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Therapeutic drug management of tyrosine kinase inhibitor

Research Project

Project/Area Number 23590168
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical pharmacy
Research InstitutionAkita University

Principal Investigator

MIURA MASATOMO  秋田大学, 医学部, 教授 (30265194)

Co-Investigator(Renkei-kenkyūsha) TAKAHASHI Naoto  秋田大学, 医学部, 講師 (80344753)
SATO Kazuhiro  秋田大学, 医学部, 講師 (30436191)
TSUCHIYA Norihiko  秋田大学, 医学部, 准教授 (70282176)
Project Period (FY) 2011 – 2013
Project Status Completed (Fiscal Year 2013)
Budget Amount *help
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2013: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2012: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2011: ¥2,470,000 (Direct Cost: ¥1,900,000、Indirect Cost: ¥570,000)
Keywords分子標的抗がん剤 / TDM / 遺伝子多型 / 分子標的治療薬 / 血中濃度 / 個別化療法
Research Abstract

Because of the variability in tyrosine kinase inhibitor(TKI) exposure among patients, therapeutic drug monitoring (TDM) to maintain a certain fixed plasma threshold level would be beneficial during TKI therapy. TDM service should be routinely provided to patients taking TKI. Patients at increased hyperbilirubinemia risk could be identified by prospective UGT1A1 genotyping prior to nilotinib therapy. The efficacy of the threshold plasma trough concentration of nilotinib should be set above 800 ng/mL for CML patients. Dasatinib efficacy and safety were associared with exposure (AUC). A lower dasatinib exposure was detected among patients with T315I compared to those without the mutation. These data suggest that sufficient exposure of dasatinib may prohibit clonal evolution by adequately inhibiting BCR-ABL kinase. And plasma trough concentration of dasatinib should not exceed 2.5 ng/mL in CML patients.

Report

(4 results)
  • 2013 Annual Research Report   Final Research Report ( PDF )
  • 2012 Research-status Report
  • 2011 Research-status Report
  • Research Products

    (33 results)

All 2014 2013 2012 2011

All Journal Article (19 results) (of which Peer Reviewed: 11 results,  Open Access: 1 results) Presentation (13 results) Book (1 results)

  • [Journal Article] Multicenter phase II clinical trial of nilotinib for patients with imatinib-resistant or -intolerant chronic myeloid leukemia from the East Japan CML study group evaluation of molecular response and the efficacy and safety of nilotinib.2014

    • Author(s)
      Takahashi N, Miura M, Kuroki J, Mitani K, Kitabayashi A, Sasaki O, Kimura H, Imai K, Tsukamoto N, Noji H, Kondo T, Motegi M, Kato Y, Mita M, Saito H, Yoshida C, Torimoto Y, Kimura T, Wano Y, Nomura J, Yamamoto S, Mayama K, Honma R, Sugawara T, Sato S, Shinagawa A, Abumiya M, Niioka T, Harigae H, Sawada K.
    • Journal Title

      Biomark Res.

      Volume: 20;2(1) Issue: 1 Pages: 2-6

    • DOI

      10.1186/2050-7771-2-6

    • Related Report
      2013 Annual Research Report 2013 Final Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] A limited sampling strategy for estimation of the area under the plasma concentration-time curve of gefitinib2014

    • Author(s)
      Miura M, Sato K, Miura H, Niioka T, Kobayashi H, Narita C, Ito H
    • Journal Title

      Ther Drug Monit

      Volume: 36(1) Pages: 24-9

    • Related Report
      2013 Final Research Report
  • [Journal Article] A Limited Sampling Model to Estimate Exposure to Lenalidomide in Multiple Myeloma Patients.2014

    • Author(s)
      Shida S, Takahashi N, Miura M, Niioka T, Matsumoto M, Hagihara M, Kobayashi T, Abumiya M, Kameoka Y, Fujishima N, Tagawa H, Hirokawa M, Sawada K.
    • Journal Title

      Ther Drug Monit.

