An overview of sipuleucel-T: Autologous cellular immunotherapy for prostate cancer

References

• Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011: the impact of eliminating socioeconomic and racial disparities on premature cancer deaths. CA Cancer J Clin 2011; 61:212 - 36; http://dx.doi.org/10.3322/caac.20121; PMID: 21685461
   PubMed Web of Science ®Google Scholar
• Prestwich RJ, Errington F, Hatfield P, Merrick AE, Ilett EJ, Selby PJ, et al. The immune system--is it relevant to cancer development, progression and treatment?. Clin Oncol (R Coll Radiol) 2008; 20:101 - 12; http://dx.doi.org/10.1016/j.clon.2007.10.011; PMID: 18037277
   PubMed Web of Science ®Google Scholar
• Sumner WC, Foraker AG. Spontaneous regression of human melanoma: clinical and experimental studies. Cancer 1960; 13:79 - 81; http://dx.doi.org/10.1002/1097-0142(196001/02)13:1<79::AID-CNCR2820130115>3.0.CO;2-4; PMID: 13835693
   PubMed Web of Science ®Google Scholar
• Cole WH. Relationship of causative factors in spontaneous regression of cancer to immunologic factors possibly effective in cancer. J Surg Oncol 1976; 8:391 - 411; http://dx.doi.org/10.1002/jso.2930080506; PMID: 792571
   PubMedGoogle Scholar
• Dillman RO. Cancer immunotherapy. Cancer Biother Radiopharm 2011; 26:1 - 64; http://dx.doi.org/10.1089/cbr.2010.0902; PMID: 21355777
   PubMed Web of Science ®Google Scholar
• June CH, Blazar BR, Riley JL. Engineering lymphocyte subsets: tools, trials and tribulations. Nat Rev Immunol 2009; 9:704 - 16; http://dx.doi.org/10.1038/nri2635; PMID: 19859065
   PubMed Web of Science ®Google Scholar
• Rosenberg SA, Restifo NP, Yang JC, Morgan RA, Dudley ME. Adoptive cell transfer: a clinical path to effective cancer immunotherapy. Nat Rev Cancer 2008; 8:299 - 308; http://dx.doi.org/10.1038/nrc2355; PMID: 18354418
   PubMed Web of Science ®Google Scholar
• Schmitt TM, Ragnarsson GB, Greenberg PD. T cell receptor gene therapy for cancer. Hum Gene Ther 2009; 20:1240 - 8; http://dx.doi.org/10.1089/hum.2009.146; PMID: 19702439
   PubMed Web of Science ®Google Scholar
• Berger C, Turtle CJ, Jensen MC, Riddell SR. Adoptive transfer of virus-specific and tumor-specific T cell immunity. Curr Opin Immunol 2009; 21:224 - 32; http://dx.doi.org/10.1016/j.coi.2009.02.010; PMID: 19304470
   PubMed Web of Science ®Google Scholar
• Chames P, Van Regenmortel M, Weiss E, Baty D. Therapeutic antibodies: successes, limitations and hopes for the future. Br J Pharmacol 2009; 157:220 - 33; http://dx.doi.org/10.1111/j.1476-5381.2009.00190.x; PMID: 19459844
   PubMed Web of Science ®Google Scholar
• Riddell SR. Finding a place for tumor-specific T cells in targeted cancer therapy. J Exp Med 2004; 200:1533 - 7; http://dx.doi.org/10.1084/jem.20042004; PMID: 15611285
   PubMed Web of Science ®Google Scholar
• Riddell SR. Engineering antitumor immunity by T-cell adoptive immunotherapy. Hematology Am Soc Hematol Educ Program 2007; 250 - 6; http://dx.doi.org/10.1182/asheducation-2007.1.250; PMID: 18024637
   PubMedGoogle Scholar
• Le DT, Pardoll DM, Jaffee EM. Cellular vaccine approaches. Cancer J 2010; 16:304 - 10; http://dx.doi.org/10.1097/PPO.0b013e3181eb33d7; PMID: 20693840
   PubMed Web of Science ®Google Scholar
• Palena C, Abrams SI, Schlom J, Hodge JW. Cancer vaccines: preclinical studies and novel strategies. Adv Cancer Res 2006; 95:115 - 45; http://dx.doi.org/10.1016/S0065-230X(06)95004-0; PMID: 16860657
   PubMed Web of Science ®Google Scholar
• Weide B, Garbe C, Rammensee HG, Pascolo S. Plasmid DNA- and messenger RNA-based anti-cancer vaccination. Immunol Lett 2008; 115:33 - 42; http://dx.doi.org/10.1016/j.imlet.2007.09.012; PMID: 18006079
