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      Analysis of characteristics and predictive factors of immune checkpoint inhibitor-related adverse events


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          We aimed to retrospectively analyze the toxicity profiles and predictors of immune-related adverse events (irAEs) as well as the correlation between irAEs and the clinical efficacy of multi-type immune checkpoint inhibitors (ICIs) in patients with advanced pan-cancer in a real-world setting.


          We retrospectively analyzed data from 105 patients with advanced pan-cancer treated with multi-type ICIs at the First Hospital of Jilin University between January 1, 2016 and August 1, 2020. We used logistic regression analyses to investigate the associations of irAEs with clinical baseline characteristics, blood count parameters, and biochemical indicators during treatment. Receiver operating characteristic curves were used to determine cutoff values for parameters and area under the curve values. Kaplan–Meier and Cox multivariate regression analyses were performed to estimate the relationships of baseline characteristics and irAEs with progression-free survival (PFS) and overall survival (OS).


          A lower relative lymphocyte count (cutoff = 28.5%), higher albumin level (cutoff = 39.05 g/L), and higher absolute eosinophil count (AEC) (cutoff = 0.175 × 10 9/L) were significantly associated with the occurrence of irAEs, among which a higher AEC (cutoff = 0.205 × 10 9/L) was strongly associated with skin-related irAEs [odds ratios (ORs) = 0.163, P = 0.004]. Moreover, a higher lactate dehydrogenase level (cutoff = 237.5 U/L) was an independent predictor of irAEs of grade ≥ 3 (OR = 0.083, P = 0.023). In immune cell subgroup analysis, a lower absolute count of CD8 +CD28 suppressor T cells (OR = 0.806; 95% confidence interval: 0.643–1.011; P = 0.062), which are regulatory T lymphocytes, was associated with the occurrence of irAEs, although the difference was not statistically significant. Furthermore, a higher percentage of CD19 + B cells was associated with the occurrence of irAEs of grade ≥ 3 ( P = 0.02) and grade ≥ 2 ( P = 0.051). In addition, patients with any grade of irAE had a significantly high PFS (8.37 vs. 3.77 months, hazard ratios (HR) = 2.02, P = 0.0038) and OS (24.77 vs. 13.83 months, HR = 1.84; P = 0.024).


          This retrospective study reports clinical profile data for irAEs in unselected patients in a real-world setting and explored some parameters that may be potential predictive markers of the occurrence, type, or grade of irAEs in clinical practice. Evidence of a correlation between safety and efficacy may facilitate a complete assessment of the risk-benefit ratio for patients treated with ICIs.

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              Index for rating diagnostic tests


                Author and article information

                Cancer Biol Med
                Cancer Biol Med
                Cancer Biology & Medicine
                Compuscript (Ireland )
                15 November 2021
                14 July 2021
                : 18
                : 4
                : 1118-1133
                [1 ]Cancer Center, the First Hospital of Jilin University, Changchun 130021, China
                Author notes
                Correspondence to: Jiuwei Cui, E-mail: cuijw@ 123456jlu.edu.cn
                Author information
                Copyright: © 2021, Cancer Biology & Medicine

                This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY) 4.0, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.

                : 20 January 2021
                : 07 April 2021
                Page count
                Figures: 2, Tables: 6, References: 51, Pages: 16
                Original Article

                neoplasm,immune checkpoint inhibitors,immune-related adverse events,predictor,efficacy


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