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Open Access Research article

Renal function during rofecoxib therapy in patients with metastatic cancer: retrospective analysis of a prospective phase II trial

Stephan W Reinhold1*, Albrecht Reichle2, Sonja Leiminger1, Tobias Bergler1, Ute Hoffmann1, Bernd Krüger13, Bernhard Banas1 and Bernhard K Krämer13

Author Affiliations

1 Klinik und Poliklinik für Innere Medizin II, University of Regensburg, Franz-Josef-Strauß-Allee 11, Regensburg, 93053, Germany

2 Abteilung für Hämatologie und Internistische Onkologie, University of Regensburg, Franz-Josef-Strauß-Allee 11, Regensburg, 93053, Germany

3 V. Medizinische Klinik, Universitätsklinikum Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, Mannheim, 68167, Germany

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BMC Research Notes 2011, 4:2  doi:10.1186/1756-0500-4-2

Published: 5 January 2011



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.


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.


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.


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