749
Views
16
CrossRef citations to date
0
Altmetric
Oncology

Efficacy and safety of post-docetaxel therapies in metastatic castration-resistant prostate cancer: a systematic review of the literature

, , , &
Pages 1995-2008 | Received 21 Feb 2017, Accepted 09 Jun 2017, Published online: 10 Jul 2017

References

  • American Cancer Society. Prostate Cancer. 2014. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf [Last accessed 30 April 2015]
  • Torre LA, Bray F, Siegel RL, et al. Global cancer statistics, 2012. CA: A Cancer Journal for Clinicians 2015;65:87-108
  • Crawford ED, Black L, Eaddy M, Kruep EJ. A retrospective analysis illustrating the substantial clinical and economic burden of prostate cancer. Prostate Cancer Prostatic Dis 2010;13:162-7
  • Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer. Curr Oncol 2010;17(Suppl2):S72-S9
  • National Institute of Health. SEER Stat Fact Sheets: Prostate Cancer. 2015. Available at: http://seer.cancer.gov/statfacts/html/prost.html [Last accessed 10 December 2015]
  • National Comprehensive Cancer Network. NCCN Guidelines for Patients – Prostate Cancer [Version 1.2015]. 2015. Available at: https://www.nccn.org/patients/guidelines/prostate/index.html [Last accessed 1 October 2016]
  • Mottet N, Bellmunt J, Briers E, van den Bergh RCN, Bolla M, van Casteren NJ, et al. EAU Guidelines on Prostate Cancer 2015 v2. 2015. Available at: https://uroweb.org/wp-content/uploads/EAU-Guidelines-Prostate-Cancer-2015-v2.pdf. [Last accessed 4 April 2017]
  • National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) – Prostate Cancer [Version 2.2017]. 2017. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf [Last accessed 4 April 2017]
  • US Food and Drug Administration. Jevtana (cabazitaxel) Injection – Drug approval package. 2010. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/201023s000TOC.cfm [Last accessed 29 April 2015]
  • US Food and Drug Administration. Enzalutamide (XTANDI Capsules). 2012. Available at: http://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm317997.htm [Last accessed 28 March 2016]
  • US Food and Drug Administration. FDA approves Zytiga for late-stage prostate cancer. 2011. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htm [Last accessed 28 March 2016]
  • Centre for Reviews and Dissemination. Systematic Reviews. York: University of York, 2009
  • Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health 1998;52:377-84
  • Drummond MF, Sculpher MJ, Torrance G, et al. Methods for the Economic Evaluation of Health Care Programmes, 3rd edn. New York: Oxford University Press, 2005
  • 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;13:983-92
  • 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
  • Hao Y, Cleeland CS, Gagnon D, et al. Effect of abiraterone acetate (AA) on patient-reported pain in metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel: results of longitudinal sensitivity analyses. J Clin Oncol 2013;31:9618
  • Logothetis CJ, Basch E, Molina A, et al. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol 2012;13:1210-17
  • Sternberg CN, Molina A, North S, et al. Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy. Ann Oncol 2013;24:1017-25
  • 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
  • Bahl A, Oudard S, Tombal B, et al. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the tropic trial. Ann Oncol 2013;24:2402-8
  • Oudard S, Joulain F, De Geer A, Sartor AO. Cabazitaxel or mitoxantrone with prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: estimating mean overall survival (OS) for health economic analyses from a phase III trial (TROPIC). J Clin Oncol 2011;29:128
  • Tombal B, Oudard S, Ozguroglu M, et al. 1090 Clinical benefit of cabazitaxel plus prednisone in the tropic trial in men with metastatic castration resistant prostate cancer (mCRPC) who progressed after docetaxel-based treatment. Eur Urol Suppl 2011;10:335-6
  • Halabi S, Armstrong AJ, Sartor O, et al. Prostate-specific antigen changes as surrogate for overall survival in men with metastatic castration-resistant prostate cancer treated with second-line chemotherapy. J Clin Oncol 2013;31:3944-50
  • Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med 2012;367:1187-97
  • Scher H, Fizazi K, Sternberg CN, et al. Sensitivity analyses for radiographic progression-free survival (rPFS): results from the phase 3 AFFIRM trial comparing enzalutamide to placebo. Eur J Cancer 2013;49:S684
