OBJECTIVE: To investigate the clinical application status and adverse drug reactions of nivolumab

a newly marketed programmed death-1（PD-1） inhibitor in China. METHODS: Hospital information system was used to retrieve the data of application of navulliumab in the day chemotherapy center of Sun Yat-Sen University Cancer Center from Jul. 2018 to Jun. 2019

and the medical records and relevant test data were consulted to analyze the patients’ basic information

medication orders

combined treatment regimens and adverse drug reactions. RESULTS: A total of 179 patients were treated with nivolumab for 480 case-times

most of the patients were male（109 patients

60. 89%）;the age was ranged from 40 to < 70 years（133 cases

74. 30%）. The main diseases were respectively lung cancer（58 cases

32. 40%）

liver cancer（40 cases

22. 35%）

cervical cancer（16 cases

8. 94%） and ovarian cancer（15 cases

8. 38%）. A total of 203 case-times of adverse drug reactions（42. 29% of the total number of case-times）were collected

mainly manifested as bone marrow toxicity

thyroid dysfunction and liver injury. The incidence of hemoglobin reduction

leukopenia

neutropenia

thrombocytopenia

elevated thyrotropin levels and elevated alanine aminotransferase levels were higher. There were 21 case-times of grade 3 to 4 adverse drug reactions（4. 38% of the total number of case-times）

mainly for hemoglobin reduction. CONCLUSIONS: Nivolumab has made a breakthrough in the field of tumor treatment

yet it is still in the early stage of immunotherapy. There are many instructions for the off-label drug use in clinical practice

is necessary to explore the best combined treatment method and control the related adverse drug reactions.