Management of patients with castration-resistant disease

Hematology/Oncology Clinics of North America

Volumn 27, Issue 6, 2013, Pages 1243-1260

  Pezaro, Carmel ^a   Omlin, Aurelius ^a   Lorente, David ^a   De Bono, Johann ^a  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

Author keywords

Androgen receptor signaling; Castration resistant prostate cancer; Novel therapies

Indexed keywords

ABIRATERONE; ABIRATERONE ACETATE; ANDROGEN RECEPTOR; ANTINEOPLASTIC AGENT; ARN 509; CABAZITAXEL; CABOZANTINIB; CUSTIRSEN; DOCETAXEL; ENZALUTAMIDE; GALETERONE; GONADORELIN DERIVATIVE; IPILIMUMAB; MITOXANTRONE; ODM 201; ORTERONEL; PLACEBO; PREDNISONE; RADIUM; RADIUM 223; RADIUM CHLORIDE RA 223; RILIMOGENE GALVACIREPVEC; SATRAPLATIN; SIPULEUCEL T; TASQUINIMOD; TAXANE DERIVATIVE; TOK 700; UNCLASSIFIED DRUG; VT 464;

CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER IMMUNOTHERAPY; CASTRATION RESISTANT PROSTATE CANCER; CHILL; CLINICAL TRIAL (TOPIC); HUMAN; METASTASIS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW;

ANDROGEN RECEPTOR SIGNALING; CASTRATION-RESISTANT PROSTATE CANCER; NOVEL THERAPIES;

ANDROGEN RECEPTOR ANTAGONISTS; ANTINEOPLASTIC AGENTS, HORMONAL; COMBINED MODALITY THERAPY; DRUG RESISTANCE, NEOPLASM; HUMANS; IMMUNOTHERAPY; MALE; ORCHIECTOMY; PROSTATIC NEOPLASMS; RECEPTORS, ANDROGEN;

EID: 84887022508     PISSN: 08898588     EISSN: 15581977     Source Type: Journal    
DOI: 10.1016/j.hoc.2013.08.008     Document Type: Review

References (77)

