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Background <p>To describe real-world data on health-related quality of life (HRQoL) in patients with locally advanced or metastatic urothelial carcinoma receiving late-line&#xa0;enfortumab vedotin (EV) monotherapy.</p> Methods <p>This study included 19 previously treated locally advanced or metastatic urothelial carcinoma patients who received late-line EV monotherapy. Time-course changes in the domains and subscales of the EORTC QLQ-C30, Functional Assessment of Cancer Therapy–General, multi-item short form-8, Pittsburgh Sleep Quality Index (PSQI), and chemotherapy-induced taste alteration scale (CiTAS) questionnaires during EV monotherapy up to 10 cycles were evaluated using linear mixed effects models for repeated measures.</p> Results <p>Generally, a negative effect on physical function-related domains was observed during EV monotherapy. In the analysis of the EORTC-QLQ-C30 global health status/QoL subscale, three (16%), nine (47%), and seven (37%) patients experienced clinically meaningful improvement, stability, and clinically meaningful deterioration during EV monotherapy, respectively, and Kaplan–Meier estimation demonstrated that the median number of cycles to deterioration was six. The global PSQI score showed marginally normalized sleep quality, with gradual decrease in population of patients with poor sleep quality (global PSQI score, ≥ 6). After the initiation of EV monotherapy, dysgeusia with worsening subscales in the decline in basic taste and general taste alterations occurred early in the first to fourth cycles. In contrast, the appetite loss score on the EORTC QLQ-C30 questionnaire did not change during EV monotherapy.</p> Conclusion <p>Late-line EV monotherapy showed a generally acceptable negative impact on HRQoL. Effective interventions are needed to maintain physical functioning and gustatory abilities in patients receiving EV monotherapy.</p>

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Longitudinal assessment of health-related quality of life, sleep quality, and gustation in patients with advanced urothelial carcinoma receiving late-line enfortumab vedotin monotherapy

  • 期刊论文

  • 发表日期：

    2025年12月28日

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  • Makito Miyake,
  • Nobutaka Nishimura,
  • Yuki Oda,
  • Takuto Shimizu,
  • Takuya Owari,
  • Kota Iida,
  • Yasushi Nakai,
  • Nobumichi Tanaka,
  • Kiyohide Fujimoto

摘要

Background

To describe real-world data on health-related quality of life (HRQoL) in patients with locally advanced or metastatic urothelial carcinoma receiving late-line enfortumab vedotin (EV) monotherapy.

Methods

This study included 19 previously treated locally advanced or metastatic urothelial carcinoma patients who received late-line EV monotherapy. Time-course changes in the domains and subscales of the EORTC QLQ-C30, Functional Assessment of Cancer Therapy–General, multi-item short form-8, Pittsburgh Sleep Quality Index (PSQI), and chemotherapy-induced taste alteration scale (CiTAS) questionnaires during EV monotherapy up to 10 cycles were evaluated using linear mixed effects models for repeated measures.

Results

Generally, a negative effect on physical function-related domains was observed during EV monotherapy. In the analysis of the EORTC-QLQ-C30 global health status/QoL subscale, three (16%), nine (47%), and seven (37%) patients experienced clinically meaningful improvement, stability, and clinically meaningful deterioration during EV monotherapy, respectively, and Kaplan–Meier estimation demonstrated that the median number of cycles to deterioration was six. The global PSQI score showed marginally normalized sleep quality, with gradual decrease in population of patients with poor sleep quality (global PSQI score, ≥ 6). After the initiation of EV monotherapy, dysgeusia with worsening subscales in the decline in basic taste and general taste alterations occurred early in the first to fourth cycles. In contrast, the appetite loss score on the EORTC QLQ-C30 questionnaire did not change during EV monotherapy.

Conclusion

Late-line EV monotherapy showed a generally acceptable negative impact on HRQoL. Effective interventions are needed to maintain physical functioning and gustatory abilities in patients receiving EV monotherapy.