Retrospective analysis of immune-related adverse events of the immune checkpoint inhibitors of PD-1/PD-l1 in the Fujian provincial hospital

Introduction: The effectiveness of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) on tumor has been reported. However, the immune-related adverse events (irAEs) and its clinical management of the immune checkpoint inhibitors (ICIs) have not been fully understood. We aimed to analyze the irAEs and its ICIs targeting the PD-1/PD-L1. Methods: The retrospective analysis was performed on the irAEs of cancer patients treated with anti-PD1/PD-L1 monoclonal antibodies from January 2020 to August 2021 including 240 patients/547 cycles. The following aspects including the categories and the grades of the adverse events (AEs), the time of onset and duration, management plan, and prognosis were evaluated. Results: Among 240 patients, 93 patients (38.75%) experienced irAEs, and 10 patients (4.16%) had AEs that involved multiple organ systems at the same time. There were 83 cases (34.58%) of grade 1-2 AEs and 10 cases (4.17%) of grade three and above AEs. AEs above grade three included five cases of grade three AEs (3 cases of hepatic toxicity, one case of colitis, and one case of skin toxicity), three cases of grade four AEs (pneumonia); and 2 cases of grade five AEs (two deaths due to pneumonia). The complete remission of AEs was achieved in 10 patients by corticosteroid impulse therapy, maintenance therapy, and symptomatic therapy. Among them, six cases continued to use anti-PD1/PD-L1 monoclonal antibodies, two cases stopped, and two patients died from systemic multi-organ failure due to the delayed observation of autoimmune pneumonia. IrAEs occurred at different times and durations in different systems or organs. Conclusion: The safety of PD-1/PD-L1 inhibitors was approved in clinical applications. The prevalence of grade three and above AEs is relatively low. Timely diagnosis and early glucocorticoid therapies are adequate and effective approaches for the management of irAEs.