Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.
University of Chicago, Chicago, IL.
J Clin Oncol. 2024 Apr 20;42(12):1403-1414. doi: 10.1200/JCO.23.01547. Epub 2024 Jan 12.
Locally advanced/metastatic urothelial cancer (la/mUC) affects patients' quality of life (QOL) and functioning. We describe the impact of first-line (1L) enfortumab vedotin (EV) alone or with pembrolizumab (P) on QOL/functioning/symptoms in patients with la/mUC who were cisplatin-ineligible from EV-103 Cohort K.
In this phase Ib/II trial, patients were randomly assigned 1:1 to EV + P or EV monotherapy (mono). Exploratory patient-reported outcomes (PROs) were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30) and Brief Pain Inventory Short Form (BPI-SF) at baseline, once per week for cycles 1-3, and then in every cycle through the end of treatment. Changes in scores from baseline to week 24, reported as least squares mean (standard error), were assessed by mixed models for repeated measures. There were no formal statistical comparisons between treatment arms.
Of 149 patients treated, 65 (EV + P) and 63 (EV mono) comprised the PRO analysis set. For EV + P, EORTC QLQ-C30 QOL was maintained through week 24 with improvements in emotional functioning, pain, and insomnia. Clinically meaningful improvements were seen in EORTC QLQ-C30 pain after EV + P at weeks 12 (-14.41 [3.14]) and 24 (-14.99 [3.56]) and BPI-SF worst pain at week 24 (-2.07 [0.37]). For EV mono, EORTC QLQ-C30 QOL remained stable with clinically meaningful improvements in EORTC QLQ-C30 pain (-12.55 [4.27]), insomnia (-14.46 [4.69]), and constipation (-10.09 [4.35]) at week 24. There were small-to-moderate improvements in BPI-SF worst pain at week 24.
EV + P in patients with la/mUC who were cisplatin-ineligible was associated with preservation or improvement of QOL/functioning/symptoms. Improvement in pain was seen in both PRO instruments and treatment arms. These data complement clinical outcomes of 1L EV + P.
局部晚期/转移性尿路上皮癌（la/mUC）影响患者的生活质量（QOL）和功能。我们描述了一线（1L）依伏替尼（EV）联合或不联合派姆单抗（P）治疗不能使用顺铂的 EV-103 队列 K 患者的 QOL/功能/症状的影响。
在这项 Ib/II 期试验中，患者按 1:1 随机分配至 EV + P 或 EV 单药（单药）组。使用欧洲癌症研究与治疗组织生存质量问卷核心问卷（EORTC QLQ-C30）和简明疼痛量表（BPI-SF），在基线时、第 1-3 周期每周评估一次，然后在每个周期直至治疗结束时进行探索性患者报告结局（PRO）。通过重复测量混合模型评估从基线到 24 周的评分变化，报告为最小二乘均数（标准误差）。未对治疗组进行正式的统计学比较。
在接受治疗的 149 例患者中，65 例（EV + P）和 63 例（EV 单药）纳入 PRO 分析集。对于 EV + P，EORTC QLQ-C30 生活质量在 24 周内保持稳定，情绪功能、疼痛和失眠得到改善。在 EV + P 治疗后第 12 周（-14.41 [3.14]）和第 24 周（-14.99 [3.56]），EORTC QLQ-C30 疼痛和第 24 周 BPI-SF 最差疼痛（-2.07 [0.37]）观察到具有临床意义的改善。对于 EV 单药，EORTC QLQ-C30 生活质量保持稳定，EORTC QLQ-C30 疼痛（-12.55 [4.27]）、失眠（-14.46 [4.69]）和便秘（-10.09 [4.35]）在第 24 周时具有临床意义的改善。在第 24 周时，BPI-SF 最差疼痛也有较小到中等程度的改善。
对于不能使用顺铂的 la/mUC 患者，EV + P 联合治疗与 QOL/功能/症状的保持或改善相关。两种 PRO 工具和治疗组均观察到疼痛的改善。这些数据补充了 1L EV + P 的临床结果。
