Applied clinical study for development of rapid plasma concentration measurement method of molecular target anti-cancer drugs

2022 Fiscal Year Final Research Report

• Project/Area Number: 19K16442
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 47060:Clinical pharmacy-related
• Research Institution: Niigata University
• Principal Investigator: Razvina Olga 新潟大学, 医歯学系, 助教 (60835312)
• Project Period (FY): 2019-04-01 – 2023-03-31
• Keywords: 治療薬物モニタリング / 導電性ダイヤモンド電極 / 分子標的薬 / 薬物動態 / イマチニブ / ダイヤモンドセンサ / TDM

Outline of Final Research Achievements

In this study, we developed a rapid method for measuring plasma concentrations of the molecularly targeted Imatinib and Lenvatinib using state-of-the-art diamond electrodes. To reduce drug side effects and maximize efficacy, blood concentrations must be measured rapidly, and medications must be administered at optimal therapeutic concentrations. The experiment was conducted by adding different concentrations of imatinib to guinea pig plasma to validate the measurement method. The results showed that the assay could measure drug concentrations ranging from 0.01 μM to 10 μM, including the recommended therapeutic concentration range for each. Each measurement was completed in approximately 20 seconds. This rapid and straightforward measurement method can potentially contribute to developing effective, safe, and secure cancer drug therapy.

Free Research Field

医療薬学

Academic Significance and Societal Importance of the Research Achievements

分子標的薬のテーラーメイド治療では、症状に照らし合わせながら“頻回”の血中モニタリングが不可欠となってくる。現在、濃度を定量するには、（1）LC-MS/MS（質量分析器）など特殊な装置が必要である。よって、殆どの医療施設では、測定を外注しており、（2）高額な費用（~数万円/1検体）と、（3）結果を得るまでの長い日数（3~16日）が問題となっている。同時に、（1）~（3）の理由から、分子標的薬の毒性や効果と血中濃度の相関を調査する臨床研究が不十分となり、最適な薬物投与法の開発が滞っている。以上の課題を解決する「迅速・簡便」な測定方法の確立は急務である。