title: Sorafenib treatment of advanced renal cell carcinoma patients in daily practice: the large international PREDICT study.
abstract: BACKGROUND
  Patients with advanced renal cell carcinoma in routine clinical practice can differ considerably from those in phase III studies.
  
  
  METHODS
  PREDICT (Patient characteristics in REnal cell carcinoma and Daily practICe Treatment with sorafenib) was a prospective, noninterventional study of open-label sorafenib for the treatment of advanced RCC conducted in 18 countries. Patient characteristics, therapy duration, tumor status, and tolerability were assessed at baseline and during routine follow-up.
  
  
  RESULTS
  Overall, 2599 patients were evaluable for safety and 2311 for efficacy. The diverse population included patients with brain metastases (5%), non-clear-cell histologies (17%), high Memorial Sloan-Kettering Cancer Center risk score (11%), poor Eastern Cooperative Oncology Group performance status (PS ≥ 2, 29%), and patients with no previous nephrectomy (16%) or no previous systemic therapy (37%). The median duration of sorafenib therapy was 7.3 months and was similar in clinically relevant subgroups (eg, patients with PS 2, brain metastases, or concomitant hypertension or diabetes [range, 6.7-7.0 months]). The median duration of therapy was shorter for patients with PS 3 or non-clear-cell histologies (4.6 and 4.8 months, respectively). The most common drug-related adverse events were hand-foot skin reaction (20%), diarrhea (17%), and rash (8%).
  
  
  CONCLUSIONS
  Sorafenib was generally well tolerated and provided clinical benefit in a large, diverse population of patients with advanced RCC treated in routine clinical practice.
authors.affiliation: National Center for Tumor Diseases, University Medical Center Heidelberg, Heidelberg, Germany. Electronic address: dirk.jaeger@nct-heidelberg.de.
authors.forename: D
authors.initials: D
authors.lastname: Jäger
authors.affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: J H
authors.initials: JH
authors.lastname: Ma
authors.affiliation: National Cancer Institute, Bratislava, Slovakia.
authors.forename: J
authors.initials: J
authors.lastname: Mardiak
authors.affiliation: Affiliated Cancer Hospital of Fudan University, Shanghai, China.
authors.forename: D W
authors.initials: DW
authors.lastname: Ye
authors.affiliation: Hospital Británico de Buenos Aires, Buenos Aires, Argentina.
authors.forename: E
authors.initials: E
authors.lastname: Korbenfeld
authors.affiliation: Charles University in Prague, First Faculty of Medicine, Prague, Czech Republic.
authors.forename: M
authors.initials: M
authors.lastname: Zemanova
authors.affiliation: Asan Medical Center, Seoul, Korea.
authors.forename: H
authors.initials: H
authors.lastname: Ahn
authors.affiliation: Beijing Cancer Hospital, Beijing, China.
authors.forename: J
authors.initials: J
authors.lastname: Guo
authors.affiliation: Department of Urology, Medical University Innsbruck, Innsbruck, Austria.
authors.forename: N
authors.initials: N
authors.lastname: Leonhartsberger
authors.affiliation: Bayer HealthCare, Leverkusen, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Stauch
authors.affiliation: Bayer HealthCare, Wuppertal, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Böckenhoff
authors.affiliation: Bayer HealthCare, Montville, NJ.
authors.forename: J
authors.initials: J
authors.lastname: Yu
authors.affiliation: Institut Gustave Roussy, Villejuif, France.
authors.forename: B
authors.initials: B
authors.lastname: Escudier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000554:Ambulatory Care Facilities; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology*; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D000077157:Sorafenib; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
keywords: Clinical practice; Multikinase inhibitor; Noninterventional study; Targeted agent; Tolerability