Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry

Abstract

Background: Metastatic prostate cancer has a 30% 5-year survival rate despite recent therapeutic advances. There is a need to improve the clinical understanding and treatment of this disease, particularly in the real-world setting and among patients who are under-represented in clinical trials.

Objective: We aimed to evaluate the characteristics and clinical outcomes of patients who received their first treatment for metastatic castration-resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used, including subgroups with baseline cardiac disease, diabetes mellitus, or visceral metastases.

Patients and methods: Prospective, noninterventional analysis of patient record data in the multicenter Prostate Cancer Registry (PCR) of men with mCRPC. The data were collected in 16 countries with the aim of recruiting more than 3000 patients between 2013 and 2016. The study end date was 9 July 2018. Data evaluated included baseline characteristics, treatment exposure, and efficacy outcomes [overall survival (OS) and time to progression (TTP)] of patients treated with abiraterone acetate plus prednisone or prednisolone (collectively, "abiraterone"), enzalutamide, or docetaxel. Descriptive outcomes are reported from the overall patient population and subgroups of patients with baseline cardiovascular disease, diabetes mellitus, or visceral metastases. The treatment effects for time to progression were compared for the overall patient population.

Results: The study enrollment period lasted 2.5 years, and each patient was followed for a maximum of 3 years. A total of 1874 patients in the PCR had not received previous mCRPC treatment at baseline, although they had received androgen-deprivation therapy. Prevalent co-morbidities included cardiovascular disease in 65.4% and diabetes mellitus in 17.4% of patients. Baseline characteristics suggested that patients with more advanced disease received docetaxel treatment. In the overall patient population, the median time to progression with abiraterone, enzalutamide, and docetaxel as first-line mCRPC therapy was 9.6, 10.3, and 7.6 months, respectively, and median OS was 27.1, 27.1, and 27.9 months, respectively. Outcomes in the subgroups of patients with cardiovascular disease or diabetes mellitus were similar to those of the whole population in the analysis. As expected, patients with visceral metastases had shorter TTP and OS than patients in the overall population.

Conclusions: This analysis shows, for the first time, the effectiveness in parallel of first-line abiraterone, enzalutamide, and docetaxel in mCRPC, including in patients with co-morbidities such as cardiovascular disease or diabetes mellitus or in patients with visceral metastases. These real-world findings from the PCR provide meaningful information to help manage mCRPC, particularly in patients under-represented in clinical studies.

Trial registration: ClinicalTrials.gov identifier NCT02236637; registered September 2014.

Conflict of interest statement

Simon Chowdhury has participated in speaker bureaus and acted as a consultant for Johnson & Johnson, Astellas, Sanofi, and Clovis and has received research grants from Clovis. Anders Bjartell has received remuneration from Janssen, Astellas, and Bayer for lectures and for participation in advisory boards. Nicolaas Lumen has participated in advisory boards for Astellas, Janssen, and Bayer, receives grants from Astellas, Janssen, Bayer, Sanofi, Ferring, and Ipsen, and receives speaker honoraria from Bayer, Astellas, Janssen, GSK, and Ipsen. Pablo Maroto has participated in advisory boards for Janssen, Astellas, and Bayer. Thomas Paiss reports no conflicts of interest. Francisco Gomez-Veiga has received remuneration from Bayer, Astellas, Janssen, and Amgen for lectures and for participation in advisory boards. Alison Birtle has participated in advisory boards and provided educational meeting support for Janssen, Astellas, Sanofi Genzyme, Bayer, and Roche. Gero Kramer reports no conflicts of interest. Ewa Kalinka has received honoraria from Janssen and Medivation/Pfizer. Dominique Spaëth reports no conflicts of interests. Susan Feyerabend reports no conflicts of interest. Vsevolod Matveev participated in advisory boards for and received speaker honoraria from Astellas, Bayer, Janssen, and Sanofi. Florence Lefresne is an employee of Janssen Pharmaceutica N.V. and holds stock in Johnson & Johnson. Martin Lukac is an employee of Parexel International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica N.V., Beerse, Belgium. Robert Wapenaar is an employee of Janssen-Cilag B.V. and holds stock in Johnson & Johnson. Luis Costa has participated in advisory boards for Janssen, Astellas, and Bayer, and has received speaker honoraria from Janssen and Bayer.

Figures

Fig. 1

Time to progression in the first-line treatment population (a), and cardiovascular (b), diabetes mellitus (c), and visceral metastases subgroups (d). Abi abiraterone, Enz enzalutamide, Doc docetaxel

Fig. 2

Overall survival in the first-line treatment population (a), and cardiovascular (b), diabetes mellitus (c), and visceral metastases subgroups (d). Abi abiraterone, Enz enzalutamide, Doc docetaxel