Association Between Drug-related Cutaneous Adverse Events and Progression Free Survival in Patients Treated with Enfortumab Vedotin

NCT ID: NCT06682845

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2024-06-30

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.

Conditions

Cutaneous Adverse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

EV patients

Adult patients who have received enfortumab vedotin treatment at the Centre Léon Bérard or Hôpital Lyon Sud, and who do not object to the collection of their data.

Collection of data in patients' medical files

Intervention Type: OTHER

• Demographic data
• Health data: body mass index, weight, tobacco consumption, history of hyperglycemia/ diabetes mellitus, Eastern Cooperative Oncology Group (ECOG) status, glomerular filtration rate, hemoglobin rate
• Cancer-related data: date of diagnosis, tumoral site, tumor histology type, histology grade, date of first metastases involvement, presence of visceral metastases, presence of liver metastases, presence of lymph node-only metastases
• Treatment-related data: previous line of treatment, co-treatment with anti-PD1, enfortumab vedotin (EV) treatment start date, EV treatment end date, EV posology, presence of EV reduction of dose or increased interval between perfusions, number of EV cycles
• Adverse events (AE)-related data: occurrence of cutaneous AE, grade of cutaneous AE, date of cutaneous AE, type of cutaneous AE, management of cutaneous AE, discontinuation of EV treatment, rechallenge of EV treatment
• Outcomes data: best overall response rate

Interventions

Collection of data in patients' medical files

• Demographic data
• Health data: body mass index, weight, tobacco consumption, history of hyperglycemia/ diabetes mellitus, Eastern Cooperative Oncology Group (ECOG) status, glomerular filtration rate, hemoglobin rate
• Cancer-related data: date of diagnosis, tumoral site, tumor histology type, histology grade, date of first metastases involvement, presence of visceral metastases, presence of liver metastases, presence of lymph node-only metastases
• Treatment-related data: previous line of treatment, co-treatment with anti-PD1, enfortumab vedotin (EV) treatment start date, EV treatment end date, EV posology, presence of EV reduction of dose or increased interval between perfusions, number of EV cycles
• Adverse events (AE)-related data: occurrence of cutaneous AE, grade of cutaneous AE, date of cutaneous AE, type of cutaneous AE, management of cutaneous AE, discontinuation of EV treatment, rechallenge of EV treatment
• Outcomes data: best overall response rate

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

-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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Lyon Sud, Hospices Civils de Lyon

Oullins, , France

Countries

France

Other Identifiers

69HCL24_0588

Identifier Type: -

Identifier Source: org_study_id