Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action

摘要

Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for cancer. Due to the mechanism of action of ICIs, inflammatory reactions against normal tissue were an anticipated side effect of these agents; these immunea??related adverse events have been documented and are typically low grade and manageable. Myocarditis has emerged as an uncommon but potentially lifea??threatening adverse reaction in patients treated with ICIs. Assessment and characterization of ICIa??associated myocarditis is challenging because of its low incidence and protean manifestations. Nevertheless, the seriousness of ICIa??associated myocarditis justifies a coordinated effort to increase awareness of this syndrome, identify patients who may be at risk, and enable early diagnosis and appropriate treatment. The a??Checkpoint Inhibitor Safety Working Group,a?? a multidisciplinary committee of academic, industry, and regulatory partners, convened at a workshop hosted by Project Data Sphere, LLC, on December 15, 2017. This meeting aimed to evaluate the current information on ICIa??associated myocarditis, determine methods to collect and share data on this adverse reaction, and establish task forces to close the identified knowledge gaps. In this report, we summarize the workshop findings and proposed steps to address the impact of ICIa??associated myocarditis in patients with cancer.