title: The efficacy and safety of sunitinib in korean patients with advanced renal cell carcinoma: high incidence of toxicity leads to frequent dose reduction.
abstract: OBJECTIVE
  The effects of sunitinib in a broad patient population, especially those of Asian ethnicity, have been rarely investigated. Here, we assessed the efficacy and safety of sunitinib in Korean patients with advanced renal cell carcinoma.
  
  
  METHODS
  Between April 2006 and August 2008, 77 Korean patients with advanced renal cell carcinoma were treated with sunitinib. We performed retrospective analysis for efficacy in terms of survival outcomes and response rate. Toxicity profiles were also assessed.
  
  
  RESULTS
  A total of 65 patients, including 39 (60%) patients without previous cytotoxic or immunotherapy, were eligible for the analysis. In 53 patients with measurable lesions, the objective response rate was 43% and disease control was achieved in 46 (86%) patients. The median time to treatment failure, time to progression and overall survival were 7.0, 11.8 and 22.8 months, respectively, with a median follow-up of 26.8 months in surviving patients. The most common treatment-related adverse events were fatigue (81%) and stomatitis (60%). The most common Grade 3 or 4 adverse events were hand-foot syndrome (16%), thrombocytopenia (16%) and stomatitis (10%). Dose reduction was required in 46% of patients.
  
  
  CONCLUSIONS
  The efficacy was similar to a previous Phase III trial and a safety profile of sunitinib was manageable in Korean patients with advanced renal cell carcinoma, although the incidence of dose reduction and Grade 3 or 4 adverse events were higher than those of western reports. Future studies should investigate the ethnic differences in toxicity profiles of sunitinib.
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul 138-736, Republic of Korea.
authors.forename: Changhoon
authors.initials: C
authors.lastname: Yoo
authors.forename: Jeong Eun
authors.initials: JE
authors.lastname: Kim
authors.forename: Jae-Lyun
authors.initials: JL
authors.lastname: Lee
authors.forename: Jin-Hee
authors.initials: JH
authors.lastname: Ahn
authors.forename: Dae Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Jung-Shin
authors.initials: JS
authors.lastname: Lee
authors.forename: Shin
authors.initials: S
authors.lastname: Na
authors.forename: Choung-Soo
authors.initials: CS
authors.lastname: Kim
authors.forename: Jun Hyuk
authors.initials: JH
authors.lastname: Hong
authors.forename: Bumsik
authors.initials: B
authors.lastname: Hong
authors.forename: Cheryn
authors.initials: C
authors.lastname: Song
authors.forename: Hanjong
authors.initials: H
authors.lastname: Ahn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D044466:Asian People; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea; D000077210:Sunitinib; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib