01 Jun TItan Study: Apalutamide (ERLEADA®) plus Androgen Deprivation Therapy Improved Survival in Some Metastatic Prostate Cancer Patients
MedicalResearch.com Interview with:
Dr. Kim Chi
Dr. Kim Chi. MD
Professor of Medicine
Medical Oncologist and Medical Director at BC Cancer – Vancouver
University of British Columbia,
Principal Investigator of the TITAN Study.
MedicalResearch.com: What is the background for this study?
Response: For more than 70 years, androgen deprivation therapy (ADT) has been the standard of care therapy for patients with metastatic prostate cancer. The Phase 3 TITAN study looked at adding apalutamide (®®®®) to ADT compared with placebo plus ADT in a broad group of patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history.
Metastatic castration-sensitive prostate cancer is prostate cancer that still responds to androgen deprivation therapy and has spread to other parts of the body. Patients with mCSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options. The dual primary endpoints of this study were overall survival and radiographic progression-free survival (rPFS).
MedicalResearch.com: What are the main findings?
Response: The TITAN study found apalutamide plus androgen deprivation therapy significantly improved both dual primary endpoints of OS and rPFS in patients with mCSPC, regardless of extent of disease or prior docetaxel treatment history. Apalutamide plus ADT significantly extended OS, compared to placebo plus ADT, with a 33 percent reduction in the risk of death (HR=0.67, 95% CI, 0.51-0.89; P=0.0053). The two-year OS rates, after a median follow up of 22.7 months, were 82 percent for apalutamide plus ADT compared to 74 percent for placebo plus ADT. Apalutamide plus ADT also significantly improved rPFS compared to placebo plus ADT (HR=0.48; 95% CI, 0.39-0.60; P<0.0001). There was an absolute 20 percent difference in the two-year rPFS, 68 percent for apalutamide plus ADT compared to 48 percent for placebo plus ADT. Treatment was well tolerated with adverse events consistent with the known safety profile of apalutamide, and quality of life that was preserved and not different from placebo.
MedicalResearch.com: What should readers take away from your report?
Response: Patients with mCSPC typically have a poor prognosis, with a median OS of less than five years. Despite advances in treatment, there is still a critical need to improve outcomes and have treatment options for these patients. These data demonstrate that apalutamide given with standard androgen deprivation therapy prolongs OS and delays disease progression in patients with mCSPC, regardless of extent of disease or prior docetaxel treatment history.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: There are ongoing studies looking at combination therapies with apalutamide and other medications for the treatment of prostate cancer across the disease spectrum. We look forward to learning the results from ongoing studies and developing therapies that may be tailored to the needs of individual patients with a goal to intercept prostate cancer in earlier stages of disease.
Citation: ASCO 2019
First results from TITAN: A phase III double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT)
J Clin Oncol 37, 2019 (suppl; abstr 5006)|
Kim N. Chi et al
NEJM
Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer
Kim N. Chi, M.D., Neeraj Agarwal, M.D., Anders Bjartell, M.D., Byung Ha Chung, M.D.,Andrea J. Pereira de Santana Gomes, M.D.Robert Given, M.D., Álvaro Juárez Soto, M.D., Axel S. Merseburger, M.D., Mustafa Özgüroğlu, M.D., Hirotsugu Uemura, M.D., Dingwei Ye, M.D., Kris Deprince, M.D.,for the TITAN Investigators*
May 31, 2019
DOI: 10.1056/NEJMoa1903307
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Last Updated on June 1, 2019 by Marie Benz MD FAAD