Abiraterone acetate

(Zytiga®)

Zytiga®

Drug updated on 11/1/2024

Dosage FormFilm-coated tablet (oral; 500 mg); uncoated tablet (oral; 250 mg)
Drug ClassCYP17 inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)
  • Indicated in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC).

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Summary
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  • This summary is based on the review of 19 systematic review(s)/meta-analysis(es). [1-19]
  • Abiraterone acetate (AA) combined with androgen deprivation therapy (ADT) significantly improves overall survival (OS) in metastatic hormone-sensitive prostate cancer (mHSPC), with a hazard ratio (HR) of 1.568 (95% credible interval [CrI]: 1.378-1.773) for the general population, and HR of 1.164 (95% CrI: 1.348-1.924) for high-volume disease subgroups.
  • In high-risk non-metastatic prostate cancer, AA combined with prednisolone significantly prolongs metastasis-free survival (MFS) compared to ADT alone, with an HR of 0.53 (95% confidence interval [CI]: 0.44-0.64, p<0.0001).
  • The combination of AA with prednisolone also significantly improves prostate cancer-specific survival (PCSS) compared to ADT alone, yielding an HR of 0.49 (95% CI: 0.37-0.65, p<0.0001).
  • Enzalutamide demonstrates superior prostate-specific antigen progression-free survival (PSA-PFS) (HR=0.365, 95% CI: 0.303-0.441) and time to PSA progression (TTPP) (HR=0.19, 95% CI: 0.17-0.22) compared to AA in metastatic castration-resistant prostate cancer (mCRPC) patients.
  • Fracture Incidence: Patients receiving (223)Ra combined with abiraterone acetate (AA) showed a higher fracture incidence compared to non-hormonal anti-androgens (NHA) monotherapy (OR: 3.22, 95% CI: 2.24-4.63, P < 0.01).
  • Adverse Events: The combination of AA with androgen deprivation therapy (ADT) is associated with an increased risk of grade III to V adverse events (RR 1.34, 95% CI 1.22 to 1.47), including more frequent occurrences of hypertension and alanine transaminitis.
  • Serious Adverse Events (SAEs): There was no significant difference in the incidence of SAEs between abiraterone and enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) (P=0.21, I(2 =) 38%).
  • There is no population-type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Zytiga (abiraterone acetate) Prescribing Information.2021Janssen Biotech, Inc., Titusville, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Health-related quality of life in patients with metastatic hormone-sensitive prostate cancer treated with androgen receptor signaling inhibitors: the role of combination treatment therapy2024 Prostate Cancer and Prostatic Diseases
The optimal upfront therapy in metastatic hormone-sensitive prostate cancer: A network meta-analysis2023 Journal of Cancer Research and Therapeutics
The safety of radium-223 combined with new-generation hormonal agents in bone metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis2023 Asian Journal of Andrology
Risk of cognitive impairment in men with advanced prostate cancer treated with NHAs: A systematic review and network meta-analysis2023 Clinical and Translational Science
Duplicated network meta-analysis in advanced prostate cancer: a case study and recommendations for change2022 Systematic Reviews
Efficacy and safety of therapies for advanced prostate cancer in Asia: Evidence from a systematic literature review2022 Therapeutic Advances in Medical Oncology
Androgen Receptor Signaling Inhibitors in Addition to Docetaxel with Androgen Deprivation Therapy for Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Meta-analysis2022 European Urology
Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol2022Evaluation of Drug Efficacy
Comparison of Treatments for Nonmetastatic Castration-Resistant Prostate Cancer: Matching-Adjusted Indirect Comparison and Network Meta-Analysis2022 Journal of the National Cancer Institute
Efficacy and Safety of Abiraterone Acetate and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer: A Systematic Review and Meta-Analysis2021 Frontiers in Oncology
Steroid switch after progression on abiraterone plus prednisone in patients with metastatic castration-resistant prostate cancer: A systematic review2021 Urologic Oncology
Quality of life in men with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone: a systematic review and meta-analysis2021 Prostate Cancer and Prostatic Diseases
Optimal treatment sequencing of abiraterone acetate plus prednisone and enzalutamide in patients with castration-resistant metastatic prostate cancer: A systematic review and meta-analysis2021 Cancer Treatment Reviews
Comparison of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis2021 JAMA Oncology
Prognostic value of ECOG performance status and Gleason score in the survival of castration-resistant prostate cancer: a systematic review2021 Asian Journal of Andrology
Health-related Quality of Life in Patients with Advanced Prostate Cancer: A Systematic Review2021 European Urology Focus
Abiraterone acetate in combination with androgen deprivation therapy compared to androgen deprivation therapy only for metastatic hormone-sensitive prostate cancer2020The Cochrane Database of Systematic Reviews
Longitudinal model-based meta-analysis for survival probabilities in patients with castration-resistant prostate cancer2020European Journal of Clinical Pharmacology
Indirect Comparisons of Efficacy between Combination Approaches in Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis2020 European Urology

Clinical Practice Guidelines

Document TitleYearSource
Prostate Cancer, Version 4.2023, NCCN Clinical Practice Guidelines in Oncology.2023Journal of the National Comprehensive Cancer Network
Updated treatment recommendations for prostate cancer from the ESMO Clinical Practice Guideline considering treatment intensification and use of novel systemic agents.2023Annals of Oncology
2022 Canadian Urological Association (CUA)-Canadian Uro Oncology Group (CUOG) guideline: Management of castration-resistant prostate cancer (CRPC).2022Canadian Urological Association
Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with prostate cancer.2022European Society for Medical Oncology
Initial management of noncastrate advanced, recurrent, or metastatic prostate cancer: ASCO guideline update.2021Journal of Clinical Oncology
Consensus on the treatment and follow-up for metastatic castration-resistant prostate cancer: A report from the first global prostate cancer consensus conference for developing countries.2021American Society of Clinical Oncology
What Do the Guidelines Say for Metastatic Prostate Cancer Starting Androgen Deprivation Therapy? National Comprehensive Cancer Network, European Society for Medical Oncology, and European Association of Urology recommendations.2021European Urology Focus
Advanced prostate cancer: AUA/ASTRO/SUO guideline.2020American Urological Association
Prostate cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up.2020Annals of Oncology
Prostate Cancer, version 2.2019.2019Journal of the National Comprehensive Cancer Network