Nephroprotection by theophylline in patients with cisplatin chemotherapy
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Nephroprotection by theophylline in patients with cisplatin chemotherapy : a randomized, single-blinded, placebo-controlled trial. / Benoehr, Peter; Krueth, Patricia; Bokemeyer, Carsten; Grenz, Almut; Osswald, Hartmut; Hartmann, Jorg T.
In: J AM SOC NEPHROL, Vol. 16, No. 2, 02.2005, p. 452-8.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Nephroprotection by theophylline in patients with cisplatin chemotherapy
T2 - a randomized, single-blinded, placebo-controlled trial
AU - Benoehr, Peter
AU - Krueth, Patricia
AU - Bokemeyer, Carsten
AU - Grenz, Almut
AU - Osswald, Hartmut
AU - Hartmann, Jorg T
PY - 2005/2
Y1 - 2005/2
N2 - 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/m(2) 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.
AB - 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/m(2) 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.
KW - Adult
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Cisplatin
KW - Dose-Response Relationship, Drug
KW - Drug Administration Schedule
KW - Female
KW - Follow-Up Studies
KW - Glomerular Filtration Rate
KW - Humans
KW - Infusions, Intravenous
KW - Kidney Diseases
KW - Male
KW - Middle Aged
KW - Neoplasms
KW - Primary Prevention
KW - Probability
KW - Prospective Studies
KW - Reference Values
KW - Risk Assessment
KW - Single-Blind Method
KW - Theophylline
KW - Treatment Outcome
U2 - 10.1681/ASN.2004030225
DO - 10.1681/ASN.2004030225
M3 - SCORING: Journal article
C2 - 15590762
VL - 16
SP - 452
EP - 458
JO - J AM SOC NEPHROL
JF - J AM SOC NEPHROL
SN - 1046-6673
IS - 2
ER -