Promising novel immunotherapies and combinations for prostate cancer. Future Oncol 2009; 5:187 - 96; http://dx.doi.org/10.2217/14796694.5.2.187; PMID: 19284377
  • Drake CG, Jaffee E, Pardoll DM. Mechanisms of immune evasion by tumors. Adv Immunol 2006; 90:51 - 81; http://dx.doi.org/10.1016/S0065-2776(06)90002-9; PMID: 16730261
  • Madan RA, Mohebtash M, Arlen PM, Vergati M, Steinberg SM, Tsang KY, et al. Overall survival (OS) analysis of a phase l trial of a vector-based vaccine (PSA-TRICOM) and ipilimumab (Ipi) in the treatment of metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 2010; 28:15s (suppl; abstr 2550).
  • Lang JM, Staab MJ, Liu G, Wilding G, McNeel DG. Phase I dose-escalation trial of tremelimumab in combination with bicalutamide in patients with recurrent prostate cancer. J Clin Oncol 2011; 29: 16s (suppl; abstr 174).
  • Kwon ED, Foster BA, Hurwitz AA, Madias C, Allison JP, Greenberg NM, et al. Elimination of residual metastatic prostate cancer after surgery and adjunctive cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) blockade immunotherapy. Proc Natl Acad Sci U S A 1999; 96:15074 - 9; http://dx.doi.org/10.1073/pnas.96.26.15074; PMID: 10611340
  • Chambers CA, Kuhns MS, Egen JG, Allison JP. CTLA-4-mediated inhibition in regulation of T cell responses: mechanisms and manipulation in tumor immunotherapy. Annu Rev Immunol 2001; 19:565 - 94; http://dx.doi.org/10.1146/annurev.immunol.19.1.565; PMID: 11244047
  • Beer TM, Slovin SF, Higano CS, Tejwani S, Dorff TB, 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). J Clin Oncol 2008; 26:13s (May 20 suppl; abstr 5004).
  • Gerritsen W, van den Eertwegh AJ, de Gruijl T, van den Berg H, Scheper RJ, Sacks N, et al. Expanded phase I combination trial of GVAX immunotherapy for prostate cancer and ipilimumab in patients with metastatic hormone-refractory prostate cancer (mHPRC). J Clin Oncol 2008; 26: 13s (May 20 suppl; abstr 5146).
  • Hodi FS, O’Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010; 363:711 - 23; http://dx.doi.org/10.1056/NEJMoa1003466; PMID: 20525992
  • Brahmer JR, Drake CG, Wollner I, Powderly JD, Picus J, Sharfman WH, et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol 2010; 28:3167 - 75; http://dx.doi.org/10.1200/JCO.2009.26.7609; PMID: 20516446
  • McNeel DG, Dunphy EJ, Davies JG, Frye TP, Johnson LE, Staab MJ, 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 - 54; http://dx.doi.org/10.1200/JCO.2008.19.9968; PMID: 19636017
  • Antonarakis ES, Zahurak M, Lin J, Keizman D, Carducci MA, Eisenberger MA. Changes in PSA kinetics predict metastasis-free survival in men with PSA-recurrent prostate cancer treated with non-hormonal agents. Cancer 2011; 118:1533-42.
