title: Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with renal insufficiency.
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.
  
  
  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 50mg 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.
authors: Division of Hematology-Oncology, Department of Internal Medicine, Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea.
authors: Ki Hyang
authors: KH
authors: Kim
authors: Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Seoul, South Korea.
authors: Ho Young
authors: HY
authors: Kim
authors: Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Research Institute, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
authors: Hye Ryun
authors: HR
authors: Kim
authors: Division of Hematology-Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, South Korea.
authors: Jong-Mu
authors: JM
authors: Sun
authors: Division of Hematology-Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, South Korea.
authors: Ho Yeong
authors: HY
authors: Lim
authors: Division of Hematology-Oncology, Department of Internal Medicine, College of Medicine, Chungnam National University, Daejeon, South Korea.
authors: Hyo Jin
authors: HJ
authors: Lee
authors: Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University Medical Center, Busan, South Korea.
authors: Suee
authors: S
authors: Lee
authors: Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun-gun, Jeollanamdo, South Korea.
authors: Woo Kyun
authors: WK
authors: Bae
authors: Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Research Institute, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: rha7655@yuhs.ac.
authors: Sun Young
authors: SY
authors: Rha
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000150:complications* / Q000188:drug therapy* / Q000453:epidemiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000150:complications* / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D012042:Registries; D051437:Renal Insufficiency / Q000453:epidemiology / Q000209:etiology* / Q000503:physiopathology; D012189:Retrospective Studies; D000077210:Sunitinib; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: Metastatic renal cell carcinoma; Renal insufficiency; Sunitinib