title: Sunitinib for Asian patients with advanced renal cell carcinoma: a comparable efficacy with different toxicity profiles.
abstract: OBJECTIVE
  We aimed to describe the efficacy and safety of sunitinib in unselected Korean advanced renal cell carcinoma (RCC) patients.
  
  
  METHODS
  From November 2005 to August 2008, 132 histologically confirmed advanced RCC patients (100 in the global expanded access program) were enrolled. Response and toxicity were assessed regularly according to the protocol.
  
  
  RESULTS
  Within this population, 82.6% had clear cell RCC, and 28.8% were treatment naïve. Patients received a median of 5 cycles of sunitinib (range 1-30), and the mean relative dose intensity was 82.0 ± 14.20 (SD). The progression-free survival (PFS) and overall survival rates were 8.2 and 23.1 months, respectively. For the 130 evaluable patients, the objective response rate was 34.1% (n = 45); 44.7% (n = 59) exhibited stable disease. Reasons for discontinuation were disease progression (75.0%) and toxicity (7.6%). The most frequent adverse events were thrombocytopenia (75.0%), neutropenia (70.5%), and anemia (69.7%). Low body surface area (OR = 4.2, 95% CI 1.2-13.8, p = 0.02) and previously treated status (OR = 3.1, 95% CI 1.3-7.4, p = 0.01) were highly predictive of grade 3-4 toxicities. Based on these findings, a nomogram predicting the probability of 12-month PFS was constructed, giving a concordance index of 0.675.
  
  
  CONCLUSIONS
  Despite the different toxicity profiles, maintaining adequate dose modifications and a careful follow-up enables comparable treatment outcomes for unselected Korean advanced RCC patients.
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, 134 Shinchondong, Seodaemun-gu, Seoul, Korea.
authors.forename: Hyo Song
authors.initials: HS
authors.lastname: Kim
authors.forename: Min Hee
authors.initials: MH
authors.lastname: Hong
authors.forename: Kiyeol
authors.initials: K
authors.lastname: Kim
authors.forename: Sang-Joon
authors.initials: SJ
authors.lastname: Shin
authors.forename: Joong-Bae
authors.initials: JB
authors.lastname: Ahn
authors.forename: Hei Chul
authors.initials: HC
authors.lastname: Jeung
authors.forename: Hyun Cheol
authors.initials: HC
authors.lastname: Chung
authors.forename: Youngil
authors.initials: Y
authors.lastname: Koh
authors.forename: Se-Hoon
authors.initials: SH
authors.lastname: Lee
authors.forename: Yung-Jue
authors.initials: YJ
authors.lastname: Bang
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Rha
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D044466:Asian People; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects*; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D049451:Nomograms; D011237:Predictive Value of Tests; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects*; D056910:Republic of Korea; D012307:Risk Factors; D000077210:Sunitinib; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib