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 language | English |
|---|---|
| Pages (from-to) | 692-698 |
| Number of pages | 7 |
| Journal | BJU International |
| Volume | 110 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Sep 2012 |
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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 journal › Article
}
TY - JOUR
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.
AB - 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.
KW - haemodialysis
KW - renal cell carcinoma
KW - tyrosine kinase inhibitors
UR - http://www.scopus.com/inward/record.url?scp=84865331376&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84865331376&partnerID=8YFLogxK
U2 - 10.1111/j.1464-410X.2012.10946.x
DO - 10.1111/j.1464-410X.2012.10946.x
M3 - Article
C2 - 22364110
AN - SCOPUS:84865331376
VL - 110
SP - 692
EP - 698
JO - BJU International
JF - BJU International
SN - 1464-4096
IS - 5
ER -