Enzalutamide (Xtandi) for Patients With Metastatic, Resistant Prostate Cancer

Annals of Pharmacotherapy

Volumn 48, Issue 4, 2014, Pages 530-537

  Bennett, Lunawati L ^a   Ingason, April ^a  

^a UNION UNIVERSITY   (United States)

Author keywords

androgen deprivation therapy; androgen receptor antagonist; antiandrogen; castration resistant prostate cancer; enzalutamide; MDV3100

Indexed keywords

ANDROGEN; ANDROGEN RECEPTOR ANTAGONIST; DOCETAXEL; ENZALUTAMIDE; GEMFIBROZIL; PLACEBO; PROSTATE SPECIFIC ANTIGEN; ANTINEOPLASTIC AGENT; PHENYLTHIOHYDANTOIN;

ANDROGEN DEPRIVATION THERAPY; ASTHENIA; CANCER FATIGUE; CANCER PROGNOSIS; CANCER SURVIVAL; CANCER THERAPY; CASTRATION RESISTANT PROSTATE CANCER; CLINICAL TRIAL (TOPIC); COST EFFECTIVENESS ANALYSIS; DIARRHEA; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECONOMIC ASPECT; EMBASE; FOOD AND DRUG ADMINISTRATION; HOT FLUSH; HUMAN; LYMPH NODE METASTASIS; MAXIMUM TOLERATED DOSE; MEDLINE; METASTASIS; MULTICENTER STUDY (TOPIC); MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REVIEW; RISK ASSESSMENT; RISK FACTOR; SEIZURE; SEIZURE THRESHOLD; SYSTEMATIC REVIEW; TREATMENT RESPONSE; ANALOGS AND DERIVATIVES; DISEASE COURSE; ECONOMICS; MALE; PATHOLOGY; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT;

ANDROGEN RECEPTOR ANTAGONISTS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; HUMANS; MALE; NEOPLASM METASTASIS; PHENYLTHIOHYDANTOIN; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT;

EID: 84898680655     PISSN: 10600280     EISSN: 15426270     Source Type: Journal    
DOI: 10.1177/1060028013518899     Document Type: Review

References (53)