1. O'Donnell A., Judson I., Dowsett M., et al. Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer 2004, 90(12):2317-2325.
2. Franke R.M., Carducci M.A., Rudek M.A., et al. Castration-dependent pharmacokinetics of docetaxel in patients with prostate cancer. JClin Oncol 2010, 28(30):4562-4567.
3. de Bono J.S., Scher H.I., Montgomery R.B., et al. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res 2008, 14(19):6302-6309.
4. Scher H.I., Jia X., de Bono J.S., et al. Circulating tumour cells as prognostic markers in progressive, castration-resistant prostate cancer: a reanalysis of IMMC38 trial data. Lancet Oncol 2009, 10(3):233-239.
5. Scher H.I., Heller G., Molina A., et al. Evaluation of circulating tumor cell (CTC) enumeration as an efficacy response biomarker of overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC): planned final analysis (FA) of COU-AA-301, a randomized double-blind, placebo-controlled phase III study of abiraterone acetate (AA) plus prednisone (P) post docetaxel. JClin Oncol 2011, 29(Suppl). [abstract LBA4517].
6. Shaffer D.R., Leversha M.A., Danila D.C., et al. Circulating tumor cell analysis in patients with progressive castration-resistant prostate cancer. Clin Cancer Res 2007, 13(7):2023-2029.
7. Attard G., Swennenhuis J.F., Olmos D., et al. Characterization of ERG, AR and PTEN gene status in circulating tumor cells from patients with castration-resistant prostate cancer. Cancer Res 2009, 69(7):2912-2918.
8. Ross R.W., Halabi S., Ou S.S., et al. Predictors of prostate cancer tissue acquisition by an undirected core bone marrow biopsy in metastatic castration-resistant prostate cancer-a Cancer and Leukemia Group B study. Clin Cancer Res 2005, 11(22):8109-8113.
9. Efstathiou E., Titus M., Tsavachidou D., et al. Effects of abiraterone acetate on androgen signaling in castrate-resistant prostate cancer in bone. JClin Oncol 2012, 30(6):637-643.
10. 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.
11. Attard G., Reid A.H., Yap T.A., et al. Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven. JClin Oncol 2008, 26(28):4563-4571.
12. de Bono J.S., Logothetis C.J., Molina A., et al. Abiraterone and increased survival in metastatic prostate cancer. NEngl J Med 2011, 364(21):1995-2005.
13. Fizazi K., Scher H.I., 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, placebo-controlled phase 3 study. Lancet Oncol 2012, 13(10):983-992.
14. Ryan C.J., Smith M.R., De Bono J.S., et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. NEngl J Med 2013, 368(2):138-148.
15. Richards J., Lim A.C., Hay C.W., et al. Interactions of abiraterone, eplerenone, and prednisolone with wild-type and mutant androgen receptor: a rationale for increasing abiraterone exposure or combining with MDV3100. Cancer Res 2012, 72(9):2176-2182.
16. Tran C., Ouk S., Clegg N.J., et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Science 2009, 324(5928):787-790.
17. Scher H.I., Beer T.M., Higano C.S., et al. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. Lancet 2010, 375(9724):1437-1446.
18. Scher H.I., Fizazi K., Saad F., et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. NEngl J Med 2012, 367(13):1187-1197.
19. Agus D.B., Stadler W.M., Shevrin D.H., et al. Safety, efficacy, and pharmacodynamics of the investigational agent orteronel (TAK-700) in metastatic castration-resistant prostate cancer (mCRPC): updated data from a phase I/II study. JClin Oncol 2012, 30(Suppl 5). [abstract 98].
20. Eisner J.R., Abbott D.H., Bird I.M., et al. VT-464: a novel, selective inhibitor of P450c17(CYP17)-17,20 lyase for castration-refractory prostate cancer (CRPC). JClin Oncol 2012, 30(Suppl 5). [abstract 198].
21. Clegg N.J., Wongvipat J., Joseph J.D., et al. ARN-509: a novel antiandrogen for prostate cancer treatment. Cancer Res 2012, 72(6):1494-1503.
22. Rathkopf D.E., Morris M.J., Danila D.C., et al. Aphase I study of the androgen signaling inhibitor ARN-509 in patients with metastatic castration-resistant prostate cancer (mCRPC). JClin Oncol 2012, 30(Suppl). [abstract 4548].
23. Massard C, James N, Culine S, etal. ARADES trial: a first-in-man, open-label, phase I/II safety, pharmacokinetic, and proof-of-concept study of ODM-201 in patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC). ESMO Congress. 2012. [abstract LBA25_PR].
24. Taplin ME, Chu F, Morrison JP, etal. ARMOR1: safety of galeterone (TOK-001) in a Phase 1 clinical trial in chemotherapy naïve patients with castration resistant prostate cancer (CRPC). AACR Annual Meeting. Chicago; 31 March-4 April. 2012. [abstract CT07].
25. Kantoff P.W., Higano C.S., Shore N.D., et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. NEngl J Med 2010, 363(5):411-422.
