Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis

A retrospective Italian survey

Cristina Masini, Roberto Sabbatini, Camillo Porta, Giuseppe Procopio, Giuseppe Di Lorenzo, Azzurra Onofri, Sebastiano Buti, Roberto Iacovelli, Roberta Invernizzi, Luca Moscetti, Maria Giuseppina Aste, Maria Pagano, Federica Grosso, Anna Lucia Manenti, Cinzia Ortega, Laura Cosmai, Cinzia Del Giovane, Pier Franco Conte

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Sunitinib and sorafenib are orally administered multikinase inhibitors approved for the treatment of advanced RCC. The limited pharmacokinetics data on sunitinib and sorafenib suggest that haemodialysis does not significantly alter plasma concentrations. In this retrospective study we define the safety and efficacy of tyrosine kinase inhibitors in patients with metastatic RCC (mRCC) and end-stage renal disease requiring haemodialysis. Even though the retrospective nature of this survey and the relatively small sample size represent major limitations, these data indicate that treatment with sunitinib and sorafenib in this cohort of patients is feasible with no unexpected toxicity and good efficacy, results similar to those in the general population of patients with mRCC. Objective To investigate the safety and efficacy of tyrosine kinase inhibitors (TKIs) in patients with metastatic renal cell carcinoma (mRCC) and end-stage renal disease requiring haemodialysis (HD). Patients and methods Between July 2006 and December 2010, 24 patients undergoing HD were treated with sunitinib and/or sorafenib for mRCC in 14 Italian institutions. We retrospectively reviewed the medical records of these patients to evaluate the administered doses of TKIs, treatment-related toxicities and the clinical response to therapy. Results Sunitinib was administered at 50 mg daily for 4-6 weeks in six patients, 37.5 mg daily for 4-6 weeks in seven patients (one patient subsequently increased the dose to 50 mg daily), 25 mg daily for 4-6 weeks in two patients and 12.5 mg daily for 4-6 weeks in one patient. Among the eight patients treated with sorafenib, four patients received 800 mg daily (400 mg every 12 h), three patients 400 mg daily and one patient 200 mg daily with a continuous schedule. The estimated median progression-free and overall survival periods of this cohort of patients were 10.3 months and 22.6 months, respectively. With regard to tolerability and safety, no unexpected adverse events were registered and no grade 4 haematological or non-haematological toxicities were reported. Conclusions Sunitinib and sorafenib treatment is not contraindicated in patients with mRCC undergoing HD. The outcome of this patient population is similar to that observed in patients with normal renal function treated with TKIs. These results merit further confirmation by a larger prospective trial.

Original languageEnglish
Pages (from-to)692-698
Number of pages7
JournalBJU International
Volume110
Issue number5
DOIs
Publication statusPublished - Sep 2012

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Kidney Neoplasms
Protein-Tyrosine Kinases
Renal Dialysis
Surveys and Questionnaires
Safety
Chronic Kidney Failure
Therapeutics

Keywords

  • haemodialysis
  • renal cell carcinoma
  • tyrosine kinase inhibitors

ASJC Scopus subject areas

  • Urology

Cite this

Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis : A retrospective Italian survey. / Masini, Cristina; Sabbatini, Roberto; Porta, Camillo; Procopio, Giuseppe; Di Lorenzo, Giuseppe; Onofri, Azzurra; Buti, Sebastiano; Iacovelli, Roberto; Invernizzi, Roberta; Moscetti, Luca; Aste, Maria Giuseppina; Pagano, Maria; Grosso, Federica; Lucia Manenti, Anna; Ortega, Cinzia; Cosmai, Laura; Del Giovane, Cinzia; Conte, Pier Franco.

In: BJU International, Vol. 110, No. 5, 09.2012, p. 692-698.

