2013, Number 4
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Rev Cubana Farm 2013; 47 (4)
Customization of doses in oncological patients with impaired hepatic function
González-Carrascosa VT, Sierra SJF, Martínez BMJ, Ladrón de Guevara GM, Manzano MMV, Rodríguez CJM
Language: Spanish
References: 53
Page: 517-526
PDF size: 91.84 Kb.
ABSTRACT
Objective: to determine the cytostatic drugs requiring dose adjustment in patients with impaired hepatic function.
Methods: aliterature review of all the papers about dosage of cytostatic drug in patients with impaired hepatic function published till July 2011 in Pubmed search was made.
They were assessed as rated by the Scottish Intercollegiate Guidelines Network. An index of pharmacotherapy recommendation strength was developed, for which the grade of recommendation of the evidence found and the number of patients included in the studies were then correlated, ranking the strength of recommendation for each drug as high, medium or low.
Results: atotal of 46 publications with information about dosing in liver failure were found for 17 cytostatic drugs. Sixty seven percent (n= 31) of the publications were cohort studies with a level of evidence 2+. High strength recommendations could not been established, but moderate strength (76 %; 13 drugs) and low strength (24 %; 4 drugs)
recommendations were finally established.
Conclusions: although level of evidence was low, dosage recommendations of cytostatic drugs to be used in liver failure patients were established to improve safety in the use of these drugs in the stated group of patients.
REFERENCES
Vila A, Pérez D, Porta B, Jiménez V. Modelo predictivo preliminar para la identificación de pacientes con oportunidades de mejora farmacoterapéutica. Farm Hosp.2010;34(6):298302.
Institute for Safe Medication Practices. ISMP's List of High-Alert Medications. 2011. Consultado el [2011 Jul 1]. Disponible en: http://www.ismp.org/tools/highalertmedicationLists.asp
Donelli MG, Zucchetti M, Munzone E, D'Incalci M, Crosignani A. Pharmacokinetics of anticancer agents in patients with impaired liver function. Eur J Cancer. 1998 Jan;34(1):33-46.
Field KM, Michael M. Part II: Liver function in oncology: towards safer chemotherapy use. Lancet Oncol. 2008;9(12):1181-90.
Niveles de evidencia científica y grados de recomendación de SIGN. In: Scottish Intercollegiate Guidelines Network. SIGN50: A guideline developers' hand-book (section 6: Forming guideline recommendations), SIGN PUBLICATION no 50, 2001. [cited 2011 Jul 1]. Available from: http://www.guiasalud.es/egpc/depresion_infancia/completa/documentos/apartado00/ evidencia.pdf
Venook AP, Egorin MJ, Rosner GL. Phase I and pharmacokinetic trial of paclitaxel in patients with hepatic dysfunction: Cancer and Leukemia Group B 9264. J Clin Oncol. 1998;16(5):1811-9.
Wilson WH, Berg SL, Bryant G. Paclitaxel in doxorubicin-refractory or mitoxantrone-refractory breast cancer: a phase I/II trial of 96-hour infusion. J Clin Oncol. 1994;12(8):1621-9.
Seidman AD, Hochhauser D, Gollub M. Ninety-six-hour paclitaxel infusion after progression during short taxane exposure: a phase II pharmacokinetic and pharmacodynamic study in metastatic breast cancer. J Clin Oncol. 1996;14(6):1877- 84.
Huizinga MT, Rosinga H, Vermorken JB. Pharmacology of paclitaxel (P) and metabolites in patients with altered liver function. Europ J of Cancer. 1995;31(Suppl 6):S192.
Payne JY, Holmes F, Cohen PR. Paclitaxel: severe mucocutaneous toxicity in a patient with hyperbilirubinemia. South Med J. 1996;89(5):542-5.
Gianni L, Munzone E, Capri G. Paclitaxel in metastatic breast cancer: a trial of two doses by a 3-hour infusion in patients with disease recurrence after prior therapy with anthracyclines. J Natl Cancer Inst. 1995;87(15):1169-75.
Bruno R, Vivier N, Vergniol JC. A population pharmacokinetic model for docetaxel (Taxotere): model building and validation. J Pharmacokinet Biopharm. 1996;24(2):153-72.
