A rapid and sensitive liquid chromatography/tandem mass spectrometry method for determination of docetaxel in human plasma

Wang, L. Z.; Goh, Boon Cher; Grigg, M. E.; Lee, S. C.; Khoo, Yok Moi; Lee, H. S.

doi:10.1002/rcm.1091

Cited by 54 publications

(43 citation statements)

References 14 publications

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“…Plasma docetaxel was quantitated using an LC-MS method developed and validated at our laboratory, which has an intra-and inter-day precision of <7% and accuracy of 96-110%. (14) The LC-MS system consisted of an API 2000 triple quadrupole mass spectrometer (Applied Biosystems ⁄ MDS SCIEX, ON, Concord, Ontario, Canada) and an Agilent 1100 autosampler injector with 100-lL loop and 1100 column oven at 23°C (Agilent Technologies, Waldbronn, Germany). Chromatographic separations were carried out using an Eclipse XDB-C8 column (50 9 2.1 mm, inside diameter 5 lm; Agilent Technologies, USA).…”

Section: Methodsmentioning

confidence: 99%

Dose modifications in Asian cancer patients with hepatic dysfunction receiving weekly docetaxel: A prospective pharmacokinetic and safety study

et al. 2016

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Hepatic dysfunction may modify the safety profile and pharmacokinetics of docetaxel in cancer patients, but no validated guideline exists to guide dose modification necessitated by this uncommon comorbidity. We carried out the first prospective study of a personalized dosage regimen for cancer patients with liver dysfunction treated with docetaxel. Weekly dosages were stratified by hepatic dysfunction classification as such: Category 1, normal; Category 2, mild -alkaline phosphatase, aspartate aminotransferase, and ⁄ or alanine aminotransferase ≤53 upper limit of normal (ULN), and total bilirubin within normal range; and Category 3, moderate -any alkaline phosphatase, and aspartate aminotransferase or alanine aminotransferase ≤5-103 ULN, and ⁄ or total bilirubin ≤1-1.53 ULN. Category 1, 2 and 3 patients received starting dosages of 40, 30, and 20 mg ⁄ m 2 docetaxel, respectively. Pharmacokinetics were evaluated on day 1 and 8 of the first treatment cycle, and entered into a multilevel model to delineate interindividual and interoccasion variability. Adverse event evaluation was carried out weekly for two treatment cycles. We found that docetaxel clearance was significantly different between patient categories (P < 0.001). Median clearance was 22.8, 16.4, and 11.3 L ⁄ h ⁄ m 2 in Categories 1, 2, and 3, respectively, representing 28% and 50% reduced clearance in mild and moderate liver dysfunction patients, respectively. However, docetaxel exposure (area under the concentration-time curve) and docetaxel-induced neutropenia (nadir and the maximum percentage decrease in neutrophil count) were not significantly different between categories. Median area under the concentration-time curve was 1.74, 1.83, and 1.77 mgÁh ⁄ L in Categories 1, 2, and 3, respectively. The most common Grade 3 ⁄ 4 toxicity was neutropenia (30.0%). An unplanned comparison with the Child-Pugh and National Cancer Institute Organ Dysfunction Working Group grouping systems suggests that the proposed classification system appears to more effectively discriminate patients by docetaxel clearance and dose requirements. (ClinicalTrials.gov registration no. NCT00703378).H epatic dysfunction is a rare comorbidity affecting approximately 0.2% of cancer patients, (1) making it particularly challenging to accrue patients with hepatic dysfunction in oncology trials that assess its effects on the pharmacokinetics and safety profile of chemotherapeutic agents. The paucity of guidance on the treatment of this patient subpopulation can be a real practice issue in clinical oncology; many drugs that form the backbone of chemotherapy have narrow therapeutic windows and are often dosed close to maximally tolerable levels. Unacceptable toxicities can quickly set in if the implications of a reduced hepatic metabolic capacity are not properly regarded, as hepatic drug biotransformation is the predominant route of elimination for many cytotoxic agents.(2) We therefore propose that it may be helpful to risk-stratify cancer patients before starting them on a personalized d...

