Inter-patient variability in docetaxel pharmacokinetics: A review

Nieuweboer, Annemieke J.M.; Morrée, Ellen S. de; Graan, Anne-Joy M. de; Sparreboom, Alex; Wit, Ronald de; Mathijssen, Ron H.J.

doi:10.1016/j.ctrv.2015.04.012

Cited by 44 publications

(37 citation statements)

References 94 publications

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“…Therefore, the influence of hepatic function on docetaxel pharmacokinetics was not evaluable in this patient population. Other currently known factors of interindividual variability in docetaxel pharmacokinetics are not believed to have major impact .…”

Section: Discussionmentioning

confidence: 99%

“…N.S., not statistically significant Therefore, the influence of hepatic function on docetaxel pharmacokinetics was not evaluable in this patient population. Other currently known factors of interindividual variability in docetaxel pharmacokinetics are not believed to have major impact [26]. Generally, older NSCLC patients who received chemotherapy had fewer previous chemotherapy events than younger patients and were less likely to receive platinum-based regimens.…”

Section: Figurementioning

confidence: 99%

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The effects of advanced age and serum α₁‐acid glycoprotein on docetaxel unbound exposure and dose‐limiting toxicity in cancer patients

Kenmotsu

Imamura

Ono

et al. 2017

Brit J Clinical Pharma

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Aimα1‐Acid glycoprotein (AAG), which is a major binding protein of docetaxel, is considered to be a determinant for docetaxel pharmacokinetics. However, there are no reports about the impact of serum AAG on pharmacokinetics and pharmacodynamics in elderly patients treated with docetaxel. The aim of this prospective study was to elucidate the effects of advanced age and serum AAG on docetaxel unbound exposure and neutropenia, dose‐limiting toxicity, in cancer patients.MethodsDocetaxel was administered at 60 mg m−2 to 51 patients with non‐small cell lung cancer, 17 of whom were ≥75 years of age. Pharmacokinetics, unbound fraction (fu), neutropenia, serum protein levels of AAG and albumin, as well as baseline absolute neutrophil count (ANC) were assessed during the first course. Population pharmacokinetic and pharmacodynamic analyses were performed to evaluate the influence of clinically relevant factors on docetaxel pharmacokinetics and neutropenia.ResultsClearance of docetaxel and degree of fu were significantly associated with serum AAG level, but not with age. Area under the concentration–time curve of unbound docetaxel (fu·AUC) was significantly higher in patients aged ≥75 years (0.389 μg·h ml−1, 95% CI; 0.329–0.448 μg·h ml−1) compared with patients aged <75 years (0.310 μg·h ml−1, 95% CI; 0.268–0.352 μg·h ml−1). Percent decrease in ANC at nadir related to fu·AUC, and was dependent on baseline ANC.ConclusionRegardless of ageing, serum level of AAG determines docetaxel unbound exposure and related dose‐limiting toxicity. Serum AAG level and ANC at baseline appear to be predictive of neutropenia for patients of all ages following the administration of docetaxel.

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Section: Discussionmentioning

confidence: 99%

Section: Figurementioning

confidence: 99%

The effects of advanced age and serum α₁‐acid glycoprotein on docetaxel unbound exposure and dose‐limiting toxicity in cancer patients

Kenmotsu

Imamura

Ono

et al. 2017

Brit J Clinical Pharma

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“…Это связано с результатом иссле-дования II фазы, показавшим бо льшую токсичность у этих пациентов по сравнению с больными из запад-ных стран [53]. К прочим факторам, снижающим кли-ренс доцетаксела и кабазитаксела и вследствие этого потенциально повышающим токсичность препарата, относятся нарушение функции печени, кастрацион-ный статус и площадь поверхности тела [54]. Интерес-но, что несмотря на то, что курение не влияет на фар-макокинетику доцетаксела, была показана меньшая частота развития нейтропении IV степени у куриль-щиков (35 %) по сравнению с некурящими пациента-ми (52 %).…”

Section: диагностика и лечение опухолей мочеполовой системы рак предunclassified

Comparison of Abiraterone Acetate and Docetaxel with Androgen Deprivation Therapy in High-risk and Metastatic Hormone-naïve Prostate Cancer: A Systematic Review and Network Meta-analysis

