Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan;
Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Anticancer Res. 2023 Sep;43(9):4055-4060. doi: 10.21873/anticanres.16594.
BACKGROUND/AIM: This study retrospectively investigated the impact of enfortumab vedotin (EV) monotherapy on the oncological outcome, safety profile, and health-related quality of life (HRQoL) in patients with metastatic urothelial carcinoma.
We assessed 26 consecutive patients who had received EV monotherapy after failure of platinum-based chemotherapy and immune checkpoint blockade therapy at our single institution from December 2021 to January 2023. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), incidence of adverse events (AEs), and EORTC QLQ-C30 as an HRQoL instrument were evaluated.
The ORR and DCR were 57.7% and 80.8%, respectively. EV was effective regardless of the patient and tumor characteristics, including the efficacy of previous systemic therapy, performance status, number of Bellmunt risk factors, and presence of variant histology. With a median follow-up time of 7.5 months, the median durations of PFS and OS were 5.4 months and 10.3 months, respectively. Grade ≥3 AEs included neutropenia (15.4%), fatigue (7.7%), appetite loss (7.7%), rash (3.8%), febrile neutropenia (3.8%), hyperglycemia (3.8%), and interstitial pneumonia (3.8%). AEs resulting in withdrawal of EV, interruption of EV, and dose reduction occurred in two (7.7%), nine (34.6%), and 13 patients (50.0%), respectively. The EORTC QLQ-C30 scores from baseline to post-EV introduction remained stable.
EV monotherapy demonstrated promising anti-tumor activity and tolerability in patients with metastatic urothelial carcinoma.
背景/目的：本研究回顾性调查了依伏替尼（EV）单药治疗在铂类化疗和免疫检查点抑制剂治疗失败后转移性尿路上皮癌患者的肿瘤学结局、安全性概况和健康相关生活质量（HRQoL）。
我们评估了 2021 年 12 月至 2023 年 1 月在我们的单机构接受 EV 单药治疗的 26 例连续患者。评估了客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）、不良反应（AE）发生率和 EORTC QLQ-C30 作为 HRQoL 工具。
ORR 和 DCR 分别为 57.7%和 80.8%。EV 的疗效与患者和肿瘤特征无关，包括既往全身治疗的疗效、表现状态、Bellmunt 风险因素的数量以及变异组织学的存在。中位随访时间为 7.5 个月，中位 PFS 和 OS 分别为 5.4 个月和 10.3 个月。≥3 级 AE 包括中性粒细胞减少症（15.4%）、疲劳（7.7%）、食欲减退（7.7%）、皮疹（3.8%）、发热性中性粒细胞减少症（3.8%）、高血糖症（3.8%）和间质性肺炎（3.8%）。由于 EV，EV 停药、中断和剂量减少的 AE 分别发生在 2 例（7.7%）、9 例（34.6%）和 13 例（50.0%）。EORTC QLQ-C30 评分从基线到 EV 引入后保持稳定。
EV 单药治疗在转移性尿路上皮癌患者中表现出有希望的抗肿瘤活性和耐受性。