1. Jemal A,Siegel R,Xu J,Ward E.Cancer statistics.CA Cancer J Clin. 2010;60:277-300.
2. La Vecchia C,Bosetti C,Lucchini F.Cancer mortality in Europe, 2000-2004, and an overview of trends since 1975.Ann Oncol. 2010;21:1323-1360.
3. American Cancer Society. Prostate cancer. http://www.cancer.org/cancer/prostatecancer/detailedguide/prostate-cancer-key-statistics. Accessed August 26, 2013.
4. Siegel R,DeSantis C,Virgo K.Cancer treatment and survivorship statistics.CA Cancer J Clin. 2012;62:220-241.
5. Cancer Facts and Figures. Atlanta, GA: American Cancer Society, Surveillance Research; 2013:.
6. Pienta K,Bradley D.Mechanisms underlying the development of androgen-independent prostate cancer.Clin Cancer Res. 2006;12:1665-1671.
7. Cannata D,Kirschenbaum A,Levine A.Androgen deprivation therapy as primary treatment for prostate cancer.J Clin Endocrinol Metab. 2012;97:360-365.
8. Crawford E,Eisenberger M,McLeod D, et al.A controlled trial of leuprolide with and without flutamide in prostatic carcinoma.N Engl J Med. 1989;321:419-424.
9. Huggins C,Hodges C.Studies of prostatic cancer: I. The effect of castration of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate.Cancer Res. 1941:293-297.
10. Petrylak D.Current clinical trials in castrate-resistant prostate cancer.Curr Urol Rep. 2011;12:173-179.
11. Taplin M,Bubley G,Shuster T, et al.Mutation of the androgen-receptor gene in metastatic androgen-independent prostate cancer.N Engl J Med. 1995;332:1393-1398.
12. Titus M,Schell M,Lih F.Testosterone and dihydrotestosterone tissue levels in recurrent prostate cancer.Clin Cancer Res. 2005;11:4653-4657.
13. Bruno R,Njar V.Targeting cytochrome P450 enzymes: a new approach in anti-cancer drug development.Bioorg Med Chem. 2007;15:6047-6060.
14. Menon M,Higano C.Enzalutamide, a second generation androgen receptor antagonist: development and clinical applications in prostate cancer.Curr Oncol Rep. 2013;15:69-75.
15. Galsky M,Small A,Tsao C,Oh W.Clinical development of novel therapeutics for castration-resistant prostate cancer: historical challenges and recent success.CA Cancer J Clin. 2012;62:299-308.
16. Golshayan A,Antonarakis E.Enzalutamide: an evidence-based review of its use in the treatment of prostate cancer.Core Evid. 2013;8:27-35.
17. Chen Y,Clegg N,Scher H.Anti androgens and androgen depleting therapies in prostate cancer: new agents for an established target.Lancet Oncol. 2009;10:981-991.
18. Ross R,Xie W,Regan M.Efficacy of androgen deprivation therapy (ADT) in patients with advanced prostate cancer: association between Gleason score, prostate specific antigen level, and prior ADT exposure with duration of ADT effect.Cancer Res. 2008;112:1247-1253.
19. Berthold D,Pond G,Soban F,DeWit R,Eisenberger M,Tannock I.Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study.J Clin Oncol. 2008;26:242-245.
20. Kantoff P,Higano C,Shore N,Berger E,Small E,Penson D.Sipuleucel-T immunotherapy for castration -resistant prostate cancer.N Engl J Med. 2010;363:411-422.
21. De Bono J,Oudard S,Ozguroglu M,Hansen S,Machiels J,Kocak I.Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomized open label trial.Lancet. 2010;376:1147-1154.
22. Fizazi K,Scher H,Molina A.Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randmized, double-blind, placebo-controlled phase 3 study.Lancet Oncol. 2013;13:983-992.
23. Ryan C,Smith M,De Bono J.Abiraterone in metastatic prostate cancer without previous chemotherapy.N Engl J Med. 2013;368:138-148.
24. Chen C,Welsbie D,Tran C.Molecular determinants of resistance to antiandrogen therapy.Nat Med. 2004;10:33-39.
25. Small E,Halabi S,Dawson N.Antiandrogen with drawl alone or in combination with ketoconazole in androgen independent prostate cancer patients: a phase III trial (CALGB 9583).J Clin Oncol. 2004;22:1025-1033.
26. Xtandi (enzalutamide) [product infromation]. St Petersburg, FL: Catalent Pharma Solutions, LLC; 2012. https://www.xtandihcp.com. Accessed December 17, 2013.
27. Tran C,Ouk S,Clegg N, et al.Development of a second-generation antiandrogen for treatment of advanced prostate cancer.Science. 2009;324:787-790.
28. Ha Y,Goodin S,DiPaola R,Kim I.Enzalutamide for the treatment of castration-resistant prostate cancer.Drugs Today (Barc). 2013;49:7-13.
