Development and validation of a liquid chromatography-tandem mass spectrometry assay for nine oral anticancer drugs in human plasma

Janssen, Julie M; Vries, Niels de; Venekamp, Nikkie; Rosing, Hilde; Huitema, Alwin D. R.; Beijnen, Jos H.

doi:10.1016/j.jpba.2019.06.034

Cited by 44 publications

(47 citation statements)

References 11 publications

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“…Our results were comparable with the results reported by Veerman et al, who described short‐term stability of OSIM in heparinized plasma for at least 3 h and a recovery after 24 h of <20% (Veerman et al, ). According to previous studies, OSIM was stable for at least 4–6 h in EDTA plasma at RT (Janssen et al, ; Mitchell et al, ). Similarly, we found that OSIM was stable in EDTA–plasma for at least 4 h at RT.…”

Section: Resultsmentioning

confidence: 79%

“…Other analytical methods for OSIM have been published previously. While some have mainly focused on OSIM alone or in combination with its metabolites (Irie et al, ; Mitchell et al, ; Rood et al, ; Zheng et al, ), others developed an analytical method for multiple TKIs (Janssen et al, ; Reis et al, ; Veerman et al, ). As the active metabolites of OSIM account for ~10% of the total OSIM AUC (Planchard et al, ; Vishwanathan et al, ), they could contribute to the efficacy and toxicity of osimertinib, with AZ5104 being the most likely option owing to the increased potency seen in in‐vitro studies (Cross et al, ).…”

Section: Resultsmentioning

confidence: 99%

“…In our method, HPLC was used for separation, whereas other studies mainly used ultra‐high‐performance liquid chromatography (UPLC) for separation (Janssen et al, ; Mitchell et al, ; Rood et al, ; Veerman et al, ; Zheng et al, ). As UPLC may not be available in all laboratories, the use of HPLC could enable more laboratories to implement the quantification of OSIM.…”

Section: Resultsmentioning

confidence: 99%

“…Contrasting results have been reported regarding the short‐term stability of OSIM, especially at RT. While multiple studies described good stability of OSIM at RT for at least 6 h (Mitchell et al, ; Reis et al, ;Rood et al, ; Zheng et al, ), others reported more limited stability, namely 3–4 h (Janssen et al, ; Veerman et al, ). However, differences in OSIM concentrations and type of plasma complicate adequate comparison of the results of these studies.…”

Section: Resultsmentioning

confidence: 99%

“…Seven liquid chromatography–tandem mass spectrometry (LC–MS/MS) methods to quantify OSIM in human plasma have previously been reported (Irie et al, ; Janssen et al, ; Mitchell, Bailey, Ewles, Swan, & Turpin, ; Reis et al, ; Rood, van Bussel, Schellens, Beijnen, & Sparidans, ; Veerman, Lam, Mathijssen, Koolen, & de Bruijn, ; Zheng et al, ). Four methods were single‐drug methods for OSIM (and its metabolites) (Irie et al, ; Mitchell et al, ; Rood et al, ; Zheng et al, ), while two other methods focused on simultaneous determination of multiple TKIs (Janssen et al, ; Reis et al, ; Veerman et al, ). Short‐term stability of OSIM has been evaluated in different types of plasma and in whole blood, but not one study evaluated OSIM stability in EDTA–plasma, heparinized plasma, human serum and whole blood, which makes it difficult to compare the stability results.…”

Section: Introductionmentioning

confidence: 99%

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Validation of an analytical method using HPLC–MS/MS to quantify osimertinib in human plasma and supplementary stability results

Veelen

Geel

Beer

et al. 2020

Biomedical Chromatography

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A new method for quantification of osimertinib (OSIM) in human plasma using a high‐performance liquid chromatography–tandem mass spectrometry method was developed and validated. Methanol was used for protein precipitation and pazopanib as internal standard. Separation was performed on a HyPURITY®C18 analytical column (50 × 2.1 mm; 3 μm) using a gradient elution of ammonium acetate in water and ammonium acetate in methanol, both acidified with formic acid 0.1%. Detection and quantification of OSIM and pazopanib was performed using a triple quadruple mass spectrometer after electrospray ionization. This method led to robust results, as the selectivity, carryover, precision and accuracy all met pre‐specified requirements. OSIM was stable in human serum when stored at −80°C. Reduced stability was found when stored at 2–4°C or room temperature. Degradation of OSIM slowed down in EDTA–plasma and acidified human serum. The limited stability of OSIM at room temperature should be considered for transport and sample preparation. Plasma samples should be frozen as soon as possible and sample preparation should be performed on dry‐ice. In the future, EDTA–plasma and sample acidification may be used to improve OSIM stability at room temperature. However, more research and validation of such an approach are required.

