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Real-world outcomes of abiraterone and enzalutamide in first-line treatment of metastatic castration-resistant prostate cancer: which patients benefit most?
  1. Macarena García Trevijano Cabetas1,
  2. Miguel Escario-Gómez1,
  3. Luis González-Del Valle1,
  4. Carmen Sobrino Jiménez1,
  5. Cristina Bilbao Gomez-Martino1,
  6. José Antonio Romero-Garrido1,
  7. Juana Benedi-González2,
  8. Enrique Espinosa Arranz3,
  9. Mariana Díaz Almirón4,
  10. Alicia Herrero Ambrosio1
  1. 1Hospital Pharmacy Department, La Paz University Hospital, Madrid, Spain
  2. 2Pharmacy Department, Universidad Complutense de Madrid, Madrid, Comunidad de Madrid, Spain
  3. 3Medical Oncology Department, La Paz University Hospital, Madrid, Spain
  4. 4Hospital Statistics Department, La Paz University Hospital, Madrid, Spain
  1. Correspondence to Macarena García Trevijano Cabetas, Hospital Pharmacy Department, La Paz University Hospital, Madrid 28046, Spain; macarena.garciatrevijano{at}salud.madrid.org

Abstract

Objectives Abiraterone and enzalutamide are two oral novel androgen receptor axis-targeted agents approved for the treatment of castration-resistant prostate cancer (mCRPC). Despite the availability of multiple treatments, there is a need to improve the knowledge and management of these drugs in the real-world setting, especially in patient groups under-represented in clinical trials. Our aim was to review the outcome of patients with chemotherapy-naïve mCRPC treated with abiraterone or enzalutamide in routine clinical practice in order to identify factors that are predictive for response.

Methods This observational retrospective study was performed in a Spanish tertiary hospital and included men with chemotherapy-naïve mCPRC who started treatment with abiraterone or enzalutamide between September 2012 and November 2018. The study end date was 30 October 2020.

Results Ninety patients with mCRPC were included, 57 with abiraterone and 33 with enzalutamide. Median overall survival (OS) was 26.87 months (95% CI 19.68 to 34.05), with no difference found between the two treatment groups. Nine variables were related to increased OS in the univariate analysis: Eastern Cooperative Oncology Group (ECOG) performance status (0–1 vs 2), pain (need of opioids for cancer pain), visceral disease, ≥3 bone lesions, exclusively lymph node metastases, baseline prostate specific antigen (PSA) (<50 vs ≥50 ng/dL and <20 vs ≥20 ng/dL), haemoglobin (<12 vs ≥12 g/dL) and alkaline phosphatase (≤116 vs >116 IU/L). A PSA response >50% was observed in 65 patients (76.5%). In the multivariate analysis, ECOG performance status, pain, visceral disease and alkaline phosphatase provided independent prognostic information. Median OS by Kaplan–Meier analysis was significantly longer for patients with a PSA response (32.1 vs 17.9 months; HR 0.46, 95% CI 0.27 to 0.78; p=0.003).

Conclusions This study assessed the efficacy of abiraterone and enzalutamide in a real-world setting, including patients under-represented in pivotal studies. Some clinical factors were correlated with improved OS in chemotherapy-naïve men with mCPRC treated with these drugs.

  • medical oncology
  • pharmacy service
  • hospital
  • urology
  • statistics
  • urogenital system

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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