Neurological Surgery 脳神経外科46巻7号

2018年07月発行

総説

成人膠芽腫に対するphase Ⅲ study

著者： 沖田典子¹ 成田善孝²

所属機関： ¹独立行政法人国立病院機構大阪医療センター脳神経外科 ²国立がん研究センター中央病院脳脊髄腫瘍科

ページ範囲：P.561 - P.571

Ⅰ．はじめに
　膠芽腫は予後不良であり，予後の改善につながるエビデンスのある治療法が限られている．エビデンスに基づく治療を行うには，治療法の安全性や効果が検証された臨床試験についての理解が必要である．臨床試験は3段階に分けて新規の治療法や薬剤の安全性，有効性を確認していく．第Ⅰ相試験では，少数の患者を対象として薬物の安全性や薬物動態を確認し，用量や投与法を検討する．第Ⅱ相試験では，対象患者数を増やし，第Ⅰ相試験で確認されたデータをもとに新規の治療法の有効性と安全性を調べる．さらに，第Ⅱ相試験の結果をもとに第Ⅲ相試験では，多数の患者を対象に，現時点でのベストな治療法である標準治療と有望な治療法を比較し，新規の薬剤や手術，機器などの有効性，安全性を検証することにより，新たな治療法が確立される．予後の改善のためには新たな治療法の開発が急がれるが，膠芽腫は希少がんであり，症例数が少ないため臨床試験の迅速化が困難なことが問題で，最近では国際共同試験も行われている．膠芽腫の治療には，手術，放射線治療，化学療法による集学的な治療が必要であり，本稿では各項目ごとに第Ⅲ相試験を中心に解説を行う．

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