  • Becker JT, Olson BM, Johnson LE, Davies JG, Dunphy EJ, McNeel DG. DNA vaccine encoding prostatic acid phosphatase (PAP) elicits long-term T-cell responses in patients with recurrent prostate cancer. J Immunother 2010; 33:639 - 47; http://dx.doi.org/10.1097/CJI.0b013e3181dda23e; PMID: 20551832
  • Ciernik IF, Berzofsky JA, Carbone DP. Induction of cytotoxic T lymphocytes and antitumor immunity with DNA vaccines expressing single T cell epitopes. J Immunol 1996; 156:2369 - 75; PMID: 8786293
  • Donnelly JJ, Ulmer JB, Shiver JW, Liu MA. DNA vaccines. Annu Rev Immunol 1997; 15:617 - 48; http://dx.doi.org/10.1146/annurev.immunol.15.1.617; PMID: 9143702
  • Acres B, Bonnefoy JY. Clinical development of MVA-based therapeutic cancer vaccines. Expert Rev Vaccines 2008; 7:889 - 93; http://dx.doi.org/10.1586/14760584.7.7.889; PMID: 18767940
  • Kaufman HL, Wang W, Manola J, Dipaola RS, Ko Y, Sweeney CJ, et al. Phase II prime/boost vaccination using poxviruses expressing PSA in hormone dependent prostate cancer: Follow-up clinical results from ECOG 7897. J Clin Oncol 2005;23:16s, (suppl; abstr 4501).
  • DiPaola RS, Plante M, Kaufman H, Petrylak DP, Israeli R, Lattime E, et al. A phase I trial of pox PSA vaccines (PROSTVAC-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM) in patients with prostate cancer. J Transl Med 2006; 4:1; http://dx.doi.org/10.1186/1479-5876-4-1; PMID: 16390546
  • Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, 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 - 105; http://dx.doi.org/10.1200/JCO.2009.25.0597; PMID: 20100959
  • Dranoff G, Jaffee E, Lazenby A, Golumbek P, Levitsky H, Brose K, et al. Vaccination with irradiated tumor cells engineered to secrete murine granulocyte-macrophage colony-stimulating factor stimulates potent, specific, and long-lasting anti-tumor immunity. Proc Natl Acad Sci U S A 1993; 90:3539 - 43; http://dx.doi.org/10.1073/pnas.90.8.3539; PMID: 8097319
  • Jaffee EM, Lazenby A, Meurer J, Marshall F, Hauda KM, Counts C, et al. Use of murine models of cytokine-secreting tumor vaccines to study feasibility and toxicity issues critical to designing clinical trials. J Immunother Emphasis Tumor Immunol 1995; 18:1 - 9; http://dx.doi.org/10.1097/00002371-199507000-00001; PMID: 8535565
  • Simons JW, Carducci MA, Mikhak B, Lim M, Biedrzycki B, Borellini F, et al. Phase I/II trial of an allogeneic cellular immunotherapy in hormone-naïve prostate cancer. Clin Cancer Res 2006; 12:3394 - 401; http://dx.doi.org/10.1158/1078-0432.CCR-06-0145; PMID: 16740763
  • Simons JW, Mikhak B, Chang JF, DeMarzo AM, Carducci MA, Lim M, et al. Induction of immunity to prostate cancer antigens: results of a clinical trial of vaccination with irradiated autologous prostate tumor cells engineered to secrete granulocyte-macrophage colony-stimulating factor using ex vivo gene transfer. Cancer Res 1999; 59:5160 - 8; PMID: 10537292
  • Halabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, et al. Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol 2003; 21:1232 - 7; http://dx.doi.org/10.1200/JCO.2003.06.100; PMID: 12663709
  • Small EJ, Sacks N, Nemunaitis J, Urba WJ, Dula E, Centeno AS, et al. Granulocyte macrophage colony-stimulating factor--secreting allogeneic cellular immunotherapy for hormone-refractory prostate cancer. Clin Cancer Res 2007; 13:3883 - 91; http://dx.doi.org/10.1158/1078-0432.CCR-06-2937; PMID: 17606721
  • Higano CS, Corman JM, Smith DC, Centeno AS, Steidle CP, 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 - 84; http://dx.doi.org/10.1002/cncr.23669; PMID: 18646045
  • Higano CS, 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). J Clin Oncol 2009;27:14s (suppl; abstr LBA150).
