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Clinical and Translational Oncology

, Volume 21, Issue 3, pp 314–323 | Cite as

Effectiveness, safety and cost of abiraterone acetate in patients with metastatic castration-resistant prostate cancer: a real-world data analysis

  • M. KoninckxEmail author
  • J. L. Marco
  • I. Pérez
  • M. T. Faus
  • V. Alcolea
  • F. Gómez
Research Article
  • 242 Downloads

Abstract

Purpose

New therapies with diverse mechanisms of action are available for metastatic castration-resistant prostate cancer (mCRPC). This study aims to evaluate the effectiveness, safety and cost of abiraterone acetate (AA) in patients with mCRPC.

Materials and methods

Observational retrospective cohort study in which mCRPC patients who initiated AA between January 1, 2012 and December 31, 2017, were included. The patients were followed-up until death or March 31, 2018. Demographic, clinical and economic data were collected from the corporate electronic information systems. Survival distributions were estimated using the Kaplan–Meier method and compared using the log-rank test.

Results

A total of 69 mCRPC patients were started on AA, of whom 18 (26.1%) received prior chemotherapy (post-CT) and 51 (73.9%) did not receive it (CT-naïve). A PSA decline of ≥ 50% was achieved in five (27.8%) post-CT and 32 (62.7%) CT-naïve patients (p = 0.011). Median time to PSA progression, progression-free survival (PFS) and overall survival (OS) were 4.4/7.9 months (p = 0.003), 5.1/7.5 months (p = 0.034) and 12.1/21.3 months (p = 0.119), respectively, for post-CT/CT-naïve patients. Treatment-related adverse events (AEs) occurred in 10 (55.6%) post-CT and 11 (21.6%) CT-naïve patients (p = 0.007). The most common AEs were hypokalaemia (11.6%), hypertension (8.7%) and fatigue (5.8%). The cost per median PFS month and per median OS month was €2818.4/€2784.3 and €1187.9/€980.4 for post-CT/CT-naïve patients, respectively.

Conclusions

CT-naïve patients treated with AA obtained a better clinical benefit in terms of effectiveness, safety and cost-effectiveness ratio than post-CT patients. The effectiveness outcomes were poorer than those reported previously in the clinical trial setting.

Keywords

Abiraterone acetate Castration-resistant prostatic cancer Chemotherapy Cost-effectiveness analysis Safety Survival analysis 

Notes

Funding

No funding was received.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

For this type of study formal consent is not required.

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Copyright information

© Federación de Sociedades Españolas de Oncología (FESEO) 2018

Authors and Affiliations

  1. 1.Department of Hospital PharmacyFrancesc de Borja Hospital of GandiaValenciaSpain
  2. 2.Department of Medical OncologyFrancesc de Borja Hospital of GandiaValenciaSpain
  3. 3.Department of Preventive MedicineArnau de Vilanova HospitalValenciaSpain

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