      Volume: 印刷中

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Journal Article] A limited sampling strategy for estimation of the area under the plasma concentration-time curve of gefitinib.2014

    • Author(s)
      Miura M, Sato K, Miura H, Niioka T, Kobayashi H, Narita C, Ito H.
    • Journal Title

      Ther Drug Monit.

      Volume: 36(1) Pages: 24-9

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Therapeutic drug management of BCR-ABL tyrosine kinase inhibitor for chronic myeloid leukemia patients.2014

    • Author(s)
      Miura M, Takahashi N.
    • Journal Title

      Rinsho Ketsueki

      Volume: 54 Pages: 1720-1729

    • NAID

      10031196316

    • Related Report
      2013 Annual Research Report
  • [Journal Article] Therapeutic drug management of BCR-ABL tyrosine kinase inhibitor for chronic myeloid leukemia patients2013

    • Author(s)
      Miura M, Takahashi N
    • Journal Title

      Rinsho Ketsueki

      Volume: Vol.54 Pages: 1720-1729

    • NAID

      10031196316

    • Related Report
      2013 Final Research Report
  • [Journal Article] A multicenter clinical study evaluating the confirmed complete molecular response rate in imatinib-treated patients with chronic phase chronic myeloid leukemia by using the international scale of real-time quantitative polymerase chain reaction.2013

    • Author(s)
      Shinohara Y, Takahashi N, Nishiwaki K, Hino M, Kashimura M, Wakita H, Hatano Y, Hirasawa A, Nakagawa Y, Itoh K, Masuoka H, Aotsuka N, Matsuura Y, Takahara S, Sano K, Kuroki J, Hata T, Nakamae H, Mugitani A, Nakane T, Miyazaki Y, Niioka T, Miura M, Sawada K.
    • Journal Title

      Haematologica.

      Volume: 98(9) Issue: 9 Pages: 1407-13

    • DOI

      10.3324/haematol.2013.085167

    • NAID

      120006986100

    • Related Report
      2013 Annual Research Report 2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Absence of effect of SLC22A2 genotype on cisplatin-induced nephrotoxicity in oesophageal cancer patients receiving cisplatin and 5-fluorouracil: report of results discordant with those of earlier studies.2013

    • Author(s)
      Hinai Y, Motoyama S, Niioka T, Miura M.
    • Journal Title

      J Clin Pharm Ther.

      Volume: 38(6) Issue: 6 Pages: 498-503

    • DOI

      10.1111/jcpt.12097

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Pharmacokinetics of dasatinib for Philadelphia-positive acute lymphocytic leukemia with acquired T315I mutation2012

    • Author(s)
      Takahashi N, Miura M, Scott SA, Niioka T, Sawada K
    • Journal Title

      J Hematol Oncol

      Volume: 5 Issue: 1 Pages: 23-23

    • DOI

      10.1186/1756-8722-5-23

    • Related Report
      2013 Final Research Report 2012 Research-status Report
  • [Journal Article] Influence of H2-receptor antagonists and proton pump inhibitors on dasatinib pharmacokinetics in Japanese leukemia patients2012

    • Author(s)
      Takahashi N, Miura M, Niioka T, Sawada K
    • Journal Title

      Cancer Chemother Pharmacol

      Volume: 69(4) Issue: 4 Pages: 999-1004

    • DOI

      10.1007/s00280-011-1797-3

    • Related Report
      2013 Final Research Report 2012 Research-status Report
  • [Journal Article] Bile acid is important for gastrointestinal absorption of nilotinib.2012

    • Author(s)
      Fujimi A, Takahashi N, Miura M, Kanisawa Y, Ono K, Sawada K.
    • Journal Title

      Eur J Clin Pharmacol.

      Volume: 68 Issue: 11 Pages: 1575-6

    • DOI

      10.1007/s00228-012-1282-x

    • Related Report
      2013 Final Research Report 2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] Pharmacokinetics of nilotinib in imatinib-resistant/intolerant chronic myeloid leukemia patients on hemodialysis for chronic renal failure.2012

    • Author(s)
      Onaka T, Takahashi N, Miura M, Yonezawa A, Imada K, Sawada K
    • Journal Title

      Am J Hematol.

