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以前治療された転移性大腸がん患者の全生存期に対するフルーキンチニブとプラセボの効果: FRESCOランダム化臨床試験

  • 0Department of Medical Oncology, Tongji University Shanghai East Hospital, Shanghai, China.

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まとめ

この要約は機械生成です。

経口フルクインチニブは,化学療法後に進行する転移性大腸がん (CRC) の患者の全生存期間を有意に改善しました. このVEGFR阻害剤は,進行したCRCの新たな治療法を提供します.

科学分野

  • 腫瘍学
  • 臨床薬理学
  • 胃腸内科

背景

  • 転移性大腸がん (CRC) は,患者にとって有効で許容できる治療の選択肢が限られている.
  • 転移性CRCの第3線または後の治療には,新しい治療戦略が必要です.

研究 の 目的

  • 血管内皮成長因子受容体 (VEGFR) 阻害剤であるフルクインチニブの有効性と安全性を評価する.
  • 転移性CRCの患者に対する第3線または後の治療としてフルクインチニブを評価する.

主な方法

  • FRESCO試験は,中国で行われた3相,ランダム化,ダブルブラインド,プラセボ対照試験でした.
  • 416人の転移性CRC患者で,少なくとも2回の化学療法とVEGFR阻害剤の治療を受けていない患者は,フラクインチニブまたはプラセボにランダムに割り当てられました.
  • 主要エンドポイントは全生存率であり,次要エンドポイントは進行性生存率と客観的な応答率であった.

主要な成果

  • フルクインチニブ (9. 3ヶ月) とプラセボ (6. 6ヶ月) の平均全生存期間は有意に長かった (HR,0. 65;P < . 001).
  • 進行のない生存期間の中央値も有意に増加しました (3. 7ヶ月対1. 8ヶ月;HR,0. 26;P < . 001).
  • フルクインチニブ患者の61. 2%,プラセボ患者の19. 7%で発生した.

結論

  • 経口フルクインチニブは,中国人の転移性CRC患者の全生存期間をプラセボと比較して統計的に有意に増加させた.
  • フルクインチニブは,前回の化学療法で進行した進行性CRCの患者にとって有望な治療法です.
  • 中国国外での様々な患者集団におけるフルクインチニブの有効性を評価するために,さらなる研究が必要である.

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