  • Goldstein NS. Immunophenotypic characterization of 225 prostate adenocarcinomas with intermediate or high Gleason scores. Am J Clin Pathol 2002; 117:471 - 7; http://dx.doi.org/10.1309/G6PR-Y774-X738-FG2K; PMID: 11888088
  • Haines AM, Larkin SE, Richardson AP, Stirling RW, Heyderman E. A novel hybridoma antibody (PASE/4LJ) to human prostatic acid phosphatase suitable for immunohistochemistry. Br J Cancer 1989; 60:887 - 92; http://dx.doi.org/10.1038/bjc.1989.385; PMID: 2605098
  • U. S. Food and Drug Administration. Package insert (Provenge; Sipuleucel-T). http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf.
  • Gryta T. Setback for Dendreon Cancer Drug. Wall Street Journal August 3, 2011.
  • Small EJ, Fratesi P, Reese DM, Strang G, Laus R, Peshwa MV, et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol 2000; 18:3894 - 903; PMID: 11099318
  • So-Rosillo R, Small EJ. Sipuleucel-T (APC8015) for prostate cancer. Expert Rev Anticancer Ther 2006; 6:1163 - 7; http://dx.doi.org/10.1586/14737140.6.9.1163; PMID: 17020451
  • Burch PA, Croghan GA, Gastineau DA, Jones LA, Kaur JS, Kylstra JW, 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; http://dx.doi.org/10.1002/pros.20040; PMID: 15176049
  • 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; 4:55 - 60; PMID: 15992463
  • 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; http://dx.doi.org/10.1002/cncr.21956; PMID: 16736512
  • Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, 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; http://dx.doi.org/10.1200/JCO.2005.04.5252; PMID: 16809734
  • Higano CS, Schellhammer PF, Small EJ, Burch PA, 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 - 9; http://dx.doi.org/10.1002/cncr.24429; PMID: 19536890
  • Liu EA. Biologics License Application (BLA) Medical Review 2007, FDA Submission Number: BLA125197.
  • Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al, IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010; 363:411 - 22; http://dx.doi.org/10.1056/NEJMoa1001294; PMID: 20818862
  • Gomella LG, Nabhan C, Whitmore JB, Frohlich MW, George DJ. Post-progression treatment with APC8015F may have prolonged survival of subjects in the control arm of sipuleucel-T phase III studies. J Clin Oncol 2011; 29: 16s (suppl; abstr 4534).
  • Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain after sipuleucel-T in asymptomatic patients with metastatic castrate-resistant prostate cancer (mCRPC): Results from three randomized phase III trials. J Clin Oncol 2011; 29: 16s (suppl; abstr 4661).
  • Sheikh NA, Wesley JD, Chadwick E, Perdue N, dela Rosa CP, Frohlich MW, Stewart FP, Urdal DL. Characterization of antigen-specific T-cell activation and cytokine expression induced by sipuleucel-T. J Clin Oncol 2011; 29: 16s (suppl; abstr 155).
  • McLeod DG, Quinn DI, Whitmore M, Tabesh M. Sipuleucel-T in African Americans: A subgroup analysis of three phase III sipuleucel-T in advanced prostate cancer. J Clin Oncol 2011; 29: 16s (suppl; abstr 15148).
  • Pak S, Reed M, Luther M, Averia M, Desai S, Pinski JK, et al. Evaluation of patients, safety, and financial implications of sipuleucel-T(Sip T) for treatment of metastatic castrate-resistant prostate cancer(mCRPC): Early real-world experience at USC. J Clin Oncol 2011; 29: 16s (suppl; abstr 15124).
  • Beer TM, Bernstein GT, Corman JM, Glode LM, Hall SJ, Poll WL, et al. Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. Clin Cancer Res 2011; 17:4558 - 67; http://dx.doi.org/10.1158/1078-0432.CCR-10-3223; PMID: 21558406
  • Beer TM, Schellhammer PF, Corman JM, Glode LM, Hall S, Xu Y, et al. Quality-of-life assessment in a randomized, double-blind study of sipuleucel-T in men with androgen-dependent prostate cancer. J Clin Oncol 2011; 29: (suppl; abstr 4648).