   PubMed Web of Science ®Google Scholar
• Eager RM, Nemunaitis J. Clinical development directions in oncolytic viral therapy. Cancer Gene Ther 2011; 18:305 - 17; http://dx.doi.org/10.1038/cgt.2011.7; PMID: 21436867
   PubMed Web of Science ®Google Scholar
• Loisel-Meyer S, Foley R, Medin JA. Immuno-gene threapy approaches for cancer: from in vitro studies to clinical trials. Front Biosci 2008; 1:3202 - 14; http://dx.doi.org/10.2741/2921
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Graddis TJ, McMahan CJ, Tamman J, Page KJ, Trager JB. Prostatic acid phosphatase expression in human tissues. Int J Clin Exp Pathol 2011; 4:295 - 306; PMID: 21487525
   PubMedGoogle Scholar
• Laus R, Yang DM, Ruegg CL, Shapero MH, Slagle PH, Small EJ, et al. Dendritic cell immunotherapy of prostate cancer: Preclinical models and early clinical experience. Cancer Research Therapy and Control 2001; 11:1 - 10
   Google Scholar
• Alberts B, Johnson A, Lewis J, Raff M, Roberts K, Walter P. Molecular Biology of the Cell. Garland Science, 2005.
   Google Scholar
• Dustin ML, Rothlein R, Bhan AK, Dinarello CA, Springer TA. Induction by IL 1 and interferon-gamma: tissue distribution, biochemistry, and function of a natural adherence molecule (ICAM-1). J Immunol 1986; 137:245 - 54; PMID: 3086451
   PubMed Web of Science ®Google Scholar
• Sheikh NA, Jones LA. CD54 is a surrogate marker of antigen presenting cell activation. Cancer Immunol Immunother 2008; 57:1381 - 90; http://dx.doi.org/10.1007/s00262-008-0474-9; PMID: 18297282
   PubMed Web of Science ®Google Scholar
• FDA/CBER. Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products. 2011 January.
   Google Scholar
• Sheikh NA, Dela Rosa C, Frohlich MW, Urdal DL, Provost NM. Sipuleucel-T treatment results in sequential ex vivo activation of APCs and T cells during the culture step - evidence for in vivo immunological priming [abstract]. AACR. Washington, DC, 2010:abstract 5608.
   Google Scholar
• Wesley JD, Chadwick E, Kuan L-Y, Dela Rosa C, Frohlich M, Urdal D, et al. Characterization of antigen specific T cell activation and cytokine expression induced by sipuleucel-T. J Immunother 2010; 33:912 - 3
   Web of Science ®Google Scholar
• Sheikh NA, Wesley JD, Chadwick E, Perdue N, Dela Rosa C, Frohlich MW, et al. Characterization of antigen specifric T-cell activation and cytokine expression induced by sipuleucel-T. [abstract 155] J Clin Oncol 2011; 29
   Google Scholar
• Burch PA, Breen JK, Buckner JC, Gastineau DA, Kaur JA, Laus RL, 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; PMID: 10873066
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   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; 4:55 - 60; PMID: 15992463
   PubMedGoogle Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Butterfield LH, Disis ML, Khleif SN, Balwit JM, Marincola FM. Immuno-oncology biomarkers 2010 and beyond: perspectives from the iSBTc/SITC biomarker task force. J Transl Med 2010; 8:130; http://dx.doi.org/10.1186/1479-5876-8-130; PMID: 21138581
   PubMed Web of Science ®Google Scholar
• Stewart FP, Dela Rosa C, Sheikh NA, McNeel DG, Frohlich MW, Urdal DL, 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 4552] J Clin Oncol 2010; 28
   Google Scholar
• Sheikh NA, Dela Rosa C, Kuan L-Y, Stewart FP, Frohlich MW, Urdal DL, et al. Sipuleucel-T generates robust and persistent cellular and humoral immune responses - results from the IMPACT trial [abstract]. AACR. Washington, DC, 2010:abstract 2932.
