Abstract
Therapeutic drug monitoring (TDM) is carried out by evaluating drug plasma (or serum) concentrations in response to individual optimal treatments by dose adjustment to improve efficacy or avoid side effects. Many molecular-targeted anticancer drugs show exposure-efficacy and exposure-toxicity relationships. Therefore, plasma concentrations of anticancer drugs can be used as biomarkers. However, to carry out TDM, therapeutic target ranges indicating exposure-response (efficacy/toxicity) relationships must be determined. In Japan, treatment fees for managing the TDM of imatinib and sunitinib have been assessed since 2012 and 2018, respectively. In therapy for imatinib or sunitinib using TDM, reduced toxicity, discontinuation rates, and costs for treatments as well asimproved clinical efficacy have been noted. To establish the use of TDM in clinical practice, it is necessary to determine target plasma concentrations (minimum effective concentration or minimum toxic concentration) of many molecular-targeted anticancer drugs by retrospective and prospective clinical trials. In these clinical trials, analytical methods with high precision are needed. By carrying out TDM, we may determine the optimal anticancer therapy for patients as precision medicine after the start of therapy.
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