Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with renal insufficiency

Ki Hyang Kim, Ho Young Kim, Hye Ryun Kim, Jong Mu Sun, Ho Yeong Lim, Hyo Jin Lee, Suee Lee, Woo Kyun Bae, Sun Young Rha

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13 Citations (Scopus)

Abstract

Background Patients with metastatic renal cell carcinoma (mRCC) with renal insufficiency are generally excluded from clinical trials, despite their increasing numbers. Thus, we evaluated the efficacy and toxicity of sunitinib in such patients. Patients and methods Korean patients with mRCC with renal insufficiency who had received sunitinib as first-line treatment between January 2008 and May 2012 were included. Patient characteristics, clinical outcomes and toxicities were evaluated. Overall survival (OS) and progression-free survival (PFS) were determined according to the degree of renal impairment. Results The median age of the 34 patients evaluated was 66 years, 90% had an Eastern Cooperative Oncology Group performance status of 0 or 1 and the median glomerular filtration rate was 46.5 mL min-1·1.73 m -2 (range, 21.1-59.5). The starting sunitinib dose was 37.5 and 50 mg for 12 and 22 patients, respectively. A 4-weeks-on-2-weeks-off regimen was followed for 31 patients; a 2-weeks-on-2-weeks-off regimen, for one patient; and a daily regimen, for two patients. The best response was partial response in eight patients and stable disease in 12. Median OS and PFS times were 26.3 months (95% confidence interval [CI]: 17.1-35.3) and 12.2 months (95% CI: 10.2-13.2), respectively. Common non-haematologic adverse events (AEs) were stomatitis, rash, general oedema and fatigue. The most common AEs of ≥grade 3 severity were fatigue, neutropenia and thrombocytopenia. Conclusions In patients with mRCC with renal insufficiency, sunitinib was efficacious and did not cause increased toxicity. Thus, clinicians should not hesitate to treat patients with mRCC with renal insufficiency with sunitinib.

Original languageEnglish
Pages (from-to)746-752
Number of pages7
JournalEuropean Journal of Cancer
Volume50
Issue number4
DOIs
Publication statusPublished - 2014 Mar 1

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Renal Cell Carcinoma
Renal Insufficiency
sunitinib
Disease-Free Survival
Fatigue
Confidence Intervals
Stomatitis
Survival
Exanthema
Neutropenia
Glomerular Filtration Rate
Thrombocytopenia
Edema
Clinical Trials
Kidney

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Kim, Ki Hyang ; Kim, Ho Young ; Kim, Hye Ryun ; Sun, Jong Mu ; Lim, Ho Yeong ; Lee, Hyo Jin ; Lee, Suee ; Bae, Woo Kyun ; Rha, Sun Young. / Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with renal insufficiency. In: European Journal of Cancer. 2014 ; Vol. 50, No. 4. pp. 746-752.
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abstract = "Background Patients with metastatic renal cell carcinoma (mRCC) with renal insufficiency are generally excluded from clinical trials, despite their increasing numbers. Thus, we evaluated the efficacy and toxicity of sunitinib in such patients. Patients and methods Korean patients with mRCC with renal insufficiency who had received sunitinib as first-line treatment between January 2008 and May 2012 were included. Patient characteristics, clinical outcomes and toxicities were evaluated. Overall survival (OS) and progression-free survival (PFS) were determined according to the degree of renal impairment. Results The median age of the 34 patients evaluated was 66 years, 90{\%} had an Eastern Cooperative Oncology Group performance status of 0 or 1 and the median glomerular filtration rate was 46.5 mL min-1·1.73 m -2 (range, 21.1-59.5). The starting sunitinib dose was 37.5 and 50 mg for 12 and 22 patients, respectively. A 4-weeks-on-2-weeks-off regimen was followed for 31 patients; a 2-weeks-on-2-weeks-off regimen, for one patient; and a daily regimen, for two patients. The best response was partial response in eight patients and stable disease in 12. Median OS and PFS times were 26.3 months (95{\%} confidence interval [CI]: 17.1-35.3) and 12.2 months (95{\%} CI: 10.2-13.2), respectively. Common non-haematologic adverse events (AEs) were stomatitis, rash, general oedema and fatigue. The most common AEs of ≥grade 3 severity were fatigue, neutropenia and thrombocytopenia. Conclusions In patients with mRCC with renal insufficiency, sunitinib was efficacious and did not cause increased toxicity. Thus, clinicians should not hesitate to treat patients with mRCC with renal insufficiency with sunitinib.",
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Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with renal insufficiency. / Kim, Ki Hyang; Kim, Ho Young; Kim, Hye Ryun; Sun, Jong Mu; Lim, Ho Yeong; Lee, Hyo Jin; Lee, Suee; Bae, Woo Kyun; Rha, Sun Young.

