直腸がんに対する臓器保存 (GRECCAR 2):将来性,ランダム化,オープンラベル,多センター,第3相試験

Eric Rullier¹, Philippe Rouanet², Jean-Jacques Tuech³

¹Department of Colorectal Surgery, Haut-Lévèque Hospital, Pessac, CHU Bordeaux, France.

Lancet (London, England)

|June 12, 2017

まとめ

直腸がん治療後の臓器保存は,局所切除が全直腸切除より優れていないことを示した. 局所切除群の完成手術は罹患率を増加させ,潜在的な利益を否定した.

科学分野:

腫瘍学
手術腫瘍学
臨床試験

背景:

臓器保存は,ネオアジュバント化学療法に良好な反応を示した直腸がん患者に対するアプローチです.
これは直腸切除の病気と副作用を回避することを目的としています.
この研究では,下直腸がんの化学放射線治療後の局所切除 (LE) と全直腸切除 (TME) を比較した.

研究の目的:

局所切除と完全切除の有効性と安全性を比較する.
低直腸がんの患者で,化学放射線治療後の良好な臨床反応を達成した患者のアウトカムを評価する.

主な方法:

ランダム化され,オープンで,多センターの第3相試験です.
臨床的に良好な反応を示した145人の下直腸がん患者は,LEまたはTMEにランダムに割り当てられました.
2年後の死亡,再発,罹病率,副作用の複合結果

主要な成果:

1つ以上の主要なアウトカムイベントは,LE群の56%とTME群の48%で2年後に発生した.
複合的な結果やその構成要素において,LEとTMEの間で有意な差は認められなかった.
局所切除は全体切除よりも優位性を示さなかった.

結論:

この研究では,局所切除が全体切除よりも優れていることが示されませんでした.
LEグループにおける TMEの完成率が高く,罹病率が増加し,LEの利益が損なわれた可能性が高い.
患者の選択が改善されれば臓器の保存戦略が改善されるかもしれません

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