title: Sunitinib in metastatic renal cell carcinoma: an ethnic Asian subpopulation analysis for safety and efficacy.
abstract: OBJECTIVE
  We evaluated and compared the safety and efficacy of sunitinib in Asian and non-Asian patients with metastatic renal cell carcinoma enrolled in a previously reported global expanded access program.
  
  
  METHODS
  Previously treated and treatment-naïve patients received open-label sunitinib at a starting dose of 50 mg/day for 4 weeks, followed by 2 weeks off treatment, in repeated 6-week cycles. Safety was assessed regularly, tumor measurements were performed per local practice, and survival data collected where possible.
  
  
  RESULTS
  Data were available for 212 Asian patients from Asian sites (Asian-A), 113 Asian patients from non-Asian sites (Asian-O) and 4046 non-Asian patients. The most common grade 3/4 treatment-related adverse events were neutropenia, thrombocytopenia, hand-foot syndrome, diarrhea, asthenia and fatigue. The incidence of many adverse events was greater in Asian-A than in Asian-O or non-Asian patients. Sunitinib efficacy was comparable between Asian and non-Asian patients, with an objective response rate of 18% versus 14%; median progression-free survival of 8.7 versus 10.9 months; and overall survival of 18.9 versus 18.4 months, respectively.
  
  
  CONCLUSIONS
  Sunitinib demonstrated tolerable safety and similar efficacy in Asian and non-Asian patients. Geographic differences in the reported frequency of specific adverse events were noted across Asian patients.
authors.affiliation: Department of Internal Medicine, Seoul National University Hospital and Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
authors.forename: Se-Hoon
authors.initials: SH
authors.lastname: Lee
authors.forename: Yung-Jue
authors.initials: YJ
authors.lastname: Bang
authors.forename: Paul
authors.initials: P
authors.lastname: Mainwaring
authors.forename: Christina
authors.initials: C
authors.lastname: Ng
authors.forename: John W-C
authors.initials: JW
authors.lastname: Chang
authors.forename: Philip
authors.initials: P
authors.lastname: Kwong
authors.forename: Rubi K
authors.initials: RK
authors.lastname: Li
authors.forename: Virote
authors.initials: V
authors.lastname: Sriuranpong
authors.forename: Chee-Keong
authors.initials: CK
authors.lastname: Toh
authors.forename: Jinyu
authors.initials: J
authors.lastname: Yuan
authors.forename: Susan
authors.initials: S
authors.lastname: Pitman Lowenthal
authors.forename: Hyun C
authors.initials: HC
authors.lastname: Chung
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000208:ethnology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000208:ethnology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D000077210:Sunitinib; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: Asian; metastatic renal cell carcinoma; sunitinib