2018 ASCO Annual Meeting!
Session: Genitourinary (Prostate) Cancer
Type: Poster Session
Time: Saturday June 2, 1:15 PM to 4:45 PM
Location: Hall A
Clinical outcomes following androgen receptor axis therapies (ARAT) among men with prostate cancer (PCa) having major cardiovascular diseases (CVDs) or extreme polypharmacy (EPP): A population based study.
Genitourinary (Prostate) Cancer
2018 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #283)
J Clin Oncol 36, 2018 (suppl; abstr 5056)
Author(s): Grace L. Lu-Yao, Ginah Nightingale, Nikita Nikita, Sheel A. Patel, Krupa Gandhi, Benjamin Leiby, Sarah Hegarty, Andrea Marie Barsevick, Norma Padron, Timothy Rebbeck, Andrew E. Chapman, Leonard G. Gomella, William Kevin Kelly; Sidney Kimmel Cancer Center at Jefferson, Philadelphia, PA; Jefferson School of Pharmacy, Thomas Jefferson University, Philadelphia, PA; Thomas Jefferson University, Philadelphia, PA, US; Thomas Jefferson University, Philadelphia, PA; Thomas Jefferson University, Department of Pharmacology and Experimental Therapeutics, Philadelphia, PA, US; Thomas Jefferson University Hospital, Philadelphia, PA; Lankenau Institute for Medical Research, Philadelphia, PA; Harvard University, T.H. Chan School of Public Health and Dana Farber Cancer Institute, Boston, MA; Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA
Background: The safety of ARAT (Abiraterone acetate (AA) and Enzalutamide (ENZ)) among men with existing CVDs or EPP (≥10 concurrent medications) is unknown since patients with these conditions are often excluded from the clinical trials. This study was undertaken to fill these knowledge gaps. Methods: This population-based study identified PCa patients from the linked Surveillance, Epidemiology and End Result-Medicare files diagnosed during 1/1/1991-12/31/2013. The primary endpoint was 6-month overall mortality after drug initiation. CVDs include acute myocardial infarction (AMI), atrial fibrillation (AFIB), congestive heart failure (CHF), stroke, and ischemic heart disease (IHD). Cox proportional hazard models were used to assess the risk of 6-month mortality. Results: Our study included 3,116 patients treated with AA only or AA as first ARAT and 1,162 patients treated with ENZ only or ENZ as first ARAT. The characteristics of the patients treated with AA and ENZ were similar. The majority of patients (67%) treated with ARAT had existing CVDs and the prevalence of EPP before drug initiation was high (46% for AA and 44% for ENZ). Six-month mortality was elevated among men with existing CVDs treated with ARAT (Table 1). EPP with ARAT was associated with an increase in 6-month mortality (AA: HR 3.22, 95% CI 2.16-4.81; ENZ: HR 1.63, 95% 1.03-2.58). To our knowledge, this is the largest population-based study to provide outcomes data among patients with existing CVDs or EPP, who were under-represented in the pivotal trials. The elevated 6-month mortality of men with CVDs or EPP treated with ARAT suggested that these patients represent a vulnerable patient population. Further studies are needed to determine the clinical benefits and risks of ARAT in men with advanced PCa and existing CVDs or EPP.
|AMI/no CVD||CHF/no CVD||AFIB/no CVD||Stroke/no CVD||IHD/no CVD|
|AA||1.89 (1.27-2.80)||1.54 (1.20-1.97)||1.61 (1.22-2.12)||1.61 (1.18-2.20)||1.14 (1.13-1.77)|
|ENZ||1.46 (0.73-2.92)||1.20 (0.79-1.81)||1.80 (1.14-2.82)||1.50 (0.90-2.50)||1.40 (0.99-1.99)|