Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry

Abstract

Background: Despite standard-of-care androgen-deprivation therapy and an increasing number of treatment options, the mortality rate for prostate cancer remains high. Progress to metastatic castration-resistant prostate cancer (mCRPC) necessitates additional treatments. Abiraterone acetate plus prednisone or prednisolone (AAP) prolongs survival in chemotherapy-naive and docetaxel-experienced patients.

Objective: To evaluate the real-world safety and efficacy of AAP as first-line and second-line [post-docetaxel only (AAP-PD)] treatment in patients with mCRPC.

Patients and methods: The Prostate Cancer Registry (PCR) was a prospective, international, observational study of patients with mCRPC in routine clinical practice. Men aged ≥ 18 years with confirmed mCRPC were included. Baseline characteristics, safety (treatment-emergent adverse events, treatment-emergent severe adverse events), and efficacy [progression-free survival (PFS) and overall survival (OS)] were analyzed.

Results: At baseline, patients who received first-line AAP (n = 754) were generally older than patients who received AAP-PD (n = 354); median age was 76 years and 70 years, respectively. However, the rate of visceral metastasis was higher in the AAP-PD cohort than in the AAP cohort (17.7% vs. 9.6%, respectively). Demographics and disease characteristics of patients with baseline cardiovascular disease were similar to those of the overall registry population. Efficacy outcomes were similar for all patients, regardless of the line of AAP therapy. For first-line AAP and AAP-PD, respectively, the median PFS was 8.9 and 5.8 months for all patients and 9.1 and 6.0 months for patients with cardiovascular comorbidities; median OS was 27.1 and 23.4 months for all patients, and 27.4 and 23.1 months for patients with cardiovascular comorbidities. There were no unexpected adverse events in any patient subgroup.

Conclusions: These real-world data complement the findings from randomized controlled trials, indicating that first- and second-line AAP is well tolerated and effective in patients with mCRPC, including those with underlying CV comorbidities.

Trial registration number: NCT02236637, registered 8 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, Sandoz, Ipsen, AstraZeneca, Merck, and Bayer for lectures and for participation in advisory boards, and from Ferring and Astellas for investigator-initiated trials. 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 has 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

Treatment duration (first-line data included for comparative purposes). aMedian duration of treatment by Kaplan-Meier estimates and censoring of patients with ongoing treatment at end of Registry. AAP abiraterone acetate plus prednisone/prednisolone, AAP-PD AAP after docetaxel, CV cardiovascular

Fig. 2

Change in Eastern Cooperative Oncology Group performance status during treatment. AAP abiraterone acetate plus prednisone/prednisolone, AAP-PD AAP after docetaxel, CV cardiovascular

Fig. 3

Progression-free survival in all patients treated with a AAP and b AAP-PD among those with and without cardiovascular comorbidities (first-line data included for comparative purposes). AAP abiraterone acetate plus prednisone/prednisolone, AAP-PD AAP after docetaxel, CV cardiovascular

Fig. 4

Overall survival in all patients treated with a AAP and b AAP-PD among those with and without cardiovascular comorbidities (first-line data included for comparative purposes). AAP abiraterone acetate plus prednisone/prednisolone, AAP-PD AAP after docetaxel, CV cardiovascular