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Construction of PK/PD evaluation system for optimizing treatment using immune checkpoint inhibitors

Research Project

Project/Area Number 16K08369
Research Category

Grant-in-Aid for Scientific Research (C)

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

Principal Investigator

Iwamoto Takuya  三重大学, 医学部附属病院, 准教授 (30447867)

Co-Investigator(Kenkyū-buntansha) 奥田 真弘  三重大学, 医学部附属病院, 教授 (70252426)
Project Period (FY) 2016-04-01 – 2019-03-31
Project Status Completed (Fiscal Year 2018)
Budget Amount *help
¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000)
Fiscal Year 2018: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2017: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2016: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
Keywords免疫チェックポイント阻害薬 / バイオマーカー / がん化学療法 / 個別化医療 / ニボルマブ / ペムブロリズマブ / PK/PD
Outline of Final Research Achievements

This study was performed to investigate the association of host factors including peripheral blood cell characteristics with the PD-1/PD-L1 therapy. A total of 20 patients were enrolled. The number of patients administrated pembrolizumab, nivolumab, and atezolizumab was 12, 7 and 1, respectively. Twelve patients were diagnosed as progressive disease (PD), and 8 were non-PD. All 6 female patients were diagnosed as PD. In the blood sample obtained within 3 weeks from the immune therapy, significantly high CD28 positive CD8+ T lymphocyte counts and low neutrophil counts were observed in the non-PD patients compared with the PD patients. Meanwhile, the distribution of tumor PD-L1 levels, clinical stage of NSCLC, and other immune markers investigated in the non-PD patients were comparable with the PD patients. CD28 positive CD8+ T lymphocyte and neutrophil counts were considered to be possible biomarkers related to the efficacy of PD-1/PD-L1 therapy.

Academic Significance and Societal Importance of the Research Achievements

本研究の目的は、免疫チェックポイント阻害薬 の治療効果や副作用を予測する血液免疫学的因子を明らかにすることであり、それらが明確になれば、免疫チェックポイント阻害薬による治療の良好な適応患者の選別、重篤な副作用回避につながり、がん薬物治療の個別最適化の進展に大きく貢献すると考えられる。また、研究成果は、がん薬物治療の成績向上に直結することはもちろんのこと、治療失敗や副作用による医療費の損失を抑える経済的な観点からも貢献が期待できる。さらに本研究は、がん診療連携拠点病院が実施する社会的意義の高い研究と位置づけられる。

Report

(4 results)
  • 2018 Annual Research Report   Final Research Report ( PDF )
  • 2017 Research-status Report
  • 2016 Research-status Report
  • Research Products

    (5 results)

All 2019 2018 2017

All Journal Article (2 results) (of which Peer Reviewed: 1 results) Presentation (3 results)

  • [Journal Article] 薬物の免疫反応性:アナフィラキシー、免疫チェックポイント2017

    • Author(s)
      岩本卓也
    • Journal Title

      BIO Clinica

      Volume: 32(5) Pages: 67-73

    • Related Report
      2017 Research-status Report
  • [Journal Article] 薬物の免疫反応性:アナフィラキシー、免疫チェックポイント2017

    • Author(s)
      岩本卓也
    • Journal Title

      BIO Clinica 32(2), 2017 (167) 67-73

      Volume: 32 Pages: 67-73

    • Related Report
      2016 Research-status Report
    • Peer Reviewed
  • [Presentation] 免疫チェックポイント阻害薬の副作用発現及び治療効果に関連する因子について2019

    • Author(s)
      岩本卓也
    • Organizer
      医療薬学フォーラム2019
    • Related Report
      2018 Annual Research Report
  • [Presentation] がん薬物療法における副作用克服を目指した研究2018

    • Author(s)
      岩本卓也
    • Organizer
      医療薬学フォーラム2018
    • Related Report
      2018 Annual Research Report
  • [Presentation] ニボルマブ投与後に血糖コントロールが悪化した2型糖尿病合併非小細胞肺癌の1症例2018

    • Author(s)
      長田知子、世古口典子、大西真裕、大西悠紀、日置三紀、岩本卓也、小林哲、奥田真弘
    • Organizer
      第27回日本医療薬学会年会
    • Related Report
      2017 Research-status Report

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Published: 2016-04-21   Modified: 2020-03-30  

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