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Section: Resultsmentioning

confidence: 79%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Validation of an analytical method using HPLC–MS/MS to quantify osimertinib in human plasma and supplementary stability results

Veelen

Geel

Beer

et al. 2020

Biomedical Chromatography

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Development and validation of an ultra‐performance liquid chromatography–tandem mass spectrometry method to quantify the small molecule inhibitors adagrasib, alectinib, brigatinib, capmatinib, crizotinib, lorlatinib, selpercatinib, and sotorasib in human plasma

Hollander,

Zimmerman,

Piet

et al. 2024

Biomedical Chromatography

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Small molecule inhibitors (SMIs) are increasingly being used in the treatment of non‐small cell lung cancer. To support pharmacokinetic research and clinical treatment monitoring, our aim was to develop and validate an ultra‐performance liquid chromatography–mass spectrometry (UPLC‐MS/MS) assay for quantification of eight SMIs: adagrasib, alectinib, brigatinib, capmatinib, crizotinib, lorlatinib, selpercatinib, and sotorasib. Development of the UPLC‐MS/MS assay was done by trying different columns and eluents to optimize peak shape. The assay was validated based on guidelines of the European Medicines Agency. Chromatographic separation was performed with a gradient elution using ammonium formate in water and methanol. Detection was performed using a triple quadrupole tandem mass spectrometer with electrospray ionization. Validation was performed in a range of 10–2500 μg/L for lorlatinib, 25–6250 μg/L for alectinib and crizotinib, 25–10,000 μg/L for capmatinib and selpercatinib, 50–12,500 μg/L for brigatinib, and 100–25,000 μg/L for adagrasib and sotorasib. Imprecision was <8.88% and inaccuracy was <12.5% for all compounds. Seven out of eight compounds were stable for 96 h at room temperature. Sotorasib was stable for 8 h at room temperature. A sensitive and reliable method has been developed to quantify eight SMIs with a single assay, enhancing efficacy and safety of targeted therapies.

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Exposure–Response Analyses of Anaplastic Lymphoma Kinase Inhibitors Crizotinib and Alectinib in Non‐Small Cell Lung Cancer Patients

Groenland

Geel

Janssen

et al. 2020

Clin Pharma and Therapeutics

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Crizotinib and alectinib are anaplastic lymphoma kinase (ALK)-inhibitors indicated for the treatment of ALKpositive metastatic non-small cell lung cancer (NSCLC). At the currently used fixed doses, interindividual variability in exposure is high. The aim of this study was to investigate whether minimum plasma concentrations (C min) of crizotinib and alectinib are related to efficacy and toxicity. An observational study was performed, in which ALK-positive NSCLC patients who were treated with crizotinib and alectinib and from whom pharmacokinetic samples were collected in routine care, were included in the study. Exposure-response analyses were explored using previously proposed C min thresholds of 235 ng/mL for crizotinib and 435 ng/mL for alectinib. Forty-eight crizotinib and 52 alectinib patients were included. For crizotinib, median progression-free survival (mPFS) was 5.7 vs. 17.4 months for patients with C min < 235 ng/mL (48%) and ≥ 235 ng/mL, respectively (P = 0.08). In multivariable analysis, C min < 235 ng/mL resulted in a hazard ratio (HR) of 1.79 (95% confidence interval (CI), 0.90-3.59, P = 0.100). In a pooled analysis of all crizotinib patients (not only ALK-positive, n = 79), the HR was 2.15 (95% CI, 1.21-3.84, P = 0.009). For alectinib, mPFS was 12.6 months vs. not estimable (95% CI, 19.8-not estimable) for patients with C min < 435 ng/mL (37%) and ≥ 435 ng/mL, respectively (P = 0.04). Multivariable analysis resulted in an HR of 4.29 (95% CI, 1.33-13.90, P = 0.015). In conclusion, PFS of crizotinib and alectinib treated NSCLC patients is prolonged in patients with C min ≥ 235 ng/mL and 435 ng/mL, respectively. Therefore, therapeutic drug monitoring should be part of routine clinical management for these agents.

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Development and validation of a liquid chromatography-tandem mass spectrometry assay for nine oral anticancer drugs in human plasma

Cited by 44 publications

References 11 publications

Validation of an analytical method using HPLC–MS/MS to quantify osimertinib in human plasma and supplementary stability results

Validation of an analytical method using HPLC–MS/MS to quantify osimertinib in human plasma and supplementary stability results

Development and validation of an ultra‐performance liquid chromatography–tandem mass spectrometry method to quantify the small molecule inhibitors adagrasib, alectinib, brigatinib, capmatinib, crizotinib, lorlatinib, selpercatinib, and sotorasib in human plasma

Exposure–Response Analyses of Anaplastic Lymphoma Kinase Inhibitors Crizotinib and Alectinib in Non‐Small Cell Lung Cancer Patients

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