03 Jun SPARTAN Study: Older Castration-Resistant Prostate Cancer Patients Can Tolerate and Benefit from Apalutamide (ERLEADA®)
MedicalResearch.com Interview with:
Julie N. Graff, MD
Associate Professor of Medicine
Knight Cancer Institute
Chief of Hematology/Oncology
VA Portland Health Care System
MedicalResearch.com: What is the background for this study?
Response: Androgen deprivation therapy is often deployed in patients with a rising PSA after local therapy (such as radical prostatectomy or radiation therapy). With time, the prostate cancer can develop resistance to ADT, at which point it is called castration resistant prostate cancer (CRPC). There were 6 treatments for metastatic CRPC that have shown improved survival. However, in non-metastatic disease, there was nothing that showed improved survival.
The SPARTAN study was designed to determine if a next generation androgen receptor antagonist could delay the time to metastatic disease. Overall survival was a secondary endpoint.
MedicalResearch.com: What are the main findings?
Response: The main findings of the SPARTAN study were that (1) it met the primary endpoint of prolonged metastasis free survival, and secondary endpoints of progression free survival 2 and symptomatic progression; and (2) it was tolerated and did not decrease quality of life.
The median age of the patients on SPARTAN was 74 years old. We conducted this study to ensure that apalutamide was both effective and safe in men 75 years and older. In this analysis, we looked at men <65, 65- <75, 75+, and found that all three groups had prolonged metastasis free survival relative to placebo. Younger patients tended to have more aggressive disease features but better performance status. Elderly patients tended to have more rashes, bone fractures, and hypothyroidism.
MedicalResearch.com: What should readers take away from your report?
Response: Providers should know that older patients can benefit from apalutamide and tolerate it well.
Citation: ASCO 2019 Abstract
Age-related efficacy and safety of apalutamide (APA) plus ongoing androgen deprivation therapy (ADT) in subgroups of patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC): Post hoc analysis of SPARTAN.
Author(s): Julie Nicole Graff, Matthew Raymond Smith, Fred Saad, Boris A. Hadaschik, Hiroji Uemura, Ji Youl Lee, Paul N. Mainwaring, David Olmos, Stephane Oudard, Anil Londhe, Amitabha Bhaumik, Oliver Brendan Rooney, Angela Lopez-Gitlitz, Eric Jay Small; Knight Cancer Institute, Oregon Health & Science University, Portland, OR; Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA; Centre Hospitalier de l’Université de Montréal/CRCHUM, Montréal, QC, Canada; Department of Urology, University of Duisburg-Essen, Essen, Germany and Ruprecht-Karls-University, Heidelberg, Germany; Department of Urology & Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan; St. Mary’s Hospital of Catholic University, Seoul, South Korea; Centre for Personalized Nanomedicine, University of Queensland, Brisbane, Australia; Spanish National Cancer Research Centre (CNIO), Madrid and Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Málaga, Spain; Georges Pompidou Hopital, Paris, France; Janssen Research & Development, Titusville, NJ; Clinical Biostatistics, Janssen Research & Development, Titusville, NJ; Janssen Research & Development, High Wycombe, United Kingdom; Janssen Research & Development, Los Angeles, CA; Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA
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