INTRODUCTION: In light of COVID-19, reducing patient exposure via remote monitoring is desirable. Patients prescribed abiraterone/ enzalutamide are scheduled for monthly in-person appointments to screen for adverse events (AEs). We determined time trends of drug-specific actionable AEs among users of abiraterone/enzalutamide to assess the safety of remote monitoring. METHODS: A chart review was conducted on 828 prostate cancer patients prescribed abiraterone and/or enzalutamide. Data were collected to determine time to actionable first AEs, including hypertension, elevated liver enzymes (aspartate transaminase [AST], alanine transaminase [ALT]), hyperbilirubinemia, and hypokalemia. Survival analysis was used to determine time to AEs. RESULTS: In this study, 425 and 403 patients received enzalutamide and abiraterone, respectively. In total, 25.6% of those who took enzalutamide experienced an AE, compared to 28.8% of patients on abiraterone. For patients using abiraterone and experiencing an AE, cumulative incidence of AEs at three, six, nine, and 12 months were: 67.2%, 81.9%, 90.5%, and 93.9%, respectively. Among enzalutamide users experiencing an AE, cumulative incidence of AEs at three, six, nine, and 12 months were 51.4%, 70.7%, 82.6%, and 88.1%, respectively. The AEs associated with enzalutamide were hypertension and liver dysfunction (77.1% and 22.9%, respectively). In the abiraterone group, associated AEs were liver dysfunction (47.4%), hypertension (47.4%), and hypokalemia (5.2%). CONCLUSIONS: Attaining AEs secondary to abiraterone/enzalutamide decreases over time and tends to occur within the first six months of therapy. Most actionable AEs can be remotely monitored. Given COVID-19, remote monitoring after six months of initiating abiraterone or enzalutamide appears appropriate.
INTRODUCTION: In light of COVID-19, reducing patient exposure via remote monitoring is desirable. Patients prescribed abiraterone/ enzalutamide are scheduled for monthly in-person appointments to screen for adverse events (AEs). We determined time trends of drug-specific actionable AEs among users of abiraterone/enzalutamide to assess the safety of remote monitoring. METHODS: A chart review was conducted on 828 prostate cancer patients prescribed abiraterone and/or enzalutamide. Data were collected to determine time to actionable first AEs, including hypertension, elevated liver enzymes (aspartate transaminase [AST], alanine transaminase [ALT]), hyperbilirubinemia, and hypokalemia. Survival analysis was used to determine time to AEs. RESULTS: In this study, 425 and 403 patients received enzalutamide and abiraterone, respectively. In total, 25.6% of those who took enzalutamide experienced an AE, compared to 28.8% of patients on abiraterone. For patients using abiraterone and experiencing an AE, cumulative incidence of AEs at three, six, nine, and 12 months were: 67.2%, 81.9%, 90.5%, and 93.9%, respectively. Among enzalutamide users experiencing an AE, cumulative incidence of AEs at three, six, nine, and 12 months were 51.4%, 70.7%, 82.6%, and 88.1%, respectively. The AEs associated with enzalutamide were hypertension and liver dysfunction (77.1% and 22.9%, respectively). In the abiraterone group, associated AEs were liver dysfunction (47.4%), hypertension (47.4%), and hypokalemia (5.2%). CONCLUSIONS: Attaining AEs secondary to abiraterone/enzalutamide decreases over time and tends to occur within the first six months of therapy. Most actionable AEs can be remotely monitored. Given COVID-19, remote monitoring after six months of initiating abiraterone or enzalutamide appears appropriate.
Authors: Tomasz M Beer; Andrew J Armstrong; Dana Rathkopf; Yohann Loriot; Cora N Sternberg; Celestia S Higano; Peter Iversen; Christopher P Evans; Choung-Soo Kim; Go Kimura; Kurt Miller; Fred Saad; Anders S Bjartell; Michael Borre; Peter Mulders; Teuvo L Tammela; Teresa Parli; Suha Sari; Steve van Os; Ad Theeuwes; Bertrand Tombal Journal: Eur Urol Date: 2016-07-28 Impact factor: 20.096
Authors: Darren R Brenner; Hannah K Weir; Alain A Demers; Larry F Ellison; Cheryl Louzado; Amanda Shaw; Donna Turner; Ryan R Woods; Leah M Smith Journal: CMAJ Date: 2020-03-02 Impact factor: 8.262
Authors: Charles J Ryan; Matthew R Smith; Karim Fizazi; Fred Saad; Peter F A Mulders; Cora N Sternberg; Kurt Miller; Christopher J Logothetis; Neal D Shore; Eric J Small; Joan Carles; Thomas W Flaig; Mary-Ellen Taplin; Celestia S Higano; Paul de Souza; Johann S de Bono; Thomas W Griffin; Peter De Porre; Margaret K Yu; Youn C Park; Jinhui Li; Thian Kheoh; Vahid Naini; Arturo Molina; Dana E Rathkopf Journal: Lancet Oncol Date: 2015-01-16 Impact factor: 41.316
Authors: Anna Cox; Grace Lucas; Afrodita Marcu; Marianne Piano; Wendy Grosvenor; Freda Mold; Roma Maguire; Emma Ream Journal: J Med Internet Res Date: 2017-01-09 Impact factor: 5.428