A new dried blood spot LC-MS/MS method for therapeutic drug monitoring of palbociclib, ribociclib, and letrozole in patients with cancer

Poetto, Ariana Soledad; Posocco, Bianca; Gagno, Sara; Orleni, Marco; Zanchetta, Martina; Iacuzzi, Valentina; Canil, Giovanni; Buzzo, Mauro; Montico, Marcella; Guardascione, Michela; Basile, Debora; Pelizzari, Giacomo; Alberti, Marco; Gerratana, Lorenzo; Puglisi, Fabio; Toffoli, Giuseppe

doi:10.1016/j.jchromb.2021.122985

Cited by 16 publications

(9 citation statements)

References 17 publications

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“…In previous studies, the appearance of carry-over has been observed mostly for ABE, PAL and RIB [ 17 , 19 , 22 ]. Multiple strategies have been proposed for its elimination, from stationary phase exchange [ 22 ], different needle wash solvents [ 17 , 18 , 22 , 34 , 35 ], linear range reduction [ 19 ] and additional gradient washing steps [ 17 , 28 , 34 , 35 ].…”

Section: Resultsmentioning

confidence: 99%

“…This is the first method which provides full chromatographic separation of all six analytes of interest; demonstrates the applicability of three detectors, including a diode array detector, a fluorescence detector and a QTOF MS detector; and is simple, selective and affordable. As opposed to previously published bioanalytical methods, that either did not include all analytes [ 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 37 ] or did not analyze all six drugs in real patient samples [ 13 ], we applied our method to analyze all the drugs of interest in real patients, in a clinical TDM context and for clinical pharmacokinetic evaluation.…”

Section: Resultsmentioning

confidence: 99%

“…Compared to other previously published methods [ 15 , 16 , 17 , 18 , 19 , 20 , 22 ], we developed a simple, fast and reliable LC-MS method for the simultaneous analysis of six drugs used in different therapeutic combinations for breast cancer chemotherapy. A simple sample preparation procedure is applied, and a small amount of plasma is required.…”

Section: Resultsmentioning

confidence: 99%

“…A few liquid chromatography (LC) methods coupled to UV detection have been published for the analysis of PAL and LET [ 15 , 16 ] focusing on drug formulation or rat plasma samples. Several LC methods coupled to mass spectrometry have been published for the analysis of PAL, RIB and LET [ 17 , 18 ] or only the CDK4/6 inhibitors [ 19 ]. Methods for the analysis of ANA and FUL in combination with the CDK4/6 inhibitors are scarce.…”

Section: Introductionmentioning

confidence: 99%

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Development and Validation of a Novel LC-MS/MS Method for the Simultaneous Determination of Abemaciclib, Palbociclib, Ribociclib, Anastrozole, Letrozole, and Fulvestrant in Plasma Samples: A Prerequisite for Personalized Breast Cancer Treatment

et al. 2022

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Palbociclib, ribociclib and abemaciclib were recently approved as chemotherapeutic agents and are currently in the post-marketing surveillance phase. They are used in combination with aromatase inhibitors anastrozole and letrozole or antiestrogen fulvestrant for HR+, HER2− breast cancer treatment. Here, a novel bioanalytical LC-ESI-MS/MS method was developed for the quantitation of these six drugs in human plasma. The samples were prepared by simple protein precipitation followed by solvent evaporation. A Kinetex biphenyl column (150 × 4.6 mm, 2.6 µm) used for chromatographic analysis adequately resolved even the closely eluting aromatase inhibitors’ peaks. The mobile phase consisted of 0.1% formic acid in water and in ACN, in a linear gradient. An additional gradient step was added to eliminate the observed carry-over. The proposed method was fully validated in the relevant linear ranges covering the expected plasma concentrations of all six drugs (correlation coefficients between 0.9996 and 0.9931). The intra-day method precision (CV) ranged from 3.1% to 15%, while intra-day accuracy (%bias) was between −1.5% and 15.0%. The inter-day precision ranged from 1.6% to 14.9%, with accuracy between −14.3% and 14.6%, which is in accordance with the EMA and ICH guidelines on bioanalytical method validation. The method was successfully applied to samples from patients treated for HR+, HER2− breast cancer.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Development and Validation of a Novel LC-MS/MS Method for the Simultaneous Determination of Abemaciclib, Palbociclib, Ribociclib, Anastrozole, Letrozole, and Fulvestrant in Plasma Samples: A Prerequisite for Personalized Breast Cancer Treatment

et al. 2022

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“…Most studies reported an analytical run time (14 of 23) [19][20][21][25][26][27][28][29]33,34,[37][38][39]41 ranging from 2.3 to 8.5 minutes, and a sample preparation time (20 of 23), [19][20][21][22][23][24][25][26][27][28][29][30]33,34,[36][37][38][39][40][41] ranging from 80 to 160 minutes. However, the actual hands-on time was not revealed in any of the included studies.…”

