Structured Symptom Monitoring During Enfortumab Vedotin Plus Pembrolizumab for Advanced or Metastatic Urothelial Carcinoma: Multicenter Retrospective Study.
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.
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.
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; p<0.01). In contrast, the rates of any documented symptomatic adverse events (100.0% vs. 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.
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.
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.
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; p<0.01). In contrast, the rates of any documented symptomatic adverse events (100.0% vs. 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.
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.
Authors
Wakamiya Wakamiya, Iwagami Iwagami, Enyo Enyo, Shibano Shibano, Nabeshima Nabeshima, Deguchi Deguchi, Kuwata Kuwata, Wada Wada, Yamashita Yamashita, Kohjimoto Kohjimoto
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