22 Feb Metastatic Prostate Cancer: Final Analysis of Adding Abiraterone Acetate (ZYTIGA® ) and Prednisone to Androgen Deprivation Therapy
MedicalResearch.com Interview with:
Kim Nguyen Chi, MD FRCPC
Professor of Medicine, University of British Columbia
Regional Medical Director, BC Cancer – Vancouver
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: For over 70 years, androgen deprivation therapy (ADT) has been the main treatment therapy for metastatic prostate cancer patients. This Phase 3 final analysis study looked at adding abiraterone acetate and prednisone to ADT for patients with metastatic prostate cancer, with the primary objectives being to assess improvements in overall survival and radiographic progression-free survival. At the first interim analysis reported in 2017, both primary endpoints were met, and the study was unblinded and patients on the ADT and placebos arm crossed over to receive ADT with abiraterone and prednisone.
This study is the final analysis reporting on overall survival. The study findings found abiraterone acetate and prednisone plus ADT continued to demonstrate an improvement in overall survival, hazard ratio (HR) = 0.66, meaning a 34% decrease in the risk of death associated with the use of ADT with abiraterone and prednisone. The median overall survival, which had not been reached before in the ADT with abiraterone and prednisone arm, was 53.3 months compared to 36.5 months for ADT plus placebo, prolonging median overall survival by 16.8 months.
MedicalResearch.com: What should readers take away from your report?
Response: In addition to meeting the primary endpoints, the study also met secondary endpoints that were in favor of the abiraterone acetate and prednisone plus ADT therapy tied to pain progression, time to skeletal-related events, time to chemotherapy initiation and time to subsequent prostate cancer therapy. In terms of subsequent prostate cancer therapy, approximately 60 percent of patients receiving ADT plus placebo received life-extending subsequent therapy. It is also important to note that time to second disease progression (PFS2), which is defined as the time from randomization to progression on subsequent therapy, was also significantly in favor of abiraterone acetate and prednisone plus ADT. This implies that patients getting subsequent therapy don’t actually ever catch up to the patients receiving abiraterone acetate upfront.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: There are other studies that are looking at adding other treatments to ADT. Recently a press release was issued on the Phase 3 TITAN study with apalutamide plus ADT, which showed overall survival and radiographic progression-free survival. Additionally, studies are evaluating the benefit of abiraterone acetate and docetaxel. We’re looking forward to the study results from ongoing studies.
Any disclosures? N/A
ASCO GU Symposium February 2019
Abstract #141 – Final Analysis of the Phase 3 LATITUDE Study
Karim Fizazi, Namphuong Tran, Luis Enrique Fein, Nobuaki Matsubara, Alfredo Rodríguez Antolín, Mustafa Ozguroglu, Dingwei Ye, Susan Feyerabend, Andrew Protheroe, Giri Sulur, Yesenia Luna, Susan Li, Suneel Mundle, Kim N. Chi; Department of Cancer Medicine, Gustave Roussy Cancer Campus, Paris-Sud University, France, Villejuif, France; Janssen Research & Development, Los Angeles, CA; Instituto de Oncología de Rosário, Rosário, Argentina; Division of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan; Hospital Universitario 12 de Octubre, Madrid, Spain; Cerrahpaşa Medical Faculty, Istanbul University, Istanbul, Turkey; Fudan University Affiliated Cancer Hospital, Shanghai, China; Studienpraxis Urologie, Nurtingen, Germany; Oxford University Hospitals Foundation NHS Trust, Oxford, United Kingdom; Janssen Research & Development, Spring House, PA; Janssen Research & Development, Raritan, NJ; BC Cancer Agency – Vancouver Centre, Vancouver, BC, Canada
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