Advanced prostate cancer - Patient survival and potential impact of enzalutamide and other emerging therapies

Therapeutics and Clinical Risk Management

Volumn 10, Issue 1, 2014, Pages 651-664

  Patel, Nihar K ^a   Finianos, Antoine ^a   Whitaker, Kristen D ^a   Aragon Ching, Jeanny B ^a  

^a GEORGE WASHINGTON UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Enzalutamide; Metastatic castration resistant prostate cancer; Systemic therapies

Indexed keywords

4 [7 [6 CYANO 5 (TRIFLUOROMETHYL) 3 PYRIDINYL] 8 OXO 6 THIOXO 5,7 DIAZASPIRO[3.4]OCTAN 5 YL] 2 FLUORO N METHYLBENZAMIDE; ABIRATERONE ACETATE; ARN 509; CABAZITAXEL; CABOZANTINIB; CUSTIRSEN; DOCETAXEL; ENZALUTAMIDE; IPILIMUMAB; MITOXANTRONE; OGX 111; ORTERONEL; PLACEBO; PREDNISONE; RADIUM CHLORIDE RA 223; RILIMOGENE GALVACIREPVEC; SIPULEUCEL T; TASQUINIMOD; UNCLASSIFIED DRUG;

ADVANCED CANCER; ANDROGEN DEPRIVATION THERAPY; ANTINEOPLASTIC ACTIVITY; BONE MARROW SUPPRESSION; BRAIN INFARCTION; CANCER HORMONE THERAPY; CANCER SURVIVAL; CASTRATION RESISTANT PROSTATE CANCER; DIARRHEA; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ELIMINATION; DRUG FATALITY; DRUG MECHANISM; DRUG METABOLISM; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEVER; HEADACHE; HOT FLUSH; HUMAN; HYPERAMYLASEMIA; HYPERTENSION; HYPOKALEMIA; INFLAMMATION; METASTATIC CASTRATION RESISTANT PROSTATE CANCER; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PANCYTOPENIA; PATIENT COMPLIANCE; PATIENT SATISFACTION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SEIZURE; SINUS TACHYCARDIA; TREMOR; UNSPECIFIED SIDE EFFECT;

EID: 84937720465     PISSN: 11766336     EISSN: 1178203X     Source Type: Journal    
DOI: 10.2147/TCRM.S57509     Document Type: Review

References (91)

