晚期尿路上皮癌二线系统治疗方案的生命质量真实世界数据分析：替雷利珠单抗单药对比二线化疗

卞晓洁; 沈益君; 朱一平; 马春光; 顾成元; 叶定伟

doi:10.19401/j.cnki.1007-3639.2020.10.011

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晚期尿路上皮癌二线系统治疗方案的生命质量真实世界数据分析：替雷利珠单抗单药对比二线化疗

更新时间：2026-01-27

- 晚期尿路上皮癌二线系统治疗方案的生命质量真实世界数据分析：替雷利珠单抗单药对比二线化疗
- Health-related quality of life study of tislelizumab versus single-agent chemotherapy in second-line treatment for advanced urothelial cancer in real-world clinical practice
- 中国癌症杂志 2020年30卷第10期页码：798-805
- 作者机构：
  
  复旦大学附属肿瘤医院泌尿外科，复旦大学上海医学院肿瘤学系,上海,200032
- 作者简介：
- 基金信息：
  
  国家自然科学基金（81872099）;国家自然科学基金（81772706）。
- DOI：10.19401/j.cnki.1007-3639.2020.10.011
  中图分类号：
- 网络出版：2020-10-15，
  
  纸质出版：2020-10-15
- 稿件说明：
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卞晓洁, 沈益君, 朱一平, 马春光, 顾成元, 叶定伟. 晚期尿路上皮癌二线系统治疗方案的生命质量真实世界数据分析：替雷利珠单抗单药对比二线化疗[J]. 中国癌症杂志, 2020, 30(10): 798-805.

BIAN xiaojie, SHEN yijun, ZHU yiping, et al. Health-related quality of life study of tislelizumab versus single-agent chemotherapy in second-line treatment for advanced urothelial cancer in real-world clinical practice[J]. China Oncology, 2020, 30(10): 798-805.
卞晓洁, 沈益君, 朱一平, 马春光, 顾成元, 叶定伟. 晚期尿路上皮癌二线系统治疗方案的生命质量真实世界数据分析：替雷利珠单抗单药对比二线化疗[J]. 中国癌症杂志, 2020, 30(10): 798-805. DOI： 10.19401/j.cnki.1007-3639.2020.10.011.

BIAN xiaojie, SHEN yijun, ZHU yiping, et al. Health-related quality of life study of tislelizumab versus single-agent chemotherapy in second-line treatment for advanced urothelial cancer in real-world clinical practice[J]. China Oncology, 2020, 30(10): 798-805. DOI： 10.19401/j.cnki.1007-3639.2020.10.011.

摘要

背景与目的：二线化疗单药在晚期尿路上皮癌（urothelial cancer）患者中的治疗疗效不佳，并且接受治疗的患者生命质量也较差。因此一个能够具有良好疗效并且提升患者生命质量的治疗方法对晚期尿路上皮癌患者十分重要。程序性死亡［蛋白］-1（programmed death-1，PD-1）单抗药物替雷利珠单抗已获批用于治疗局部晚期或转移性尿路上皮癌。本项研究探索分析了真实世界中，替雷利珠单抗单药与化疗单药治疗方案分别在二线治疗晚期尿路上皮癌患者中的健康相关生命质量（health-related quality of life，HRQoL）数据。方法：利用“肿瘤免疫治疗进展与实践提升项目”数据库，纳入接受替雷利珠单抗治疗或化疗单药治疗的晚期经治尿路上皮癌患者。预先指定的关键HRQoL分析是治疗后第2个月和第4个月较基线的平均变化值以及EORTC QLQ-C30量表中总体健康状况/生命质量（quality of life，QoL）评分的恶化时间。结果：分析纳入了207例既往接受过一线含铂类药物治疗的晚期尿路上皮癌患者，其中替雷利珠单抗单药二线治疗组102例，化疗单药二线治疗组105例。研究结果显示，与基线相比，替雷利珠单抗组患者治疗后第2个月的总体健康状况/QoL评分的平均变化值为4.69，化疗单药组为-8.05，两组之间差异有统计学意义（t=-2.199，P=0.030）；替雷利珠单抗组患者治疗后第4个月的整体健康状况/QoL评分的平均变化值为14.58，化疗单药组为-8.97，两组之间同样差异有明显的统计学意义（t=-3.538，P0.001）。并且，替雷利珠单抗组患者总体健康状况/QoL评分的TTD优于化疗单药组（χ

=7.214，P=0.007）。结论：本次分析表明，在晚期尿路上皮癌的二线治疗方案中替雷利珠单抗较化疗单药可提高患者的HRQol。但因本次调研收集Qol量表所设计的时间节点少，收集到的案例数少，分析结果可能存在偏倚风险，所以仍需进一步增加观察例数和随访频率，以获得更坚实的数据结果。

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

P0.001). TTD in global health status/quality-of-life score is better in tislelizumab group than chemotherapy group (χ

=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.

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