Section: Sample Preparation Timementioning

confidence: 99%

Dried Blood Spot Sampling in the Monitoring of Anticancer Therapy for Solid Tumors: A Systematic Review

Shafiei

Mahmood

Beale

et al. 2023

Therapeutic Drug Monitoring

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Background:Dried blood spot (DBS) sampling is a convenient alternative to whole-blood sampling for therapeutic drug monitoring (TDM) in clinical practice. The aim of this study was to systematically review studies that have examined and used DBS sampling for the TDM of chemotherapy and targeted therapy agents for the treatment of patients with solid cancers.Methods:Using the PRISMA guidelines, a systematic literature search of EMBASE and PUBMED was performed to identify eligible clinical studies that used DBS sampling to monitor chemotherapy or targeted therapy for the treatment of solid cancers.Results:Of the 23 eligible studies, 3 measured concordance between drug concentrations determined by DBS and whole-blood, 7 developed analytical methods of DBS, and 13 performed both. DBS was employed for the TDM of everolimus (3 studies), vemurafenib (2 studies), pazopanib (2 studies), abiraterone (2 studies), mitotane, imatinib, adavosertib, capecitabine, 5-fluorouracil, gemcitabine, cyclophosphamide, ifosfamide, etoposide, irinotecan, docetaxel, gefitinib, palbociclib/ribociclib, and paclitaxel (one study each). The studies included a median of 14 participants (range: 6–34), with 10–50 μL of blood dispensed on DBS cards (20) and Mitra devices (3). Seventeen of the 20 studies that used DBS found no significant impact of the hematocrit on the accuracy and precision of the developed method in the normal hematocrit ranges (eg, 29.0%–59.0%). DBS and plasma or venous concentrations were highly correlated (correlation coefficient, 0.872–0.999) for all drugs, except mitotane, which did not meet a predefined level of significance (r > 0.872; correlation coefficient, r = 0.87, P < 0.0001).Conclusions:DBS provides an alternative sampling strategy for the TDM of many anticancer drugs. Further research is required to establish a standardized approach for sampling and processing DBS samples to allow future implementation.

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Simple and rapid quantification of ribociclib in rat plasma by protein precipitation and LC‐MS/MS: An application to pharmacokinetics of ribociclib nanoparticles in rats

Alshogran,

Al‐Shdefat,

Hailat

2023

J Mass Spectrom

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Ribociclib is a cyclin‐dependent kinase (CDK4/6) inhibitor and is a standard of care for treating metastatic breast cancer. The drug has moderate oral bioavailability and exhibits permeability‐controlled absorption. Novel formulations to enhance ribociclib pharmacokinetics are being developed and tested in rats. This requires developing analytical assays for quantifying ribociclib monitoring in rat plasma. We present a fully validated, sensitive, and simple LC‐MS/MS method for measuring ribociclib in rat plasma. Ribociclib‐D6 was utilized as an internal standard, and a simple protein precipitation procedure with acetonitrile was used in sample preparation. Excellent assay linearity was observed over a standard curve concentration of 1.008–1027.624 ng/mL. Acceptable intra‐ and inter‐day accuracy and reproductivity were demonstrated for ribociclib quality controls (bias and CV% within ±15%). Complete extraction recovery of ribociclib was achieved, and a negligible matrix effect of analyte to internal standard ratio was observed. Ribociclib was stable at various conditions, including bench‐top, freeze–thaw, and short‐term stability. Overall, the presented method is simple, sensitive, accurate, and precise and was successfully applied to quantify ribociclib in plasma samples from a pharmacokinetic study of ribociclib suspension and nanoparticle formulation in rats.

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A new dried blood spot LC-MS/MS method for therapeutic drug monitoring of palbociclib, ribociclib, and letrozole in patients with cancer

Cited by 16 publications

References 17 publications

Development and Validation of a Novel LC-MS/MS Method for the Simultaneous Determination of Abemaciclib, Palbociclib, Ribociclib, Anastrozole, Letrozole, and Fulvestrant in Plasma Samples: A Prerequisite for Personalized Breast Cancer Treatment

Development and Validation of a Novel LC-MS/MS Method for the Simultaneous Determination of Abemaciclib, Palbociclib, Ribociclib, Anastrozole, Letrozole, and Fulvestrant in Plasma Samples: A Prerequisite for Personalized Breast Cancer Treatment

Dried Blood Spot Sampling in the Monitoring of Anticancer Therapy for Solid Tumors: A Systematic Review

Simple and rapid quantification of ribociclib in rat plasma by protein precipitation and LC‐MS/MS: An application to pharmacokinetics of ribociclib nanoparticles in rats

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