26. Small E.J., Schellhammer P.F., Higano C.S., et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. JClin Oncol 2006, 24(19):3089-3094.
27. Higano C.S., Schellhammer P.F., Small E.J., 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(16):3670-3679.
28. Beer T.M., Bernstein G.T., Corman J.M., et al. Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. Clin Cancer Res 2011, 17(13):4558-4567.
29. Kantoff P.W., Schuetz T.J., Blumenstein B.A., 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. JClin Oncol 2010, 28(7):1099-1105.
30. Small E.J., Tchekmedyian N.S., Rini B.I., et al. Apilot trial of CTLA-4 blockade with human anti-CTLA-4 in patients with hormone-refractory prostate cancer. Clin Cancer Res 2007, 13(6):1810-1815.
31. Madan R.A., Mohebtash M., Arlen P.M., et al. Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial. Lancet Oncol 2012, 13(5):501-508.
32. Brahmer J.R., Tykodi S.S., Chow L.Q., et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. NEngl J Med 2012, 366(26):2455-2465.
33. Tannock I.F., de Wit R., Berry W.R., et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. NEngl J Med 2004, 351(15):1502-1512.
34. Gravis G, Fizazi K, Joly Lobbedez FJ, etal. Survival analysis of a randomised Phase III trial comparing androgen deprivation therapy (ADT) plus docetaxel versus ADT alone in hormone-sensitive metastatic prostate cancer (GETUG-AFU 15/0403). ESMO Congress. 2012. [abstract 8930].
35. Darshan M.S., Loftus M.S., Thadani-Mulero M., et al. Taxane-induced blockade to nuclear accumulation of the androgen receptor predicts clinical responses in metastatic prostate cancer. Cancer Res 2011, 71(18):6019-6029.
36. Galsky M.D., Dritselis A., Kirkpatrick P., et al. Cabazitaxel. Nat Rev Drug Discov 2010, 9(9):677-678.
37. Mita A.C., Denis L.J., Rowinsky E.K., 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(2):723-730.
38. Bissery M.C. Preclinical evaluation of new taxoids. Curr Pharm Des 2001, 7(13):1251-1257.
39. Yap T.A., Pezaro C.J., de Bono J.S. Cabazitaxel in metastatic castration-resistant prostate cancer. Expert Rev Anticancer Ther 2012, 12(9):1129-1136.
40. de Bono J.S., 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.
41. Tannock I.F., Osoba D., Stockler M.R., et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. JClin Oncol 1996, 14(6):1756-1764.
42. Sternberg C.N., Whelan P., Hetherington J., et al. Phase III trial of satraplatin, an oral platinum plus prednisone vs. prednisone alone in patients with hormone-refractory prostate cancer. Oncology 2005, 68(1):2-9.
43. Henriksen G., Breistol K., Bruland O.S., et al. Significant antitumor effect from bone-seeking, alpha-particle-emitting (223)Ra demonstrated in an experimental skeletal metastases model. Cancer Res 2002, 62(11):3120-3125.
44. Ritter M.A., Cleaver J.E., Tobias C.A. High-LET radiations induce a large proportion of non-rejoining DNA breaks. Nature 1977, 266(5603):653-655.
45. Nilsson S., Franzen L., Parker C., et al. Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study. Lancet Oncol 2007, 8(7):587-594.
46. Parker C., Nilsson S., Heinrich D., et al. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). JClin Oncol 2012, 30(Suppl). [abstract LBA4512].
47. 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.
48. Yakes F.M., Chen J., Tan J., et al. Cabozantinib (XL184), a novel MET and VEGFR2 inhibitor, simultaneously suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer Ther 2011, 10(12):2298-2308.
49. Inaba M., Koyama H., Hino M., et al. Regulation of release of hepatocyte growth factor from human promyelocytic leukemia cells, HL-60, by 1,25-dihydroxyvitamin D3, 12-O-tetradecanoylphorbol 13-acetate, and dibutyryl cyclic adenosine monophosphate. Blood 1993, 82(1):53-59.
50. Ono K., Kamiya S., Akatsu T., et al. Involvement of hepatocyte growth factor in thedevelopment of bone metastasis of a mouse mammary cancer cell line, BALB/c-MC. Bone 2006, 39(1):27-34.
51. Schoffski P., Elisei R., Müller S., et al. An international, double-blind, randomized, placebo-controlled phase III trial (EXAM) of cabozantinib (XL184) in medullary thyroid carcinoma (MTC) patients (pts) with documented RECIST progression at baseline. JClin Oncol 2012, 30(Suppl). [abstract 5508].
52. Hussain M., Smith M.R., Sweeney C., et al. Cabozantinib (XL184) in metastaticcastration-resistant prostate cancer (mCRPC): results from a phase IIrandomized discontinuation trial. JClin Oncol 2011, 29(Suppl). [abstract 4516].
53. Smith M.R., Sweeney C., Rathkopf D.E., et al. Cabozantinib (XL184) in chemotherapy-pretreated metastatic castration resistant prostate cancer (mCRPC): results from a phase II nonrandomized expansion cohort (NRE). JClin Oncol 2012, 30(Suppl). [abstract 4513].
