Abstract: Background and purpose: Single-agent chemotherapy shows limited efficacy in second-line treatment for advanced urothelial cancer patients, and significantly reduces the quality of life (QoL) of patients. Hence, ideal therapy that may prolong overall survival and improve Health-related QoL (HRQoL) of advanced urothelial cancer patients is essential. Tislelizumab, a programmed death-1 (PD-1) monoclonal antibody, has been approved for the treatment of locally advanced or metastatic urothelial cancer in China. Here, we investigate and analysis HRQoL data of tislelizumab and single agent chemotherapy treatment as second line systemic therapy in advanced urothelial cancer patients. Method: The "Tumor Immunotherapy Progress and Practice Improvement Project" database was used to include previously treated advanced urothelial cancer patients receiving tislelizumab or single-agent chemotherapy treatment. Key prespecified HRQoL analyses were and mean change from baseline 2 months and 4 months after therapy and time to deterioration (TTD) in EORTC QLQ-C30 global health status/QoL score. Results: 207 patients previously treated with platinum-based chemotherapy for advanced urothelial cancer were included in HRQoL analyses (tislelizumab, n=102; single-agent chemotherapy, n=105). The results showed that mean change from baseline to month 2 in global health status/quality-of-life score was 4.69 with tislelizumab and -8.05 with chemotherapy (t=-2.199, P=0.030). Mean change from baseline to month 4 in global health status/quality-of-life score was 14.58 with tislelizumab and -8.97 with chemotherapy (t=-3.538, P<0.001). TTD in global health status/quality-of-life score is better in tislelizumab group than chemotherapy group (χ ² =7.214, P=0.007). Conclusion: The results of this analysis suggest that tislelizumab improved HRQol compared with single-agent chemotherapy in second-line treatment for advanced urothelial cancer. The limitations of the analysis design include potential bias due to few time points for QoL data collection and limited case included. Thus, it will be necessary to increase cases number and follow-up frequency in our future work to obtain more solid results.

Key words: Advanced urothelial cancer, Health-related quality of life, Tislelizumab, The real world data