Successful determination of imatinib re‐administration dosage by therapeutic drug monitoring in a case of chronic myeloid leukemia initiating dialysis for acute renal dysfunction

Nakahara, Ryosuke; Sumimoto, Takahiro; Tanaka, Ryota; Ogata, Masao

doi:10.1002/ccr3.4357

Cited by 6 publications

(4 citation statements)

References 25 publications

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“…We developed a rapid, sensitive, and efficient UPLC-MS/MS method to simul ously determine osimertinib, aumolertinib, and furmonertinib concentrations in hu Therapeutic drug monitoring (TDM) is an important technique for formulating dosing regimens for drugs with strong toxic effects, and great individual differences measured by drug concentrations in biological samples can identify inter-patient differences and improve the therapeutic effects of drugs while reducing AEs [22][23][24]. Several studies have also shown that TDM can improve the therapeutic efficacy of TKIs, supporting rational clinical use [25][26][27][28]. The ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method is a standard analytical tool for TDM and is widely used in clinical practice for precise treatment with targeted oral drugs.…”

Section: Introductionmentioning

confidence: 99%

Determination of Osimertinib, Aumolertinib, and Furmonertinib in Human Plasma for Therapeutic Drug Monitoring by UPLC-MS/MS

Li¹,

Ma³

et al. 2022

Molecules

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The third-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), osimertinib, aumolertinib, and furmonertinib represent a new treatment option for patients with EGFR p.Thr790 Met (T790 M)-mutated non-small cell lung cancer (NSCLC). Currently, there are no studies reporting the simultaneous quantification of these three drugs. A simple ultra-performance liquid chromatography–tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the simultaneous quantitative determination of osimertinib, aumolertinib, and furmonertinib concentrations in human plasma, and it was applied for therapeutic drug monitoring (TDM). Plasma samples were processed using the protein precipitation method (acetonitrile). A positive ion monitoring mode was used for detecting analytes. D3-Sorafenib was utilized as the internal standard (IS), and the mobile phases were acetonitrile (containing 0.1% formic acid) and water with gradient elution on an XSelect HSS XP column (2.1 mm × 100.0 mm, 2.5 µm, Waters, Milford, MA, USA) at a flow rate of 0.5 mL·min−1. The method’s selectivity, precision (coefficient of variation of intra-day and inter-day ≤ 6.1%), accuracy (95.8–105.2%), matrix effect (92.3–106.0%), extraction recovery, and stability results were acceptable according to the guidelines. The linear ranges were 5–500 ng·mL−1, 2–500 ng·mL−1, and 0.5–200 ng·mL−1 for osimertinib, aumolertinib, and furmonertinib, respectively. The results show that the method was sensitive, reliable, and simple and that it could be successfully applied to simultaneously determine the osimertinib, aumolertinib, and furmonertinib blood concentrations in patients. These findings support using the method for TDM, potentially reducing the incidence of dosing blindness and adverse effects due to empirical dosing and inter-patient differences.

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Section: Introductionmentioning

confidence: 99%

Determination of Osimertinib, Aumolertinib, and Furmonertinib in Human Plasma for Therapeutic Drug Monitoring by UPLC-MS/MS

Li¹,

Ma³

et al. 2022

Molecules

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“…between post-24h of Wednesday and pre-dialysis of Thursday) did not show any statistically significant difference. Probably, as hypothesized in a LMC study [ 27 ], due to hemodialysis, the steady state was not yet reached after one week from the start of treatment, as it normally happens in patients with normal renal function. Since RBC have some of the transporters used by imatinib to move through the cellular membrane [ 20 , 21 ] we also analyzed levels of imatinib in those cells, which remained relatively constant over time.…”

Section: Discussionmentioning

confidence: 99%

“…Among chronic myeloid leukemia patients, in one study a progressive increase of plasma levels of imatinib was reported, causing severe adverse effects requiring dose reduction [ 26 ]. In a more recent study, levels of imatinib were evaluated with a single analysis at day 8 and 28, with evidence of a large fluctuation of values, thought to occur because the steady state was reached on day 28 after re-administration [ 27 ]. The patient did not experience any clinically relevant toxicity.…”

Section: Discussionmentioning

confidence: 99%

Hemodialysis and imatinib: Plasma levels, efficacy and tolerability in a patient with metastatic GIST - Case report

De Luca,

Miliziano,

Guerra

et al. 2024

Heliyon

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“…14,15 A few studies have reported imatinib-related renal dysfunction and haematological toxicity. 16 Measuring creatinine concentration is not a reliable test for renal function; glomerulus filtration rate (GFR) estimation is a reliable or more validated assessment tool. 17 Several pieces of evidence have recommended that imatinib 400mg/day treatment is responsible for improved survival with a high rate of clinical outcomes or responses.…”

Section: Introductionmentioning

confidence: 99%

Effect of Imatinib treatment on renal anaemia in chronic myeloid leukemia patients

Singh

Vidyadhari

Bhurani

et al. 2023

J Oncol Pharm Pract

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Purpose In this study, we investigate renal function and anaemia during imatinib treatment in patients with chronic myeloid leukaemia. Methods The patients with chronic myeloid leukaemia with chronic phase who had been treated with only imatinib for 12 months at Rajiv Gandhi Cancer Institute and Research Centre (New Delhi, India) were enrolled and prospectively analysed. The chronic renal impairment parameters, including estimated glomerular filtration rate and haemoglobin levels for anaemia from June 2020 to June 2022, were monitored in newly diagnosed in patients with chronic myeloid leukaemia-chronic phase. The data were analysed by SPSS software version 22. Results In total 55 patients with chronic myeloid leukaemia chronic phase who had been on imatinib for 12 months were monitored. The mean estimated glomerular filtration rate was significantly decreased (74 ± 14 to 59 ± 12 mL/min/1.73m2, p < 0.001) with a decrease in mean haemoglobin levels after 12 months (10.9 ± 2.01 to 9.0 ± 1.02, p < 0.004). The decreased estimated glomerular filtration rate was negatively correlated with haemoglobin levels after 1 year of imatinib administration (correlation coefficient = 0.892, R2 = 0.7976, p < 0.05). Conclusion We recommended close monitoring of renal function and haemoglobin levels in patients with chronic myeloid leukaemia patients.

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Successful determination of imatinib re‐administration dosage by therapeutic drug monitoring in a case of chronic myeloid leukemia initiating dialysis for acute renal dysfunction

Abstract: Fixed dose regimen is currently the standard administration method for TKI. However, this case report indicated that TDM may by a useful approach to individualized dosing of TKI for the treatment of CML when initiating dialysis.

Cited by 6 publications

References 25 publications

Determination of Osimertinib, Aumolertinib, and Furmonertinib in Human Plasma for Therapeutic Drug Monitoring by UPLC-MS/MS

Determination of Osimertinib, Aumolertinib, and Furmonertinib in Human Plasma for Therapeutic Drug Monitoring by UPLC-MS/MS

Hemodialysis and imatinib: Plasma levels, efficacy and tolerability in a patient with metastatic GIST - Case report

Effect of Imatinib treatment on renal anaemia in chronic myeloid leukemia patients

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