Roni Shouval: Insights into Renal Injury in CAR-T Therapy from Global FDA Reports
Roni Shouval , Assistant Attending Adult BMT and Cellular Therapy Service at MSKCC, shared on X:
“Excited to share our latest study in Haematologica , led by Alec Board man: Renal injury, often overlooked in CART, poses significant challenges. What did we learn from nearly 6,000 global FDA reports and 399 NHL patients? Here’s a tread on key findings!
First, from the FDA Database, we noted AKI was disproportionately reported in CAR-T patients (~3.6%, n=211). Concurrent CRS was common & reported fatality rate of AKI was higher compared to other toxicities.
At MSKCC, we analyzed 399 NHL patients treated with CD19 CAR-T. AKI occurred in 10% (all grades) within 9 days post-infusion, with 4.8% experiencing grade ≥2 AKI. 3 required dialysis. Pre-renal factors (71.8%) dominated AKI cases, often linked to CRS.
While pre-CAR-T renal dysfunction wasn’t linked to survival, AKI post-CAR-T reduced overall survival (OS) & progression-free survival (PFS). Prevention & early mitigation are imperative.
Biomarkers of systemic inflammation – may predict AKI risk. Could these guide preemptive strategies? Hydration, nephrotoxin avoidance, & tailored interventions could help.
AKI isn’t just a side effect. It’s a window into systemic toxicity and inflammation in CAR-T. As CAR-T eligibility broadens, addressing renal toxicity is more important than ever.
Many thanks to Sean Devlin and Jessica Flynn from MSK Biostatistics Service and our nephrology colleagues – Victoria Gutgarts and Insara Jaffer-Sathick.
Check out the paper.”
Predictors and implications of renal injury after CD19 chimeric antigen receptor T-cell therapy
Authors: Alexander P. Boardman, Victoria Gutgarts, Jessica Flynn, Sean M. Devlin, Adam Goldman, Ana Alarcon Tomas, Joshua A. Fein, John B. Slingerland, Allison Parascondola, Richard J. Lin, Michael Scordo, Parastoo B. Dahi, Sergio Giralt, M. Lia Palomba, Gilles Salles, Karthik Nath, Moneeza Walji, Magdalena Corona, Jae H. Park, Gunjan L. Shah, Miguel-Angel Perales, Insara Jaffer-Sathick, Roni Shouval
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