| Summary: | Sveinbjörn Gizurarson, professor við lyfjafræðideild var umsjónarkennari fyrir hönd lyfjafræðideildar. Background and aims: Immune checkpoint inhibitors (ICPis) have revolutionized the treatment of selected types of cancer, due to durable effects, selectivity and overall improved survival and tolerance when compared to chemotherapy. ICPis work by blocking inhibitory signals of T cells and thereby activating an immune response against cancer cells. By increasing the activity of the immune system, ICPis can lead to autoimmune and inflammatory AEs. These AEs can be serious and even fatal. The aims of this study are to create an overview of the use of ICPi therapies in Iceland, to evaluate the tolerability of ICPis, to create an overview of the management of AEs associated with ICPis and to collect the incidence of AEs reported to Icelandic Medicines Agency. Methods: This is a single-center retrospective, descriptive chart review of patient cases who received at least one dose of nivolumab, pembrolizumab, atezolizumab or ipilimumab at Landspitali - The National University Hospital of Iceland between 1 January 2015 and 31 December 2018. The social security numbers of the patients were obtained from a central database through the department of finance and the drug and therapy committee at Landspitali. All symptoms recorded by a physician in the medical records of patients during or after the ICPi treatment that could be classified as an AE related to the ICPi, were recorded as possible AEs. The primary endpoint was the tolerability of ICPis including the incidence, type and severity of AEs. Secondary endpoint was the management of AEs associated with ICPis. The incidence of AEs reported to Icelandic Medicines Agency was also evaluated. Results: A total of 135 patients were enrolled in the study. 50% of patients experienced a total of 114 AEs of which 25% experienced AEs leading to discontinuation of ICPi therapy that can be classified as grade 3-4 AEs. The most common AEs were skin reactions, thyroid reactions and ...
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