January 23, 2022

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Immune checkpoint inhibitors within 90 days after radiotherapy does not increase the risk of serious AEs

Immune checkpoint inhibitors within 90 days after radiotherapy does not increase the risk of serious AEs



 

FDA data shows that the use of immune checkpoint inhibitors within 90 days after radiotherapy does not increase the risk of serious AEs.

JAMA Oncology 丨 Meta-analysis of trials in the FDA database: the association between radiotherapy and the risk of adverse events in patients receiving immunotherapy

 

Importance: Immune checkpoint inhibitors (ICI) and radiotherapy (RT) are widely used to treat various cancers, but there are few data available to guide clinicians in the sequential use of ICI and radiotherapy.

 

 

Purpose:

To assess whether the risk of serious adverse events (AE) related to radiotherapy given within 90 days before ICI has increased.

 

 

Design, set-up, and participants:

Individual patients were aggregated in 68 prospective ICI trials submitted in the initial or supplementary license application filed in the US Food and Drug Administration (FDA) database from December 2019 to December 2019 data. Two cohorts were generated:

(1) radiotherapy within 90 days before starting ICI treatment

(2) patients who did not receive radiotherapy within 90 days before starting ICI treatment, and the frequency of AEs was determined.

 

A 1:1 propensity score matching analysis was performed.

 

 

Intervention:

All patients received ICI (atezolizumab, avelumab, cemipilimab, durvalumab, ipilimumab, nivolumab, or pembrolizumab); 1733 people received radiotherapy within 90 days before starting ICI treatment, 13956 did not.

 

 

Main results and measures:

The main results are the frequency and severity of AEs. In the propensity score matching group, the incidence of AEs between participants who received and who did not receive RT was compared descriptively.

Because all analyses are exploratory (ie, no pre-planning and no allocation of α), it is considered inappropriate to assess the statistical significance of differences between groups.

 

Results: A total of 25,469 patients were identified; 8,634 were excluded because they did not receive radiotherapy (n = 976), did not receive ICI (n = 4949), received radiotherapy outside the target window (n = 2338), or were Among the controls with missing data in one or more variables used in the propensity analysis (n = 371), the remaining 16,835 patients were included in the analysis.

The majority are under 65 years of age (9447 [56.1%]), males (10459 [62.1%]), and whites (13422 [79.7%]).

Patients who received radiotherapy generally had a similar incidence of AEs to patients who did not receive radiotherapy. The average absolute difference in AE incidence was 1.2%, and the difference ranged from 0% in nervous system AE to 8% in fatigue. No difference in grade 3 to 4 AE was observed between the two groups (absolute difference ranged from 0.01% to 2%).

 

Conclusions and relevance: In this meta-analysis, the use of ICI within 90 days after radiotherapy does not appear to be associated with an increased risk of serious AEs.

Therefore, it seems safe to give ICI within 90 days of receiving radiotherapy. These findings should be confirmed in future prospective trials.

 

 

 

 

Reference:

Anscher MS, Arora S, Weinstock C, et al. Association of Radiation Therapy With Risk of Adverse Events in Patients Receiving ImmunotherapyA Pooled Analysis of Trials in the US Food and Drug Administration Database. JAMA Oncol. 2022 Jan 6. doi: 10.1001/jamaoncol .2021.6439.

 

(source:internet, reference only)


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