Measurement of paclitaxel in biological matrices: high-throughput liquid chromatographic–tandem mass spectrometric quantification of paclitaxel and metabolites in human and dog plasma

Alexander, Michael; Kiser, Melissa M; Culley, Travis; Kern, John R.; Dolan, John W.; McChesney, James D.; Zygmunt, Jan; Bannister, Steve J.

doi:10.1016/s1570-0232(02)00913-3

Cited by 63 publications

(74 citation statements)

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“…To the best of our knowledge, this is the first paper investigating adduct ion formation of paclitaxel. In literature, quantitative analysis of paclitaxel by the analysis of [PAC ϩ H] ϩ has been reported with acetic acid as mobile phase additive [12]. Nevertheless we observed strong adduct formation of paclitaxel with sodium and potassium under such conditions.…”

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confidence: 56%

Adduct formation in quantitative bioanalysis: Effect of ionization conditions on paclitaxel

Mortier

Zhang

Peteghem

et al. 2004

J. Am. Soc. Mass Spectrom.

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Quantitative analysis of target compounds with liquid chromatography atmospheric pressure ionization mass spectrometry is sometimes hampered by adduct formation. In these situations, cationization with alkali metal ions instead of proton addition is often observed in the positive ion mode. This work studies the process of adduct formation and investigates potential strategies to control this phenomenon. Paclitaxel, a pharmaceutical chemotherapeutic agent, was used as a model compound. Electrospray (ESI), atmospheric pressure chemical ionization (APCI) and sonic spray ionization (SSI) are evaluated and compared. The work was performed on two different instruments, allowing the evaluation of different ionization behavior for different source design for electrospray, if any. Different mobile phase additives were compared, including acetic acid, formic acid, ammonium formate, and a range of primary amines. Continuous infusion was used for a fast screening, to detect optimal conditions. These were then further investigated in detail by LC-MS. The results indicate that electrospray is the more sensitive interface for this compound on the investigated apparatus. Unacceptable quantitative data were acquired without additives in the mobile phase. Generally, additives increased the reproducibility significantly. A response of mainly one ion was achieved with dodecylamine/acetic acid and acetic acid/sodium acetate. The data also point out the importance of evaluating adduct formation for compounds prone to this phenomenon during method development, especially in view of accurate quantitation. (J Am Soc Mass Spectrom 2004, 15, 585-592)

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confidence: 56%

Adduct formation in quantitative bioanalysis: Effect of ionization conditions on paclitaxel

Mortier

Zhang

Peteghem

et al. 2004

J. Am. Soc. Mass Spectrom.

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“…Paclitaxel was purchased from Sigma, St Louis, MI, USA and docetaxel from Fluka, Buchs, CH. The extraction method was performed as described by Alexander et al 25 The sample was transferred to a conical 300 ml polypropylene high-performance liquid chromatography micro vial. An aliquot of 40 ml was injected into a LaChrom high-performance liquid chromatography system (MerckHitachi, Darmstadt, Germany) and monitored at l ¼ 227 nm on the ultraviolet-detector.…”

Section: Patientsmentioning

confidence: 99%

Impact of CYP2C8*3 on paclitaxel clearance: a population pharmacokinetic and pharmacogenomic study in 93 patients with ovarian cancer

et al. 2010

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The primary purpose of this study was to evaluate the effect of CYP2C8*3 and three genetic ABCB1 variants on the elimination of paclitaxel. We studied 93 Caucasian women with ovarian cancer treated with paclitaxel and carboplatin. Using sparse sampling and nonlinear mixed effects modeling, the individual clearance of unbound paclitaxel was estimated from total plasma paclitaxel and Cremophor EL. The geometric mean of clearance was 385 l h -1 (range 176-726 l h -1 ). Carriers of CYP2C8*3 had 11% lower clearance than non-carriers, P ¼ 0.03. This has not been shown before in similar studies; the explanation is probably the advantage of using both unbound paclitaxel clearance and a population of patients of same gender. No significant association was found for the ABCB1 variants C1236T, G2677T/A and C3435T. Secondarily, other candidate single-nucleotide polymorphisms were explored with possible associations found for CYP2C8*4 (P ¼ 0.04) and ABCC1 g.7356253C4G (P ¼ 0.04).

