Retrospective Analysis on Safety and Efficacy of Everolimus in Treatment of Metastatic Renal Cancer Patients Receiving Dialysis

Guida, Annalisa; Masini, Cristina; Milella, Michèle; Lorenzo, Giuseppe Di; Santoni, Matteo; Prati, Veronica; Porta, Camillo; Cosmai, Laura; Donati, D.; Giovane, Cinzia Del; Mighali, Pasquale; Sabbatini, Roberto

doi:10.2217/fon.15.256

Cited by 10 publications

(4 citation statements)

References 26 publications

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“…Grade 3 AEs occurred in ten cases, and no grade 4 AEs were observed. The estimated median PFS and OS of 9.0 and 15.7 months, respectively, reported by Guida et al in RCC patients on dialysis receiving everolimus [ 73 ], are in line with those reported in the phase III everolimus RECORD-1 study [ 74 ]. Therefore, mTORis seem to be an effective and safe treatment option for patients with mRCC and severe renal impairment requiring dialysis.…”

Section: Renal Toxicities Of Mtoris Therapysupporting

confidence: 83%

Renal toxicity of targeted therapies for renal cell carcinoma in patients with normal and impaired kidney function

Mielczarek

Brodziak

Sobczuk

et al. 2021

Cancer Chemother Pharmacol

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The introduction of novel targeted therapies during the last 2 decades has led to a significant improvement in patients' clinical outcomes with renal cell carcinoma. However, this improvement came at the price of a whole new spectrum of adverse events, including renal toxicity. Systemic treatment of patients with kidney neoplasms who often present with impairment of kidney function, even prior to treatment, poses an increasing diagnostic and therapeutic challenge for clinicians. Common lifestyle-related comorbidities, i.e., hypertension and diabetes, may contribute to further impairment of kidney function. The lack of official guidelines and the exclusion of patients with reduced kidney function from the clinical trials of recently approved drugs complicate the issue even further. Early detection and correct management of renal toxic effects are crucial to preserve kidney function and ensure the optimal administration of life-prolonging therapies. This review presents detailed information on the renal toxicities of three groups of drugs commonly used in renal cell carcinoma treatment: tyrosine kinase inhibitors, mammalian target of rapamycin inhibitors, and immune checkpoint inhibitors. We outline the incidence and underlying mechanisms of renal adverse effects with a focus on patients on renal replacement therapy, as well as present suggestions for their management.

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Section: Renal Toxicities Of Mtoris Therapysupporting

confidence: 83%

Renal toxicity of targeted therapies for renal cell carcinoma in patients with normal and impaired kidney function

Mielczarek

Brodziak

Sobczuk

et al. 2021

Cancer Chemother Pharmacol

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“…There have been few reports describing TKI or immune-check point inhibitor treatment [8, 9, 10]. While the ideal dose of TKI for end-stage kidney disease has not been established, in most cases, some degree of dose reduction is applied.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

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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.

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“…With regard to VEGFR TKIs and mTOR inhibitors, there is some evidence to suggest that mRCC patients on dialysis treated with these agents have similar outcomes in terms of both efficacy and safety, compared to mRCC patients with normal or minimally impaired kidney function [ 7 – 10 ]. On the contrary, some reports have shown a higher incidence of adverse events with VEGFR TKIs in mRCC patients on dialysis despite initiation of therapy at reduced doses [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

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

Ansari

Ali

Farrag

et al. 2018

Case Reports in Immunology

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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.

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Retrospective Analysis on Safety and Efficacy of Everolimus in Treatment of Metastatic Renal Cancer Patients Receiving Dialysis

Abstract: Everolimus appears to be safe in mRCC patients with renal impairment or end-stage renal disease requiring dialysis. Larger prospective studies are required to confirm these findings.

Cited by 10 publications

References 26 publications

Renal toxicity of targeted therapies for renal cell carcinoma in patients with normal and impaired kidney function

Renal toxicity of targeted therapies for renal cell carcinoma in patients with normal and impaired kidney function

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

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

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