  • Fizazi K. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol 2014;15:1147-56
  • Cella D, Ivanescu C, Holmstrom S, et al. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol 2015;26:179-85
  • Miller K, Scher H, Fizazi K, et al. Enzalutamide improves health-related quality of life in men with metastatic castration-resistant prostate cancer following docetaxel-based therapy: results from the affirm study. Urology 2013;82:S52
  • Fizazi K, De Bono JS, Flechon A, et al. Randomised phase II study of siltuximab (CNTO 328), an anti-IL-6 monoclonal antibody, in combination with mitoxantrone/prednisone versus mitoxantrone/prednisone alone in metastatic castration-resistant prostate cancer. Eur J Cancer 2012;48:85-93
  • Fleming MT, Sonpavde G, Kolodziej M, et al. Association of rash with outcomes in a randomized phase II trial evaluating cetuximab in combination with mitoxantrone plus prednisone after docetaxel for metastatic castration-resistant prostate cancer. Clin Genitourin Cancer 2012;10:6-14
  • Hoskin P, Sartor O, O’Sullivan JM, et al. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol 2014;15:1397-406
  • Cislo P, Reuning-Scherer J. Effect of radium-223 dichloride (Ra-223) on risk for and duration of hospitalization in ALSYMPCA by docetaxel (D) subgroup. J Clin Oncol 2015;33:S254
  • Logue J, Wedel S, Chodacki A, et al. 770P Reasons for patients (pts) discontinuing study treatment (tx) in the phase 3 ALSYMPCA trial of radium-223 dichloride (Ra-223) in castration-resistant prostate cancer (CRPC) with bone metastases (mets). Ann Oncol 2014;25:iv264-iv5
  • Nilsson S, Tomblyn M, Cislo P, et al. Patient-reported quality of life (QOL) analysis of radium-223 dichloride (Ra-223) evaluating pain relief from the phase 3 ALSYMPCA study. J Clin Oncol 2014;32:5069
  • Sartor O, Coleman R, Nilsson S, et al. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol 2014;15:738-46
  • Joly F, Delva R, Mourey L, et al. Clinical benefits of non-taxane chemotherapies in unselected patients with symptomatic metastatic castration-resistant prostate cancer after docetaxel: the GETUG-P02 study. BJU Int 2015;115:65-73
  • 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, phase 3 trial. Lancet Oncol 2014;15:700-12
  • Fizazi K, Drake CG, Kwon ED, et al. 763PD Updated overall survival (OS) from the phase 3 trial, CA184-043: ipilimumab (ipi) vs placebo (pbo) in patients with post-docetaxel metastatic castration-resistant prostate cancer (mCRPC). Ann Oncol 2014;25:iv259-60
  • Ryan CJ, Rosenthal M, Ng S, et al. Targeted MET inhibition in castration-resistant prostate cancer: a randomized phase II study and biomarker analysis with rilotumumab plus mitoxantrone and prednisone. Clin Cancer Res 2013;19:215-24
  • 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;17:5765-73
  • Hussain M, Rathkopf DE, Liu G, et al. A phase II randomized study of cixutumumab (IMC-A12: CIX) or ramucirumab (IMC-1121B: RAM) plus mitoxantrone (M) and prednisone (P) in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) following disease progression (PD) on docetaxel (DCT) therapy. J Clin Oncol 2012;30:abstr 97
  • Basch EM, Scholz MC, De Bono JS, et al. Final analysis of COMET-2: cabozantinib (Cabo) versus mitoxantrone/prednisone (MP) in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) with moderate to severe pain who were previously treated with docetaxel (D) and abiraterone (A) and/or enzalutamide (E). J Clin Oncol 2015;33:abstr 141
  • Dawson NA, Pessis DA, McNeel DG, et al. Patients treated with sipuleucel-T who had prior docetaxel had positive immune responses and survival benefit. Eur J Cancer 2011;47:S487-S8
  • Malik ZI, Di Lorenzo G, Basaran M, et al. Interim safety analysis of a compassionate-use program (CUP) and early-access program (EAP) providing cabazitaxel (Cbz) plus prednisone (P) to patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel. J Clin Oncol 2013;31:abstr 5055
  • Heidenreich A, Bracarda S, Mason M, et al. Safety of cabazitaxel in senior adults with metastatic castration-resistant prostate cancer: Results of the European compassionate-use programme. Eur J Cancer 2014;50:1090-9
  • Heidenreich A, Scholz HJ, Ozen H, et al. Safety of cabazitaxel + prednisone (CBZ + P) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (DOC): cohort compassionate use programme (CUP). Ann Oncol 2014;25:782P
  • Bracarda S, Gernone A, Gasparro D, et al. Real-world cabazitaxel safety: the Italian early-access program in metastatic castration-resistant prostate cancer. Future Oncol 2014;10:975-83
