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Dataset Information

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.


ABSTRACT:

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 therap

SUBMITTER: Anscher MS 

PROVIDER: S-EPMC8739815 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature