プラチナ感受性卵巣がん (ICON6) の再発患者におけるセディラニブ:ランダム化,ダブルブラインド,プラセボ対照の第3相試験
Jonathan A Ledermann1, Andrew C Embleton2, Fharat Raja3
1Cancer Research UK and UCL Cancer Trials Centre, University College London and UCL Hospitals, London, UK.
Lancet (London, England)
|March 31, 2016
まとめ
セディラニブを化学療法と併用して投与すると,プラチナ敏感性卵巣がんの再発における無進行生存率が著しく改善されました. この新しい治療法は 毒性の付加的な効果があるにもかかわらず 患者にとって有意義な利点をもたらします
科学分野:
- 腫瘍学
- 薬理学について
背景:
- 血管新生は進行した上皮卵巣がんの重要な標的です.
- 経口VEGFR阻害剤であるセディラニブは,再発性卵巣がんにおいて抗腫瘍作用を示す.
研究 の 目的:
- プラチナに敏感な卵巣がん患者の最初の再発で,セディラニブを化学療法と併用して投与する効果と安全性を評価する.
主な方法:
- ランダム化,ダブルブラインド,プラセボ制御のフェーズ3試験で,456人の患者が参加しました.
- 患者はプラセボまたはセディラニブによるプラセボまたはセディラニブによる維持療法を受けた.
- 主なエンドポイントは,セディラニブ維持 (Arm C) とプラセボ維持 (Arm A) を比較した無進行生存 (PFS) でした.
主要な成果:
- PFSの中央値はセディラニブ維持アーム (アームC) で11. 0ヶ月,プラセボアーム (アームA) で8. 7ヶ月でした (HR0. 56,p< 0. 0001).
- 併用セディラニブアーム (アームB) のPFSの中央値は9. 9ヶ月でした.
- 腹,中性高血圧,高血圧を含む毒性の増加がセディラニブで観察され,維持期間中に不十分な順守が観察されました.
結論:
- セディラニブは,化学療法による維持療法として,プラチナ敏感性卵巣がんの再発のPFSを有意に改善します.
- この組み合わせは新しい治療法ですが,関連する毒性は慎重に管理する必要があります.
- 全体的な生存効果を評価するために,さらなるフォローアップが必要です.
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