title: Efficacy and Safety of Sorafenib Therapy on Metastatic Renal Cell Carcinoma in Korean Patients: Results from a Retrospective Multicenter Study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of sorafenib for Korean patients with metastatic renal cell carcinoma (mRCC).
  
  
  METHODS
  A total of 177 mRCC patients using sorafenib as first- (N = 116), second- (N = 43), and third-line (N = 18) therapies were enrolled from 11 Korean centers between 2006 and 2012. The patient characteristics, therapy duration, tumor response, disease control rate, and tolerability were assessed at baseline and at routine follow-ups, and the progression-free survival (PFS) and overall survival (OS) times and rates were analyzed.
  
  
  RESULTS
  Among all patients, 18 (10.2%) stopped sorafenib treatment for a median of 1.7 weeks, including 15 (8.5%) who discontinued the drug, while 40 (22.6%) and 12 (6.8%) patients required dose reductions and drug interruptions, respectively. Severe adverse events (AEs) or poor compliance was observed in 64 (36.2%) patients, with 118 (7.4%) ≥grade 3 AEs. During the treatment, one myocardial infarction was observed. The number of ≥grade 3 AEs in the first-line sorafenib group was 71 (6.8% of the total 1048 AEs). During a median follow-up of 17.2 months, the radiologically confirmed best objective response rate, disease control rate, median PFS, and median OS were 22.0%, 53.0%, 6.4 months (95% confidence interval [CI], 5.2-8.9), and 32.6 months (95% CI, 27.3-63.8) for the total 177 sorafenib-treated patients, respectively, and 23.2%, 56.0%, 7.4 months (95% CI, 5.5-10.5), and not reached yet (95% CI, 1.0-31.1) for the first-line sorafenib group, respectively.
  
  
  CONCLUSIONS
  Sorafenib produced tolerable safety, with a ≥grade 3 AE rate of 7.4% and an acceptable disease control rate (53.0%) in Korean mRCC patients.
authors: Departments of Urology, Center for Prostate Cancer, National Cancer Center, Goyang, Korea.
authors: Sung Han
authors: SH
authors: Kim
authors: Biometric Research Branch, Center for Prostate Cancer, National Cancer Center, Goyang, Korea.
authors: Sohee
authors: S
authors: Kim
authors: Biometric Research Branch, Center for Prostate Cancer, National Cancer Center, Goyang, Korea.
authors: Byung-Ho
authors: BH
authors: Nam
authors: Seoul National University Bundang Hospital, SeongNam, Korea.
authors: Sang Eun
authors: SE
authors: Lee
authors: Asan Medical Center, Seoul, Korea.
authors: Choung Soo
authors: CS
authors: Kim
authors: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Ill Young
authors: IY
authors: Seo
authors: Pusan National University Hospital, Busan, Korea.
authors: Tae Nam
authors: TN
authors: Kim
authors: Seoul St. Mary's Hospital, Seoul, Korea.
authors: Sung-Hoo
authors: SH
authors: Hong
authors: School of Medicine, Kyungpook National University, Daegu, Korea.
authors: Tae Gyun
authors: TG
authors: Kwon
authors: Wonkwang University School of Medicine and Hospital, Iksan, Korea.
authors: Seong Il
authors: SI
authors: Seo
authors: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Kwan Joong
authors: KJ
authors: Joo
authors: Korea Cancer Center Hospital, Seoul, Korea.
authors: Kanghyon
authors: K
authors: Song
authors: Seoul National University Hospital, Seoul, Korea.
authors: Cheol
authors: C
authors: Kwak
authors: Departments of Urology, Center for Prostate Cancer, National Cancer Center, Goyang, Korea.
authors: Jinsoo
authors: J
authors: Chung
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D007723:Korea; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects* / Q000494:pharmacology* / Q000627:therapeutic use; D012189:Retrospective Studies; D012449:Safety; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib