Abstract
Background/aim
Symptomatic adverse events during enfortumab vedotin plus pembrolizumab (EV+P) therapy may be incompletely documented in routine practice. This study evaluated whether structured symptom monitoring (SSM) using treatment-specific questionnaires was associated with more comprehensive documentation of symptomatic adverse events in patients with advanced or metastatic urothelial carcinoma.Patients and methods
This multicenter retrospective study included 34 consecutive patients with advanced or metastatic urothelial carcinoma who initiated EV+P between October 2024 and August 2025. Fourteen patients treated at Wakayama Medical University Hospital underwent SSM via two locally developed questionnaires, whereas 20 patients treated at affiliated hospitals received usual care without structured questionnaires. The primary endpoint was the number of documented symptomatic adverse event types per patient.Results
The median number of documented symptomatic adverse event types per patient was higher in the SSM group than in the non-SSM group (3 vs. 2; median difference: 2; 95% confidence interval: 1-3; pvs. 90.0%, p=0.50), grade ≥3 symptomatic adverse events (21.4% vs. 20.0%, p=1.00), and symptomatic adverse events leading to EV dose reduction (57.1% vs. 35.0%, p=0.29) were similar between groups. Subjective or lower-grade symptoms, including alopecia, dysgeusia, decreased appetite, and pruritus, were more commonly documented in the SSM group.Conclusion
SSM implemented at a single institution was associated with more comprehensive documentation of symptomatic adverse events during EV+P therapy compared with external institutional usual care, particularly subjective or lower-grade symptoms. Clinical benefit was not established, but treatment-specific symptom monitoring may provide a practical framework for more systematic toxicity assessment in routine EV+P care.