Background  The survival benefit of immunotherapy in the treatment of urothelial carcinoma is inspiring, but there is still a lack of effective predictors for screening patients benefiting from immunotherapy.

  Objective  To explore the value of peripheral blood related indicators in predicting the efficacy and survival prognosis of anti-PD-1 therapy for patients with advanced UC, and provide practical experience for clinical application.

  Methods  Totally 46 patients with advanced UC who received first-line anti-PD-1 therapy from March 2017 to April 2020 in the Department of Oncology, the First Medical Center of Chinese PLA General Hospital were collected. The correlation between the peripheral blood related indicators at baseline and at 6 weeks after treatment and the efficacy of anti-PD-1 was statistically analyzed. The value of related indicators in predicting efficacy and prognosis was evaluated.

  Results  There were 32 males and 14 females, with a median age of 64 years. Of the 46 patients who received first-line anti-PD-1 therapy, the median PFS was 10.5 months (3 to 22 months). At 6 weeks after treatment, PFS of the high Hb group (15.0 months vs 6.6 months), the low neutrophil-to-lymphocyte ratio (NLR) group (not reach vs 6.6 months) and the low systemic immune-inflammation index (SII) group (15.0 mongths vs 6.6 months) were significantly prolonged (P＜0.05). Cox analysis showed that Hb, NLR and SII after 6 weeks of treatment were associated with the prognosis of patients (all P＜0.05). ROC analysis showed that the ROC-AUC (95% CI) of Hb, NLR and SII was 0.760 (0.570-0.943), 0.698 (0.435-0.958) and 0.666 (0.391-0.944), respectively, all of which had certain predictive value for patients receiving immunotherapy.

  Conclusion  Hb, NLR and SII at 6 weeks after treatment have predictive value for the efficacy and prognosis of immunotherapy in patients with advanced UC and may be biomarkers for the response of patients to first-line anti-PD-1 therapy.