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“…Two methods were used for the analysis of paclitaxel samples in this study. The first was a validated liquid chromatography/mass spectrometry assay (21). This assay was used to analyze the samples from patients 1 to 17.…”

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confidence: 99%

Phase I and Pharmacokinetic Study of Sequential Paclitaxel and Trabectedin Every 2 Weeks in Patients with Advanced Solid Tumors

Chu

Mita

Forouzesh

et al. 2010

Clinical Cancer Research

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Purpose: This phase I study evaluated the feasibility, safety, pharmacokinetics (PK), and preliminary evidence of anticancer activity of the sequential administration of paclitaxel and trabectedin on an every-2-week schedule in patients with refractory solid malignancies. The study also sought to determine the maximum tolerated dose (MTD) level on this schedule, as well as to recommend doses for diseasedirected studies.Experimental Design: Twenty-seven patients were treated with paclitaxel (80-120 mg/m 2 ; 1-hour i.v.infusion, day 1) and trabectedin (0.525-0.775 mg/m 2 ; 3-hour i.v. infusion, day 2) with doses increased in successive cohorts. Blood sampling for PK and drug-drug interaction studies was done.Results: Neutropenia, which resulted in treatment delay exceeding 1 week, was the principal doselimiting toxicity for this paclitaxel-trabectedin regimen and precluded dose escalation above 120 mg/m 2 paclitaxel and 0.650 mg/m 2 trabectedin. At the MTD (120 mg/m 2 paclitaxel and 0.650 mg/m 2 trabectedin), the safety profile was favorable in patients receiving cumulative treatment. Relevant drug-drug PK interactions between paclitaxel and trabectedin were not identified. A patient with soft tissue sarcoma had a complete response and several patients with various refractory solid malignancies showed protracted stable disease as their best response. Conclusions:The MTD level of sequential paclitaxel 1-hour infusion (day 1) and trabectedin 3-hour infusion (day 2) administered every 2 weeks is 120 and 0.650 mg/m 2 , respectively. The manageable toxicities at the MTD, preliminary evidence of antitumor activity, and lack of notable PK drug-drug interactions warrant further disease-directed studies of this regimen in relevant tumor types and settings.Clin Cancer Res; 16(9); 2656-65. ©2010 AACR.Trabectedin, a marine-derived antineoplastic agent initially isolated from the tunicate Ecteinascidia turbinata and currently produced synthetically, is a first-in-class antitumor agent with a complex mechanism of action at the level of transcription (1-3). As a single agent, trabectedin has shown antitumor activities in soft tissue sarcoma (STS; ref. 4) as well as in patients with several types of cancer, such as ovarian (5-7) and breast cancer (8), in which paclitaxel plays a principal role in therapeutic management and confers robust clinical benefit.In addition to clinical pragmatism as support for evaluating the combination of trabectedin and paclitaxel in the clinical settings, in which there is relevant single-agent activity, several preclinical studies have shown favorable interactions between these agents. For example, treatment of human CALU-3 lung and MCF-7 breast carcinoma xenografts with the combination of trabectedin and paclitaxel resulted in at least additive cytotoxicity (9). Furthermore, sequence-dependent cytotoxic synergism between trabectedin and paclitaxel has been noted in human HT-1080 and HS-18 sarcoma in vitro (10). Cytotoxic synergism was apparent when paclitaxel treatment occurred before trabe...

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Measurement of paclitaxel in biological matrices: high-throughput liquid chromatographic–tandem mass spectrometric quantification of paclitaxel and metabolites in human and dog plasma

Cited by 63 publications

References 4 publications

Adduct formation in quantitative bioanalysis: Effect of ionization conditions on paclitaxel

Adduct formation in quantitative bioanalysis: Effect of ionization conditions on paclitaxel

Impact of CYP2C8*3 on paclitaxel clearance: a population pharmacokinetic and pharmacogenomic study in 93 patients with ovarian cancer

Phase I and Pharmacokinetic Study of Sequential Paclitaxel and Trabectedin Every 2 Weeks in Patients with Advanced Solid Tumors

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