臨床外科64巻6号

2009年06月発行

特集 消化器癌外科治療のrandomized controlled trial

大腸癌肝転移のrandomized controlled trial

著者： 山本順司¹ 初瀬一夫¹ 柿原稔¹ 谷水長丸¹ 守屋智之¹ 上野秀樹¹ 辻本広紀¹ 小野聡¹ 市倉隆¹ 橋口陽二郎¹ 愛甲聡¹ 長谷和生¹

所属機関： ¹防衛医科大学校外科

ページ範囲：P.779 - P.783

要旨：肝切除後の再発率は全体で40～80％，肝に限った再発も30～60％と高率であり，それらを抑制することが肝転移切除の成績をさらに向上させると期待される．補助療法のRCTに共通していることは，比較治療は標準治療に対して無再発生存率を有意に向上させるが，生存率は向上させないという点である．レジメンについては，5-フルオロウラシル＋フォリン酸（FU/LV）が無治療に対して肝切除後の再発を有意に抑制すると報告された．現状で肝転移切除症例を対象にRCTを計画する際には，コントロールアームとして無治療群を設定することは難しい．

　肝切除術前後のFOLFOX治療が多施設共同RCTにより検証されたが，intent-to-treat basisの解析では治療群と無治療群の無再発生存期間は有意差がなく，肝切除症例の比較で10％未満の差が認められたのみであった．肝動注化学療法と全身化学療法を比較したRCTでは，肝動注療法は全身化学療法に比べて肝転移巣に対する奏効率は優れるものの，生存予後は有意差がないとされた．今後は欧米の報告を吟味しながら，より高精度な，わが国の医療レベルに見合った研究を計画していく必要がある．

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