Tanigawara Y, Sasaki Y, Otsu T. Population pharmacokinetics of docetaxel in Japanese patients. [abstract no. 1518]. Proc Am Soc Clin Oncol. 1996;15:479.
Oulid D, Bruno R, Lebecq A. Taxotere safety inpatients with impaired liver function (LF) [abstract no. 1508]. Proc Am Soc Clin Oncol. 1996;15:476.
Hooker AC, Ten AJ, Carducci MA. Population Pharmacokinetic Model for Docetaxel in Patients with Varying Degrees of Liver Function: Incorporating Cytochrome P450 3A Activity Measurements. Clin Pharmacol Ther. 2008;84:111-8.
Klink-Alakl M, Riva A, Bruno R. Taxotere (T) safety profile in patients (pts) with liver metastases (LM) with or without impaired liver function (ILF). [abstract]. Proc Am Soc Clin Oncol. 1997;16:220a.
Hamilton M, Wolf JL, Rusk J. Effects of smoking on the pharmacokinetics of erlotinib. Clin Cancer Res. 2006;12(7 Pt 1):2166-71.
Miller AA, Murry DJ, Owzar K. Phase I and pharmacokinetic study of erlotinib for solid tumors in patients with hepatic or renal dysfunction: CALGB 60101. J Clin Oncol. 2007;25(21):3055-60.
Venook AP, Enders Klein C, Fleming G. A phase I and pharmacokinetic study of irinotecan in patients with hepatic or renal dysfunction or with prior pelvic radiation: CALGB 9863. Ann Oncol. 2003;14(12):1783-90.
Raymond E, Boige V, Faivre S. Dosage adjustment and pharmacokinetic profile of irinotecan in cancer patients with hepatic dysfunction. J Clin Oncol. 2002;20(21):4303-12.
Schaaf LJ, Hammond LA, Tipping SJ. Phase 1 and pharmacokinetic study of intravenous irinotecan in refractory solid tumor patients with hepatic dysfunction. Clin Cancer Res. 2006;12(12):3782-91.
Twelves C, Glynne-Jones R, Cassidy J. Effect of hepatic dysfunction due to liver metastases on the pharmacokinetics of capecitabine and its metabolites. Clin Cancer Res. 1999;5(7):1696-702.
Schüll B, Scheithauer W, Kornek GV. Capecitabine as salvage therapy for a breast cancer patient with extensive liver metastases and associated impairment of liver function. Onkologie. 2003;26(6):578-80.
Dobbs NA, Twelves CJ, Gregory W. Epirubicin in patients with liver dysfunction: development and evaluation of a novel dose modification scheme. Eur J Cancer. 2003;39(5):580-6.
Fleming GF, Schilsky RL, Schumm LP. Phase I and pharmacokinetic study of 24- hour infusion 5-fluorouracil and leucovorin in patients with organ dysfunction. Ann Oncol. 2003;14(7):1142-7.
Venook AP, Egorin MJ, Rosner GL. Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565. J Clin Oncol. 2000;18(14):2780-7.
Eckel F, von Delius S, Mayr M. Pharmacokinetic and clinical phase II trial of imatinib in patients with impaired liver function and advanced hepatocellular carcinoma. Oncology. 2005;69(5):363-71.
Doroshow JH, Synold TW, Gandara D. Pharmacology of oxaliplatin in solid tumor patients with hepatic dysfunction: a preliminary report of the National Cancer Institute Organ Dysfunction Working Group. Semin Oncol. 2003;30(4 Suppl 15):14-9.
Miller A, Murry D, Owzar K, et al. Pharmacokinetic (PK) and phase I study of sorafenib (S) for solid tumors and hematologic malignancies in patients with hepatic or renal dysfunction (HD or RD): CALGB 60301. J Clin Oncol. 2007;25;(18) (Suppl):147s.
O'Reilly S, Rowinsky E, Slichenmyer W et al. Phase I and pharmacologic studies of topotecan in patients with impaired hepatic function. J Natl Cancer Inst. 1996;88(12):817-24.
Benjamin RS, Wiernik PH, Bachur NR. Adriamycin chemotherapy-efficacy, safety, and pharmacologic basis of an intermittent single high-dosage schedule. Cancer. 1974; 33:19-27.
