BACKGROUND: With the recent introduction of novel treatment options, real-world data from patients with metastatic castration-resistant prostate cancer (mCRPC) are required to better understand the impact on routine clinical practice. This study primarily aimed to describe the time to treatment failure (TTF) of mCRPC patients treated with abiraterone acetate plus prednisone or the corticosteroid of choice (AAP) in the pre-chemotherapy setting. Other relevant outcomes, clinical and treatment characteristics of these patients were also evaluated. METHODS: This retrospective, observational study collected data from chemotherapy-naïve mCRPC patients treated with AAP from four European countries. Kaplan-Meier curves were used to estimate TTF, progression-free survival (PFS), and time to first skeletal-related event. The impact of baseline characteristics on TTF and PFS was explored using univariate and multivariate Cox proportional hazard models. Log-rank test was used to assess the potential role of duration of response to ADT in predicting response to AAP treatment. RESULTS: Data from 481 eligible patients (Belgium: 68; France: 61; Germany: 150; UK: 202) were analysed. At AAP initiation, the median age of patients was 75.0 years (interquartile range [IQR]: 69.0-81.0), and the median PSA was 56.2 ng/mL (IQR: 22.2-133.1), with over 50% of patients presenting an ECOG score of 0 or 1. Visceral metastases were present in 7.5% of patients; an exclusion criterion in the COU-AA-302 clinical trial. The median TTF with AAP was 10.0 months (95%CI: 9.2-11.1) and the median PFS was 10.8 months (95%CI: 9.6-11.8). Shorter TTF was significantly associated with higher ALP (> 119 units/L), higher PSA (> 56.2 ng/mL), or poorer ECOG PS scores at AAP initiation (p < 0.05). Patients with longer duration of response to ADT (≥12 months) presented longer TTF and longer time to progression (p < 0.0001). CONCLUSIONS: This European real-world study provides valuable insights into the characteristics, treatment, and outcomes of chemotherapy-naïve patients with mCRPC who received AAP in routine clinical practice. Treatment effectiveness of AAP in the real-world is maintained despite patients having poorer clinical features at initiation than those observed in the COU-AA-302 trial population.

Agaplesion Markus Hospital Frankfurt Germany

AZ Nikolaas Sint Niklaas Belgium

CHC Cliniques Saint Joseph Liège Belgium

CHWapi site IMC Tournai Belgium

Clinique Saint Anne Strasbourg France

Department of Urology University of Muenster Medical Center Albert Schweitzer Campus 1 GB A1 D 48149 Muenster Germany

Groupe Hospitalier Bretagne Sud Hôpital du Scorff Lorient France

Institut Sainte Catherine Avignon France

IQVIA Barcelona Spain

Janssen EMEA London High Wycombe UK

Janssen Pharmaceutica NV Beerse Belgium

PAREXEL International Prague Czech Republic

Refrath Urological Center Bergisch Gladbach Germany

Rosemere Cancer Centre Royal Preston Hospital and University of Manchester Manchester UK

St Luke's Cancer Centre The Royal Surrey County Hospital Guildford UK

The Christie Hospital Manchester UK

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Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368(2):138–148. doi: 10.1056/NEJMoa1209096. PubMed DOI PMC

Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PFA, Sternberg CN, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015;16(2):152–160. doi: 10.1016/S1470-2045(14)71205-7. PubMed DOI

European Medicines Agency. Zytiga® Summary of Opinion. 2012.

Loriot Y, Eymard JC, Patrikidou A, Ileana E, Massard C, Albiges L, et al. Prior long response to androgen deprivation predicts response to next-generation androgen receptor axis targeted drugs in castration resistant prostate cancer. Eur J Cancer (Oxford, England: 1990) 2015;51(14):1946–1952. doi: 10.1016/j.ejca.2015.06.128. PubMed DOI

Janssen Cilag International NV . Zytiga: summary of product characteristics. 2017.

Gillessen S, Omlin A, Attard G, de Bono JS, Efstathiou E, Fizazi K, et al. Management of patients with advanced prostate cancer: recommendations of the St Gallen advanced prostate Cancer consensus conference (APCCC) 2015. Ann Oncol. 2015;26(8):1589–1604. doi: 10.1093/annonc/mdv257. PubMed DOI PMC

Poon DM, Chan K, Lee SH, Chan TW, Sze H, Lee EK, et al. Abiraterone acetate in metastatic castration-resistant prostate cancer - the unanticipated real-world clinical experience. BMC Urol. 2016;16:12. doi: 10.1186/s12894-016-0132-z. PubMed DOI PMC

Thortzen A, Thim S, Roder MA, Brasso K. A single-center experience with abiraterone as treatment for metastatic castration-resistant prostate cancer. Urol Oncol. 2016;34(7):291.e1–291.e7. doi: 10.1016/j.urolonc.2016.02.013. PubMed DOI

Pilon D, Behl AS, Ellis LA, Emond B, Lefebvre P, Dawson NA. Duration of treatment in prostate Cancer patients treated with Abiraterone acetate or enzalutamide. J Manag Care Spec Pharm. 2017;23(2):225–235. PubMed PMC

Cornford P, Bellmunt J, Bolla M, Briers E, De Santis M, Gross T, et al. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part II: Treatment of Relapsing, Metastatic, and Castration-Resistant Prostate Cancer. Eur Urol. 71(4):630–42. PubMed