Clinical Observation Of Skin-related Adverse Events Induced By Anti-PD-1 Antibody BGB-A317 In Patients With Solid Tumor

Background and PurposeAnti-PD-1 monoclonal antibodies can block the binding of PD-1 and PD-L1,enhance the anti-tumor effect of human T cells,and have a significant effect in a variety of advanced cancers.However,at the same time,it may also cause damage to the body’s own immune function.When it involves normal tissues and organs,it displays an autoimmune-like inflammatory response,called ir AEs.The most common is skin AE.Although most cases are mild and manageable,some are still serious and sometimes life-threatening.Therefore,this study aims to explore the clinical characteristics of skin AEs and their relationship with PFS during anti-PD-1 antibody immunotherapy,so as to avoid the risk of medication and ensure the treatment effect of patients.Diagnose,treat and prevent adverse reactions.MethodsCollect clinical data of patients receiving anti-PD-1 antibody BGB-A317 at the Cancer Hospital Affiliated to Harbin Medical University from 2017 to 2020,and observe the incidence and clinical of skin toxicity during anti-PD-1 monoclonal antibody BGB-A317 immunotherapy Features;To explore the relationship between skin toxicity and patient prognosis during anti-PD-1 antibody immunotherapy.Statistical analysis was performed using SPSS 22.0 software,and general information was calculated using the rate.Theχ~2test was used to compare the correlation between gender,age,ECOG score,and adverse skin reactions.Logistic regression was used to analyze the correlation between skin toxicity and other toxicity.KM was used.Curve analysis of skin,the difference was statistically significant with P<0.05.ResultsAs of January 10,2020,statistics have collected 53 cases of anti-PD-1monoclonal antibody BGB-A317 in the treatment of advanced solid tumors,including30 cases of hepatocellular carcinoma,1 case of urothelial carcinoma,and 4 cases of esophageal squamous cell carcinoma,2 cases of lung adenocarcinoma,1 case of gastric adenocarcinoma,2 cases of colon cancer,1 case of ovarian cancer,1 case of nasopharyngeal carcinoma,9 cases of renal cell carcinoma,1 case of melanoma and 1case of tonsil cancer.Observed adverse reactions:skin AE incidence rate of 20.8%,fatigue 17.0%,nausea 13.2%,diarrhea 11.3%,loss of appetite 5.7%,thyroid toxicity5.7%,eosinophilia 5.7%,Hepatotoxicity was 3.8%,nephrotoxicity was 3.8%,blood glucose increased by 1.9%,and immunopneumonia was 1.9%.Three skin AEs were observed:rash(macular papules or eczema)(n=7,13.2%),vitiligo(n=1,1.9%),and isolated itching(n=3,5.7%).The comparison between the groups showed that there was no significant correlation between gender,age,ECOG score and the occurrence of adverse skin reactions.The results of multivariate regression analysis suggest that hypothyroidism and nephrotoxicity are associated with adverse skin reactions.The results of survival analysis showed that patients with adverse skin reactions had a significantly better progression-free survival than patients without adverse skin reactions,and the results were significantly different.ConclusionsAdverse events related to immunotherapy of anti-PD-1 monoclonal antibody BGB-A317 are mainly low-grade and easy to manage.The incidence of skin toxicity is 20.8%,mainly manifested as rash,itching and vitiligo;thyroid toxicity,nephrotoxicity and Adverse skin reactions are related,so attention should be paid to monitoring thyroid function and creatinine levels when adverse skin reactions occur.The results of survival analysis indicate that patients with adverse skin reactions have a longer progression-free survival period than patients without adverse skin reactions,so adverse skin reactions may be a predictor of the efficacy of anti-PD-1 antibodies.