恩福妥单抗 Vedotin 用于老年晚期尿路上皮癌患者或体能状态不佳者。

Enfortumab Vedotin for Elderly Advanced Urothelial Carcinoma Patients or Those With a Poor Performance Status.

机构信息

Department of Urology, NHO Kyushu Cancer Center, Fukuoka, Japan;

Department of Urology, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.

出版信息

Anticancer Res. 2024 Aug;44(8):3409-3417. doi: 10.21873/anticanres.17161.

DOI:10.21873/anticanres.17161

PMID:39060060

Abstract

BACKGROUND/AIM: The efficacy, safety, and liver toxicity of enfortumab vedotin (EV) for elderly advanced urothelial carcinoma (UC) patients and patients with a poor performance status (PS) are unclear.

PATIENTS AND METHODS

We retrospectively analyzed the efficacy, safety, and liver toxicity of EV in elderly patients and patients with a poor PS between December 2021 and August 2023.

RESULTS

Sixty-two patients (≥75 years old, n=22; PS≥2, n=10) were enrolled. Patients with PS≥2 had significantly lower albumin levels than those with PS<2 (p=0.023). The objective response and disease control rates did not differ significantly between patients <75 and ≥75 years old (p=0.598 and p=0.769, respectively) or between those with PS<2 and PS≥2 (p>0.99 and p=0.178, respectively). Progression-free survival (PFS) and overall survival (OS) were not significantly different in patients <75 years and ≥75 years (p=0984, 0.368). A significant difference in PFS (p=0.047) but not OS (p=0.086) was observed between the PS<2 and PS≥2 groups. The rates of any-grade and severe (grade ≥3) adverse events did not differ significantly between patients <75 and ≥75 years (p=0.471, p=0.136) or between PS<2 and PS≥2 groups (p>0.99, 0.99). Aspartate aminotransferase (AST) levels significantly increased, but alanine aminotransferase levels did not, following EV treatment (p<0.001). Multivariate analyses revealed that the albumin level was an independent prognostic factor (hazard ratio=0.159; p<0.001).

CONCLUSION

EV demonstrated similar efficacy and safety in elderly and younger patients with advanced UC. In patients with a poor PS, although the safety was similar, survival was significantly worse in terms of PFS, while the AST levels were significantly elevated.

摘要

背景/目的：对于老年晚期尿路上皮癌（UC）患者和体能状态（PS）较差的患者，恩福妥单抗（EV）的疗效、安全性和肝毒性尚不清楚。

方法

我们回顾性分析了 2021 年 12 月至 2023 年 8 月期间 EV 在老年患者和 PS 较差患者中的疗效、安全性和肝毒性。

结果

共纳入 62 例患者（≥75 岁，n=22；PS≥2，n=10）。PS≥2 的患者白蛋白水平明显低于 PS<2 的患者（p=0.023）。PS<2 和 PS≥2 的患者之间，客观缓解率和疾病控制率差异无统计学意义（p=0.598 和 p=0.769）。<75 岁和≥75 岁的患者之间（p=0.984，0.368）以及 PS<2 和 PS≥2 的患者之间（p>0.99，p=0.178）的无进展生存期（PFS）和总生存期（OS）无显著差异。PFS（p=0.047）而非 OS（p=0.086）在 PS<2 和 PS≥2 两组之间存在显著差异。<75 岁和≥75 岁的患者之间（p=0.471，p=0.136）或 PS<2 和 PS≥2 两组之间（p>0.99，p=0.99），任何级别和严重（≥3 级）不良事件的发生率无显著差异。EV 治疗后，天冬氨酸氨基转移酶（AST）水平显著升高，但丙氨酸氨基转移酶（ALT）水平无显著升高（p<0.001）。多因素分析显示，白蛋白水平是独立的预后因素（风险比=0.159；p<0.001）。