title: Efficacy of sorafenib correlates with Memorial Sloan-Kettering Cancer Center (MSKCC) risk classification and bone metastasis in Chinese patients with metastatic renal cell carcinoma.
abstract: OBJECTIVE
  Several prognostic models have been developed to assess the efficacy and safety of sorafenib for metastatic renal cell carcinoma (mRCC), but few studies have validated its use in Chinese patients. The objective of this single center, single arm retrospective study was to examine the efficacy and safety of sorafenib and its related prognostic clinico-pathologic factors in Chinese mRCC patients.
  
  
  METHODS
  One hundred thirty four mRCC patients were enrolled. All patients received 400 mg of sorafenib orally twice daily. The dose was subsequently adjusted in the event of treatment-induced toxicity. Tumor response, progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were determined.
  
  
  RESULTS
  The median PFS and OS were 10 months (1-36 months) and 22 months (2-37 months), respectively. Complete, partial, and stable disease were observed in two (1.49%), 24 (17.91%), and 99 (73.88%) patients, respectively. Hand/foot skin reactions, diarrhea and fatigue were the most commonly observed AEs following sorafenib treatment. Among the AEs, only 13 grades 3 and 4 were observed. Multivariate analysis revealed that independent predictive factors for PFS included Eastern Cooperative Oncology Group (ECOG) status, Memorial Sloan-Kettering Cancer Center (MSKCC) risk status, and bone metastasis (all p < 0.05). Factors associated with OS included MSKCC risk values, bone metastasis and sorafenib-induced hypertension (all p < 0.05).
  
  
  CONCLUSIONS
  The introduction of sorafenib therapy for mRCC in Chinese patients may lead to a favorable disease control with acceptable tolerability. In addition, the parameters predicting favorable outcomes, including ECOG status, MSKCC risk status and bone metastasis, may have prognostic value in clinical practice.
authors.affiliation: Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan Dongdan, Dongcheng District, Beijing, 100730, China.
authors.forename: Yushi
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan Dongdan, Dongcheng District, Beijing, 100730, China.
authors.forename: Yongqiang
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan Dongdan, Dongcheng District, Beijing, 100730, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Cai
authors.affiliation: Department of Epidemiology, Institute of Basic Medicine, Chinese Academy of Medical Sciences, Shuaifuyuan Dongdan, Dongcheng District, Beijing, 100730, China.
authors.forename: Ke
authors.initials: K
authors.lastname: Wang
authors.affiliation: Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan Dongdan, Dongcheng District, Beijing, 100730, China. Lihz12@yeah.net.
authors.forename: Hanzhong
authors.initials: H
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D012307:Risk Factors; D000077157:Sorafenib; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
keywords: Chinese; Metastatic renal cell carcinoma; Prognostic factors; Safety; Sorafenib