Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin
- Conditions
- Cutaneous Adverse
- Registration Number
- NCT06682845
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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.
-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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) according to the occurrence of cutaneous adverse events (AE) 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.
- Secondary Outcome Measures
Name Time Method 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. Overall Survival (OS) is defined as the time from the start of EV treatment to death from any cause. This measure will assess the impact of any grade cutaneous adverse events (AEs) on OS.
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. This measure will assess PFS and OS in relation to the occurrence of blistering toxicity. Blistering toxicity is defined as a dermatosis with vesicular, bullous, and/or exfoliative lesions.
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. This measure will assess PFS and OS in relation to the occurrence of cutaneous adverse events in patients who are also receiving anti-PD1 treatment.
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. Identification of potential predictive risk factors associated with the occurrence of cutaneous adverse events (defined as any grade skin rash, excluding isolated pruritus).
Trial Locations
- Locations (1)
Hôpital Lyon Sud, Hospices Civils de Lyon
🇫🇷Oullins, France