Vinorelbine/docetaxel combination treatment of metastatic breast cancer: a phase I study

Bonneterre, Jacques; Campone, Mario; Koralewski, P.; Błasińska-Morawiec, Maria; Deporte-Fety, R.; Chatelut, Étienne; Leger, Frédéric; Longerey, B.; Ecochard, Laurent; Douville, I.

doi:10.1007/s00280-006-0375-6

Cited by 8 publications

(1 citation statement)

References 26 publications

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“…Topotecan administration followed by docetaxel also results in a decreased clearance of the latter, but in this case, the order of administration is important [38]. More recently, the absence of clinically relevant PK interactions was shown for docetaxel and lapatinib [80], bortezomib [81,82], ispinesib [83], erlotinib [84], the combination erlotinib/capecitabine [85], vinorelbine [86,87], pertuzumab [88], tipifarnib [89], granisetron [90] or celecoxib [91]. The combination of docetaxel and paclitaxel only changes the docetaxel PK parameters: increase in docetaxel clearance when the administration order is changed from paclitaxel/docetaxel into docetaxel/paclitaxel [29].…”

Section: Sources Of Variabilitymentioning

confidence: 99%

Level of evidence for therapeutic drug monitoring of taxanes

Schieveen

Royer

Therapeutics³

2010

Fundamental &Amp; Clinical Pharmacology

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Taxanes are anticancer drugs on the market for more than 10 years that are thought to be interesting for therapeutic drug monitoring (TDM): high inter- and intra-patient variability, relationship between exposure and efficacy and especially toxicity. Nevertheless, the paclitaxel and docetaxel characteristics result in different conclusions for these two molecules with respect to their TDM. For paclitaxel, the nonlinear pharmacokinetics makes that the parameter which seems the more reliable to toxicity or outcome is the time during which the plasma concentration exceeds 0.05 μm. Concentration controlled studies using Bayesian adaptation showed that the TDM of paclitaxel is feasible in routine. However, this target needs to be prospectively validated with new weekly schedules of administration, leading to a balance between 'recommended' and 'potentially useful'. For docetaxel, the 3-weekly administration, which is the more effective scheme, is also the more toxic. However, neutropenia can be individually modeled and efficiently predicted without using plasma drug concentrations. The docetaxel TDM using this docetaxel-related neutropenia modeling however needs to be prospectively validated in routine. The level of evidence of TDM thus 'needs to be assessed'.

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Section: Sources Of Variabilitymentioning

confidence: 99%

Level of evidence for therapeutic drug monitoring of taxanes

Schieveen

Royer

Therapeutics³

2010

Fundamental &Amp; Clinical Pharmacology

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Sensitive measurement of vinorelbine in dog plasma by liquid chromatography–electrospray ionization tandem mass spectrometry utilizing transitions from double‐charged precursor ions

Niwa

Kawashiro

2011

Biomedical Chromatography

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A sensitive high-performance liquid chromatography/tandem mass spectrometry (LC/MS/MS) method for measuring vinorelbine was developed. A 100 µL aliquot of plasma was spiked with deuterium-labeled internal standard and subjected to solid-phase extraction using an Oasis HLB μ-elution plate. Two microliters of the extracted samples was directly injected into LC/MS/MS. Chromatographic separation was achieved on a Capcell Pak C18 UG column (2 × 75 mm) with a gradient elution of methanol (mobile phase B) against 0.05% formic acid in aqueous 10 mm ammonium formate (mobile phase A). The LC flow rate was set to 0.28 mL/min and the gradient (solvent B concentration) was processed from 40 to 90%. In mass spectrometric detection, observation of the reaction from a double-charged precursor ion [M + 2H](2+) (m/z 390) to product ion m/z 122 provided very high sensitivity. The method was validated with a lower limit of detection of 0.2 ng/mL with 0.1 mL of plasma, and the method was used to determine the plasma pharmacokinetics of vinorelbine in dogs.

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Phase II study of vinorelbine (alternating intravenous and oral) in combination with docetaxel as first-line chemotherapy in metastatic breast cancer

Campone

Błasińska-Morawiec²,

Tekiela³

et al. 2008

Cancer Chemother Pharmacol

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Vinorelbine/docetaxel combination treatment of metastatic breast cancer: a phase I study

Abstract: This phase I study established the recommended doses and schedules of the combination alternating i.v. and oral VRL with DCT, this recommended regimen being further explored in a phase II study.

Cited by 8 publications

References 26 publications

Level of evidence for therapeutic drug monitoring of taxanes

Level of evidence for therapeutic drug monitoring of taxanes

Sensitive measurement of vinorelbine in dog plasma by liquid chromatography–electrospray ionization tandem mass spectrometry utilizing transitions from double‐charged precursor ions

Phase II study of vinorelbine (alternating intravenous and oral) in combination with docetaxel as first-line chemotherapy in metastatic breast cancer

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