Safety and Efficacy of Enfortumab Vedotin and Pembrolizumab in 2 Hemodialysis Patients with Metastatic Urothelial Carcinoma: A Case Series.

INTRODUCTION: Enfortumab vedotin plus pembrolizumab (EV-P) is a new first-line treatment for metastatic urothelial carcinoma; however, its safety and efficacy in patients undergoing maintenance hemodialysis remain unclear because such patients were excluded from pivotal clinical trials. We report 2 hemodialysis patients with metastatic urothelial carcinoma treated with EV-P. CASE PRESENTATION: The first patient was a 78-year-old man with bladder cancer who developed pulmonary metastases. Because he also had a history of primary lung adenocarcinoma, computed tomography-guided biopsy was performed and confirmed metastatic urothelial carcinoma. EV-P was initiated on non-dialysis days. Grade 1 skin toxicity developed and required topical corticosteroid treatment and stepwise dose reduction of enfortumab vedotin. After three cycles, computed tomography showed a partial response, which was maintained after seven cycles and remained durable for 11 months after treatment initiation, even after treatment discontinuation. The second patient was a 62-year-old man with right upper tract urothelial carcinoma who developed multiple liver metastases and peritoneal dissemination after robot-assisted right nephroureterectomy. EV-P was initiated on non-dialysis days. After three cycles, computed tomography showed shrinkage of the liver metastases and peritoneal lesions, consistent with a partial response. At the latest follow-up, he had completed nine cycles, and the response was maintained without severe adverse events. CONCLUSION: These cases suggest that EV-P may be a treatment option for selected hemodialysis patients with metastatic urothelial carcinoma.