1. Siegel R, Ma J, Zou Z, et al. Cancer statistics,2014. CA Cancer J Clin. 2014;64(1):9-29.
2. Mohler JL, Kantoff PW, Armstrong AJ, et al. Prostate cancer, version1. 2014. J Natl Compr Canc Netw.2013;11(12):1471-1479.
3. Cookson MS, Roth BJ, Dahm P, et al. Castration-resistant prostate cancer: AUA Guideline. J Urol.2013;190(2):429-438.
4. Mezynski J, Pezaro C, Bianchini D, et al. Antitumour activity of docetaxel following treatment with the CYP17A1 inhibitor abiraterone: clinical evidence for cross-resistance? Ann Oncol.2012;23(11):2943-2947.
5. Noonan KL, North S, Bitting RL, et al. Clinical activity of abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after enzalutamide. Ann Oncol.2013;24(7): 1802-1807.
6. Pezaro CJ, Omlin AG, Altavilla A, et al. Activity of Cabazitaxel in Castration-resistant Prostate Cancer Progressing After Docetaxel and Next-generation Endocrine Agents. Eur Urol. In press2013.
7. Mohler JL, Kantoff PW, Armstrong AJ, et al. Prostate cancer, version 2.2014. J Natl Compr Canc Netw.2014;12(5):686-718.
8. El-Amm J, Aragon-Ching JB. The changing landscape in the treatment of metastatic castration-resistant prostate cancer. Ther Adv Med Oncol.2013;5(1):25-40.
9. Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin.1972;22(4):232-240.
10. McLeod DG. Hormonal therapy: historical perspective to future directions. Urology.2003;61(2 Suppl1):3-7.
11. Hellerstedt BA, Pienta KJ. The current state of hormonal therapy for prostate cancer. CA Cancer J Clin.2002;52(3):154-179.
12. Sharifi N, Gulley JL, Dahut WL. Androgen deprivation therapy for prostate cancer. JAMA.2005;294(2):238-244.
13. Montgomery RB, Mostaghel EA, Vessella R, et al. Maintenance of intratumoral androgens in metastatic prostate cancer: a mechanism for castration-resistant tumor growth. Cancer Res.2008;68(11): 4447-4454.
14. Mohler JL, Titus MA, Bai S, et al. Activation of the androgen receptor by intratumoral bioconversion of androstanediol to dihydrotestosterone in prostate cancer. Cancer Res.2011;71(4):1486-1496.
15. Auchus RJ. Overview of dehydroepiandrosterone biosynthesis. Semin Reprod Med.2004;22(4):281-288.
16. Goyal J, Antonarakis ES. Clinical Evaluation of Abiraterone in the Treatment of Metastatic Prostate Cancer. Clin Med Insights Urol. 2013;2013(7):1-14.
17. Attard G, Reid AH, Olmos D, et al. Antitumor activity with CYP17 blockade indicates that castration-resistant prostate cancer frequently remains hormone driven. Cancer Res.2009;69(12):4937-4940.
18. Attard G, Reid AH, A'Hern R, et al. Selective inhibition of CYP17 with abiraterone acetate is highly active in the treatment of castrationresistant prostate cancer. J Clin Oncol.2009;27(23):3742-3748.
19. Pia A, Vignani F, Attard G, et al. Strategies for managing ACTH dependent mineralocorticoid excess induced by abiraterone. Cancer Treat Rev.2013;39(8):966-973.
20. Attard G, Reid AH, Yap TA, et al. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castrationresistant prostate cancer commonly remains hormone driven. J Clin Oncol.2008;26(28):4563-4571.
21. Danila DC, Morris MJ, de Bono JS, et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxeltreated castration-resistant prostate cancer. J Clin Oncol.2010;28(9): 1496-1501.
22. Reid AH, Attard G, Danila DC, et al. Significant and sustained antitumor activity in post-docetaxel, castration-resistant prostate cancer with the CYP17 inhibitor abiraterone acetate. J Clin Oncol.2010;28(9): 1489-1495.
23. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med.2011;364(21): 1995-2005.
24. Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebocontrolled phase3study. Lancet Oncol.2012;13(10):983-992.
25. Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368(2):138-148.
26. Rathkopf DE, Smith MR, de Bono JS, et al. Updated interim eff icacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. In press2014.
27. Bostwick DG, Pacelli A, Blute M, et al. Prostate specific membrane antigen expression in prostatic intraepithelial neoplasia and adenocarcinoma: a study of184 cases. Cancer.1998;82(11): 2256-2261.
28. Goldfarb DA, Stein BS, Shamszadeh M, Petersen OR. Age-related changes in tissue levels of prostatic acid phosphatase and prostate specific antigen. J Urol.1986;136(6):1266-1269.
29. Patel PH, Kockler DR. Sipuleucel-T: a vaccine for metastatic, asymptomatic, androgen-independent prostate cancer. Ann Pharmacother.2008;42(1):91-98.
30. Sheikh NA, Petrylak D, Kantoff PW, et al. Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase3clinical trials in men with castration-resistant prostate cancer. Cancer Immunol Immunother.2013;62(1):137-147.
31. Small EJ, Fratesi P, Reese DM, et al. Immunotherapy of hormonerefractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol.2000;18(23):3894-3903.
32. 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.
33. Higano CS, Schellhammer PF, Small EJ, et al. Integrated data from2 randomized, double-blind, placebo-controlled, phase3trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer.2009;115(16):3670-3679.
