Sipuleucel-T: A therapeutic cancer vaccine for the treatment of castration- or hormone-refractory prostate cancer

Expert Review of Clinical Pharmacology

Volumn 4, Issue 6, 2011, Pages 685-692

  Bulloch, Marilyn N ^a,b   Elayan, Mohammed M ^b   Renfroe, Holly R ^b  

^a UNIVERSITY OF ALABAMA   (United States)

^b AUBURN UNIVERSITY   (United States)

Author keywords

APC8015; cancer vaccine; immunotherapy; prostate cancer; sipuleucel T

Indexed keywords

BEVACIZUMAB; DIPHENHYDRAMINE; KEYHOLE LIMPET HEMOCYANIN; PARACETAMOL; PLACEBO; PROSTATE SPECIFIC ANTIGEN; PROVENGE;

ANDROGEN DEPRIVATION THERAPY; ANEMIA; ANOREXIA; ANTIBODY TITER; ANTIGEN PRESENTING CELL; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; ASTHENIA; BRONCHOSPASM; CANCER IMMUNIZATION; CANCER IMMUNOTHERAPY; CANCER PATIENT; CASTRATION RESISTANT PROSTATE CANCER; CELL IMMORTALIZATION; CHILL; COUGHING; DIAPHORESIS; DISEASE COURSE; DIZZINESS; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FLU LIKE SYNDROME; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEMATURIA; HOT FLUSH; HUMAN; HUMORAL IMMUNITY; HYPERTENSION; HYPOXIA; INSOMNIA; LYMPHOCYTE PROLIFERATION; MAXIMUM TOLERATED DOSE; NAUSEA; NONHUMAN; OVERALL SURVIVAL; PAIN; PERIPHERAL EDEMA; RESPIRATORY TRACT INFECTION; SIDE EFFECT; T LYMPHOCYTE ACTIVATION; TREATMENT DURATION; TREATMENT RESPONSE; TREMOR; URINARY TRACT INFECTION; VOMITING; WEIGHT REDUCTION;

ANIMALS; CANCER VACCINES; CLINICAL TRIALS AS TOPIC; DRUG ADMINISTRATION SCHEDULE; HUMANS; MALE; ORCHIECTOMY; PROSTATIC NEOPLASMS; PROTEIN TYROSINE PHOSPHATASES; TISSUE EXTRACTS; TREATMENT OUTCOME;

EID: 80155142273     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1586/ecp.11.60     Document Type: Article

References (29)

