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Nephroprotection by Theophylline in Patients with Cisplatin Chemotherapy: A Randomized, Single-Blinded, Placebo-Controlled Trial

Peter Benoehr^*, Patricia Krueth, Carsten Bokemeyer, Almut Grenz, Hartmut Osswald and Jorg T. Hartmann

^* Department of Nephrology and Rheumatology, University of Göttingen, Göttingen, Germany; and Medical Center II, Department of Hematology and Oncology, Immunology, Rheumatology and Pneumonology and Department of Pharmacology and Toxicology, Eberhard-Karls University of Tübingen, Tübingen, Germany

Address correspondence to: Dr. Peter Benöhr, Department of Nephrology and Rheumatology, Georg-August-University, Robert-Koch Strasse 40, 37075 Göttingen, Germany. Phone: +49-551-39-8509; Fax: +49-551-39-8507; E-mail pbenoeh{at}gwdg.de

The aim of the present study was to assess the possible prevention of cisplatin-induced impairment of GFR by theophylline in patients with various malignancies. The trial design was parallel, randomized, single blinded, and placebo controlled. Patients received cisplatin at a dosage of 50 mg/m² either combined with etoposide, ifosfamide, and epirubicin or with paclitaxel and 5-fluorouracil/folinic acid with the usual precautions, including a standard hydration scheme before application of cisplatin in both arms. In the control arm, placebo was administered; in the verum arm, patients received theophylline in a loading dose of 4 mg/kg intravenously over 30 min before cisplatin, followed by 0.4 mg/kg per min over a minimum of 6 h, and then 350 mg three times daily orally for 4 consecutive days after completion of chemotherapy. GFR of each patient was assessed by renal clearance of inulin within 3 d before and at day 5 after cisplatin chemotherapy. Despite usual precautions, patients in the placebo group had a 21% decrease (range, 11 to 31%) of inulin clearance after a single cycle of cisplatin-containing chemotherapy (92.9 ± 3.4 versus 71.8 ± 3.5 ml/min; P < 0.01). Patients who received theophylline had no deterioration of GFR (91.5 ± 3.7 versus 90.0 ± 3.8 ml/min; P > 0.05). No adverse effects have been observed during theophylline application. Conventional precautions such as hydration and osmotic diuresis cannot prevent a significant decrease of GFR after a single cycle of cisplatin-containing chemotherapy. The prophylactic application of theophylline as an intravenous loading dose and oral maintenance regimen may preserve kidney function in terms of GFR.

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