Clinical analysis of molecularly-targeted drug-induced dermatologic toxicity and development of new treatment method with special reference to sweat gland dysfunction
| Project/Area Number |
16K10140
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Dermatology
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| Research Institution | Japanese Foundation for Cancer Research (2018-2019)
National Defense Medical College (2016-2017) |
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Principal Investigator |
Nishizawa Aya 公益財団法人がん研究会, 有明病院 皮膚科, 副医長 (30431456)
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| Co-Investigator(Kenkyū-buntansha) |
山崎 直也 国立研究開発法人国立がん研究センター, 中央病院, 科長 (70501873)
田原 信 国立研究開発法人国立がん研究センター, 東病院, 科長 (50523198)
佐藤 貴浩 防衛医科大学校(医学教育部医学科進学課程及び専門課程、動物実験施設、共同利用研究施設、病院並びに防衛, 皮膚科学, 教授 (30235361)
石川 貴裕 防衛医科大学校(医学教育部医学科進学課程及び専門課程、動物実験施設、共同利用研究施設、病院並びに防衛, 皮膚科学, 助教 (60782985)
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| Project Period (FY) |
2016-04-01 – 2020-03-31
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| Project Status |
Completed (Fiscal Year 2019)
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| Budget Amount *help |
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2018: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
Fiscal Year 2017: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2016: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
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| Keywords | 手足症候群 / マルチキナーゼ阻害剤 / 被覆材 / 皮膚障害 / 発汗抑制 / 塩化アルミニウム / レゴラフェニブ / 有害事象 / 新規予防対策 / ソラフェニブ / 発汗 / 汗腺機能 / 分子標的薬 |
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| Outline of Final Research Achievements |
The aim of this study is to examine whether or not dermatologic toxicity such as hand-foot syndrome frequently associated with regorafenib can be prevented by applying aluminum chloride to the skin to reduce sweating from the palms and soles in addition to removing the external stimuli by wound dressing. Inclusion criteria for this study included patients with colon cancer scheduled to start regorafenib at 120 mg with a follow-up period of 12 weeks. Ten patients have been registered for this study at the time of writing this report, including six discontinued cases, four on-going cases and no completed cases. Six discontinued cases include three cases of progressive disease, one case of hypertension, one case of thrombocytopenia and one case of severe drug-induced dermatitis. Hand-foot syndrome was not listed as the cause of discontinuation of this study. Seven cases among nine registered cases developed hand-foot syndrome. Among them, two cases (22 %) were graded as grade 3.
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| Academic Significance and Societal Importance of the Research Achievements |
まだ登録症例10例で登録予定の28例の半分以下であるため本研究の評価は難しい。しかし、当該薬の開始投与量を有害事象を減らす目的で160mgから120mgへ減量して開始したが、実際は観察期間の12週投薬可能であった症例は今のところ0例である。試験中止となった理由に手足症候群はなく、手足症候群以外の有害事象や病勢進行であった。休薬、減量については手足症候群が1例であった。手足症候群自体は7例で発現しているが、Grade 3は2例であった。塩化アルミニウムによる発汗抑制、被覆材による保護除圧で手足症候群発現抑制効果についての評価はできないが、手足症候群自体が治療中止の誘因とはならない可能性がある。
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Report
(5 results)
Research Products
(15 results)
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[Journal Article] Predictive Value of Cetuximab-Induced Skin Toxicity in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NECK2018
Author(s)
Uozumi S, Enokida T, Suzuki S, Nishizawa A, Kamata H, Okano T, Fujisawa T, Ueda Y, Okano S, Tahara M, Yamaguchi M.
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Journal Title
Front Oncol
Volume: 13(8)
Pages: 616-616
DOI
Related Report
Peer Reviewed / Open Access
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