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Section: Methodsmentioning

confidence: 99%

Dose modifications in Asian cancer patients with hepatic dysfunction receiving weekly docetaxel: A prospective pharmacokinetic and safety study

et al. 2016

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“…Sample Determination by UPLC -MS/MS (16) Chromatography was performed on an ACQUITY TM UPLC system (Waters Corp., Milford, MA, USA) with a conditioned autosampler at 4°C. The separation of the DTX and PTX was achieved by using an ACQUITY TM UPLC BEH C18 column (50×2.1 mm i.d., 1.7 μm; Waters Corp., Milford, MA, USA) at a column temperature of 35°C…”

Section: Sample Preparationmentioning

confidence: 99%

Evaluation of Docetaxel-Loaded Intravenous Lipid Emulsion: Pharmacokinetics, Tissue Distribution, Antitumor Activity, Safety and Toxicity

Zhao

Xia

et al. 2010

Pharm Res

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“…A total of 25 patients enrolled to TXT q 3w and 15 enrolled to TXT q w had blood samples collected for docetaxel pharmacokinetics with and without concomitant prednisone. Plasma docetaxel concentrations were measured with a validated liquid chromatography/ mass spectroscopy method (13). Plasma concentration/time data were analyzed with the previously developed population pharmacokinetics Nonlinear Mixed Effect Model (14,15).…”

Section: Drug-drug Interactionsmentioning

confidence: 99%

Approval Summary

Dagher

Abraham

et al. 2004

Clinical Cancer Research

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Purpose: Docetaxel, a taxane previously approved for the treatment of breast cancer and non-small cell lung cancer, was approved by the United States Food and Drug Administration on May 19, 2004 for use in combination with prednisone for the treatment of metastatic androgen-independent (hormone-refractory) prostate cancer. The purpose of this summary is to review the database supporting this approval.Experimental Design: In a randomized, global study enrolling 1,006 patients, two schedules of docetaxel were compared with mitoxantrone ؉ prednisone as follows: MTZ q 3w, mitoxantrone 12 mg/m2 every 21 days ؉ prednisone 5 mg twice a day for a total of 10 cycles; TXT q 3w, docetaxel 75 mg/m 2 every 21 days ؉ prednisone 5 mg twice a day for a total of 10 cycles; and TXT qw, docetaxel 30 mg/m 2 days 1, 8, 15, 22, and 29 every 6 weeks ؉ prednisone 5 mg twice a day for a total of 5 cycles.Results: There was a statistically significant overall survival advantage shown for the TXT q 3w arm over MTZ q 3w (median survival 18.9 months versus 16.5 months, P ‫؍‬ 0.0094). No overall survival advantage was shown for TXT qw compared with MTZ q 3w. The most commonly occurring adverse events included anemia, neutropenia, infection, nausea, sensory neuropathy, fluid retention, alopecia, nail changes, diarrhea, and fatigue.Conclusions: This report describes the Food and Drug Administration review supporting this first approval of a combination therapy for hormone-refractory prostate cancer based on demonstration of a survival benefit.

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A rapid and sensitive liquid chromatography/tandem mass spectrometry method for determination of docetaxel in human plasma

Cited by 54 publications

References 14 publications

Dose modifications in Asian cancer patients with hepatic dysfunction receiving weekly docetaxel: A prospective pharmacokinetic and safety study

Dose modifications in Asian cancer patients with hepatic dysfunction receiving weekly docetaxel: A prospective pharmacokinetic and safety study

Evaluation of Docetaxel-Loaded Intravenous Lipid Emulsion: Pharmacokinetics, Tissue Distribution, Antitumor Activity, Safety and Toxicity

Approval Summary

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