髄膜腫の臨床研究における課題

Challenges to Overcome in Clinical Research on Meningiomas

Point

・髄膜腫の臨床研究では，治療に対する有効性評価に他のがん研究領域で用いられるような標準的な基準がないことが解決されるべき課題である．

・2014年に手術および放射線治療抵抗性髄膜腫における有効性評価に関するレビューが報告され，2019年に髄膜腫の臨床試験における奏効評価とエンドポイントの提案が提唱されている．

・近年の髄膜腫の第Ⅱ相臨床試験における有効性エンドポイントの分析では，無増悪生存率，奏効割合，無増悪生存期間，全生存期間の順で設定されていた．

　In contrast to other cancer research areas, the development of chemotherapy and radiotherapy for meningiomas has been challenging, lacking standardized criteria for assessing treatment response and progression. Although efforts by RANO have proposed evaluation criteria, a consensus on effective evaluation parameters for meningiomas remains elusive. This paper underscores the importance of establishing efficacy endpoints in clinical trials, compares efficacy assessment in meningioma research with other solid tumor areas, and outlines the challenges ahead in meningioma research. Recent analyses revealed the absence of consensus on efficacy endpoints in meningioma trials, complicating trial design and hindering cross-trial comparisons. The unique anatomical constraints and histological variability of meningiomas pose challenges in determining appropriate efficacy measures. To address these challenges, future research must focus on accumulating prognostic data, standardizing evaluation criteria, and considering multiple endpoints in trial designs. Akin to other cancer areas, investigating targeted therapies and establishing international consensus on efficacy endpoints are crucial steps forward.