In comparison to chemotherapy, enfortumab vedotin (EV) prolonged overall survival in patients with previously treated advanced urothelial carcinoma in EV-301. The objective of the present study was to assess patient experiences of EV versus chemotherapy using patient-reported outcome (PRO) analysis of health-related quality of life (HRQoL). For patients in the phase 3 EV-301 trial randomized to EV or chemotherapy we assessed responses to the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, weekly for the first 12 wk, and then every 12 wk until discontinuation. We analyzed the QLQ-C30 change from baseline to week 12, the confirmed improvement rate, and the time to improvement or deterioration. Baseline PRO compliance rates were 91% for the EV arm ( = 301) and 89% for the chemotherapy arm ( = 307); the corresponding average rates from baseline to week 12 were 70% and 67%. Patients receiving EV versus chemotherapy had reduced pain (difference in change from baseline to week 12: −5.7, 95% confidence interval [CI] −10.8 to −0.7; = 0.027) and worsening appetite loss (7.3, 95% CI 0.90–13.69; = 0.026). Larger proportions of patients in the EV arm reported HRQoL improvement from baseline than in the chemotherapy arm; the odds of a confirmed improvement across ten QLQ-C30 function/symptom scales were 1.67 to 2.76 times higher for EV than for chemotherapy. Patients in the EV arm had a shorter time to first confirmed improvement in global health status (GHS)/QoL, fatigue, pain, and physical, role, emotional, and social functioning (all 0.05). EV delayed the time to first confirmed deterioration in GHS/QoL ( = 0.027), but worsening appetite loss occurred earlier ( = 0.009) in comparison to chemotherapy. HRQoL with EV was maintained, and deterioration in HRQoL was delayed with EV in comparison to chemotherapy. Better results with EV were reported for some scales, with the greatest difference observed for pain. These findings reinforce the EV safety and efficacy outcomes and benefits observed in EV-301. Patients with previously treated advanced cancer of the urinary tract receiving the drug enfortumab vedotin maintained their HRQoL in comparison to patients treated with chemotherapy.

中文翻译：

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既往接受 EV-301 治疗的晚期尿路上皮癌患者的健康相关生活质量：Enfortumab Vedotin 与化疗的 3 期试验

与化疗相比，enfortumab vedotin (EV) 延长了 EV-301 中既往接受过治疗的晚期尿路上皮癌患者的总生存期。本研究的目的是使用健康相关生活质量 (HRQoL) 的患者报告结果 (PRO) 分析来评估 EV 与化疗的患者体验。对于 3 期 EV-301 试验中随机接受 EV 或化疗的患者，我们在基线时评估了对经过验证的欧洲癌症研究和治疗组织生活质量问卷核心 30 (QLQ-C30) 的反应，前 12 周每周一次，然后每 12 周一次，直至停药。我们分析了 QLQ-C30 从基线到第 12 周的变化、确认的改善率以及改善或恶化的时间。 EV 组的基线 PRO 依从率为 91% (= 301)，化疗组的基线 PRO 依从率为 89% (= 307)；从基线到第 12 周的相应平均比率分别为 70% 和 67%。与化疗相比，接受 EV 的患者疼痛减轻（从基线到第 12 周的变化差异：-5.7，95% 置信区间 [CI] -10.8 至 -0.7；= 0.027），食欲减退恶化（7.3，95% CI 0.90–13.69） ; = 0.026)。 EV 组中报告 HRQoL 较基线有所改善的患者比例高于化疗组； EV 的 10 个 QLQ-C30 功能/症状量表确认改善的几率比化疗高 1.67 至 2.76 倍。 EV 组患者首次确认整体健康状况 (GHS)/QoL、疲劳、疼痛以及身体、角色、情绪和社会功能改善的时间较短（均为 0.05）。与化疗相比，EV 延迟了首次确认 GHS/QoL 恶化的时间 (= 0.027)，但食欲减退恶化发生得更早 (= 0.009)。与化疗相比，EV 维持了 HRQoL，并且 EV 延迟了 HRQoL 的恶化。据报告，EV 在某些量表上取得了更好的结果，其中在疼痛方面观察到的差异最大。这些发现强化了 EV-301 中观察到的 EV 安全性和有效性结果以及益处。与接受化疗的患者相比，既往接受过药物 enfortumab vedotin 治疗的晚期泌尿道癌症患者的 HRQoL 保持不变。