New agents in the arsenal to fight castrate-resistant prostate cancer

Current Oncology Reports

Volumn 15, Issue 3, 2013, Pages 239-248

  Ezzell, Erin E ^a   Chang, Kuang S ^a   George, Benjamin J ^a  

^a SAN ANTONIO MILITARY MEDICAL CENTER   (United States)

Author keywords

Abiraterone; Androgen deprivation therapy; Androgen receptor; Cabazitaxel; Cancer vaccine; Castrate resistant prostate cancer; Chemotherapy; CYP17 inhibitor; Enzalutamide; Immunotherapy; Sipuleucel T

Indexed keywords

ABIRATERONE; ACID PHOSPHATASE PROSTATE ISOENZYME; ANDROGEN; ANDROGEN RECEPTOR; ANTIANDROGEN; ANTIHISTAMINIC AGENT; BICALUTAMIDE; CABAZITAXEL; DASATINIB; DEXAMETHASONE; DOCETAXEL; ENZALUTAMIDE; GONADORELIN ANTAGONIST; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HISTAMINE H1 RECEPTOR ANTAGONIST; HISTAMINE H2 RECEPTOR ANTAGONIST; IPILIMUMAB; KETOCONAZOLE; MITOXANTRONE; PA 2024; PARACETAMOL; PETHIDINE; PLACEBO; PREDNISONE; PROSTATE SPECIFIC ANTIGEN; SIPULEUCEL T; STEROID 17ALPHA MONOOXYGENASE; TESTOSTERONE; UNCLASSIFIED DRUG;

ADRENAL INSUFFICIENCY; ANDROGEN DEPRIVATION THERAPY; ANDROGEN SYNTHESIS; ANEMIA; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BINDING AFFINITY; BRONCHOSPASM; CANCER ADJUVANT THERAPY; CANCER CELL; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER IMMUNOTHERAPY; CANCER MODEL; CANCER MORTALITY; CANCER RESISTANCE; CASTRATION RESISTANT PROSTATE CANCER; CHILL; CYTOKINE RELEASE SYNDROME; DIARRHEA; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG FEVER; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG SENSITIVITY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; FATIGUE; GENE OVEREXPRESSION; HORMONE INHIBITION; HOT FLUSH; HUMAN; HYPERALDOSTERONISM; HYPOXIA; INFUSION RELATED REACTION; JOINT SWELLING; KIDNEY FAILURE; LIVER FAILURE; LIVER TOXICITY; LOW DRUG DOSE; MAXIMUM TOLERATED DOSE; METASTASIS POTENTIAL; NAUSEA; NEUTROPENIA; NONHUMAN; OPTIMAL DRUG DOSE; ORCHIECTOMY; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; SEIZURE; THROMBOCYTOPENIA; TREATMENT CONTRAINDICATION; TREATMENT RESPONSE; TUMOR XENOGRAFT; VOMITING;

ANDROGEN ANTAGONISTS; ANDROSTENOLS; CANCER VACCINES; COMBINED MODALITY THERAPY; HUMANS; MALE; ORCHIECTOMY; PHENYLTHIOHYDANTOIN; PROSTATIC NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TAXOIDS; TISSUE EXTRACTS; UNITED STATES;

EID: 84877921622     PISSN: 15233790     EISSN: 15346269     Source Type: Journal    
DOI: 10.1007/s11912-013-0305-9     Document Type: Article

References (71)