In: European Journal of Cancer, Vol. 50, No. 4, 01.03.2014, p. 746-752.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with renal insufficiency

AU - Kim, Ki Hyang

AU - Kim, Ho Young

AU - Kim, Hye Ryun

AU - Sun, Jong Mu

AU - Lim, Ho Yeong

AU - Lee, Hyo Jin

AU - Lee, Suee

AU - Bae, Woo Kyun

AU - Rha, Sun Young

PY - 2014/3/1

Y1 - 2014/3/1

N2 - Background Patients with metastatic renal cell carcinoma (mRCC) with renal insufficiency are generally excluded from clinical trials, despite their increasing numbers. Thus, we evaluated the efficacy and toxicity of sunitinib in such patients. Patients and methods Korean patients with mRCC with renal insufficiency who had received sunitinib as first-line treatment between January 2008 and May 2012 were included. Patient characteristics, clinical outcomes and toxicities were evaluated. Overall survival (OS) and progression-free survival (PFS) were determined according to the degree of renal impairment. Results The median age of the 34 patients evaluated was 66 years, 90% had an Eastern Cooperative Oncology Group performance status of 0 or 1 and the median glomerular filtration rate was 46.5 mL min-1·1.73 m -2 (range, 21.1-59.5). The starting sunitinib dose was 37.5 and 50 mg for 12 and 22 patients, respectively. A 4-weeks-on-2-weeks-off regimen was followed for 31 patients; a 2-weeks-on-2-weeks-off regimen, for one patient; and a daily regimen, for two patients. The best response was partial response in eight patients and stable disease in 12. Median OS and PFS times were 26.3 months (95% confidence interval [CI]: 17.1-35.3) and 12.2 months (95% CI: 10.2-13.2), respectively. Common non-haematologic adverse events (AEs) were stomatitis, rash, general oedema and fatigue. The most common AEs of ≥grade 3 severity were fatigue, neutropenia and thrombocytopenia. Conclusions In patients with mRCC with renal insufficiency, sunitinib was efficacious and did not cause increased toxicity. Thus, clinicians should not hesitate to treat patients with mRCC with renal insufficiency with sunitinib.

AB - Background Patients with metastatic renal cell carcinoma (mRCC) with renal insufficiency are generally excluded from clinical trials, despite their increasing numbers. Thus, we evaluated the efficacy and toxicity of sunitinib in such patients. Patients and methods Korean patients with mRCC with renal insufficiency who had received sunitinib as first-line treatment between January 2008 and May 2012 were included. Patient characteristics, clinical outcomes and toxicities were evaluated. Overall survival (OS) and progression-free survival (PFS) were determined according to the degree of renal impairment. Results The median age of the 34 patients evaluated was 66 years, 90% had an Eastern Cooperative Oncology Group performance status of 0 or 1 and the median glomerular filtration rate was 46.5 mL min-1·1.73 m -2 (range, 21.1-59.5). The starting sunitinib dose was 37.5 and 50 mg for 12 and 22 patients, respectively. A 4-weeks-on-2-weeks-off regimen was followed for 31 patients; a 2-weeks-on-2-weeks-off regimen, for one patient; and a daily regimen, for two patients. The best response was partial response in eight patients and stable disease in 12. Median OS and PFS times were 26.3 months (95% confidence interval [CI]: 17.1-35.3) and 12.2 months (95% CI: 10.2-13.2), respectively. Common non-haematologic adverse events (AEs) were stomatitis, rash, general oedema and fatigue. The most common AEs of ≥grade 3 severity were fatigue, neutropenia and thrombocytopenia. Conclusions In patients with mRCC with renal insufficiency, sunitinib was efficacious and did not cause increased toxicity. Thus, clinicians should not hesitate to treat patients with mRCC with renal insufficiency with sunitinib.

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