  • Buonerba C, Pond GR, Sonpavde G, et al. Potential value of Gleason score in predicting the benefit of cabazitaxel in metastatic castration-resistant prostate cancer. Future Oncol 2013;9:889-97
  • Di Lorenzo G, D’Aniello C, Buonerba C, et al. Peg-filgrastim and cabazitaxel in prostate cancer patients. Anti-Cancer Drugs 2013;24:84-9
  • Castellano D, Anton Aparicio LM, Esteban E, et al. Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program. Expert Opin Drug Saf 2014;13:1165-73
  • Sridhar SS, Winquist E, Hubay S, et al. Cabazitaxel in docetaxel-pretreated metastatic castration resistant prostate cancer (mCRPC): Canadian experience. J Clin Oncol 2013;31:abstr e16082
  • Bahl A, Masson S, Malik ZI, et al. Cabazitaxel for metastatic castration-resistant prostate cancer (mCRPC): final quality-of-life (QOL) results with safety data from the United Kingdom (UK) Early Access Programme (EAP) (NCT01254279). J Clin Oncol 2013;31:abstr 31
  • Heidenreich A, Scholz HJ, Rogenhofer S, et al. Cabazitaxel plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel: results from the German compassionate-use programme. Eur Urol 2013;63:977-82
  • Wissing MD, Van Oort IM, Gerritsen WR, et al. Cabazitaxel in patients with metastatic castration-resistant prostate cancer: results of a compassionate use program in the Netherlands. Clin Genitourin Canc 2013;11:238-50e.1
  • Houede N, Eymard JC, Tahar Z. Safety data of cabazitaxel in patients treated for metastatic castration-resistant prostate cancer after docetaxel treatment: results of a cohort of patients during the temporary authorization for use in France (ATU). J Clin Oncol 2012;30:abstr e15142
  • Lee JL, Park SH, Koh SJ, et al. Effectiveness and safety of cabazitaxel plus prednisolone chemotherapy for metastatic castration-resistant prostatic carcinoma: Data on Korean patients obtained by the cabazitaxel compassionate-use program. Cancer Chemoth Pharm 2014;74:1005-13
  • Pripatnanont C, Srimuninnimit V, Reungpoca P, et al. Cohort compassionate use program with cabazitaxel plus prednisolone in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: data in Thai patients. Urol 2014;84:MP-16.2
  • Joshua AM, Shore ND, Saad F, et al. Safety results of the enzalutamide expanded access program in the United States and Canada for patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel. J Clin Oncol 2014;32:abstr 5051
  • Brasso K, Thomsen FB, Schrader AJ, et al. Enzalutamide antitumour activity against metastatic castration-resistant prostate cancer previously treated with docetaxel and abiraterone: a multicentre analysis. Eur Urol 2014;68:317-24
  • Stevenson R, Fackrell DG, Ford D, et al. The sequential use of abiraterone and enzalutamide in metastatic castrate resistant prostate cancer patients: experience from seven U.K. Centers. J Clin Oncol 2014;32:abstr 125
  • Bianchini D, Lorente D, Rodriguez-Vida A, et al. Antitumour activity of enzalutamide (MDV3100) in patients with metastatic castration-resistant prostate cancer (CRPC) pre-treated with docetaxel and abiraterone. Eur J Cancer 2014;50:78-84
  • Thomson D, Charnley N, Parikh O. Enzalutamide after failure of docetaxel and abiraterone in metastatic castrate resistant prostate cancer (mCRPC): results from an expanded access program. J Clin Oncol 2014;32:abstr 188
  • Badrising S, Van Der Noort V, Van Oort IM, et al. Clinical activity and tolerability of enzalutamide (MDV3100) in patients with metastatic, castration-resistant prostate cancer who progress after docetaxel and abiraterone treatment. Cancer 2014;120:968-75
  • Schmid SC, Geith A, Boker A, et al. Enzalutamide after docetaxel and abiraterone therapy in metastatic castration-resistant prostate cancer. Adv Ther 2014;31:234-41
  • Schrader AJ, Boegemann M, Ohlmann CH, et al. Enzalutamide in castration-resistant prostate cancer patients progressing after docetaxel and abiraterone. Eur Urol 2014;65:30-6
  • Thomsen FB, Roder MA, Rathenborg P, et al. Enzalutamide treatment in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy and abiraterone acetate. Scand J Urol 2014;48:268-75
  • Caffo O, Maines F, Donner D, et al. Impact of enzalutamide administration on primary prostate cancer volume: a metabolic evaluation by choline positron emission tomography in castration-resistant prostate cancer patients. Clin Genitourin Canc 2014;12:312-16