1. Howlader, N, Noone AM, Krapcho, M, et al. SEER cancer statistics review, 1975-2009, National Cancer Institute, Bethesda, MD. Available at http://seer.cancer.gov/csr/1975-2009-pops09/ Accessed December 2012.
2. Huggins C, Stephens RE, Hodges CV. Studies on prostate cancer: the effects of castration on advanced carcinoma of the prostate. Arch Surg. 1941;43:209-23.
3. NCCN clinical practice guidelines in oncology: prostate cancer. Available at http://www.nccn.org/professionals/physician-gls/pdf/prostate.pdf Accessed Jan 2013.
4. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone for advanced prostate cancer. N Engl J Med. 2004;351:1502-12.
5. US Food and Drug Administration: enzalutamide (XTANDI capsules). Available at http://www.fda.gov/drugs/informationondrugs/approveddrugs/ ucm317997.htm Accessed Jan 2013.
6. US Food and Drug Administration: abiraterone acetate. Available at http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm331628.htm Accessed Jan 2013.
7. US Food and Drug Administration: cabazitaxel. Available at http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/ CDER/ucm216214.htm Accessed Jan 2013.
8. US Food and Drug Administration: Provenge (sipuleucel-T). Available at http://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/ approvedproducts/ucm210012.htm Accessed Jan 2013.
9. Feldman BJ, Felman D. The development of androgen-independent prostate cancer. Nat Rev Cancer. 2001;1:34-45.
10. Chen CD, Welsbie DS, Tran C, et al. Molecular determinants of resistance to antiandrogen therapy. Nat Med. 2004;10:33-9.
11. Chen Y, Clegg NJ, Scher HI. Antiandrogens and androgen depleting therapies in prostate cancer: novel agents for an established target. Lancet Oncol. 2009;10:981-91.
12. Montgomery RB, Mostaghel EA, Vessella R, et al. Maintenance of intratumoral androgens in the metastatic prostate cancer: a mechanism for castration-resistant tumor growth. Cancer Res. 2008;68:4447-54.
13. Stanbrough M, Bubley GJ, Ross K, et al. Increased expression of genes converting adrenal androgens to testosterone in androgen-independent prostate cancer. Cancer Res. 2006;66:2815-25.
14. Jung ME, Ouk S, Yoo D, et al. Structure-activity relationship for thiohydantoin androgen receptor antagonists for castration-resistant prostate cancer. J Med Chem. 2010;53:2779-96.
15. Tran C, Ouk S, Clegg N, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science. 2009;324:787-90.
16. Scher HI, Beer TM, Higano CS, et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet. 2010;375:1437-46.
17. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. NEJM. 2012;367:1187-97. The results of this study led to FDA approval on enzalutamide in CRPC patients who have previously received docetaxel.
18. Xtandi (enzalutamide) prescribing information. Last revised 8/2012. Available at http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf. Accessed January 2013
19. U.S. National Institutes of Health. A safety and efficacy study of oral MDV3100 in chemotherapy-naïve patients with progressive metastatic prostate cancer (PREVAIL). Available at http://www.clinicaltrials.gov/ct2/show/ NCT01212991. Accessed January 2013.
20. U.S. National Institutes of Health. Safety and efficacy study of enzalutamide versus bicalutamide in men with prostate cancer (STRIVE). Available at http://www.clinicaltrials.gov/ct2/show/NCT01664923. Accessed January 2013.
21. U.S. National Institutes of Health. A study of MDV3100 versus bicalutamide in castrate men with metastatic prostate cancer. Available at http://www.clinicaltrials.gov/ct2/show/NCT01288911. Accessed January 2013.
22. U.S. National Institutes of Health. Safety and tolerability study of MDV3100 in combination with docetaxel in men with advanced prostate cancer. Available at http://www.clinicaltrials.gov/ct2/show/NCT01565928. Accessed January 2013.
23. U.S. National Institutes of Health. A study to determine safety and tolerability of enzalutamide (MDV3100) in combination with abiraterone acetate in bone metastatic catration-resistant prostate cancer patients. Available at http://www.clinicaltrials.gov/ct2/show/NCT01650194. Accessed January 2013.
24. U.S. National Institutes of Health. Study of MDV3100 as a neoadjuvant therapy for patients undergoing prostatectomy for localized prostate cancer. Available at http://www.clinicaltrials.gov/ct2/show/NCT01547299. Accessed January 2013.
25. Huggins C, Hodges CV. Studies on prostatic cancer:I. The effect of castratrion, of estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. J Urol 1941, 2002;168:9-12.
