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Oxaliplatin pharmacokinetics and pharmacodynamics in adult cancer patients with impaired renal function.
Takimoto, Chris H; Graham, Martin A; Lockwood, Graham; Ng, Chee M; Goetz, Andrew; Greenslade, Dennis; Remick, Scot C; Sharma, Sunil; Mani, Sridhar; Ramanathan, Ramesh K; Synold, Timothy W; Doroshow, James H; Hamilton, Anne; Mulkerin, Daniel L; Ivy, Percy; Egorin, Merrill J; Grem, Jean L.
Afiliación
  • Takimoto CH; Institute for Drug Development, Cancer Therapy and Research Center, San Antonio, Texas 78245-3217, USA. ctakimot@idd.org
Clin Cancer Res ; 13(16): 4832-9, 2007 Aug 15.
Article en En | MEDLINE | ID: mdl-17699862
PURPOSE: To characterize the pharmacokinetics and pharmacodynamics of oxaliplatin in cancer patients with impaired renal function. EXPERIMENTAL DESIGN: Thirty-four patients were stratified by 24-h urinary creatinine clearance (CrCL) into four renal dysfunction groups: group A (control, CrCL, >or=60 mL/min), B (mild, CrCL, 40-59 mL/min), C (moderate, CrCL, 20-39 mL/min), and D (severe, CrCL, <20 mL/min). Patients were treated with 60 to 130 mg/m2 oxaliplatin infused over 2 h every 3 weeks. Pharmacokinetic monitoring of platinum in plasma, plasma ultrafiltrates, and urine was done during cycles 1 and 2. RESULTS: Plasma ultrafiltrate platinum clearance strongly correlated with CrCL (r2 = 0.712). Platinum elimination from plasma was triphasic, and maximal platinum concentrations (Cmax) were consistent across all renal impairment groups. However, only the beta-half-life was significantly prolonged by renal impairment, with values of 14.0 +/- 4.3, 20.3 +/- 17.7, 29.2 +/- 29.6, and 68.1 h in groups A, B, C, and D, respectively (P = 0.002). At a dose level of 130 mg/m2, the area under the concentration time curve increased in with the degree of renal impairment, with values of 16.4 +/- 5.03, 39.7 +/- 11.5, and 44.6 +/- 14.6 mug.h/mL, in groups A, B, and C, respectively. However, there was no increase in pharmacodynamic drug-related toxicities. Estimated CrCL using the Cockcroft-Gault method approximated the measured 24-h urinary CrCL (mean prediction error, -5.0 mL/min). CONCLUSIONS: Oxaliplatin pharmacokinetics are altered in patients with renal impairment, but a corresponding increase in oxaliplatin-related toxicities is not observed.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Compuestos Organoplatinos / Enfermedades Renales / Neoplasias / Antineoplásicos Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2007 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Compuestos Organoplatinos / Enfermedades Renales / Neoplasias / Antineoplásicos Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2007 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos