NAUTILUS臨床試験における臨床病理学的特徴とリンパ節の状態:KBCSG-21
Jai Min Ryu1, Han-Byoel Lee2, Wonshik Han2
1Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
まとめ
NAUTILUS試験では,乳がんの初期段階におけるセンチネルリンパ節生検 (SLNB) を省略した試験を評価した. 結果は,状リンパ節転移率が腫瘍サイズによって異なることを示し,特定の患者グループにおけるSLNBの省略を告げる.
科学分野:
- 腫瘍学 腫瘍学
- 外科腫瘍学外科腫瘍学
- 乳がんの研究 乳がんの研究
背景:
- NAUTILUS試験は,乳がんの初期段階 (cT1-2/N0) でセンチネルリンパ節生検 (SLNB) を省略した時の非劣等性を評価した.
- このレポートは,NAUTILUS試験の臨床病理学的特徴と状リンパ節 (ALN) の状態を詳細に記載しています.
- 結果は,SOUNDとINSEMAの試験,特に50歳以上の参加者に対して文脈化されています.
研究 の 目的:
- NAUTILUS試験のSLNB部門における臨床病理学的変数とALN状態を分析する.
- NAUTILUS試験の結果に対する期待を,他の関連する臨床試験と比較することによって確立する.
- 乳がん初期におけるSLNB省略に関する意思決定プロセスに係るデータを提供すること.
主な方法:
- 1734人の被験者をランダムにSLNBまたは非SLNBのグループに分けました.
- 臨床的なN0状態を確認するために,強制的な頭超音波検査.
- SLNBの腕における臨床病理学的変数とALNの状態の分析.
主要な成果:
- 1664人の被験者が分析のために利用でき,SLNBグループでは50.4%,非SLNBグループでは49.6%でした.
- 平均年齢は55歳であり,40.1%が閉経前でした.
- SLNBアームの患者の11.2%がALN転移を起こし,その割合は腫瘍のサイズに伴い増加しました (7.0%は≤1.0cmから17.2%は>2.0&≤5.0cm).
結論:
- NAUTILUS試験には,14.0%のpT2と40.1%の閉経前状態の患者が登録されました.
- この試験では,これらの特定のサブグループにおいてSLNBを省略した結果の影響を実証することが期待されています.
- 結果は,乳がんの早期管理におけるSLNB省略の理解に貢献します.
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