Treatment with immune checkpoint inhibitors (ICIs) has significantly improved the prognosis of cancer patients, although it can be associated with a wide variety of adverse events (AEs) affecting multiple organs. An international study on AEs related to ICIs reported in real clinical practice has found that the annual frequency has increased between 2012 and 2023, as expected due to the increasing use of immunotherapy. However, the mortality of reported AEs remains stable, around 25%. By developing an algorithm based on data from more than 290,000 cases reported in total, both to the North American FDA and the WHO, the study researchers have detected that 20% of AEs related to ICI have a high mortality. 36% of patients who presented certain AEs died, compared to 11% of those who presented other AEs related to ICI. The highly fatal AEs are specifically 63 and include respiratory, cardiac, muscular, vascular, hepatic and infectious events. The identification of these high-mortality AEs can help establish surveillance measures for patients receiving ICIs, as well as improve their management.
It is a retrospective study based on a large amount of pharmacovigilance data, on all reported cancer types, ICI types, and AE types. The methodology is robust, with validation in other databases after the initial analysis. The results reinforce previously described observations (pneumonitis, hepatitis, myositis, etc.), from an epidemiological and global point of view. The main contribution is that it detects AEs with higher mortality, which is very important when assessing the safety and risks of ICI therapy, considering their surveillance and the treatment of these complications.
The main limitations of the study are well reflected in the discussion, for example, the fact that among the causes of the high mortality observed, it is not possible to differentiate those attributed to the cancer itself, to the direct effect of the drug or to other derived effects; reflects overall mortality. In our clinical practice, the results impact various specialties, such as pulmonology, cardiology, hepatology, neurology or rheumatology, which together with oncology, care for and treat cancer patients when they present AEs related to ICI.