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Augustin H, Freibauer C, Bayer L, Lunglmayr G, Tschurlovich F, Kuber W, et al. Molecular markers and their prognostic impact in patients with advanced prostate cancer undergoing intermittent androgen suppression. Prostate Cancer Prostatic Dis 2006; 9:279 - 83; http://dx.doi.org/10.1038/sj.pcan.4500883; PMID: 16702984
   PubMed Web of Science ®Google Scholar
• Akyol F, Ozyigit G, Selek U, Karabulut E. PSA bouncing after short term androgen deprivation and 3D-conformal radiotherapy for localized prostate adenocarcinoma and the relationship with the kinetics of testosterone. Eur Urol 2005; 48:40 - 5; http://dx.doi.org/10.1016/j.eururo.2005.04.007; PMID: 15967250
   PubMed Web of Science ®Google Scholar
• Bates AT, Pickles T, Paltiel C. PSA doubling time kinetics during prostate cancer biochemical relapse after external beam radiation therapy. Int J Radiat Oncol Biol Phys 2005; 62:148 - 53; http://dx.doi.org/10.1016/j.ijrobp.2004.09.048; PMID: 15850915
   PubMed Web of Science ®Google Scholar
• Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, et al, Prostate Cancer Clinical Trials Working Group. 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 2008; 26:1148 - 59; http://dx.doi.org/10.1200/JCO.2007.12.4487; PMID: 18309951
   PubMed Web of Science ®Google Scholar
• Scher HI, Warren M, Heller G. The association between measures of progression and survival in castrate-metastatic prostate cancer. Clin Cancer Res 2007; 13:1488 - 92; http://dx.doi.org/10.1158/1078-0432.CCR-06-1885; PMID: 17332293
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Stein WD, Gulley JL, Schlom J, Madan RA, Dahut W, Figg WD, et al. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy. Clin Cancer Res 2011; 17:907 - 17; http://dx.doi.org/10.1158/1078-0432.CCR-10-1762; PMID: 21106727
   PubMed Web of Science ®Google Scholar
• Gulley JL, Drake CG. Immunotherapy for prostate cancer: recent advances, lessons learned, and areas for further research. Clin Cancer Res 2011; 17:3884 - 91; http://dx.doi.org/10.1158/1078-0432.CCR-10-2656; PMID: 21680544
   PubMed Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1634/theoncologist.2010-0129; PMID: 20798195
   PubMed Web of Science ®Google Scholar
• Tuma RS. Immunotherapies in clinical trials: do they demand different evaluation tools?. J Natl Cancer Inst 2011; 103:780 - 1; http://dx.doi.org/10.1093/jnci/djr184; PMID: 21551417
   PubMed Web of Science ®Google Scholar
• Kudo-Saito C, Schlom J, Hodge JW. Induction of an antigen cascade by diversified subcutaneous/intratumoral vaccination is associated with antitumor responses. Clin Cancer Res 2005; 11:2416 - 26; http://dx.doi.org/10.1158/1078-0432.CCR-04-1380; PMID: 15788693
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• Hall SJ, Klotz L, Pantuck AJ, George DJ, Whitmore JB, Frohlich MW, et al. Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. J Urol 2011; 186:877 - 81; http://dx.doi.org/10.1016/j.juro.2011.04.070; PMID: 21788048
   PubMed Web of Science ®Google Scholar
• Flanigan R, Price T, Whitmore J, Holman J. Safety of leukapheresis in prostate cancer patients receiving sipuleucel-T. [Abstract 646] J Urol 2011; 185:e261; http://dx.doi.org/10.1016/j.juro.2011.02.1548
   Google Scholar
• Sims RB. Development of sipuleucel-T: Autologous cellular immunotherapy for the treatment of metastatic castrate resistant prostate cancer. Vaccine 2011; In press http://dx.doi.org/10.1016/j.vaccine.2011.11.058; PMID: 22122856
   PubMed Web of Science ®Google Scholar