Issue link: https://viewer.e-digitaledition.com/i/1462307
IN A NEW study published by Scientific Reports, resea rchers found a higher incidence of myoca rditis in patients who used multiple immune checkpoint inhibitors (ICIs). CARDIOVASCULAR CONDITIONS AND CANCER TREATMENT " ICIs represent new a nd , for some cancers, revolutionary treatment," says Ruben Abag yan, PhD, co-author of the study and Professor at Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California San Diego. "The FDA data accumulated by the time of our analysis represented a sufficient number of reports to analyze contributing factors to the cardiac adverse effects of these innovative therapies." INCREASED MYOCARDITIS RISK AMONG PATIENT GROUPS R e s e a r c h e r s d e t e r m i n e d p a t i e nt s who used t wo or more immunother- apies (ICI+ICI) resu lted in a hig her risk of myocarditis. Additiona lly, as a mono-treatment, Ipilimumab, a CTLA4 antibody, showed the lowest reported odds ratio for myocarditis. "The myocarditis symptoms associ- ated with checkpoint inhibitors [are] rea l, but not uniform," Abag yan says. "The association with complications does not depend on the duration of the antibody treatment." Resea rchers noted that individua l clinical cases showed clearly that myo- carditis occurred shortly after completion or discontinuation of ICI treatment. " We hope t hat physicia ns w i l l be more obser va nt of this unusua l pro- gression of symptoms," Abag yan says. "Particularly for patients at higher risk of cardiac complications." PROCESS SUMMARY In this study, the FDA adverse event reporting system (FAERS/AERS) and MedWatch were used to create a retro- spective analysis. At the onset of the study, the FAERS database included upwards of 14 mil- lion post marketing safety surveillance reports submitted to the manufacturer on a voluntary basis. Researchers wrote scripts and code to reformat the data into a convenient format for computer analysis. T he r e s ea rcher s e xc lude d i n fe c - tion-associated myocarditis — including v i ra l , ba c t er ia l a nd f u n ga l t y pes — a l low i ng t hem to focus on i m mu ne, autoimmune and adverse event-related forms of myoca rditis. The resea rch- ers then divided data into cohor ts to a na lyze immunotherapy a nd ca ncer type. Increased risk of myocarditis was found across all cancer types and nearly a ll cohorts. COHORT SELECTION Resea rchers divided the strea mlined FA ER S repor ting into three cohor ts to account for each type of ICI patient including: 1) monotherapy, 2) anti-PD-1/ CTLA-4 combinations, 3) ICI + a xitinib. They a lso looked at a control/ a nth- r a c y c l i ne g r oup w it h a n d w it hout chemotherapy. Since a nthracyclines have a lready been found to increa se myocarditis risk, researchers deemed the separation necessary. ADVANCED TREATMENT FOR BETTER CARE Although research is still ongoing, the current data show a need for continued collaboration between cardiolog y and oncolog y treatment. Abag yan and his team continue to analyze new ICIs and combinations used in oncology practice to monitor cardiac adverse effects during cancer treatment. "Cardio-oncolog y is a relatively new f ield," Abag ya n says. " We envision a tighter integration of oncologists and cardiologists to benefit their patients." n Increased Myocarditis Reported in Patients Receiving Immune Checkpoint Inhibitors BY W YNNE KONTOS NE W DATA INDICATES PATIENTS REPORT MYOCARDITIS AT HIGHER R ATES AF TER THE USE OF IMMUNE CHECKPOINT INHIBITORS DURING CANCER TRE ATMENT. 1 0