title: Renal function during rofecoxib therapy in patients with metastatic cancer: retrospective analysis of a prospective phase II trial.
abstract: BACKGROUND
  Angiostatic/antiinflammatory therapy with COX-II inhibitors and pioglitazone seems to be a well tolerated and promising regimen in patients with metastatic cancer. COX-II inhibitors may have less gastrointestinal side effects than conventional non-steroidal antiinflammatory drugs, but their impact on renal function seems to be similar.
  
  
  METHODS
  87 patients with metastatic/advanced cancer were treated up to 12 months (mean 19.5 weeks) with rofecoxib, pioglitazone and either capecitabine (group A with gastrointestinal and urological cancer, n = 50) or trofosfamide (group B with non-gastrointestinal/non-urological cancer, n = 37) and followed for further 6 months.
  
  
  RESULTS
  Baseline serum creatinine concentration was 0.81 ± 0.28 mg/dl, and increased by about 0.15 mg/dl during months 1-3. Accordingly estimated glomerular filtration rate (eGFR) decreased from 90.3 ml/min ± 3.6 ml/min at baseline by about 10 ml/min during months 1-3. Renal function decreased in 75 patients (86%) in the first month (p < 0.0001). This decrease went along with clinical signs of volume expansion. Renal function tended to recover after discontinuation of the study medication.
  
  
  CONCLUSIONS
  Therapy with rofecoxib in an antiangiogenic/antiinflammatory setting results in a decrease of renal function in nearly every patient.
  
  
  BACKGROUND
  German Clinical Trials Register DRKS: DRKS00000119.
authors.affiliation: Klinik und Poliklinik für Innere Medizin II, University of Regensburg, Franz-Josef-Strauß-Allee 11, Regensburg, 93053, Germany. stephan.reinhold@klinik.uni-regensburg.de.
authors.forename: Stephan W
authors.initials: SW
authors.lastname: Reinhold
authors.forename: Albrecht
authors.initials: A
authors.lastname: Reichle
authors.forename: Sonja
authors.initials: S
authors.lastname: Leiminger
authors.forename: Tobias
authors.initials: T
authors.lastname: Bergler
authors.forename: Ute
authors.initials: U
authors.lastname: Hoffmann
authors.forename: Bernd
authors.initials: B
authors.lastname: Krüger
authors.forename: Bernhard
authors.initials: B
authors.lastname: Banas
authors.forename: Bernhard K
authors.initials: BK
authors.lastname: Krämer