Objective  To investigate the correlation between therapeutic effects and changes in serum TNF-α levels in patients with advanced non-small cell lung cancer before and after anti-PD-1 treatment.

  Methods  Thirty-three patients with advanced non-small cell lung cancer receiving anti-PD-1 therapy in our department from December 2016 to May 2018 were included in this study and divided into two groups according to the efficacy of immunotherapy. The correlation between therapeutic effects and changes in serum TNF-α level were assessed using univariate and multivariate analysis. The predictive value of changes in serum TNF-α level for the response to anti-PD-1 therapy was analyzed by ROC curve.

  Results  The levels of TNF-α before the immunotherapy in the disease control group (n=23) and the progressive disease group (n=10) were 60.7 (41.7, 70.8) pg/ml and 60.2 (46.7, 117.4) pg/ml, respectively (P > 0.05). After 2 cycles of treatment, the levels of TNF-α and the change rate of TNF-α in the disease control group were significantly higher than those in the progressive disease group TNF-α level, 80.1(58.7, 108.5) pg/ml vs 57.6(49.8, 62.8) pg/ml; change rate of TNF-α, 33.3% (9.2%, 91.2%) vs-0.1% (-5.6%, 22.6%); P < 0.05, respectively; The change rate of TNF-α was an independent predictive factor of response to anti-PD-1 therapy (OR, 2.584, P=0.045). The ROC curve showed that TNF-α change rate predictied the efficacy of anti-PD-1 therapy with AUC (95% CI) of 0.804 (0.651-0.975), and the change rate of 29.5% as the cut-off to predict the efficacy of disease control with sensitivity of 70.9% and specificity of 80.0%.

  Conclusion  The change rate of TNF-α in patients with advanced non-small cell lung cancer is associated with outcomes of immunotherapy, which can be served as a predictive factor for response to anti-PD-1 therapy.