54. De Bono JS, Smith MR, Rathkopf DE, etal. Cabozantinib (XL184) at 40mg in patients with metastatic castration resistant prostate cancer (mCRPC): results of a Phase 2 non-randomised expansion cohort (NRE). ESMO Congress. 2012. [abstract 8970].
55. Miyake H., Chi K.N., Gleave M.E. Antisense TRPM-2 oligodeoxynucleotides chemosensitize human androgen-independent PC-3 prostate cancer cells both invitro and invivo. Clin Cancer Res 2000, 6(5):1655-1663.
56. Zellweger T., Miyake H., Cooper S., et al. Antitumor activity of antisense clusterin oligonucleotides is improved invitro and invivo by incorporation of 2'-O-(2-methoxy)ethyl chemistry. JPharmacol Exp Ther 2001, 298(3):934-940.
57. Sowery R.D., Hadaschik B.A., So A.I., et al. Clusterin knockdown using the antisense oligonucleotide OGX-011 re-sensitizes docetaxel-refractory prostate cancer PC-3 cells to chemotherapy. BJU Int 2008, 102(3):389-397.
58. Chi K.N., Eisenhauer E., Fazli L., et al. Aphase I pharmacokinetic and pharmacodynamic study of OGX-011, a 2'-methoxyethyl antisense oligonucleotide to clusterin, in patients with localized prostate cancer. JNatl Cancer Inst 2005, 97(17):1287-1296.
59. Chi K.N., Hotte S.J., Yu E.Y., et al. Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer. JClin Oncol 2010, 28(27):4247-4254.
60. Saad F., Hotte S., North S., et al. Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG trial P-06c. Clin Cancer Res 2011, 17(17):5765-5773.
61. Bjork P., Bjork A., Vogl T., et al. Identification of human S100A9 as a novel target for treatment of autoimmune disease via binding to quinoline-3-carboxamides. PLoS Biol 2009, 7(4):e97.
62. Zoubeidi A., Zardan A., Beraldi E., et al. Cooperative interactions between androgen receptor (AR) and heat-shock protein 27 facilitate AR transcriptional activity. Cancer Res 2007, 67(21):10455-10465.
63. Hotte S.J., Yu E.Y., Hirte H.W., et al. Phase I trial of OGX-427, a 2'methoxyethyl antisense oligonucleotide (ASO), against heat shock protein 27 (Hsp27): final results. JClin Oncol 2010, 28(15S). [abstract 3077].
64. Chi K.N., Hotte S.J., Ellard S., et al. Arandomized phase II study of OGX-427 plus prednisone (P) versus P alone in patients (pts) with metastatic castration resistant prostate cancer (CRPC). JClin Oncol 2012, 30(Suppl 5). [abstract 121].
65. Ni L., Yang C.S., Gioeli D., et al. FKBP51 promotes assembly of the Hsp90 chaperone complex and regulates androgen receptor signaling in prostate cancer cells. Mol Cell Biol 2010, 30(5):1243-1253.
66. Carver B.S., Chapinski C., Wongvipat J., et al. Reciprocal feedback regulation of PI3K and androgen receptor signaling in PTEN-deficient prostate cancer. Cancer Cell 2011, 19(5):575-586.
67. Reid A.H., Attard G., Ambroisine L., et al. Molecular characterisation of ERG, ETV1 and PTEN gene loci identifies patients at low and high risk of death from prostate cancer. Br J Cancer 2010, 102(4):678-684.
68. Brenner J.C., Ateeq B., Li Y., et al. Mechanistic rationale for inhibition of poly(ADP-ribose) polymerase in ETS gene fusion-positive prostate cancer. Cancer Cell 2011, 19(5):664-678.
69. Fong P.C., Boss D.S., Yap T.A., et al. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. NEngl J Med 2009, 361(2):123-134.
70. Taplin M.E., Bubley G.J., Shuster T.D., et al. Mutation of the androgen-receptor gene in metastatic androgen-independent prostate cancer. NEngl J Med 1995, 332(21):1393-1398.
71. Taplin M.E., Bubley G.J., Ko Y.J., et al. Selection for androgen receptor mutations in prostate cancers treated with androgen antagonist. Cancer Res 1999, 59(11):2511-2515.
72. Steinkamp M.P., O'Mahony O.A., Brogley M., et al. Treatment-dependent androgen receptor mutations in prostate cancer exploit multiple mechanisms to evade therapy. Cancer Res 2009, 69(10):4434-4442.
73. Scher HI, Fizazi K, Saad F, etal. Association of baseline corticosteroid with outcomes in a multivariate analysis of the Phase 3 AFFIRM study of enzalutamide (ENZA), an androgen receptor signaling inhibitor (ARSI). ESMO Congress. 2012. [abstract 899PD].
74. Kawata H., Ishikura N., Watanabe M., et al. Prolonged treatment with bicalutamide induces androgen receptor overexpression and androgen hypersensitivity. Prostate 2010, 70(7):745-754.
75. Hornberg E., Ylitalo E.B., Crnalic S., et al. Expression of androgen receptor splice variants in prostate cancer bone metastases is associated with castration-resistance and short survival. PLoS One 2011, 6(4):e19059.
76. Guo Z., Yang X., Sun F., et al. Anovel androgen receptor splice variant is up-regulated during prostate cancer progression and promotes androgen depletion-resistant growth. Cancer Res 2009, 69(6):2305-2313.
77. Locke J.A., Guns E.S., Lubik A.A., et al. Androgen levels increase by intratumoral de novo steroidogenesis during progression of castration-resistant prostate cancer. Cancer Res 2008, 68(15):6407-6415.