Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) according to the occurrence of cutaneous adverse events (AE)
研究概览
简要总结
Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) targeting nectin-4. In patients with metastatic urothelial carcinoma, EV in combination with pembrolizumab (anti-PD1) provides significantly better progression-free and global survival than platinum-based chemotherapies, with the benefit observed from the first line of treatment. However, EV is associated with a high frequency of cutaneous adverse events (AE), which may be due to physiological Nectin-4 expression in keratinocytes. These cutaneous toxicities include bullous/blistering toxicities and toxic epidermal necrolysis-like AE. While the association between cutaneous AE and survival has been demonstrated with anti-PD1, its association with survival in patient treated with ADC remains unknown. The objective of this retrospective dual-centric study is to determine whether there is an association between drug-related cutaneous AE and progression free survival in patients treated with EV.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients who have been treated with enfortumab vedotin at Hôpital Lyon Sud or Centre Léon Bérard and for whom follow-up data of at least 6 months are available are eligible for inclusion. To be included, patients must be willing and able to provide non-opposition consent for participation in this study and for the use of their medical data in this context.
排除标准
- •Any medical, social, or psychiatric condition that might impair the patient's capacity to provide informed consent to participate in the study and to the use of their medical data is considered an exclusion criterion
结局指标
主要结局
Progression-Free Survival (PFS) according to the occurrence of cutaneous adverse events (AE)
时间窗: From the start of EV treatment until disease progression or death, with data collected from 01/01/2015 to 02/05/2024.
Progression-Free Survival (PFS) is defined as the time from the start of EV treatment to the occurrence of disease progression or death from any cause, whichever occurs first. This measure will assess the impact of any grade cutaneous adverse events (AEs) on PFS.
次要结局
- Overall Survival (OS) according to the occurrence of cutaneous adverse events (AE)(From the start of EV treatment until death from any cause, with data collected from 01/01/2015 to 02/05/2024.)
- PFS/OS according to blistering toxicity(From the start of EV treatment until disease progression, death, or first occurrence of blistering toxicity, with data collected from 01/01/2015 to 02/05/2024.)
- PFS/OS according to cutaneous AE in patients co-treated with anti-PD1(From the start of combined EV and anti-PD1 treatment until disease progression or death, with data collected from 01/01/2015 to 02/05/2024.)
- Identification of predictive risk factors for cutaneous AE(Retrospective analysis of data from the treatment initiation until the last recorded follow-up, with data collected from 01/01/2015 to 02/05/2024.)