Grace Lu-Yao1, Nikita Nikita2, Scott W Keith3, Ginah Nightingale4, Krupa Gandhi5, Sarah E Hegarty5, Timothy R Rebbeck6, Andrew Chapman7, Philip W Kantoff8, Jennifer Cullen9, Leonard Gomella10, William Kevin Kelly2. 1. Department of Medical Oncology, Sidney Kimmel Cancer Center at Jefferson, Sidney Kimmel Medical College, Philadelphia, PA, USA; Sidney Kimmel Cancer Center at Jefferson, Philadelphia, PA, USA; Jefferson College of Population Health, Philadelphia, PA, USA. Electronic address: grace.luyao@jefferson.edu. 2. Department of Medical Oncology, Sidney Kimmel Cancer Center at Jefferson, Sidney Kimmel Medical College, Philadelphia, PA, USA; Sidney Kimmel Cancer Center at Jefferson, Philadelphia, PA, USA. 3. Sidney Kimmel Cancer Center at Jefferson, Philadelphia, PA, USA; Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College, Philadelphia, PA, USA. 4. Department of Pharmacy Practice, Jefferson College of Pharmacy, Philadelphia, PA, USA. 5. Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College, Philadelphia, PA, USA. 6. Dana Farber Cancer Institute and Harvard TH Chan School of Public Health, Boston, MA, USA. 7. Department of Medical Oncology, Jefferson Senior Adult Oncology Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA. 8. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. 9. Center for Prostate Disease Research (CPDR), Rockville, MD, USA. 10. Sidney Kimmel Cancer Center at Jefferson, Philadelphia, PA, USA; Department of Urology, Sidney Kimmel Cancer Center at Jefferson, Sidney Kimmel Medical College, Philadelphia, PA, USA.
Abstract
BACKGROUND: Elderly patients (≥65yr) with advanced prostate cancer and cardiovascular disease (CVD) conditions are often excluded from clinical trials of abiraterone acetate (AA) or enzalutamide (ENZ). Consequently, little is known about the effects of these medications on these vulnerable patients. OBJECTIVE: To assess the short-term outcomes of AA and ENZ in patients with pre-existing CVDs. DESIGN, SETTING, AND PARTICIPANTS: A population-based retrospective study. The Surveillance, Epidemiology, and End Results-Medicare-linked database was used to identify prostate cancer patients using AA or ENZ. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was 6-mo all-cause mortality, analyzed using modified Poisson regression modeling of relative risk (RR) adjusted for confounders and comorbidities. RESULTS AND LIMITATIONS: Among eligible patients (2845 with AA and 1031 with ENZ), 67% had at least one pre-existing CVD. Compared with those without pre-existing CVDs, having one to two pre-existing CVDs was associated with 16% higher 6-mo mortality (RR=1.16, 95% confidence interval [CI]: 1.00-1.36), and the risk increased further among those having three or more CVDs (RR=1.56, 95% CI: 1.29-1.88). Most of the differences in survival of patients with pre-existing CVD condition occurred within the first 6mo of treatment. CONCLUSIONS: After treatment with AA or ENZ, elderly prostate cancer patients with pre-existing CVDs experienced higher short-term mortality than otherwise similar patients without CVDs. Mortality associated with CVDs did not depend on having received AA versus ENZ. PATIENT SUMMARY: Patients with pre-existing cardiovascular diseases (CVDs) experienced higher short-term mortality after abiraterone acetate or enzalutamide than those without pre-existing CVDs. It is recommended that a multidisciplinary team, including a cardiologist, evaluate patients having pre-existing CVDs in the process of making treatment decisions and monitoring potential side effects.
BACKGROUND: Elderly patients (≥65yr) with advanced prostate cancer and cardiovascular disease (CVD) conditions are often excluded from clinical trials of abiraterone acetate (AA) or enzalutamide (ENZ). Consequently, little is known about the effects of these medications on these vulnerable patients. OBJECTIVE: To assess the short-term outcomes of AA and ENZ in patients with pre-existing CVDs. DESIGN, SETTING, AND PARTICIPANTS: A population-based retrospective study. The Surveillance, Epidemiology, and End Results-Medicare-linked database was used to identify prostate cancerpatients using AA or ENZ. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was 6-mo all-cause mortality, analyzed using modified Poisson regression modeling of relative risk (RR) adjusted for confounders and comorbidities. RESULTS AND LIMITATIONS: Among eligible patients (2845 with AA and 1031 with ENZ), 67% had at least one pre-existing CVD. Compared with those without pre-existing CVDs, having one to two pre-existing CVDs was associated with 16% higher 6-mo mortality (RR=1.16, 95% confidence interval [CI]: 1.00-1.36), and the risk increased further among those having three or more CVDs (RR=1.56, 95% CI: 1.29-1.88). Most of the differences in survival of patients with pre-existing CVD condition occurred within the first 6mo of treatment. CONCLUSIONS: After treatment with AA or ENZ, elderly prostate cancerpatients with pre-existing CVDs experienced higher short-term mortality than otherwise similar patients without CVDs. Mortality associated with CVDs did not depend on having received AA versus ENZ. PATIENT SUMMARY:Patients with pre-existing cardiovascular diseases (CVDs) experienced higher short-term mortality after abiraterone acetate or enzalutamide than those without pre-existing CVDs. It is recommended that a multidisciplinary team, including a cardiologist, evaluate patients having pre-existing CVDs in the process of making treatment decisions and monitoring potential side effects.
