Abstract：
OBJECTIVE: 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.
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).
CONCLUSIONS: 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.
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).
CONCLUSIONS: 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：
目的：疗效，安全,enfortumabvedotin（EV）对老年晚期尿路上皮癌（UC）患者和表现状态差（PS）的患者的肝毒性尚不清楚。
方法：我们回顾性分析疗效，安全,2021年12月至2023年8月，老年患者和PS较差患者的EV肝毒性。
结果：62例患者（≥75岁，n=22；PS≥2，n=10）。PS≥2的患者的白蛋白水平明显低于PS<2的患者（p=0.023）。在<75岁和≥75岁的患者之间（分别为p=0.598和p=0.769）或PS<2和PS≥2的患者之间（分别为p>0.99和p=0.178）的客观反应和疾病控制率没有显着差异。<75岁和≥75岁患者的无进展生存期（PFS）和总生存期（OS）没有显着差异（p=0984，0.368）。在PS<2和PS≥2组之间观察到PFS（p=0.047）而非OS（p=0.086）的显着差异。任何级别和严重（≥3级）不良事件的发生率在<75岁和≥75岁的患者之间（p=0.471，p=0.136）或PS<2和PS≥2组之间（p>0.99，0.99）没有显着差异。天冬氨酸转氨酶(AST)水平显著升高,但丙氨酸转氨酶水平没有,EV治疗后（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）。
结论：EV在老年和年轻晚期UC患者中表现出相似的疗效和安全性。在PS较差的患者中，虽然安全性相似，生存率在PFS方面明显更差，而AST水平显著升高。
方法：我们回顾性分析疗效，安全,2021年12月至2023年8月，老年患者和PS较差患者的EV肝毒性。
结果：62例患者（≥75岁，n=22；PS≥2，n=10）。PS≥2的患者的白蛋白水平明显低于PS<2的患者（p=0.023）。在<75岁和≥75岁的患者之间（分别为p=0.598和p=0.769）或PS<2和PS≥2的患者之间（分别为p>0.99和p=0.178）的客观反应和疾病控制率没有显着差异。<75岁和≥75岁患者的无进展生存期（PFS）和总生存期（OS）没有显着差异（p=0984，0.368）。在PS<2和PS≥2组之间观察到PFS（p=0.047）而非OS（p=0.086）的显着差异。任何级别和严重（≥3级）不良事件的发生率在<75岁和≥75岁的患者之间（p=0.471，p=0.136）或PS<2和PS≥2组之间（p>0.99，0.99）没有显着差异。天冬氨酸转氨酶(AST)水平显著升高,但丙氨酸转氨酶水平没有,EV治疗后（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）。
结论：EV在老年和年轻晚期UC患者中表现出相似的疗效和安全性。在PS较差的患者中，虽然安全性相似，生存率在PFS方面明显更差，而AST水平显著升高。
