{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T23:07:53Z","timestamp":1783897673519,"version":"3.55.0"},"reference-count":22,"publisher":"Walter de Gruyter GmbH","issue":"3","license":[{"start":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T00:00:00Z","timestamp":1620086400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,5,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_raon-2021-0019_s_006\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Immunotherapy with CTLA-4 inhibitors and PD1 checkpoint inhibitors has initiated a breakthrough in the treatment and prognosis of patients with metastatic melanoma. The survival of these patients has increased from the expected survival time of less than 12 months to at least forty months. However, immunotherapy with either anti-CTLA-4 antibodies or PD1 inhibitors alone or in combination has a broad palette of significant immune-related adverse events. The aim of the study was to assess the correlation of immune-related adverse events with treatment outcomes defined as significant differences in the overall response rate (ORR) and progression-free survival (PFS) of patients, who developed immune-related adverse events during immunotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_raon-2021-0019_s_007\">\n                    <jats:title>Patients and methods<\/jats:title>\n                    <jats:p>A retrospective analysis of patients with metastatic melanoma treated with immunotherapy in 2020 at the Oncology Institute of Ljubljana was performed. Only patients with radiological evaluation of the immunotherapy response were included. The patients were divided into two cohorts: a cohort of patients with immune-related adverse events (irAE group) and a cohort of patients with no immune-related adverse events (NirAE group). Significantly better overall response and progression-free survival in the irAE cohort defined the primary aim of our study. To investigate the differences in progression-free survival between the irAE cohort and NirAE cohort, we used survival analysis. In particular, a Cox proportional hazards model with covariates of time to progression and adverse events was used for survival analysis. The Kruskal-Wallis H-test was applied, and a p-value of p &lt;= 0.05 was considered the cut-off point for a statistically significant difference between the groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_raon-2021-0019_s_008\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among the 120 patients treated with immunotherapy, radiological response evaluation was performed for 99 patients: 38 patients in the irAE cohort and 61 patients in the NirAE cohort. The ORRs for the irAE and NirAE cohorts were 57% and 37%, respectively. The PFS was significantly better for the irAE cohort (301.6 days) than for the NirAE cohort (247.29 days). The results of the survival regression analysis showed a significant increase in the survival probability from less than 60% for the NirAE cohort to almost 80% for the irAE cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_raon-2021-0019_s_009\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Patients with metastatic melanoma treated with immunotherapy who developed immune-related adverse events showed better treatment outcomes with longer times to disease progression and better overall response rates than patients treated with immunotherapy who did not develop immune-related adverse events, with a significant increase in the survival probability from less than 60% for the NirAE cohort to almost 80% for the irAE cohort.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2478\/raon-2021-0019","type":"journal-article","created":{"date-parts":[[2021,5,3]],"date-time":"2021-05-03T18:46:03Z","timestamp":1620067563000},"page":"354-361","source":"Crossref","is-referenced-by-count":6,"title":["Adverse events during immunotherapy in Slovenian patients with metastatic melanoma reveal a positive correlation with better treatment outcomes"],"prefix":"10.2478","volume":"55","author":[{"given":"Tanja","family":"Mesti","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Institute of Oncology Ljubljana , Ljubljana , Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vid","family":"Ceplak Mencin","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Institute of Oncology Ljubljana , Ljubljana , Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Biljana","family":"Mileva Boshkoska","sequence":"additional","affiliation":[{"name":"Faculty of information studies in Novo mesto , Novo mesto , Slovenia"},{"name":"Department for Knowledge Technologies, Institute Jo\u017eef Stefan , Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janja","family":"Ocvirk","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Institute of Oncology Ljubljana , Ljubljana , Slovenia"},{"name":"Faculty of Medicine, University of Ljubljana , Ljubljana Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2021,5,4]]},"reference":[{"key":"2026071212043075453_j_raon-2021-0019_ref_001","doi-asserted-by":"crossref","unstructured":"Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski R, Lao CD, et al. 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