34. Kantoff PW, Higano CS, Shor e ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363(5):411-422.
35. Mita AC, Denis LJ, Rowinsky EK, et al. Phase I and pharmacokinetic study of XRP6258 (RPR116258A), a novel taxane, administered as a 1-hour infusion every3weeks in patients with advanced solid tumors. Clin Cancer Res.2009;15(2):723-730.
36. 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(9747):1147-1154.
37. Pal SK, Twardowski P, Sartor O. Critical appraisal of cabazitaxel in the management of advanced prostate cancer. Clin Interv Aging. 2010;5:395-402.
38. Bahl A, Oudard S, Tombal B, et al. Impact of cabazitaxel on2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol.2013;24(9):2402-2408.
39. Lewington VJ, McEwan AJ, Ackery DM, et al. A prospective, randomised double-blind crossover study to examine the efficacy of strontium-89 in pain palliation in patients with advanced prostate cancer metastatic to bone. Eur J Cancer.1991;27(8):954-958.
40. Laing AH, Ackery DM, Bayly RJ, et al. Strontium-89 chloride for pain palliation in prostatic skeletal malignancy. Br J Radiol. 1991;64(765):816-822.
41. Seraf ini AN, Houston SJ, Resche I, et al. Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial. J Clin Oncol. 1998;16(4):1574-1581.
42. Sartor O, Reid RH, Hoskin PJ, et al. Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology.2004;63(5):940-945.
43. Finlay IG, Mason MD, Shelley M. Radioisotopes for the palliation of metastatic bone cancer: a systematic review. Lancet Oncol. 2005;6(6):392-400.
44. Goyal J, Antonarakis ES. Bone-targeting radiopharmaceuticals for the treatment of prostate cancer with bone metastases. Cancer Lett. 2012;323(2):135-146.
45. El-Amm J, Freeman A, Patel N, Aragon-Ching JB. Bone-targeted therapies in metastatic castration-resistant prostate cancer: evolving paradigms. Prostate Cancer.2013;2013:210686.
46. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med.2013;369(3): 213-223.
47. Bruland OS, Nilsson S, Fisher DR, et al. High-linear energy transfer irradiation targeted to skeletal metastases by the alpha-emitter223Ra: adjuvant or alternative to conventional modalities? Clin Cancer Res. 2006;12(20 Pt2):6250s-6257s.
48. Liepe K. Alpharadin, a223Ra-based alpha-particle-emitting pharmaceutical for the treatment of bone metastases in patients with cancer. Curr Opin Investig Drugs.2009;10(12):1346-1358.
49. Kerr C. (223)Ra targets skeletal metastases and spares normal tissue. Lancet Oncol.2002;3(8):453.
50. Nilsson S, Larsen RH, Fossa SD, et al. First clinical experience with alpha-emitting radium-223 in the treatment of skeletal metastases. Clin Cancer Res.2005;11(12):4451-4459.
51. Sartor O, Gillessen S. Treatment sequencing in metastatic castrateresistant prostate cancer. Asian J Androl.2014;16(3):426-431.
52. Pisters LL, Troncoso P, Zhau HE, et al. c-met proto-oncogene expression in benign and malignant human prostate tissues. J Urol. 1995;154(1):293-298.
53. Borre M, Offersen BV, Nerstrom B, Overgaard J. Microvessel density predicts survival in prostate cancer patients subjected to watchful waiting. Br J Cancer.1998;78(7):940-944.
54. Smith DC, Smith MR, Sweeney C, et al. Cabozantinib in patients with advanced prostate cancer: results of a phase II randomized discontinuation trial. J Clin Oncol.2013;31(4):412-419.
55. Lee RJ, Saylor PJ, Michaelson MD, et al. A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases. Clin Cancer Res.2013;19(11):3088-3094.
56. Isaacs JT, Pili R, Qian DZ, et al. Identification of ABR-215050 as lead second generation quinoline-3-carboxamide anti-angiogenic agent for the treatment of prostate cancer. Prostate.2006;66(16): 1768-1778.
57. Isaacs JT. The long and winding road for the development of tasquinimod as an oral second-generation quinoline-3-carboxamide antiangiogenic drug for the treatment of prostate cancer. Expert Opin Investig Drugs.2010;19(10):1235-1243.
58. Bratt O, Haggman M, Ahlgren G, et al. Open-label, clinical phase I studies of tasquinimod in patients with castration-resistant prostate cancer. Br J Cancer.2009;101(8):1233-1240.
59. Pili R, Haggman M, Stadler WM, et al. Phase II randomized, double-blind, placebo-controlled study of tasquinimod in men with minimally symptomatic metastatic castrate-resistant prostate cancer. J Clin Oncol.2011;29(30):4022-4028.
60. Weber J. Review: anti-CTLA-4 antibody ipilimumab: case studies of clinical response and immune-related adverse events. Oncologist. 2007;12(7):864-872.
61. Drake C, Kwon E, Fizazi K, et al. Results of subset analyses on overall survival (OS) from study CA184-043: Ipilimumab (Ipi) versus placebo (Pbo) in post-docetaxel metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol.2014;32(Suppl4):Abstr2.
62. Kwon ED, Drake CG, Scher HI, et al. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase3trial. Lancet Oncol. 2014;15(7):700-712.
