Longer Control of Nivolumab in Metastatic Renal Cell Carcinoma Patients with End-Stage Kidney Disease on Dialysis

Abstract

Introduction: Nivolumab has been introduced for metastatic renal cell carcinoma (mRCC) as a second-line therapy for years. However, despite widespread evidence of its utility, few reports have described the efficacy of nivolumab for mRCC patients on hemodialysis. Case Presentation: A 68-year-old man with a 20-year history of dialysis due to chronic glomerulotubular nephritis was referred to our department for bilateral renal tumors in 2015. In February 2015, contrast-enhanced CT revealed findings suggestive of RCC, so we performed right nephrectomy. The pathological diagnosis was clear cell carcinoma and papillary renal cell carcinoma. In July 2015, we consequently performed left nephrectomy, and the pathological diagnosis was metastatic RCC. In February 2016, because follow-up CT revealed a right adrenal tumor with time-dependent growth, sunitinib (25 mg/body) was introduced. In January 2017, although sunitinib had controlled the adrenal metastasis for 9 courses (11 months), liver metastasis was observed, so nivolumab was introduced as a second-line chemotherapy in March 2017. Nivolumab was able to control the mRCC for 15 months (32 courses). While CT showed no metastatic sites except for the liver and adrenal glands, his general condition gradually decreased, and he died in October 2018. Conclusion: We herein report a patient with RCC on hemodialysis with long-term cancer control by nivolumab.

Safe administration of ipilimumab plus nivolumab to a dialysis patient with renal cell carcinoma

“…Previous case reports have recommended no dose adjustments of ipilimumab and nivolumab for mRCC in dialysis-dependent patients. [7][8][9][10][11][12] In our case, the patient was able to complete four cycles of ipilimumab plus nivolumab, with neither dose adjustment nor major adverse events (e.g. irAE).…”

“…Because of the lack of efficacy or tolerability data, oncologists might be reluctant to use ICIs in dialysis patients. Previous case reports have recommended no dose adjustments of ipilimumab and nivolumab for mRCC in dialysis‐dependent patients 7–12 . In our case, the patient was able to complete four cycles of ipilimumab plus nivolumab, with neither dose adjustment nor major adverse events (e.g.…”

“…Additionally, a thorough search of ClinicalTrials.gov revealed no planned, ongoing, or completed trials investigating the safety and efficacy of ipilimumab or nivolumab in patients with renal impairment or those undergoing dialysis. There are some case reports suggesting the safety and efficiency of monotherapy with either ipilimumab or nivolumab in dialysis patients 7–12 . In a study by Cheun et al , for instance, 10 of 13 dialysis patients responded to ICIs 10 .…”

“…There are some case reports suggesting the safety and efficiency of monotherapy with either ipilimumab or nivolumab in dialysis patients. [7][8][9][10][11][12] In a study by Cheun et al, for instance, 10 of 13 dialysis patients responded to ICIs. 10 However, to the best of our knowledge, there are no case reports of nivolumab plus ipilimumab combined immunotherapy in dialysis patients with mRCC.…”

“…5,6 This uncertainty over drug dosing/pharmacokinetics and the lack of efficacy and safety data could potentially lead to medication denial or undertreatment in mRCC patients receiving dialysis. While there are several case reports suggesting the efficacy and safety of monotherapy with either ipilimumab or nivolumab in dialysis patients [7][8][9][10][11][12] to the best of our knowledge, no case of combination therapy with ipilimumab and nivolumab has been reported yet.…”