      Volume: 87 Issue: 4 Pages: 451-451

    • DOI

      10.1002/ajh.23125

    • Related Report
      2013 Final Research Report 2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] H2-receptor antagonist influences dasatinib pharmacokinetics in a patient with Philadelphia-positive acute lymphoblastic leukemia2012

    • Author(s)
      Matsuoka A, Takahashi N, Miura M, Niioka T, Kawakami K, Matsunaga T, Sawada K
    • Journal Title

      Cancer Chemother Pharmacol

      Volume: 70(2) Issue: 2 Pages: 351-2

    • DOI

      10.1007/s00280-012-1900-4

    • Related Report
      2013 Final Research Report 2012 Research-status Report
  • [Journal Article] Drug interaction between lenalidomide and itraconazole2012

    • Author(s)
      Takahashi N, Miura M, Kameoka Y, Abumiya M, Sawada K
    • Journal Title

      Am J Hematol

      Volume: 87 Issue: 3 Pages: 338-9

    • DOI

      10.1002/ajh.22260

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] Influence of H2-receptor antagonists and proton pump inhibitors on dasatinib pharmacokinetics in Japanese leukemia patients.2012

    • Author(s)
      Takahashi N, Miura M, Niioka T, Sawada K.
    • Journal Title

      Cancer Chemother Pharmacol

      Volume: 69(4) Pages: 999-1004

    • Related Report
      2011 Research-status Report
    • Peer Reviewed
  • [Journal Article] Quantitative determination of imatinib in human plasma with high-performance liquid chromatography and ultraviolet detection2011

    • Author(s)
      Miura M, Takahashi N, Sawada K
    • Journal Title

      J Chromatogr Sci

      Volume: 49(5) Pages: 412-5

    • Related Report
      2013 Final Research Report
  • [Journal Article] Therapeutic drug monitoring of imatinib for chronic myeloid leukemia patients in the chronic phase2011

    • Author(s)
      Takahashi N, Miura M
    • Journal Title

      Pharmacology

      Volume: 87(5-6) Issue: 5-6 Pages: 241-8

    • DOI

      10.1159/000324900

    • Related Report
      2013 Final Research Report
  • [Journal Article] Quantitative determination of imatinib in human plasma with high-performance liquid chromatography and ultraviolet detection.2011

    • Author(s)
      Miura M, Takahashi N, Sawada K.
    • Journal Title

      J Chromatogr Sci.

      Volume: 49(5) Pages: 412-5

    • Related Report
      2011 Research-status Report
    • Peer Reviewed
  • [Journal Article] Therapeutic drug monitoring of imatinib for chronic myeloid leukemia patients in the chronic phase.2011

    • Author(s)
      Takahashi N, Miura M.
    • Journal Title

      Pharmacology.

      Volume: 87(5-6) Pages: 241-8

    • Related Report
      2011 Research-status Report
    • Peer Reviewed
  • [Presentation] 非小細胞肺癌患者のゲフィチニブによる治療に複数規格は必要ないか?2014

    • Author(s)
      新岡丈典, 佐藤一洋, 小林裕幸,三浦 肇,伊藤 宏,三浦昌朋
    • Organizer
      日本薬学会第134年会
    • Place of Presentation
      熊本
    • Related Report
      2013 Annual Research Report
  • [Presentation] 慢性骨髄性白血病に対するBCR-ABLチロシンキナーゼ阻害剤の血中濃度を用いた治療マネジメント2013

    • Author(s)
      三浦昌朋
    • Organizer
      第75回日本血液学会学術集会
    • Place of Presentation
      札幌
    • Related Report
      2013 Annual Research Report 2013 Final Research Report
  • [Presentation] Inter- and intra-individual variability of nilotinib plasma trough concentration in CML patients2013

    • Author(s)
      Abumiya M, Miura M, Takahashi N, Niioka T, Sawada K
    • Organizer
      第75回日本血液学会学術集会
    • Place of Presentation
      札幌
    • Related Report
      2013 Final Research Report
  • [Presentation] 進行性腎細胞がん患者におけるスニチニブ血中濃度モニタリングによる副作用発現予測の検討2013

