高リスクの局所的に進行した結腸がんに対するFOLFOXIRIによるネオアジュバント化学療法:単腕II相試験
Y-W Zhou1, G-X Wei1, X-R Chen1
1Colorectal Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
ESMO open
|August 21, 2025
まとめ
高リスクの局所進行結腸癌 (hr- LACC) の患者で,FOLFOXIRIによる新補助化学療法 (NAC) は有望な安全性と耐受性を示しています. この治療法は腫瘍の減期とR0切除を促進し,改善の可能性を示唆しています.
科学分野:
- 腫瘍学
- 胃腸内科
- 臨床試験
背景:
- 局所的に進行した結腸癌 (LACC) は,再発および転移の危険因子があり,効果的な新補助治療を必要とします.
- 3種類の薬剤 (オキシリプラチン,イリノテカン,フルオロウラシール - FOLFOXIRI) を含む新補助化学療法 (NAC) の評価は,HR-LACCの管理において極めて重要です.
研究 の 目的:
- hr- LACC患者における NACとしてのFOLFOXIRIの安全性と投与可能性を評価する.
- 腫瘍の回帰度 (TRG) と外科的結果を含む腫瘍の反応を評価する.
主な方法:
- 2020年7月から2023年10月にかけて実施された単一アーム,オープンラベル,第2相臨床試験.
- 72人のHR-LACC患者は,FOLFOXIRIとNACを4回投与し,その後手術と補助療法を受けた.
- 主要評価項目は安全性,提供能力,TRG0−2率 (NCCN基準) でした.
主要な成果:
- FOLFOXIRIの4サイクルを完了した患者は80. 6%で,グレード3〜4の有害事象は51. 4%であった.
- すべての切除された患者 (61/ 61) でR0切除が達成され,TRG 0- 2率は86. 9%であった.
- 2年後の腫瘍再発率は17. 2%でした.
結論:
- FOLFOXIRIのネオアジュバント化学療法は,HR-LACC患者で許容可能な安全性と効果を示しています.
- この治療法は,腫瘍の進行を遅らせ,R0切除を容易にする可能性を示しており,より大きな研究でさらなる調査が必要である.
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