Abstract:
Background The application of immune checkpoint inhibitors (ICIs) is gradually increasing in advanced bile tract carcinoma (BTC), but only some patients have benefited from it. Immunosuppressants are not only costly, but also have risks of immune-related adverse reactions. Looking for effective predictors of immune efficacy can screen the benefiting group earlier.
Objective To explore the correlation between neutrophil-to-lymphocyte ratio (NLR) and the disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) of advanced BTC with ICIs.
Methods Totally 106 advanced BTC patients who received ICIs treatment for the first time from September 2015 to April 2021 in the First and Fifth Medical Center of Chinese PLA General Hospital were included in this study. The optimal cut-off value of NLR was obtained by ROC curve according to the disease control status. Patients were divided into high-level group and low-level group based on cut-off value of NLR. Kaplan-Meier was used for univariate analysis, and Cox for multivariate analysis.
Results The median age of the 106 enrolled advanced BTC patients was 59 years old, and 44 patients were female, and 62 patients were male. Compared to the NLR low level group, patients in the high level group had higher rate of disease progression (OR=4.365, 95% CI: 1.849-10.302, P=0.001). The median OS was 33.9 months in the NLR low level group, and 8.7 months in the high level group, and the median PFS was 10.7 months in the NLR low level group, and 4.6 months in the high level group, with significant difference (all P<0.05). The results of multivariate analysis showed that LDH was an effective predictor of OS and PFS.
Conclusion Baseline NLR are independent factors influencing the prognosis of advanced BTC immunotherapy. Advanced BTC patients with high level of baseline NLR may be difficult to benefit from ICIs.