    • Author(s)
      藤山信弘,土谷順彦,羽渕友則,三浦昌朋
    • Organizer
      4. 医療薬学フォーラム2013/第21回クリニカルファーマシーシンポジウム
    • Place of Presentation
      金沢
    • Related Report
      2013 Annual Research Report
  • [Presentation] Inter- and intra-individual variability of nilotinib plasma trough concentration in CML patients.2013

    • Author(s)
      2) Maiko Abumiya, Masatomo Miura, Naoto Takahashi, Takenori Niioka, Kenichi Sawada
    • Organizer
      第75回日本血液学会学術集会
    • Place of Presentation
      札幌
    • Related Report
      2013 Annual Research Report
  • [Presentation] Multicenter Phase II Clinical Trial of Nilotinib for Patients with Imatinib-Resistant or Intolerant CML from the East Japan CML Study Group (EJCML) Trial : Evaluation of Molecular Responses by the BCR-ABL1 Mutational Status and Plasma Trough Concentration of Nilotinib2012

    • Author(s)
      Takahashi N, Miura M, et al
    • Organizer
      54th American Society of Hematology Annual Meeting and Exposition
    • Place of Presentation
      Atlanta
    • Related Report
      2013 Final Research Report
  • [Presentation] ダサチニブと胃酸分泌抑制剤との相互作用2012

    • Author(s)
      三浦昌朋,高橋直人,新岡丈典,澤田賢一
    • Organizer
      日本薬学会第132年会
    • Place of Presentation
      札幌
    • Related Report
      2013 Final Research Report 2011 Research-status Report
  • [Presentation] チロシンキナーゼ阻害剤のTDM2012

    • Author(s)
      三浦昌朋
    • Organizer
      医療薬学フォーラム2012/第20回クリニカルファーマシーシンポジウム
    • Place of Presentation
      福岡
    • Related Report
      2013 Final Research Report 2012 Research-status Report
  • [Presentation] 経口分子標的治療薬の個別化治療2012

    • Author(s)
      三浦昌朋,高橋直人
    • Organizer
      第33回日本臨床薬理学会学術総会
    • Place of Presentation
      沖縄
    • Related Report
      2013 Final Research Report 2012 Research-status Report
  • [Presentation] Multicenter phase II clinical trial of Nilotinib for patients with Imatinib-resistance or -intolerant CML from the East Japan CML Study Group (EJCML): Evaluation of molecular response by BCR-ABL1 mutation status and plasma trough concentration of Nilotinib2012

    • Author(s)
      Takahashi N, Miura M, Niioka T, et al
    • Organizer
      ASH Annual Meeting
    • Place of Presentation
      アトランタ
    • Related Report
      2012 Research-status Report
  • [Presentation] 遺伝子多型情報とTDMに基づいたイマチニブ個別化療法2011

    • Author(s)
      三浦昌朋
    • Organizer
      第28回日本TDM学会・学術大会
    • Place of Presentation
      広島
    • Related Report
      2013 Final Research Report
  • [Presentation] 遺伝子多型情報とTDMに基づいたイマチニブ個別化療法2011

    • Author(s)
      三浦 昌朋、高橋 直人
    • Organizer
      第28回 日本TDM学会
    • Place of Presentation
      広島
    • Related Report
      2011 Research-status Report
  • [Presentation] イマチニブ服用患者に対して我々薬剤師ができること2011

    • Author(s)
      三浦 昌朋
    • Organizer
      日本病院薬剤師会第一回東北ブロック学術大会
    • Place of Presentation
      弘前
    • Related Report
      2011 Research-status Report
  • [Book] Therapeutic Drug Monitoring of Imatinib for Chronic Myeloid Leukemia Patients. Myeloid Leukemia–Clinical Diagnosis and Treatment2011

    • Author(s)
      Takahashi, N and Miura, M
    • Publisher
      INTECH, Croatia
    • Related Report
      2013 Final Research Report

URL: 

Published: 2011-08-05   Modified: 2019-07-29  

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