大腸がん患者の補助化学療法と観察:ランダム化研究
1, Richard Gray, Jennifer Barnwell
1Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Lancet (London, England)
|December 18, 2007
まとめ
フロロウオラシルとフォリン酸による補助化学療法により,II段階の結腸直腸がん患者の生存期間が改善されました. この治療は,死亡と再発のリスクを低減し,わずかな,しかし重要な生存効果をもたらしました.
科学分野:
- 腫瘍学 腫瘍学
- クリニック・トライアル 臨床試験
- 胃腸腫瘍学 胃腸腫瘍学
背景:
- QUASAR試験では,低リスクの結腸直腸がん患者の補助化学療法の有効性を調査した.
- この患者グループにおける補助化学療法の徴候は,以前は不明でした.
研究 の 目的:
- 再発リスクが低い大腸直腸がん患者の補助化学療法による生存効果を判断する.
- 観察された生存優位性の持続期間を評価する.
主な方法:
- ステージIIの結腸直腸がんの3239人の患者は,フルオロウラシルとフォリン酸の化学療法または観察を受けるようにランダムに割り当てられました.
- 治療のスケジュールは,前年では,レバミゾールと併用または併用せずに,静脈内注射フルオロウラシールとL-フォリン酸の異なるスケジュールを含んでいた.
- 主要エンドポイントは全原因死亡率であり,治療の意図による分析が行われました.
主要な成果:
- 化学療法は,観察と比較して,死亡 (0.82; p=0.008) と再発 (0.78; p=0.001) の相対的リスクを有意に低下させた.
- 追跡期間の中央値は5.5年であり,化学療法群では311人が死亡し,観察群では370人が死亡しました.
- 治療効果は,腫瘍の部位,ステージ,性別,年齢を含むサブグループ全体で一貫していました.
結論:
- フロロウオラシルとフォリン酸による補助化学療法は,ステージIIの結腸直腸がん患者の生存率を向上させることができます.
- 絶対生存率の改善は控えめで,5年間で3.6%と推定されています.
- この研究は,選択されたII段階の結腸直腸がん患者のために,この化学療法療法の使用を支持しています.
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