Successful sunitinib treatment of metastatic renal cell carcinoma in a patient with end stage renal disease on hemodialysis

Park, Chi Young

doi:10.1097/cad.0b013e32832fffc7

Cited by 8 publications

(5 citation statements)

References 6 publications

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“…There are currently few published data available on the use of TKIs in patients receiving HD (Table 4[19,25–32,38–44]). Owing to the very limited number of cases reported in the literature, it is impossible to make any definitive conclusions regarding the tolerability and efficacy of TKIs in patients with mRCC receiving HD.…”

Section: Discussionmentioning

confidence: 99%

Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis: a retrospective Italian survey

et al. 2012

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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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Section: Discussionmentioning

confidence: 99%

Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis: a retrospective Italian survey

et al. 2012

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“…Our findings are similar to those of recently published case reports. In the cases of a single patient [12] and two separate patients [13] with mRCC treated with sunitinib on haemodialysis, Park [12] administered sunitinib at a dose of 50 mg/day for 4 weeks out of every 6 weeks and Zastrow et al . [13] administered escalating doses of sunitinib with one patient reaching 37.5 mg/day and the other receiving 50 mg/day.…”

Section: Discussionmentioning

confidence: 99%

“…As a result, knowledge regarding the effect of sunitinib in patients with renal impairment is limited. Case reports have shown the feasibility of using sunitinib in patients with severe renal impairment [11] (defined as an eGFR < 30 mL/min/1.73 m 2 [4]) or on haemodialysis [12,13] but the pharmacokinetic data for sunitinib in patients on haemodialysis is inconsistent. Izzedine et al .…”

Section: Introductionmentioning

confidence: 99%

Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with severe renal impairment or on haemodialysis

et al. 2011

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Study Type – Therapy (case series) Level of Evidence 4 What’s known on the subject? and What does the study add? Sunitinib is approved for the first‐ and second‐line treatment of advanced renal cell carcinoma (RCC). Chronic kidney disease is commonly seen in patients with RCC, but knowledge regarding the effect of sunitinib in patients with severe renal impairment or on haemodialysis is limited. In this study we define the toxicity profile and clinical outcomes of a patient cohort with RCC with severe renal impairment, or on haemodialysis who were treated with sunitinib. This retrospective study suggests that these patients can be safely treated with sunitinib at the standard dose, and the observed efficacy of therapy is similar to that reported in patients with normal renal function. OBJECTIVE To further investigate the effect of sunitinib, which is currently a standard of care for the treatment of metastatic renal cell carcinoma (mRCC), in patients with severe renal impairment or those undergoing dialysis. PATIENTS AND METHODS Clinical databases were used to identify all patients with mRCC treated with sunitinib in seven institutions internationally. Databases were searched to identify only those patients with an estimated glomerular filtration rate of <30 mL/min/1.73 m2 or those who had end‐stage renal disease requiring dialysis. Baseline characteristics, adverse event data, response and progression‐free survival were recorded. RESULTS Nineteen patients met the inclusion criteria, 10 of whom were undergoing haemodialysis. Of the nine non‐dialysis‐dependent patients at drug initiation, the median estimated glomerular filtration rate was 27 mL/min/1.73 m2 (range 23–29). Baseline characteristics included a median age of 61 years (range 44–77); 17 patients had a Karnofsky performance status of >80; eight patients had more than two metastatic sites and 17 had undergone prior nephrectomy. The estimated median progression‐free survival of this cohort was 43 weeks (range 7 to 158+) and progression has not yet been reached in six patients. Partial response or stable disease was observed as best response in 15 patients. The most common treatment‐related adverse events included fatigue, diarrhoea, hand–foot skin reaction (HFSR), nausea and vomiting and rash. Grade three treatment‐related adverse events including fatigue (seven patients), HFSR (two patients), diarrhoea (one patient), rash (one patient) and stomatitis (one patient) occurred in a total of 12 patients. Only one patient experienced a grade four adverse event (HFSR). Only diarrhoea (P = 0.0002), HFSR (P < 0.0001) and neutropenia (P = 0.001) were more common in patients undergoing haemodialysis compared with non‐dialysis‐dependent patients. Four of the non‐dialysis dependent patients started at a dose of 50 mg compared with three of the patients undergoing haemodialysis. However five and two of the patients undergoing haemodialysis started at doses of 37.5 mg and 25 mg daily, respectively, compared with four and one of the non‐dialysis‐dependent patients. All p...

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“…Such data is required to optimize our current treatment strategies in specific patients population [24]. Prospective expanded access clinical trials, with pharmacokinetic st udies, in a larger cohort of patients is required [10,27].…”

Section: Future Perspectivementioning

confidence: 99%

“…future science group www.futuremedicine.comDiscussion• • TKI treatment efficacy in hemodialyzed patientsA sizeable number of RCC patients with RCC have renal impairment have been reported in prior publications. Until today total number of 61 patients with renal insufficiency treated with hemodialysis and sunitinib (Table3) and 29 with sorafenib (Table4) until now [9,[20][21][22][23][24][25][26][27][28]. We report on additional eight patients treated with TKI and HD.…”

mentioning

confidence: 99%

Feasibility, Efficacy and Safety of Tyrosine Kinase Inhibitor Treatment in Hemodialyzed Patients with Renal Cell Cancer: 10 Years of Experience

et al. 2015

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Our report supports statement that TKI treatment of dialyzed patients is safe and effective. ccRCC increases risk of developing renal insufficiency as well as end-stage renal disease that require dialysis. Introduction of multitargeted receptor kinase inhibitors (TKIs), including sunitinib, sorafenib and pazopanib significantly expanded life time expectancy of metastatic renal clear cell carcinoma. The advance also applies to patients with ccRCC and end-stage renal disease who undergo dialyses.

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Successful sunitinib treatment of metastatic renal cell carcinoma in a patient with end stage renal disease on hemodialysis

Cited by 8 publications

References 6 publications

Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis: a retrospective Italian survey

Use of tyrosine kinase inhibitors in patients with metastatic kidney cancer receiving haemodialysis: a retrospective Italian survey

Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with severe renal impairment or on haemodialysis

Feasibility, Efficacy and Safety of Tyrosine Kinase Inhibitor Treatment in Hemodialyzed Patients with Renal Cell Cancer: 10 Years of Experience

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