Reacción a "Study warns of risks associated with a type of cancer immunotherapy"

Treatment with immune checkpoint inhibitors (ICIs) has significantly improved the prognosis for cancer patients, although it can be associated with a wide variety of adverse effects (AEs) affecting multiple organs. An international study on ICIs-related AEs reported in real-world clinical practice has found that the annual frequency has increased between 2012 and 2023, as expected due to the growing use of immunotherapy. However, the mortality rate of reported AEs remains stable at around 25%. By developing an algorithm based on data from more than 290,000 cases reported in total to both the US FDA and the WHO, the study's researchers found that 20% of ICI-related AEs have a high mortality rate. Thirty-six per cent of patients who experienced certain AEs died, compared with 11 per cent of those who experienced other ICI-related AEs. There are 63 highly fatal AEs, including respiratory, cardiac, muscular, vascular, hepatic, and infectious events. Identifying these AEs with high mortality rates can help establish surveillance measures for patients receiving ICIs and improve their management.

This is a retrospective study based on a large amount of pharmacovigilance data on all types of cancer, types of ICIs and types of AEs reported. 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 perspective. 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 its surveillance and the treatment of these complications.

The main limitations of the study are well covered in the discussion, for example, the fact that among the causes of the high mortality observed, it is not possible to differentiate between those attributed to the cancer itself, the direct effect of the drug, or other derived effects; it reflects overall mortality. In our clinical practice, the results have an impact on various specialities, such as pulmonology, cardiology, hepatology, neurology, and rheumatology, which, together with oncology, we use to care for and treat cancer patients when they present with ICI-related AEs.