63. Ning YM, Pierce W, Maher VE, et al. Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: US Food and Drug Administration drug approval summary. Clin Cancer Res.2013;19(22): 6067-6073.
64. Lamb AD, Massie CE, Neal DE. The transcriptional programme of the androgen receptor (AR) in prostate cancer. BJU Int. 2014;113(3):358-366.
65. El-Amm J, Patel N, Freeman A, Aragon-Ching JB. Metastatic castration-resistant prostate cancer: critical review of enzalutamide. Clin Med Insights Oncol.2013;7:235-245.
66. Jung ME, Ouk S, Yoo D, et al. Structure-activity relationship for thiohydantoin androgen receptor antagonists for castration-resistant prostate cancer (CRPC). J Med Chem.2010;53(7):2779-2796.
67. Scher HI, Beer TM, Higano CS, et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase1-2 study. Lancet. 2010;375(9724):1437-1446.
68. Bennett LL, Ingason A. Enzalutamide (Xtandi) for patients with metastatic, resistant prostate cancer. Ann Pharmacother.2014;48(4): 530-537.
69. Enzalutamide (Xtandi) [package insert]. Northbrook, IL: Astellas Pharma US,2014.
70. Chen CD, Welsbie DS, Tran C, et al. Molecular determinants of resistance to antiandrogen therapy. Nat Med.2004;10(1):33-39.
71. Kolvenbag GJ, Furr BJ, Blackledge GR. Receptor affinity and potency of non-steroidal antiandrogens: translation of preclinical findings into clinical activity. Prostate Cancer Prostatic Dis.1998;1(6): 307-314.
72. Fossa SD, Slee PH, Brausi M, et al. Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: a phase III study of the European organization for research and treatment of cancer genitourinary group. J Clin Oncol.2001;19(1):62-71.
73. Akaza H, Hinotsu S, Usami M, et al. Combined androgen blockade with bicalutamide for advanced prostate cancer: long-term follow-up of a phase3, double-blind, randomized study for survival. Cancer. 2009;115(15):3437-3445.
74. Crawford ED, Eisenberger MA, McLeod DG, et al. A controlled trial of leuprolide with and without flutamide in prostatic carcinoma. N Engl J Med.1989;321(7):419-424.
75. Tran C, Ouk S, Clegg NJ, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science. 2009;324(5928):787-790.
76. Rodriguez-Vida A, Bianchini D, Van Hemelrijck M, et al. Is there an anti-androgen withdrawal syndrome with enzalutamide? BJU Int. In press2014.
77. Higano CS, Beer TM, Taplin ME. Antitumor activity of MDV3100 in pre-and post-docetaxel advanced prostate cancer: long-term follow-up of a phase I/II study. J Clin Oncol.2011;29(Supp7): Abstr134.
78. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187-1197.
79. Scher H, Fizazi K, Saad F, et al. Association of baseline corticosteroid with outcomes in a multivariate analysis of the phase3 AFFIRM study of Enzalutamide (ENZA), an androgen receptor signaling inhibitor (ARSI). Annals of Oncology.2012;23(Suppl9): Abstr899PD.
80. Arora VK, Schenkein E, Murali R, et al. Glucocorticoid receptor confers resistance to antiandrogens by bypassing androgen receptor blockade. Cell.2013;155(6):1309-1322.
81. Beer TM, Armstrong AJ, Sternberg CN, et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study. J Clin Oncol.2014; 32(Suppl 4):LBA1.
82. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in Metastatic Prostate Cancer before Chemotherapy. N Engl J Med. Epub June1, 2014.
83. van Soest RJ, van Royen ME, de Morree ES, et al. Cross-resistance between taxanes and new hormonal agents abiraterone and enzalutamide may affect drug sequence choices in metastatic castration-resistant prostate cancer. Eur J Cancer.2013;49(18):3821-3830.
84. Cheng H, Nadal R, Gulati R, et al. The effect of prior abiraterone (Abi) use on the activity of enzalutamide (Enza) in men with mCRPC. J Clin Oncol.2014;32(Suppl4):Abstr8.
85. Chism DD, De Silva D, Whang YE. Mechanisms of acquired resistance to androgen receptor targeting drugs in castration-resistant prostate cancer. Expert Rev Anticancer Ther.2014;13:1-10.
86. Liu C, Lou W, Zhu Y, et al. Niclosamide inhibits androgen receptor variants expression and overcomes enzalutamide resistance in castrationresistant prostate cancer. Clin Cancer Res.2014;20(12):3198-3210.
87. Sanda MG, Dunn RL, Michalski J, et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med.2008;358(12):1250-1261.
88. Harland S, Staffurth J, Molina A, et al. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy. Eur J Cancer.2013;49(17):3648-3657.
89. Miller K, Scher HI, Fizazi K, et al. Effect of enzalutamide on health-related quality of life (HRQoL) in men with metastatic castration-resistant prostate cancer (mCRPC) following docetaxel-based therapy: Results from the AFFIRM study. ASCO Meeting Abstracts. 2013;31(6_Suppl):17.
90. Dreicer R, Jones R, Oudard S, et al. Results from a phase3, randomized, double-blind, multicenter, placebo-controlled trial of orteronel (TAK-700) plus prednisone in patients with metastatic castrationresistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy (ELM-PC5trial). J Clin Oncol. 2014;32 (4_Suppl):Abstr7.
91. Tannock IF, de Wit 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.