Research output: Contribution to journalArticle

Masini, C, Sabbatini, R, Porta, C, Procopio, G, Di Lorenzo, G, Onofri, A, Buti, S, Iacovelli, R, Invernizzi, R, Moscetti, L, Aste, MG, Pagano, M, Grosso, F, Lucia Manenti, A, Ortega, C, Cosmai, L, Del Giovane, C & Conte, PF 2012, 'Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis: A retrospective Italian survey', BJU International, vol. 110, no. 5, pp. 692-698. https://doi.org/10.1111/j.1464-410X.2012.10946.x
Masini, Cristina ; Sabbatini, Roberto ; Porta, Camillo ; Procopio, Giuseppe ; Di Lorenzo, Giuseppe ; Onofri, Azzurra ; Buti, Sebastiano ; Iacovelli, Roberto ; Invernizzi, Roberta ; Moscetti, Luca ; Aste, Maria Giuseppina ; Pagano, Maria ; Grosso, Federica ; Lucia Manenti, Anna ; Ortega, Cinzia ; Cosmai, Laura ; Del Giovane, Cinzia ; Conte, Pier Franco. / Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis : A retrospective Italian survey. In: BJU International. 2012 ; Vol. 110, No. 5. pp. 692-698.
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abstract = "Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Sunitinib and sorafenib are orally administered multikinase inhibitors approved for the treatment of advanced RCC. The limited pharmacokinetics data on sunitinib and sorafenib suggest that haemodialysis does not significantly alter plasma concentrations. In this retrospective study we define the safety and efficacy of tyrosine kinase inhibitors in patients with metastatic RCC (mRCC) and end-stage renal disease requiring haemodialysis. Even though the retrospective nature of this survey and the relatively small sample size represent major limitations, these data indicate that treatment with sunitinib and sorafenib in this cohort of patients is feasible with no unexpected toxicity and good efficacy, results similar to those in the general population of patients with mRCC. Objective To investigate the safety and efficacy of tyrosine kinase inhibitors (TKIs) in patients with metastatic renal cell carcinoma (mRCC) and end-stage renal disease requiring haemodialysis (HD). Patients and methods Between July 2006 and December 2010, 24 patients undergoing HD were treated with sunitinib and/or sorafenib for mRCC in 14 Italian institutions. We retrospectively reviewed the medical records of these patients to evaluate the administered doses of TKIs, treatment-related toxicities and the clinical response to therapy. Results Sunitinib was administered at 50 mg daily for 4-6 weeks in six patients, 37.5 mg daily for 4-6 weeks in seven patients (one patient subsequently increased the dose to 50 mg daily), 25 mg daily for 4-6 weeks in two patients and 12.5 mg daily for 4-6 weeks in one patient. Among the eight patients treated with sorafenib, four patients received 800 mg daily (400 mg every 12 h), three patients 400 mg daily and one patient 200 mg daily with a continuous schedule. The estimated median progression-free and overall survival periods of this cohort of patients were 10.3 months and 22.6 months, respectively. With regard to tolerability and safety, no unexpected adverse events were registered and no grade 4 haematological or non-haematological toxicities were reported. Conclusions Sunitinib and sorafenib treatment is not contraindicated in patients with mRCC undergoing HD. The outcome of this patient population is similar to that observed in patients with normal renal function treated with TKIs. These results merit further confirmation by a larger prospective trial.",
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T1 - Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis

T2 - A retrospective Italian survey

AU - Masini, Cristina

AU - Sabbatini, Roberto

AU - Porta, Camillo

AU - Procopio, Giuseppe

AU - Di Lorenzo, Giuseppe

AU - Onofri, Azzurra

AU - Buti, Sebastiano

AU - Iacovelli, Roberto

AU - Invernizzi, Roberta

AU - Moscetti, Luca

AU - Aste, Maria Giuseppina

AU - Pagano, Maria

AU - Grosso, Federica

AU - Lucia Manenti, Anna

AU - Ortega, Cinzia

AU - Cosmai, Laura

AU - Del Giovane, Cinzia

AU - Conte, Pier Franco

PY - 2012/9

Y1 - 2012/9

N2 - Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Sunitinib and sorafenib are orally administered multikinase inhibitors approved for the treatment of advanced RCC. The limited pharmacokinetics data on sunitinib and sorafenib suggest that haemodialysis does not significantly alter plasma concentrations. In this retrospective study we define the safety and efficacy of tyrosine kinase inhibitors in patients with metastatic RCC (mRCC) and end-stage renal disease requiring haemodialysis. Even though the retrospective nature of this survey and the relatively small sample size represent major limitations, these data indicate that treatment with sunitinib and sorafenib in this cohort of patients is feasible with no unexpected toxicity and good efficacy, results similar to those in the general population of patients with mRCC. Objective To investigate the safety and efficacy of tyrosine kinase inhibitors (TKIs) in patients with metastatic renal cell carcinoma (mRCC) and end-stage renal disease requiring haemodialysis (HD). Patients and methods Between July 2006 and December 2010, 24 patients undergoing HD were treated with sunitinib and/or sorafenib for mRCC in 14 Italian institutions. We retrospectively reviewed the medical records of these patients to evaluate the administered doses of TKIs, treatment-related toxicities and the clinical response to therapy. Results Sunitinib was administered at 50 mg daily for 4-6 weeks in six patients, 37.5 mg daily for 4-6 weeks in seven patients (one patient subsequently increased the dose to 50 mg daily), 25 mg daily for 4-6 weeks in two patients and 12.5 mg daily for 4-6 weeks in one patient. Among the eight patients treated with sorafenib, four patients received 800 mg daily (400 mg every 12 h), three patients 400 mg daily and one patient 200 mg daily with a continuous schedule. The estimated median progression-free and overall survival periods of this cohort of patients were 10.3 months and 22.6 months, respectively. With regard to tolerability and safety, no unexpected adverse events were registered and no grade 4 haematological or non-haematological toxicities were reported. Conclusions Sunitinib and sorafenib treatment is not contraindicated in patients with mRCC undergoing HD. The outcome of this patient population is similar to that observed in patients with normal renal function treated with TKIs. These results merit further confirmation by a larger prospective trial.

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KW - haemodialysis

KW - renal cell carcinoma

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