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Cardiac Adverse Events in Patients Receiving Immune Checkpoint Inhibitors in the Adjuvant Setting: An FDA Pooled

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Summary

Immune checkpoint inhibitors (ICIs) increase cardiac risks in cancer patients receiving adjuvant therapy. This analysis highlights the need for cardiac monitoring and risk assessment in long-term survivors.

Keywords:

adjuvant cancer cardio oncology cardiotoxicity immune checkpoint inhibitors immunotherapy

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Area of Science:

Cardiology
Oncology
Pharmacology

Background:

Immune checkpoint inhibitors (ICIs) have transformed cancer treatment by enhancing antitumor immunity.
While effective, ICIs carry risks of serious cardiac toxicities, particularly in advanced cancer.
Data on ICI cardiotoxicity in the curative, non-metastatic setting are limited, raising concerns for long-term survivors.

Purpose of the Study:

To evaluate the incidence and nature of cardiac adverse events (AEs) and cardio-metabolic risks associated with ICIs in the adjuvant cancer setting.
To assess the relative risk (RR) of cardiotoxicity in patients receiving ICIs compared to placebo.
To identify patient factors associated with increased risk of fatal cardiac events.

Main Methods:

A pooled analysis of ten randomized controlled trials involving atezolizumab, ipilimumab, nivolumab, and pembrolizumab in the adjuvant setting.
Exclusion of trials involving combination chemotherapy.
Assessment of cardiac AEs, cardio-metabolic risks (hyperglycemia, weight gain, hypothyroidism), and fatal cardiac events.

Main Results:

Among 9244 patients (5338 receiving ICIs), cardiac AEs occurred in 6% of ICI patients versus 4.6% of placebo.
A fatal cardiac AE occurred in 0.2% of ICI patients (RR 4.76).
Arrhythmia was the most common AE; hypothyroidism was significantly more frequent in ICI-treated patients (14% vs. 2.5%).

Conclusions:

This study represents the largest pooled analysis of cardiac AEs from ICIs in the adjuvant setting.
ICI treatment significantly increases the risk of cardiac AEs, even without routine subclinical monitoring.
Findings underscore the importance of considering cardiotoxicity in long-term cancer survivors and in the development of new cancer therapies.