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Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving Immunotherapy: A Pooled Analysis of Trials in the US Food and Drug Administration Database by Mitchell S. Anscher; Shaily Arora; Chana Weinstock; Anup Amatya; Pradeep Bandaru; Chad Tang; Andrew T. Girvin; Mallorie H. Fiero; Shenghui Tang; Rachael Lubitz; Laleh Amiri-Kordestani; Marc R. Theoret; Richard Pazdur; Julia A. Beaver is a Medicine article available to read on EtoBox.

What is Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving Immunotherapy: A Pooled Analysis of Trials in the US Food and Drug Administration Database about?

## Importance: Immune checkpoint inhibitors (icis) and radiation therapy (rt) are widely used to treat various cancers, but little data are available to guide clinicians on ici use sequentially with rt. ## Objective: To assess whether there is an increased risk of serious adverse events (aes) associated with rt given within 90 days prior to an ici. ## Design, setting, and participants: Individual patient data were pooled from 68 prospective trials of icis submitted in initial or supplemental licensing applications in the us food and drug administration (fda) databases through december 2019. two cohorts were generated: (1) patients who received rt within the 90 days prior to beginning ici therapy and (2) those who did not receive rt within the 90 days prior to beginning ici therapy, and ae frequencies were determined. a 1:1 propensity score-matched analysis was performed. ## Interventions: All patients received an ici (atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab, or pembrolizumab); 1733 received rt within the 90 days prior to starting ici therapy, and 13 956 did not. ## Main outcomes and measures: The primary outcome was frequency and severity of aes. incid

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Author

Mitchell S. Anscher; Shaily Arora; Chana Weinstock; Anup Amatya; Pradeep Bandaru; Chad Tang; Andrew T. Girvin; Mallorie H. Fiero; Shenghui Tang; Rachael Lubitz; Laleh Amiri-Kordestani; Marc R. Theoret; Richard Pazdur; Julia A. Beaver

Publisher

American Medical Association (AMA)

Published

2022

Language

EN

Field

Medicine (Health Sciences)