Bibliographic Details
| Title: |
UPLC-MS/MS-Based Analysis of Trastuzumab in Plasma Samples: Application in Breast Cancer Patients Sample Monitoring. |
| Authors: |
Sheikh, Aadil Ahmad, Alam, Ozair, Rub, Rehan Abdur, Iqbal, Muzaffar, Medhi, Kunjahari, Alsalman, Abdulkhaliq J., Imran, Mohd, Alshehri, Sultan, Ghoneim, Mohammed M., Shakeel, Faiyaz |
| Source: |
Processes; Mar2022, Vol. 10 Issue 3, p509, 15p |
| Subject Terms: |
TRASTUZUMAB, CANCER patients, PATIENT monitoring, METASTATIC breast cancer, BREAST cancer, MONOCLONAL antibodies, DIGESTION |
| Abstract: |
Trastuzumab is a target-based recombinant humanized IgG1 monoclonal antibody (mAbs), extensively employed for treatment of metastatic breast cancer with human epidermal growth receptor 2 (HER2) overexpression. Studies around the world have reported that mAbs have substantial inter-patient unpredictable absorption, distribution, metabolism, and excretion (ADME-pharmacokinetics) because of multiple elements manipulating the concentration of mAbs in plasma. Herein, we have established a bioanalytical technique using UPLC-MS/MS with an easy sample workup method and in-solution digestion protocol to assay the trastuzumab plasma samples from breast cancer patients in clinical studies. Surrogated proteolytic peptides were used for accurate quantification of trastuzumab (CanMab) with a trastuzumab signature peptide with [13C6, 15N4]-arginine and [13C6, 15N2]-lysine stable isotope-labeled (SIL) peptide. Experiments to validate the method were accurately carried out according to the guidelines mentioned in the bioanalytical method validation protocol. The evaluation established excellent linearity over a wide range of 5–500 µg/mL. The experimental procedure was efficaciously performed in a pilot study of five breast cancer patients and residual concentrations of drugs from responding and non-responding subjects were compared. The receiver operating characteristic (ROC) examination displayed that 52.25 µg/mL was the Cmin threshold predictive response with a satisfactory sensitivity of 88.58% and specificity of 79.25%. [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |
