title: Efficacy of sorafenib in advanced renal cell carcinoma independent of prior treatment, histology or prognostic group.
abstract: OBJECTIVE
  To assess the response rate and safety of sorafenib in different subpopulations of patients with advanced renal cell carcinoma (RCC).
  
  
  METHODS
  Single-arm open access trial. Key eligibility: advanced RCC with either clear-cell or non-clear-cell histopathology; progression on prior systemic chemotherapy or treatment naïve. Sorafenib was commenced at 400 mg twice daily continuously.
  
  
  RESULTS
  A total 47 participants with metastatic RCC were treated with sorafenib. Overall, 1 participant experienced complete response, 6 (13%) had documented partial response (PR) and 29 (62%) had stable disease (SD) as the best response. Eight (17%) had non-clear-cell histopathology and five (10%) had sarcomatoid features. In the non-clear-cell histopathology cohort, five participants (62.5%) had SD. Twenty-three (49%) participants were treatment naïve; of these, 1/23 showed CR, 5/23 experienced PR and 13/23 had SD (clinical benefit: 83%). Overall, 14 (30%) and 22 (47%) participants had high-risk status according to MSKCC (Memorial Sloan-Kettering Cancer Center) and Heng prognostic scores, respectively. In the MSKCC poor prognostic group (14 participants), one participant had CR, two participants showed PR and eight participants had SD (clinical benefit: 79%). In Heng poor prognostic group (22 participants), 1 participant experienced CR, 2 participants showed PR and 13 had SD (clinical benefit: 73%). Hand-foot syndrome (53%), rash (47%), fatigue (42%), nausea (40%), anorexia (34%) and diarrhea (32%) were the most common adverse events.
  
  
  CONCLUSIONS
  This study confirms the efficacy and tolerability of sorafenib in a different spectrum of advanced RCC patients including non-clear-cell histology, poor prognostic status and as first-line treatment.
authors.affiliation: Joint Austin-Ludwig Oncology Unit, Austin Health, Melbourne, Victoria, Australia.
authors.forename: Ali
authors.initials: A
authors.lastname: Tafreshi
authors.forename: Eddy
authors.initials: E
authors.lastname: Thientosapol
authors.forename: Mun Sem
authors.initials: MS
authors.lastname: Liew
authors.forename: Yuan
authors.initials: Y
authors.lastname: Guo
authors.forename: Melissa
authors.initials: M
authors.lastname: Quaggiotto
authors.forename: Michael
authors.initials: M
authors.lastname: Boyer
authors.forename: Ian D
authors.initials: ID
authors.lastname: Davis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000627:therapeutic use*; D011379:Prognosis; D000077157:Sorafenib
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
keywords: angiogenesis; clinical trial; renal cell carcinoma; sorafenib