1. American Cancer Society. Cancer Facts & Figures 2011. American Cancer Society, GA, USA (2011).
2. Heidenreich A, Bellmunt J, Bolla M et al. EAU Guidelines on prostate cancer: part 1: screening, diagnosis, and treatment of clinically localized disease. Eur. Urol. 59, 61-71 (2011).
3. Hayward SW Cunha GR. The prostate: development and physiology. Radiol. Clin. North Am. 38, 1-14 (2000). (Pubitemid 30059002)
4. Nelson WG, De Marzo AM, Isaacs WB. Prostate cancer. N. Engl. J. Med. 349, 366-381 (2003). (Pubitemid 36886244)
5. US Preventive Services Task Force. Screening for prostate cancer: US Preventive Services Task Force recommendation statement. Ann. Intern. Med. 149, 185-191 (2008).
6. Mohler J, Bahnson RR, Boston B et al. NCCN clinical practice guidelines in oncology: prostate cancer. J. Natl Compr. Canc. Netw. 8, 162-200 (2010).
7. Kawachi MH, Bahnson RR, Barry M et al. NCCN clinical practice guidelines in oncology: prostate cancer early detection. J. Natl Compr. Canc. Netw. 8, 240-262 (2010).
8. Heidenreich A, Bellmunt J, Bolla M et al. EAU Guidelines on prostate cancer: part II: treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur. Urol. 59, 572-583 (2011)
9. Small E, Fratesi P, Reese D et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J. Clin. Oncol. 18, 3894-3903 (2000).
10. Burch P, Breen J, Buckner J et al. Priming tissue-specific cellular immunity in a Phase I trial of autologous dendritic cells for prostate cancer. Clin. Cancer Res. 6, 2175-2182 (2000). (Pubitemid 30399182)
11. Burch P, Croghan G, Gastineau D et al. Immunotherapy (APC8015, Provenge®) targeting prostatic acid phosphatase can induce durable remission of metastatic androgen-independent prostate cancer: a Phase 2 trial. Prostate 60, 197-204 (2004). (Pubitemid 38971831)
12. Small E, Schellhammer P, Higano C et al. Placebo-controlled Phase III trial of immunologic therapy with sipuleucel-T (APC8051) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J. Clin. Oncol. 24, 3089-3094 (2006). (Pubitemid 46638945)
13. Kantoff P, Higano C, Shore N et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N. Engl. J. Med. 363, 411-422 (2010).
14. Kelly WK, Halabi S, Carducci MA 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(Suppl.) (2010) (Abstract LBA4511).
15. Schlom J, Arlene PM, Gulley JL. Cancer vaccines: moving beyond current paradigms. Clin. Cancer Res. 13, 3776-3781 (2007).
16. Gulley JL, Madan RA, Arlen PM. Enhancing efficacy of therapeutic vaccinations by combinations with other modalities. Vaccine 25S, B89-B96 (2007). (Pubitemid 47488548)
17. Gardasil® (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Prescribing Information. Merck & Co., Inc., NJ, USA (2006).
18. Cervarix® (Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant) Prescribing Information. GlaxoSmithKline, NC, USA (2009).
19. Provenge (Sipuleucel-T). Prescribing Information. Dendreon Corp., WA USA (2010).
20. Rini B, Weinberg V, Fong L et al. Combination immunotherapy with prostatic acid phasphatase pulsed antigen-presenting cells (Provenge) plus bevicizumab in patients with serologic progression of prostate cancer after definitive local therapy. Cancer 107, 67-74 (2006). (Pubitemid 43939032)
21. Beinart G, Rini B, Weinberg V et al. Antigen-presenting cells 8051 (Provenge®) in patients with androgen-dependent, biochemically relapsed prostate cancer. Clin. Prostate Cancer 4, 55-60 (2005). (Pubitemid 41018184)
22. American Society of Clinical Oncology. FDA approves PROVENGE (sipuleucel-T) for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer www.asco.org/ASCOv2/Practice+Guidelines/Practice+Manage ment+& +Reimbursement/FDA+Drug+Alerts/FDA+approves+PROV ENGE+(sipuleucel-T) +for+the+treatment+ of+asymptomatic+or+minimally+symptom atic+metastatic+castrate+resistant+(hormo ne+refractory)+prostate+cancer (Accessed 10 December 2010)
23. European Medicines Agency. Human Medicines. European public assessment reports www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/landing/epar- search. jsp&murl=menus/medicines/medicines. jsp&mid=WC0b01ac058001d125 (Accessed 1 March 2011)
24. Health Canada. Therapeutic Products Directorate. Health Products and Food Branch www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/tpd-dpt/index-eng.php (Accessed 1 March 2011)
25. Australian Government. Department of Health and Ageing, Therapeutic Goods Administration www.tga.gov.au (Accessed 1 March 2011)
26. Ministry of Health, Labour and Welfare www.mhlw.go.jp/english/index.html (Accessed 1 March 2011)
27. National Cancer Institute. Surveillance Epidemiology and End Results. SEER Stat Fact Sheets: Prostate http://seer.cancer.gov/statfacts/html/prost.html (Accessed 10 December 2010)
28. Marchione M, Associated Press. $93,000 cancer drug renews debate on price of life www.msnbc.msn.com/id/39329909/ns/health-cancer (Accessed 10 December 2010)
29. Marcotty J, StarTribune.com. Provenge: pricey prostate cancer breakthrough www.startribune.com/lifestyle/104249968.html (Accessed 10 December 2010)