Multicenter retrospective observational study of the effectiveness of enfortumab vedotin for metastatic urothelial carcinoma in the real-world setting
This repository contains the R code used for analyzing the effectiveness of enfortumab vedotin (EV) in patients with treatment-resistant advanced urothelial cancer in a real-world setting. The study is based on data from a multicenter observational study of 103 evaluable patients.
The main objectives of this study were to:
- Explore the characteristics of patients with advanced urothelial cancer treated with EV.
- Assess the effectiveness of EV in terms of radiographic response, progression-free survival (PFS), and overall survival (OS).
- Evaluate the treatment-related adverse events (trAEs) associated with EV.
- Patients: 103 evaluable patients with advanced urothelial cancer who received EV.
- Outcomes: Assessed by radiographic response, PFS, and OS, with trAEs evaluated.
- Assessment Tools: Radiographic response was assessed using Response Evaluation Criteria in Solid Tumors version 1.1, while trAEs were studied in line with Common Terminology Criteria for Adverse Events version 5.0.
- Median follow-up: 8.9 months.
- Objective response rate: 50.5%.
- Median PFS: 6.0 months (95% CI: 4.7–9.8).
- Median OS: 14.5 months (95% CI: 12.4–not reached).
- trAEs: 26 patients (25.2%) reported 49 trAEs, with 9 (18.3%) being grade 3 or higher.
The study demonstrates that EV shows robust anti-tumor activity and has a manageable safety profile in the treatment of previously treated advanced urothelial cancer outside the clinical trial setting.
The study has been published in the journal International Journal of Urology and is available at the following link: https://onlinelibrary.wiley.com/doi/abs/10.1111/iju.15368.