Efficacy of Nivolumab in a Patient with Metastatic Renal Cell Carcinoma and End-Stage Renal Disease on Dialysis: Case Report and Literature Review

Abstract

Treatment of patients with metastatic renal cell carcinoma (mRCC) and end-stage renal disease (ESRD) on dialysis poses a therapeutic challenge, particularly as this patient group was excluded from the pivotal clinical trials. In addition, there is uncertainty regarding drug dosing/pharmacokinetics, lack of safety and efficacy data, and potential for increased toxicity when using targeted therapy or immunotherapy for the management of patients with mRCC on dialysis. Nivolumab, an anti-programmed death-1 immune checkpoint inhibitor antibody, is indicated for the treatment of patients with mRCC who have received prior antiangiogenic therapy. Given the above-mentioned uncertainties, clinicians may be reluctant to use nivolumab for this patient population, leading to potential denial of life-prolonging medications. We report the case of a 72-year-old gentleman with mRCC and ESRD on dialysis who received second-line nivolumab therapy and achieved an excellent symptomatic and radiological response, remaining progression-free for over 22 months. In addition, we have reviewed the pharmacokinetic data and published retrospective case studies to review the management options for patients with mRCC and ESRD on dialysis.

Safety and Efficacy of Immune Checkpoint Inhibitors in Patients on Dialysis: A Retrospective Case Series

“…3 Currently, there are few published cases of ICI use in patients receiving dialysis. [4][5][6][7] We aimed to characterize cancer response rates and the incidence of overall and severe (grade 3/4) irAEs in nonselected patients undergoing dialysis receiving ICIs at Partners Healthcare.…”

Monitoring antibody binding to T cells in a pembrolizumab‐treated patient with lung adenocarcinoma on hemodialysis

“…Few case reports have reported the successful administration of anti-PD-1 antibodies in cancer patients receiving HD. [11][12][13] Here, we present a patient on HD who achieved complete remission after one dose of the anti-PD-1 antibody pembrolizumab, without severe adverse events. Renal impairment reportedly has little effect on the pharmacokinetics of pembrolizumab.…”

Outcomes and Safety of Biweekly and Monthly Nivolumab in Patients with Metastatic Renal Cell Carcinoma and Dialysis: Three Case Reports and Literature Review

“…Current evidence about the efficacy and safety of nivolumab in met-astatic RCC patients on dialysis is very scarce, limited to three case reports ( Table 1). None of them suffered significant toxicities (grade 2-4), and two patients showed clinical benefit [6][7][8].…”

“…This is due to the exclusion of these patients from the pivotal clinical trials of these drugs. [6] Pharmacokinetic studies found that renal dysfunction did not affect nivolumab clearance, and the EMA (European Medicines Agency) does not recommend dose reductions for chronic kidney disease. As nivolumab is an immunoglobulin G4 with high molecular weight, it is very probably not cleared by dialysis [7].…”