Article ; Online: Value of therapeutic drug monitoring of endoxifen in Egyptian premenopausal patients with breast cancer given tamoxifen adjuvant therapy: A pilot study.
2022 Volume 29, Issue 7, Page(s) 1673–1686
Abstract: Background: The complex metabolic profile of tamoxifen anticancer drug and polymorphism in its metabolizing enzymes particularly CYP2D6 contribute to the high-observed inter-individual variability in its main active metabolite endoxifen. Therapeutic ... ...
| Abstract | Background: The complex metabolic profile of tamoxifen anticancer drug and polymorphism in its metabolizing enzymes particularly CYP2D6 contribute to the high-observed inter-individual variability in its main active metabolite endoxifen. Therapeutic drug monitoring of endoxifen may play a key role in optimizing tamoxifen therapy, and control of both adverse effects and cancer recurrence. This pilot study aims to assess the clinical benefits of applying endoxifen measurement during tamoxifen therapy in patients with breast cancer. Methods: Adult premenopausal breast cancer patients ≥ 18 years who received tamoxifen at a fixed dose of 20 mg daily were included. The primary endpoint was to identify the inter-subject variability in serum concentration of the drug and its metabolites especially endoxifen, through fixation of the tamoxifen dose. The secondary endpoint was to check the correlation between endoxifen metabolite concentration and the development of tamoxifen's adverse effects and cancer recurrence. Results: Sixty patients were included in the study with a mean age of 38.4 ± 0.6 years (range: 26-50). The mean concentration of tamoxifen and endoxifen was 181 ± 9.6 ng/mL and 31.49 ng/mL, respectively. The inter-individual variability in concentrations for the drug and its active metabolite as estimated by the coefficient of variation percentage was in 41% and 31%, respectively. Cancer recurrence was observed in a group of patients ( Conclusion: The measurement of the endoxifen active metabolite of tamoxifen in breast cancer patients can help dose optimization in light of the observed wide inter-individual variability in drug fixed-dose related concentration of the metabolite. Monitoring of serum concentration of endoxifen can help to reveal, reduce and control tamoxifen's adverse effects and cancer recurrence. |
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| MeSH term(s) | Adult ; Female ; Humans ; Breast Neoplasms ; Pilot Projects ; Drug Monitoring ; Egypt ; Neoplasm Recurrence, Local/drug therapy ; Tamoxifen/therapeutic use ; Antineoplastic Agents, Hormonal/therapeutic use |
| Chemical Substances | 4-hydroxy-N-desmethyltamoxifen (46AF8680RC) ; Tamoxifen (094ZI81Y45) ; Antineoplastic Agents, Hormonal |
| Language | English |
| Publishing date | 2022-12-25 |
| Publishing country | England |
| Document type | Journal Article |
| ZDB-ID | 1330764-2 |
| ISSN | 1477-092X ; 1078-1552 |
| ISSN (online) | 1477-092X |
| ISSN | 1078-1552 |
| DOI | 10.1177/10781552221146531 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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