29. Scher H,Beer T,Higano C, et al.Antitumor activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study.Lancet. 2010;375:1437-1446.
30. Scher H,Fizazi K,Saad F.Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), an overall survival in patients with prostate cancer postdocetaxel: results from the phase III AFFIRM study [abstract 1].J Clin Oncol. 2012;30:LBA1.
31. Scher H,Fizazi K,Saad F, et al.Increased survival with enzalutamide in prostate cancer after chemotherapy.N Engl J Med. 2012;367:1187-1197.
32. Scher H,Heller G,Molina A,Kheoh T,Attard G,Moreira J.Evaluation of circulating tumor cell (CTC) enumeration as an efficacy response biomarker of overall survival (OS) in metastatic castration-resistance 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 low-dose prednisone post docetaxel [abstract 2].J Clin Oncol. 2011;29:LBA4517.
33. Danila D,Fleischer M,Scher H.Circulating tumor cells as biomarkers in prostate cancer.Clin Cancer Res. 2011;17:3903-3912.
34. Pal S,Stein CA,Sartor O.Enxalutamide for the treatment of prostate cancer.Expert Opin Pharmacother. 2013;14:679-685.
35. Higano C,Beer T,Yu E.Anti tumor activity of MDV3100 in pre- and post docetaxel advanced prostate cancer: long term follow up of phase 1-2 study [abstract 1].J Clin Oncol. 2011;29:1342011.
36. Atkinson T,Rosenfeld B,Sit L, et al.Using confirmatory factor analysis to evaluate construct validity of the Brief Pain Inventory (BPI).J Pain Symptom Manage. 2011;41:558-565.
37. Morganroth J.A definitive or thorough phase 1 QT ECG trial as a requirement for drug safety assessment.J Electrocardiol. 2004;37:25-29.
38. Schrader A,Boegemann M,Ohlmann C, et al.Enzalutamide in castration-resistant prostate cancer patients progressing after docetaxel and abiraterone.Eur Urol. 2014;65:30-36.
39. ClinicalTrials.gov. http://clinicaltrials.gov/ct2/results?term=enzalutamide&Search=Search. Accessed November 2013.
40. Oudard S.Progress in emerging therapies for advanced prostate cancer.Cancer Treat Rev. 2013;39:275-289.
41. Libener R,Montefiore F,Bonini F, et al.Sensitivity and specificity of osteopontin (OPN) versus prostate specific an 275-89. tigen (PSA) in prostate carcinoma (PCa): a case control study [abstract 1].ASCO Meeting. 2009;27:e16082.
42. Prager A,Peng C,Lita E, et al.Urinary osteopontin as a marker for localized and metastatic prostate cancer [abstract 1].J Am Clin Oncol. 2011;29:e15147.
43. Shaffer D,Leversha M,Danila D, et al.Circulating tumor cell analysis in patients with progressive castration resistant prostate cancer.Clin Cancer Res. 2007;13:2023-2029.
44. Rescigno P,Buonerba C,Bellmunt J,Sonpavde G,DePlacido S,Di Lorenzo G.New perspective in the therapy of castration resistant prostate cancer.Curr Drug Targets. 2012;13:1676-1678.
45. Yap T,Zivi A,Omlin A,De Bono J.The changing therapeutic landscape of castration-resistant prostate cancer.Nat Rev Clin Oncol. 2011;8:597-610.
46. Kuruma H,Matsumoto H,Zoubeidi AUse of MDV3100 to Establish Androgen-Receptor Antagonist Resistant LNCaP Cells for Modeling Castrate-Resistant Progression. Orlando, FL: American Association of Cancer Research; 2011:.
47. Korpal M,Korn J,Gao X, et al.An F876L mutation in androgen receptor confers genetic and phenotypic resistance to MDV 3100 (enzalutamide). Cancer Discov; 2013; 2013. 1030.
48. Haile S,Sadar M.Androgen receptor and its splice variants in prostate cancer.Cell Mol Life Sci. 2011;68:3971-3981.
49. Niraula S,Chi K,Joshua A.Beyond castration: defining future directions in the hormonal treatment of prostate cancer.Horm Cancer. 2012;3:3-13.
50. National Institute for Health and Care Excellence. http://www.nice.org.uk/guidance/index.jsp?action=download&o=33354. Accessed December 17, 2013.
51. Medscape. http://www.medscape.com/viewarticle/757986. Accessed December 17, 2013.
52. PallerCJAntonarakisES. Cabazitaxel: a novel second-line treatment for metastatic castration-resistant prostate cancer. Drug Des Devel Ther. 2011;5:117-124. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063116/. Accessed December 17, 2013.
53. Wilson L,Tang J,Zhong L, et al.New therapeutic options in metastatic castration-resistant prostate cancer: can cost-effectiveness analysis help in treatment decisions.J Oncol Pharm Pract. 2013;:.