Hormonal therapeutics enzalutamide and abiraterone acetate in the treatment of metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel-an indirect comparison

Clinical Medicine Insights: Oncology

Volumn 8, Issue , 2014, Pages 29-36

  Tan, Pui S ^a   Haaland, Benjamin ^a,b   Montero, Alberto J ^c   Kyriakopoulos, Christos E ^c   Lopes, Gilberto ^d,e,f,g  

^a DUKE NUS MEDICAL SCHOOL   (Singapore)

^b NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^c TAUSSIG CANCER INSTITUTE   (United States)

^d Hospital Do Coração Cancer Center HCor Onco   (Brazil)

^e Centro Paulista de Oncologia   (Brazil)

^f Centro Paulista de Oncologia ^*  (Brazil)

^g JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Abiraterone acetate; Enzalutamide; mCRPC; Metastatic castration resistant prostate cancer; Post docetaxel

Indexed keywords

ABIRATERONE ACETATE; DOCETAXEL; ENZALUTAMIDE; PLACEBO; PROSTATE SPECIFIC ANTIGEN;

ARTICLE; CANCER HORMONE THERAPY; CASTRATION RESISTANT PROSTATE CANCER; COMPARATIVE STUDY; DIARRHEA; FATIGUE; HEART DISEASE; HUMAN; HYPERTENSION; HYPERVOLEMIA; HYPOKALEMIA; LIVER DYSFUNCTION; META ANALYSIS; METASTATIC CASTRATION RESISTANT PROSTATE CANCER; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; SEIZURE; SENSITIVITY ANALYSIS; SYSTEMATIC REVIEW;

EID: 84897853368     PISSN: 11795549     EISSN: 11795549     Source Type: Journal    
DOI: 10.4137/CMO.S13671     Document Type: Article

References (41)

1. Globocan 2008. Country Fast Stat. http://globocan.iarc.fr/factsheet.asp. Accessed June 22, 2013.
2. Saad F, Hotte SJ. Guidelines for the management of castrate-resistant prostate cancer. Can Urol Assoc J. 2010;4(6):380-4.
3. Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer. Curr Oncol. 2010;17(suppl 2):S72-9.
4. 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(15):1513-20.
5. 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):1502-12.
6. Berthold DR, Pond GR, Soban F, de Wit R, Eisenberger M, Tannock IF. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008;26(2):242-5.
7. 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):1147-54.
8. Sartor AO. Progression of metastatic castrate-resistant prostate cancer: impact of therapeutic intervention in the post-docetaxel space. J Hematol Oncol. 2011;4:18.
9. Chen CD, Welsbie DS, Tran C, et al. Molecular determinants of resistance to antiandrogen therapy. Nat. Med. 2003;10(1):33-9.
10. Scher HI, Sawyers CL. Biology of progressive, castration-resistant prostate cancer: directed therapies targeting the androgen-receptor signaling axis. J Clin Oncol. 2005;23(32):8253-61.
11. Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011;103(22):1665-75.
12. Saad F, Miller K. Treatment options in castration-resistant prostate cancer: current therapies and emerging docetaxel-based regimens. Urol Oncol. 2014:32(2):70-9.
13. Chi KN, Bjartell A, Dearnaley D, et al. Castration-resistant prostate cancer: from new pathophysiology to new treatment targets. Eur Urol. 2009;56(4):594-605.
14. Agarwal N, Sonpavde G, Sternberg CN. Novel molecular targets for the therapy of castration-resistant prostate cancer. Eur Urol. 2012;61(5):950-60.
15. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13):1187-97.
16. 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.
17. 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, placebo-controlled phase 3 study. Lancet Oncol. 2012;13(10):983-92.
18. Tran C, Ouk S, Clegg NJ, et al. Development of a second-generation antiandrogen for treatment of advanced prostate cancer. Sci Signal. 2009;324(5928):787.
19. Ang JE, Olmos D, de Bono JS. CYP17 blockade by abiraterone: further evidence for frequent continued hormone-dependence in castration-resistant prostate cancer. Br J Cancer. 2009;100(5):671-5.
20. Iacovelli R, Altavilla A, Procopio G, et al. Are post-docetaxel treatments effective in patients with castration-resistant prostate cancer and performance of 2? A meta-analysis of published trials. Prostate Cancer Prostatic Dis. 2013;16(4):323-7.
21. Lumley T. Network meta-analysis for indirect treatment comparisons. Stat Med. 2002;21(16):2313-24.
22. Mills EJ, Thorlund K, Ioannidis JPA. Demystifying trial networks and network meta-analysis. BMJ. 2013;346:f2914.
23. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. The Cochrane Collaboration; 2011. Available from www.cochrane-handbook.org.
24. Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539-58.
25. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327(7414):557-60.
26. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177-88.
27. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.
28. ClinicalTrials.gov. Enzalutamide. http://www.clinicaltrials.gov/ct2/results?term = enzalutamide&Search=Search. Accessed June 12, 2013.
29. ClinicalTrials.gov. Abiraterone. http://www.clinicaltrials.gov/ct2/results?term=abiraterone&Search=Search. Accessed June 12, 2013.
30. Prednisone-National Cancer Institute. http://www.cancer.gov/cancertopics/druginfo/prednisone. Accessed June 12, 2013.
31. Richards J, Lim AC, Hay CW, 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):2176-82.
32. Scher HI, Fizazi K, Saad F, et al. 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). In: ESMO. European Society for Medical Oncology; 2012. Abstract 2887. Vienna.
33. Scher HI, Fizazi K, Saad F, et al. Impact of on-study corticosteroid use on efficacy and safety in the phase III AFFIRM study of enzalutamide (ENZA), an androgen receptor inhibitor. In: 2013 Genitourinary Cancers Symposium. [Journal of Clinical Oncology. 2013;31(suppl 6):abstr 6]. Orlando, Florida.
34. Foster WR, Car BD, Shi H, et al. Drug safety is a barrier to the discovery and development of new androgen receptor antagonists. Prostate. 2011;71(5):480-8.
35. Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368(2):138-48.
36. ClinicalTrials.gov. A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients with Progressive Metastatic Prostate Cancer-Full Text View-ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/show/NCT01212991?term=prevail+trial+enzalutamide&rank=1. Accessed June 12, 2013.
37. Machado P, Bowdidge A, Kite J, Beyer M. Medivation and Astellas Announce the Phase 3 PREVAIL Trial of Enzalutamide Meets Both Co-Primary Endpoints of Overall Survival and Radiographic Progression-Free Survival in Chemotherapy Naï ve Patients with Advanced Prostate Cancer. Press Release (Medivation, Astellas). 2013;(415):1-5. Available at: http://www.astellas.com/en/corporate/news/pdf/131022_1_Eg.pdf. Accessed December 19, 2013.
38. ClinicalTrials.gov. Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer-Full Text View-ClinicalTrials.gov. http://clinicaltrials.gov/show/NCT00744497. Accessed June 12, 2013.
39. Araujo JC, Trudel GC, Saad F, et al. Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial. Lancet Oncol. 2013;14(13):1307-16.
40. ClinicalTrials.gov. Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with OGX-011 in Men with Prostate Cancer-Full Text View-ClinicalTrials.gov. http://clinicaltrials.gov/show/NCT01188187. Accessed June 12, 2013.
41. ClinicalTrials.gov. A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination with Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients-Full Text View-ClinicalTrials.gov. http://clinicaltrials.gov/show/NCT01650194. Accessed June 12, 2013.