  • Antonarakis ES, Kibel AS, Lin DW, Tyler RC, Tabesh M, Drake CG. Design of an open-label randomized phase II trial examining the effect of sequencing of sipuleucel-T androgen deprivation therapy (ADT) on immune markers in prostate cancer patients with a rising prostate specific antigen (PSA) after primary therapy. J Clin Oncol 2011; 29: 16s (suppl; abstr TPS189).
  • Fizazi K, Powles T, George DJ, Poehlein CH. A randomized, controlled phase III global trial comparing sipuleucel-T plus androgen deprivation therapy versus androgen deprivation therapy alone in men with metastatic androgen dependent (hormone sensitive) prostate cancer. J Clin Oncol 2011; 29: 16s (suppl; abstr TPS188).
  • Makarov DV, Humphreys EB, Mangold LA, Carducci MA, Partin AW, Eisenberger MA, et al. The natural history of men treated with deferred androgen deprivation therapy in whom metastatic prostate cancer developed following radical prostatectomy. J Urol 2008; 179:156 - 61, discussion 161-2; http://dx.doi.org/10.1016/j.juro.2007.08.133; PMID: 18001801
  • Hoos A, Eggermont AM, Janetzki S, Hodi FS, Ibrahim R, Anderson A, et al. Improved endpoints for cancer immunotherapy trials. J Natl Cancer Inst 2010; 102:1388 - 97; http://dx.doi.org/10.1093/jnci/djq310; PMID: 20826737
  • Cha E, Fong L. Immunotherapy for prostate cancer: biology and therapeutic approaches. J Clin Oncol 2011; 29:3677 - 85; http://dx.doi.org/10.1200/JCO.2010.34.5025; PMID: 21825260
  • Gulley JL, Arlen PM, Madan RA, Tsang KY, Pazdur MP, 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 - 74; http://dx.doi.org/10.1007/s00262-009-0782-8; PMID: 19890632
  • Nilsson S, O'Bryan-Tear CG, Bolstad B, Lokna A, Parker C. Alkaline phosphatase (ALP) normalization and overall survival in patients with bone metastases from castration-resistant prostate cancer (CRPC) treated with radium-223. J Clin Oncol 2011; 29: 16s (suppl; abstr 4620).
  • Madan RA, Gulley JL, Schlom J, Steinberg SM, Liewehr DJ, Dahut WL, 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; http://dx.doi.org/10.1158/1078-0432.CCR-07-5048; PMID: 18628467
  • Naito M, Itoh K, Komatsu N, Yamashita Y, Shirakusa T, Yamada A, et al. Dexamethasone did not suppress immune boosting by personalized peptide vaccination for advanced prostate cancer patients. Prostate 2008; 68:1753 - 62; http://dx.doi.org/10.1002/pros.20847; PMID: 18767041
  • Pollack A. New drugs fight prostate cancer, but at high cost. New York Times. June 27, 2011.
  • Horgan AM, Bradbury PA, Amir E, Ng R, Douillard JY, Kim ES, et al. An economic analysis of the INTEREST trial, a randomized trial of docetaxel versus gefitinib as second-/third-line therapy in advanced non-small-cell lung cancer. Ann Oncol 2011; 22:1805 - 11; http://dx.doi.org/10.1093/annonc/mdq682; PMID: 21273345
  • Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al, TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351:1502 - 12; http://dx.doi.org/10.1056/NEJMoa040720; PMID: 15470213
  • Paller CJ, Antonarakis ES. Cabazitaxel: a novel second-line treatment for metastatic castration-resistant prostate cancer. Drug Des Devel Ther 2011; 5:117 - 24; PMID: 21448449
  • Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol 2008; 26:242 - 5; http://dx.doi.org/10.1200/JCO.2007.12.4008; PMID: 18182665

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.