et al. 2018

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ВведениеРак предстательной железы (РПЖ) является наи-более часто выявляемым некожным злокачественным заболеванием в США и Европе и одной из наиболее частых причин онкологической летальности [1]. Не-смотря на эффективность гормональной терапии (ГТ), у всех пациентов с метастатическим процессом рано или поздно отмечается прогрессирование заболева-ния -переход в кастрационно-резистентный РПЖ (КРРПЖ), который ассоциирован с плохим исходом. В 2004 г. по результатам 2 исследований препарат из группы таксанов доцетаксел был внесен в рекомен-дации как метод 1-й линии лечения метастатического КРРПЖ (мКРРПЖ), продемонстрировавший свою относительную безопасность и эффективность [2,3]. В случае дальнейшего прогрессирования возможности эффективного лечения были крайне ограничены. Не-сколько препаратов было оценено во II фазе исследо-ваний, однако показан лишь умеренный ответ -сни-жение уровня простатического специфического антигена (ПСА) на ≥50 % у 17-24 % пациентов. На се-годняшний день ввиду отсутствия улучшения выжи-ваемости и качества жизни больных эти препараты не рекомендуются в качестве терапии 2-й линии мКРРПЖ [4].Разработка и внедрение в клиническую практику препарата группы таксанов 2-го поколения стали сле-дующим шагом лечения мКРРПЖ [5].

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“…It is known that some carriers are involved in the pharmacokinetics of docetaxel: different SLCs (solute carriers) as SLC22A7, SLCO1B1, SLCO1B3, or ABC transporters (ATP-binding cassette) as ABCB1 (PGP), ABCC2, and ABCC 10 [20]. These carriers may be subject to genetic polymorphism, and several SNPs (single nucleotide polymorphisms) are associated with changes in the pharmacokinetics of docetaxel (clearance, Vmax, AUC) [20]. Although a possible explanation for toxicity risks, this pharmacokinetic or genetic information was not available in our database.…”

Section: Discussionmentioning

confidence: 99%

Prediction of docetaxel toxicity in older cancer patients: a Bayesian network approach

Khayi

Lafarge

Terret

et al. 2019

Fundamemntal Clinical Pharma

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Chemotherapy is an essential therapy in the fight against cancer. Polypathology and polymedication are often encountered in elderly patients, making this population especially at risk for adverse drug reactions, and particularly with cytotoxic drugs. The objective of this study was to build a model to predict high‐grade toxicity in elderly patients treated with docetaxel. Data from the trial TAX‐108 have been used to create the model. The variable to predict was the occurrence of grade 3 or 4 toxicity. The explanatory variables entered in the model were anthropometric and biological characteristics of patients at inclusion; fragility criteria (SMAF, CIRS‐G, performance status); location of the primary tumor; chemotherapy history, radiotherapy or surgery; weekly dose of docetaxel, cumulative dose administered. A Bayesian network model was developed using a global search procedure and an Expectation–Maximization algorithm. A 10‐fold cross‐validation was performed. A toxicity of grade 3 or higher was observed in 54% of patients. The variables providing the most information were the primary site (19.4%), the dose per course (17.5%), and albuminemia (13.1%). The area under the curve of the model obtained after cross‐validation was 74 ± 1.4%. The model built allows classifying correctly 71.21 ± 0.9% of patients in our sample in the cross‐validation procedure. The sensitivity and specificity of the model were 75 and 67%, respectively, and the positive and negative predictive values were 73 and 69%. The encouraging results from this first study show that Bayesian networks could help assess the benefit–risk ratio of chemotherapy in elderly patients.

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Inter-patient variability in docetaxel pharmacokinetics: A review

Cited by 44 publications

References 94 publications

The effects of advanced age and serum α₁‐acid glycoprotein on docetaxel unbound exposure and dose‐limiting toxicity in cancer patients

The effects of advanced age and serum α₁‐acid glycoprotein on docetaxel unbound exposure and dose‐limiting toxicity in cancer patients

Comparison of Abiraterone Acetate and Docetaxel with Androgen Deprivation Therapy in High-risk and Metastatic Hormone-naïve Prostate Cancer: A Systematic Review and Network Meta-analysis

Prediction of docetaxel toxicity in older cancer patients: a Bayesian network approach

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Inter-patient variability in docetaxel pharmacokinetics: A review

Cited by 44 publications

References 94 publications

The effects of advanced age and serum α1‐acid glycoprotein on docetaxel unbound exposure and dose‐limiting toxicity in cancer patients

The effects of advanced age and serum α1‐acid glycoprotein on docetaxel unbound exposure and dose‐limiting toxicity in cancer patients

Comparison of Abiraterone Acetate and Docetaxel with Androgen Deprivation Therapy in High-risk and Metastatic Hormone-naïve Prostate Cancer: A Systematic Review and Network Meta-analysis

Prediction of docetaxel toxicity in older cancer patients: a Bayesian network approach

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The effects of advanced age and serum α₁‐acid glycoprotein on docetaxel unbound exposure and dose‐limiting toxicity in cancer patients

The effects of advanced age and serum α₁‐acid glycoprotein on docetaxel unbound exposure and dose‐limiting toxicity in cancer patients