A single center investigation of efficacy and safety datas of immune checkpoint inhibitors used in cancer patients of Cukurova University Faculty of Medicine

Introduction and goal: Despite their important clinical benefits, immune checkpoint in-hibitors (ICI) can cause immune-related adverse effects (irAE). In our thesis, we primarily ai-med to investigate safety and secondly efficacy of the new and frequently used ICIs. Materials and methods: 117 patients who received ICI in CUTF between 2010-2022 were included in the study. In terms of irAE occurrence; cutaneous, pulmonary, hepato-biliary, ocular, hematological, central-peripheral nerve, endocrine, cardiovasculer, musculoskeletal systems were evaluated by observation. The distribution of irAE's frequencies according to diseases and agents and also survival data were analyzed in the SPSS 22.0 program. Results: The male/female ratio of the patients were 88/29, the median age was 59. In our study, the frequencies of all grade/grade 3-4 irAEs were determined in percentage respectively as; total 50/6; cutaneous 21/2,5; pneumonitis 19/3; hepatotoxicity 2,5/1,7 was determined as. Colitis was 1,7%, endocrine irAE was 5% (thyroid 4,2%/adrenal 0,8%). Hematological irAE was 1 auto-immune hemolytic anemia and 1 hemophagocytic syndrome. Eleven (9%) ANA, RF or anti-dsDNA positivity, 3 ophtalmic irAE, 1 irAE peripheral neuropathy were observed. There was no significant survival difference between patients having irAE or not for melanoma and lung cancer patients whose irAE were found 32% and 28% respectively. irAE for any agent were as follows; Nivolumab 30%, pembrolizumab 28%, atezolizumab 44%, ipilimumab 14% and nivolumab+ipiliumab 75%. After 27 months follow up, the survival curves of PDL-1 positive versus negative patients were seperated (p=0,234). The median survival of the patients with melanoma, lung cancer, RCC and Hodgkin lymphoma were 22,3, 17,4, 28,3 and 47,5 months, respectively. While the overall response was 42% in all patients, the highest response rate was found 41% in patients with melanoma. Atypical responses like pseudoprogression and hyperprogression were evidenced in 3% and 8% of the patients. Conclusion: Differing from prospective randomized studies, an observational study like ours for the investigation of adverse effects when they are at low grades in unselected patients yields superior results for managing adverse effects of ICI. Key words: immune checkpoint inhibitor (ICI), immune-related adverse effect (irAE)