  • Maroto Rey JP, Esteban E, Gomez De Liano Lista A, et al. Impact of prior therapy with ketoconazol or abiraterone and pattern of PSA response in a cohort of patients with metastatic castrate resistant prostate cancer (mCRPC) receiving enzalutamide for postdocetaxel. J Clin Oncol 2014;32:e16082
  • Sternberg CN, Castellano D, Daugaard G, et al. Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. Lancet Oncol 2014;15:1263-8
  • Castellano D, Bracarda S, Tucci M, et al. Analysis of European patients enrolled in a global early access protocol with abiraterone acetate for metastatic castration-resistant prostate cancer progressing after chemotherapy. Ann Oncol 2014;25:781P
  • Caffo O, Fratino L, Re GL, et al. Safety and clinical outcome of a cohort of patients (pts) with castration resistant prostate cancer (CRPC) treated with abiraterone acetate (AA) in a named patient program (NPP): updated results of a retrospective study from an Italian cooperative group. J Clin Oncol 2014;32:abstr 253
  • Francini E, Fiaschi AI, Petrioli R, et al. Abiraterone in heavily pretreated patients with metastatic castrate-resistant prostate cancer. Anti-Cancer Drugs 2014;25:472-7
  • Fratino L, Lo Re G, Polesel J, et al. Abiraterone acetate, an efficient treatment option for elderly patients with metastatic castration-resistant prostate carcinoma. Anticancer Res 2012;32:1914-15
  • Caffo O, De Giorgi U, Fratino L, et al. Clinical outcomes of castration-resistant prostate cancer treatments administered as third or fourth line following failure of docetaxel and other second-line treatment: results of an Italian multicentre study. Eur Urol 2014;68:147-53
  • Caffo O, De Giorgi U, Facchini G, et al. Activity of new agents (NAs) as third-line treatment in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) showing a primary resistance (PRes) to NAs-based second line therapy after docetaxel (DOC): preliminary results from a multicenter Italian study. J Clin Oncol 2015;33:abstr 216
  • Caffo O, Veccia A, Maines F, et al. Potential value of rapid prostate-specific antigen decline in identifying primary resistance to abiraterone acetate and enzalutamide. Future Oncol 2014;10:985-93
  • Heck MM, Hoppner M, Horn T, et al. Compassionate use of abiraterone and cabazitaxel: first experiences in docetaxel-pretreated castration-resistant prostate cancer patients. Urologe A 2012;51:390-7
  • 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;351:1502-12
  • Unger JM, Barlow WE, Martin DP, et al. Comparison of survival outcomes among cancer patients treated in and out of clinical trials. J Natl Cancer Inst 2014;106:dju002
  • Booth CM, Tannock IF. Evaluation of treatment benefit: randomized controlled trials and population-based observational research. J Clin Oncol 2013;31:3298-9
  • Booth CM, Tannock IF. Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer 2014;110:551-5
  • Wissing MD, Coenen JLLM, Van Den Berg P, et al. CAST: a retrospective analysis of cabazitaxel and abiraterone acetate sequential treatment in patients with metastatic castrate-resistant prostate cancer previously treated with docetaxel. Int J Cancer 2015;136:E760-72
  • Sonpavde G, Bhor M, Hennessy D, et al. Outcomes with different sequences of cabazitaxel and abiraterone acetate following docetaxel in metastatic castration-resistant prostate cancer (mCRPC). Eur J Cancer 2013;49:S698
  • Scher HI, Morris MJ, Stadler WM, et al. Trial design and objectives for castration-resistant prostate cancer: updated recommendations from the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol 2016;34:1402-18
  • Massard C, Mateo J, Loriot Y, et al. Phase I/II trial of cabazitaxel plus abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone. Ann Oncol 2017;28:90-5
  • Ellis L, Lafeuille M-H, Gozalo L, et al. Treatment patterns of new metastatic castration-resistant prostate cancer (mCRPC) therapies: real-world evidence from three datasets. J Clin Oncol 2015;33:abstr 228
  • Sternberg CN, Baskin-Bey ES, Watson M, et al. Treatment patterns and characteristics of European patients with castration-resistant prostate cancer. BMC Urol 2013;13:1-7
  • Mateo J, Carreira S, Sandhu S, et al. DNA-repair defects and olaparib in metastatic prostate cancer. N Engl J Med 2015;373:1697-708
  • Graff JN, Alumkal JJ, Drake CG, et al. Early evidence of anti-PD-1 activity in enzalutamide-resistant prostate cancer. Oncotarget 2016;7:52810-17

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.