Nivolumab, Pembrolizumab의 임상적 사용 적정성, 유효성 및 안전성 평가

Abstract

Background : Nivolumab (NV) and pembrolizumab (PB) are humanized IgG4 anti PD-1 monoclonal antibody that blocks the immune surveillance pathway and reactivates one’s immune system T-cell. The purpose of this study was to evaluate the adequacy of use in the real world, the efficacy of treatment, and the safety of adverse events. Methods : This study included those who received NV or PB at least once January 1, 2016, March 31, 2019. We excluded those unable to evaluate progressive disease (PD) or adverse events after NV or PB administration. Indications and prescribed doses were evaluated for use adequacy. We assessed the time to progression (TTP) as risk factors affecting the progressive disease (PD) and frequency of adverse events as safety evaluation. Results : Subjects were a total of 31 people, and 165 prescriptions were analyzed. The most common indications were non-small cell lung cancer (NSCLC), melanoma, hepatocellular carcinoma (HCC), and ovarian cancer. The fit rate of the indication was 100%. The average prescribed dose (%) 96.7±8.6% (72.5-108.1) of the approved dose, of which 22 (71%) were the optimal dose, seven were the low dose, and two were the overdose. Median TTP for efficacy evaluation was 84 days (46-136). Age, treatment group, and the prescribed doses were not significantly related to PD. The risk factors of developing PD were the appropriate dosage (%), no immune-related adverse events, and underlying disease. The presence of immune-related adverse events reduced the risk of PD by 0.078-fold (P<0.001). The appropriate dosage increased the risk of PD by 3.83-fold (p=0.018). Among the 230 cases, 18 cases (7.8%) of grade 3 and above adverse events were found. Among them, only one case was the immune-related adverse event. Conclusion : One TTP was outlier and required attention in interpretation. Immune-related adverse events significantly reducing the risk of PD requires further study.