26. Yap TA, Carden CP, Attard G, et al. Targeting CYP17: established and novel approaches in prostate cancer. Curr Opin Pharmacol. 2008;9:449-57.
27. Attard G, Reid A, Yap TA, et al. Phase I clinical trial of selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. J Clin Oncol. 2008;26:4563-71.
28. Attard G, Alison HM, 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. 2009;27:3742-8.
29. Gregory CW, Johnson RT, Mohler JL, et al. Androgen receptor stabilization in recurrent prostate cancer is associated with hypersensitivity to low androgen. Cancer Res. 2001;61:2892-8.
30. Potter GA, Barrie SE, Jarman M, et al. Novel Steroidal inhibitors of human cytochrome P45017 alpha (17 alphahydroxylase-C17,20-lyase): potential agents for the treatment of prostatic cancer. J Med Chem. 1995;28:2463-71.
31. Attard G, Belldegrun AS, de Bono JS. Selective blockade of androgenic steroid synthesis by novel lyase inhibitors as a therapeutic strategy for treating metastatic prostate cancer. BJU Int. 2005;96:1241-6.
32. Barie SE, Haynes BP, Potter GA, et al. Biochemistry and pharmacokinetics of potent non-steroidal cytochrome P450(17 alpha) inhibitors. J Steroid Biochem Mol Biol. 1997;60:347-51.
33. Zytiga (abiraterone acetate) tablets, prescribing information. Horsham, PA: Janssen Biotech; December 2012. Available at: http://www.zytiga.com/ downloads/full-product-information.pdf#zoom=100. Accessed January 4, 2013.
34. Small EJ, Halabi S, Dawson NA, et al. Antiandrogen withdrawal alone or in combination with ketoconazole in androgen-independent prostate cancer patients: A phase III trial (CALGB 9583). J Clin Oncol. 2004;22:1025-33.
35. Ryan CJ, Smith MR, Lawrence F, et al. Phase I clinical trial of the CYP17 inhibitor abiraterone acetate demonstrating clinical activity in patients with castration-resistant prostate cancer who received ketoconazole therapy. J Clin Oncol. 2010;28:1481-8.
36. Danila DC, Morris MJ, de Bono JS, et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castrastion-resistant prostate cancer. J Clin Oncol. 2010;28:1496-501.
37. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364:1995-2005. This study lead to the FDA approval of abiraterone for treatment of metastatic CRPC after previous chemotherapy with docetaxel.
38. Ryan CJ, Smith MR, de Bono JS, et al. Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone (AA) in chemotherapy-naïve patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) [abstract LBA4518] Presented at ASCO Annual Meeting. Chicago, Illinois; June 1-5, 2012. These results lead to expanded FDA approval of abiraterone for treatment of metastatic CRPC before or after chemotherapy.
39. Melmed, S., K. S. Polonsky, P. R. Larsen, and H. M. Kronenberg. Williams textbook of endocrinology, expert consult. 12th. Section IV. Philadelphia, PA: W B Saunders Co, 2011. Print.
40. U.S. National Institute of Health. A study of abiraterone acetate plus low-dose prednisone plus androgen deprivation therapy (ADT) versus ADT alone in newly diagnosed patients with high-risk, metastatic hormone-naïve prostate cancer (mHNPC). Available at: http://clinicaltrials.gov/ct2/show/NCT01715285. Accessed January 2013.
41. U.S. National Institute of Health. Abiraterone acetate and prednisone with or without dasatinib in treating patients with metastatic hormone-resistant prostate cancer. Available at: http://clinicaltrials.gov/ct2/show/NCT01685125. Accessed January 2013.
42. U.S. National Institute of Health. Combining ipilimumab with abiraterone acetate plus prednisone in chemotherapy and immunotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer. Available at: http://clinicaltrials.gov/ct2/show/NCT01688492. Accessed January 2013.
43. U.S. National Institute of Health. Concurrent versus sequential treatment with sipuleucel-T and abiraterone in men with metastatic castrate resistant prostate cancer (mCRPC). Available at: http://clinicaltrials.gov/ct2/show/ NCT01487863. Accessed January 2013.
44. 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. 2008;26:1148-59.
45. 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;351:1513-20.
46. Jevtana (cabazitaxel) Injection, prescribing information. Bridgewater, NJ: Sanofi; October 2012. Available at: http://products.sanofi.us/jevtana/ jevtana.html. Accessed December 2012.
47. Horwitz SB, Cohen D, Rao S, Ringel I, et al. Taxol: mechanisms of action and resistance. J Natl Cancer Inst Monogr. 1993;15:55-61.
