"Clinicians should counsel patients regarding myocarditis risk, implement baseline and serial cardiac evaluations for at least six months following ICI initiation, and maintain a low threshold for cardiology referral upon symptom onset."
BUFFALO, NY — May 16, 2025 — A new editorial was published in Volume 12 of Oncoscience on May 2, 2025, titled " Immune checkpoint inhibitors and myocarditis: Lessons from a nationwide cohort study ."
In this editorial, Bishal Tiwari from Nassau University Medical Center discusses findings from a large Chinese cohort study that links immune checkpoint inhibitors (ICIs) with a significantly increased risk of myocarditis, a rare but potentially life-threatening inflammation of the heart, in patients with advanced non-small cell lung cancer (NSCLC).
While ICIs have transformed the treatment of NSCLC by enhancing the body's immune response against tumors, they can also provoke unintended immune-related side effects. The editorial highlights new real-world data showing that patients treated with ICIs are over seven times more likely to develop myocarditis than those not receiving these therapies. Based on a nationwide dataset of more than 55,000 patients, the study also found that 36% of myocarditis cases occurred more than three months after treatment began. These findings suggest the need for extended cardiac monitoring for at least six months following ICI initiation.
"In their nationwide cohort study, Li et al. report a 7.4-fold increase in 1-year risk of myocarditis among ICI users versus non-users (HR 7.41; 95% CI 3.29–16.67), based on 55219 patients drawn from China's National Anti-Tumor Drug Surveillance System (NATDSS) between 2013 and 2021."
Dr. Tiwari explains how ICIs may trigger myocarditis by disrupting immune checkpoints, allowing T cells to attack not only tumors but also healthy heart tissue. Evidence from tissue studies has confirmed immune cell infiltration in the myocardium of affected patients. The editorial emphasizes that early warning signs, such as elevated cardiac biomarkers, may help identify high-risk patients before symptoms appear.
The cohort study reviewed in the editorial employed rigorous statistical methods, including time-dependent modeling and well-matched comparison groups, to improve the reliability of the conclusions. The integration of national death registries, imaging records, and laboratory data provided a comprehensive view of patient outcomes and strengthened the validity of the findings.
Despite these strengths, the editorial acknowledges several limitations. The use of diagnostic coding may underestimate the number of mild or subclinical cases. Additionally, the data do not distinguish between individual ICI drugs or combinations, which could be important for understanding specific risk profiles. Nonetheless, the evidence presented reinforces the importance of proactive cardiac screening, educating patients about symptoms, and involving cardiologists early in the treatment process when needed.
As ICIs become more widely used in oncology, the editorial highlights the growing need to balance their life-extending benefits with a clearer understanding of rare but serious risks such as myocarditis. Ongoing research into biomarkers and risk prediction tools will be essential for optimizing patient safety and improving outcomes in cancer immunotherapy.
Continue reading: DOI: https://doi.org/10.18632/oncoscience.617