Johnson PJ, Dobbs N, Kalayci C. Clinical efficacy and toxicity of standard dose adriamycin in hyperbilirubinaemic patients with hepatocellular carcinoma: relation to liver testsand pharmacokinetic parameters. Br J Cancer. 1992;64:751-5.
Mross K, Maessen P, van der Vijgh WJF. Pharmacokinetics and metabolism of epidoxorubicin and doxorubicin in humans. J Clin Oncol. 1988;6:517-26.
Piscitelli SC, Rodvold KA, Rushing DA, et al. Pharmacokinetics and pharmacodynamics of doxorubicin in patients with small cell lung cancer. Clin Pharmacol Ther. 1993;53:555-61.
Juma FD. Efect of liver failure on the pharmacokinetics of cyclophosphamide. Eur J Clin Pharmacol. 1984;26:591:3.
Savaraj N, Lu K, Manuel V, et al. Pharmacology of mitoxantrone in cancer patients. Cancer Chemother Pharmacol. 1982;8:113:7.
Smyth JF, Macpherson JS, Warrington PS. The clinical pharmacology of mitoxantrone. Cancer Chemother Pharmacol. 1986;17:149-52.
Desai ZR, Van den Berg HW, Bridges JM. Can severe vincristine neurotoxicity be prevented? Cancer Chemother Pharmacol. 1982;8:211-4.
D'Incalci M, Rossi C, Zucchetti M. Pharmacokinetics of etoposide in patients with abnormal renal and hepatic function. Cancer Res .1986;46:2566-71.
Joel SP, Shah R, Clark PI, Slevin ML. Predicting etoposide toxicity: Relationship to organ function and protein binding. J Clin Oncol. 1996;14:257-67.
Liu B, Earl HM, Poole CJ, Dunn J, Kerr DJ. Etoposide protein binding in cancer patients. Cancer Chemother Pharmacol. 1995;36:506:12.
Hande KR, WolV SN, Greco FA. Etoposide kinetics in patients with obstructive jaundice. J Clin Oncol. 1990;8:1101-7.
Arbruck SG, Douglass HO, Grom WR. Etoposide pharmacokinetics in patients with normal and abnormal organ function. J Clin Oncol. 1986;4:1690-5.
Jakobsen P, Steiness E, Bastholt L. Multiple-dose pharmacokinetics of epirubicin at four different dose levels: studies in patients with metastatic breast cancer. Cancer Chemother Pharmacol. 1991;28:63-8.
Twelves CJ, Dobbs NA, Michael Y. Clinical pharmacokinetics of epirubicin: the importance of liver biochemistry tests. Br J Cancer. 1992;66:765-769.
Speth PAJ, Linssen PCM, Beex LVAM. Cellular and plasma pharmacokinetics of weekly 20 mg 4'-epi-adriamycin bolus injection in patients with advanced breast carcinoma. Cancer Chemother Pharmacol. 1986;18:78-82.
Hughes A, O'Brien M, Petty W. Overcoming CYP1A1/1A2 Mediated Induction of Metabolism by Escalating Erlotinib Dose in Current Smokers. J Clin Oncol. 2009 10;27(8):1220-6.
Minami H, Kawada K, Sasaki Y. Population pharmacokinetics of docetaxel in patients with hepatic dysfunction treated in an oncology practice. Cancer Sci. 2009;100(1):144-9.
Synold TW, Takimoto CH, Doroshow JH. Dose-escalating and pharmacologic study of oxaliplatin in adult cancer patients with impaired hepatic function: a National Cancer Institute Organ Dysfunction Working Group study. Clin Cancer Res. 2007;13(12):3660-6.
Baur M, Drescher A, Gneist M. Pharmacokinetics of oxaliplatin in patients with severe hepatic dysfunction. Cancer Chemother Pharmacol. 2008;61(1):97-104.
Joerger M, Huitema AD, Huizing MT, et al. Safety and pharmacology of paclitaxel in patients with impaired liver function: a population pharmacokineticpharmacodynamic study. Br J Clin Pharmacol. 2007;64(5):622-33.
Koufuji K, Takeda J, Toyonaga A. Gastric Cancer Surgery in the Octogenarian. Tde Kurume Med J. 1997;44:91-7.
Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function. Committee for medicinal products for human use (CHMP). London: European Medicines Agency; August 2005.