48. Lockhart AC, Tirona RG, Kim RB. Pharmacogenetics of ATP-binding cassette transporters in cancer and chemotherapy. Mol Cancer Ther. 2003;2:685-98.
49. Sanofi-aventis. XRP6258 investigator's brochure. Antony (France): Sanofi-aventis; 2000.
50. Archimbaud Y, Gires P, Pellerin R, et al. Pharmacokinetics of a new taxoid, 14C-TXD258, in blood, plasma, and brain of the mouse, rat, and dog. Proceedings of the American Association for Cancer Research 2000:41. Abstract 1375.
51. Cisternino S, Bourasset F, Archimbaud Y, et al. Nonlinear accumulation in the brain of the new taxoid TXD258 following saturation of P-glycoprotein at the blood-brain barrier in mice and rats. Br J Pharmacol. 2003;138:1367-75.
52. Mita AC, Denis LJ, Rowinsky EK, et al. Phase I and pharmacokinetic study of XRP6258 (RPR 116258A), a novel taxane, administered as a 1-hour infusion every 3 weeks in patients with advanced solid tumors. Clin Cancer Res. 2009;15:723-30.
53. Pivot X, Koralewski P, Hidalgo JL, et al. A multicenter phase II study of XRP6258 administered as a 1-h IV infusion every 3 weeks in taxane-resistant metastatic breast cancer patients. Ann Oncol. 2008;19:1547-52.
54. de Bono JS, Oudard S, Ozguroglu M, et al. 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. This study led to FDA approval of cabazitaxel for metastatic hormone refractory prostate cancer patients previously treated with docetaxel.
55. Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American society of clinical oncology clinical practice guidelines update. American Society of Clinical Oncology ClGuideline update. J Clin Oncol. 2011;29:4189-98.
56. Cabazitazel versus docdetaxel both with prednisone in patients with metastatic castration resistant prostate cancer (FIRSTANA). March 1, 2012. Available at: http://clinicaltrials.gov/ct2/show/NCT01308567. Accessed January 2013.
57. Banchereau J, Steinman RM. Dendritic cells and the control of immunity. Nature. 1998;392:245-52.
58. Fang L, Ruegg CL, Brockstedt D, et al. Induction of tissue-specific autoimmune prostatitis with prostatic acid phosphatase immunization: implications for immunotherapy of prostate cancer. J Immunol. 1997;159:3113-7.
59. Valone FH, Small E, MacKenzie M, et al. Dendritic cell-based treatment of cancer: closing in on a cellular therapy. Cancer J. 2001;7 Suppl 2:S53-61.
60. Small EJ, Fratesi P, Reese DM, et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol. 2000;18:3894-903.
61. 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. 2000;6:2175-82.
62. Burch PA, Groghan GA, Gastineau DA, et al. Immunotherapy (APC, Provenge) targeting prostatic acid phosphatase can induce durable remission of metastatc androgen-independent prostate cancer: a phase 2 trial. Prostate. 2004;60:197-204.
63. Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patient with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006;24:3089-94.
64. 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. Cancer. 2009;115:3670-9.
65. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;362:411-22. This study led to FDA approval of sipuleucel T as 1st cancer immunotherapy for asymptomatic or minimally symptomatic metastatic prostate cancer.
66. Hall SJ, Klotz L, Pantuck AJ, et al. Integrated safety data from 4 randomized, double-blind controlled trials of autologous cellular immunotherapy with sipuleucel-T in patient with prostate cancer. J Urol. 2011;186:877-81.
67. Beer TM, Bernstein GT, Corman JM. Randomized trial of active cellular immunotherapy with sipuleucel-T in androgen dependent prostate cancer (ADPC) [abstract 5059]. Presented at the 43rd ASCO Annual Meeting Proceedings. Chicago, Illinois; June 1-5, 2007.
68. Common Terminology Criteria for Adverse Events v(3.0) 2006. Available at http://ctep.cancer.gov/protocoldevelopment/electronic-applications/docs/ctaev3. pdf. Access January 2013.
69. U.S. National Institutes of Health. Sipuleucel-T as neoadjuvant treatment in prostate cancer (NeoAct). Available at http://www.clinicaltrials.gov/ct2/ show/NCT00715104. Accessed January 2013.
70. U.S. National Institutes of Health. Provenge ™ for the treatment of hormone sensitive prostate cancer (PROTECT). Available at http://www. clinicaltrials.gov/ct2/show/NCT00779402. Accessed January 2013.
71. U.S. National Institutes of Health. Sequencing of sipuleucel-T in men with non-metastatic prostate cancer. Available at http://www.clinicaltrials.gov/ ct2/show/NCT01431391. Accessed January 2013.