Authors: A J Templeton; F E Vera-Badillo; L Wang; M Attalla; P De Gouveia; R Leibowitz-Amit; J J Knox; M Moore; S S Sridhar; A M Joshua; G R Pond; E Amir; I F Tannock Journal: Ann Oncol Date: 2013-10-14 Impact factor: 32.976
Authors: Lowell E Schnipper; Nancy E Davidson; Dana S Wollins; Courtney Tyne; Douglas W Blayney; Diane Blum; Adam P Dicker; Patricia A Ganz; J Russell Hoverman; Robert Langdon; Gary H Lyman; Neal J Meropol; Therese Mulvey; Lee Newcomer; Jeffrey Peppercorn; Blase Polite; Derek Raghavan; Gregory Rossi; Leonard Saltz; Deborah Schrag; Thomas J Smith; Peter P Yu; Clifford A Hudis; Richard L Schilsky Journal: J Clin Oncol Date: 2015-06-22 Impact factor: 44.544
Authors: Paul L Nguyen; Ming-Hui Chen; Joshua A Beckman; Clair J Beard; Neil E Martin; Toni K Choueiri; Jim C Hu; Karen E Hoffman; Daniel E Dosoretz; Brian J Moran; Sharon A Salenius; Michelle H Braccioforte; Philip W Kantoff; Anthony V D'Amico; Ronald D Ennis Journal: Int J Radiat Oncol Biol Phys Date: 2011-06-25 Impact factor: 7.038
Authors: Nicholas D James; Johann S de Bono; Melissa R Spears; Noel W Clarke; Malcolm D Mason; David P Dearnaley; Alastair W S Ritchie; Claire L Amos; Clare Gilson; Rob J Jones; David Matheson; Robin Millman; Gerhardt Attard; Simon Chowdhury; William R Cross; Silke Gillessen; Christopher C Parker; J Martin Russell; Dominik R Berthold; Chris Brawley; Fawzi Adab; San Aung; Alison J Birtle; Jo Bowen; Susannah Brock; Prabir Chakraborti; Catherine Ferguson; Joanna Gale; Emma Gray; Mohan Hingorani; Peter J Hoskin; Jason F Lester; Zafar I Malik; Fiona McKinna; Neil McPhail; Julian Money-Kyrle; Joe O'Sullivan; Omi Parikh; Andrew Protheroe; Angus Robinson; Narayanan N Srihari; Carys Thomas; John Wagstaff; James Wylie; Anjali Zarkar; Mahesh K B Parmar; Matthew R Sydes Journal: N Engl J Med Date: 2017-06-03 Impact factor: 91.245
Authors: Nirmanmoh Bhatia; Marilia Santos; Lee W Jones; Joshua A Beckman; David F Penson; Alicia K Morgans; Javid Moslehi Journal: Circulation Date: 2016-02-02 Impact factor: 29.690
Authors: Sherry-Ann Brown; Svetlana Zaharova; Peter Mason; Jonathan Thompson; Bicky Thapa; David Ishizawar; Erin Wilkes; Gulrayz Ahmed; Jason Rubenstein; Joyce Sanchez; David Joyce; Balaraman Kalyanaraman; Michael Widlansky Journal: Front Cardiovasc Med Date: 2020-12-04
Authors: Ximena Morales; Diego Garnica; Daniel Isaza; Nicolas Isaza; Felipe Durán-Torres Journal: BMC Cardiovasc Disord Date: 2021-03-12 Impact factor: 2.298
Authors: Chiara Melloni; Susan F Slovin; Allan Blemings; Shaun G Goodman; Christopher P Evans; Jan Nilsson; Deepak L Bhatt; Konstantin Zubovskiy; Tine K Olesen; Klaus Dugi; Noel W Clarke; Celestia S Higano; Matthew T Roe Journal: JACC CardioOncol Date: 2020-03-17
Authors: Juan José Serrano Domingo; Teresa Alonso Gordoa; Javier Lorca Álvaro; Javier Molina-Cerrillo; Arantzazu Barquín García; Olga Martínez Sáez; Javier Burgos Revilla; Alfredo Carrato; Sara Álvarez Rodríguez Journal: Ther Adv Urol Date: 2021-09-17
Authors: Yash B Shah; Amy L Shaver; Jacob Beiriger; Sagar Mehta; Nikita Nikita; William Kevin Kelly; Stephen J Freedland; Grace Lu-Yao Journal: Cancers (Basel) Date: 2022-08-03 Impact factor: 6.575