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

Abstract

Nivolumab is a fully human immunoglobulin G4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody that selectively blocks the interaction between PD-1, which is expressed on activated T cells, and its ligands PD-L1 and PD-L2, which are expressed on immune cells and tumour cells. Patients with severe renal dysfunction and haemodialysis are not enrolled in clinical trials. However, in daily clinical practice, we have patients with metastatic renal cell carcinoma (mRCC) and end-stage renal disease (ESRD). The scientific evidence about the efficacy and safety of nivolumab in these patients is scarce. We report three cases of mRCC patients with ESRD treated with second-line nivolumab therapy. They received both biweekly and monthly schemes. None of our patients showed grade 2-4 toxicities. Two patients achieved partial response and one progressive disease as best response. Our patients did not show increased toxicity by ESRD; also, two of the three patients had objectifiable clinical benefit. Nivolumab seems to be similarly safe for ESRD or dialysis patients as for patients without impaired kidney function (IKF). Dose adjustments might not be necessary. We suggest that patients on dialysis could be treated with nivolumab in the same way as populations without IKF.

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.…”

Effect of rechallenge nivolumab in a hemodialysis patient with multiple metastases from a rapidly progressed T1a renal clear cell carcinoma: An autopsy case

“…A clinical study investigating its safety and efficacy in metastatic patients with RCC and ESRD reported that progression free survival, OS, and the frequency of irAEs were not significantly different between the ESRD and non‐ESRD groups. 7 Five cases of nivolumab use in patients undergoing HD have been reported 4 , 8 , 9 , 10 showing good efficacy. During nivolumab treatment, the patient's disease no longer progressed for 24 months.…”

Nephrotoxicity of combination drug therapy in metastatic renal cancer

“…На настоящий момент однозначно сложно делать выводы о прогнозе для пациентов с терминальной стадией ХБП на фоне иммунотерапии злокачественного новообразования. Необходимо проводить дальнейшие исследования в данной группе для получения более репрезентативных выборок и оценки прогноза в зависимости от гистологического типа опухоли [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37].…”