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.

TRIAL REGISTRATION NUMBER:

German Clinical Trials Register DRKS: DRKS00000119.

• Authors: Stephan W Reinhold, Albrecht Reichle, Sonja Leiminger, Tobias Bergler, Ute Hoffmann, Bernd Krüger, Bernhard Banas, Bernhard K Krämer
• Journal: BMC research notes (BMC Res Notes) Vol. 4 Pg. 2 (Jan 05 2011) ISSN: 1756-0500 [Electronic] England
• PMID: 21208422 (Publication Type: Journal Article)