Safety and efficacy of enfortumab vedotin and pembrolizumab in two hemodialysis patients with metastatic urothelial carcinoma: A case series

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 two hemodialysis patients with metastatic urothelial carcinoma treated with EV-P. 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 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. These cases suggest that EV-P may be a treatment option for selected hemodialysis patients with metastatic urothelial carcinoma.