HER2陽性早期乳がん (PERSEPHONE) の治療に補助剤トラストズマブを6ヶ月対12ヶ月投与:ランダム化第3相非劣等性試験の4年生存率
Helena M Earl1, Louise Hiller2, Anne-Laure Vallier3
1Department of Oncology, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK; Cambridge Breast Cancer Research Unit, Cambridge University Hospitals National Health Service (NHS) Foundation Trust, Cambridge, UK; National Institute for Health Research Cambridge Biomedical Research Centre, Cambridge, UK.
Lancet (London, England)
|June 11, 2019
まとめ
HER2 陽性乳がんの早期治療の12ヶ月の治療と同じくらい有効です. 短期間の治療は重度の有害事象と心臓毒性を軽減し,より安全で費用対効果の高い選択肢を提供します.
科学分野:
- 腫瘍学
- 臨床試験
- 薬理学について
背景:
- トラストズマブはHER2陽性乳がんの初期治療の標準薬である.
- 現在の12ヶ月の期間は 毒性と高いコストを引き起こす可能性があります
- 治療期間が短くなり,同様の効果が認められるか検討中です.
研究 の 目的:
- トラストズマブの6ヶ月の補助療法は12ヶ月の治療に劣らないかどうかを判断する.
- 2つの治療期間間の無疾患生存を比較する.
- 短いトラストズマブ療法の安全性および毒性プロフィールを評価する.
主な方法:
- 3段階の無作為化非劣等性試験
- 4089人の患者の1対1のランダム化により,トラストズマブを6ヶ月または12ヶ月投与した.
- 主要エンドポイント: 3%の非劣等性差で4年生存率.
主要な成果:
- 6ヶ月の治療で4年無病生存率は89. 4%,12ヶ月の治療で89. 8% (劣らぬ) でした.
- 6ヶ月の治療では,重度の有害事象 (19% 対 24%) が著しく減少した.
- 6ヶ月のグループでは心臓毒性が低かった (3%対8%).
結論:
- 6ヶ月の補助薬トラストズマブは12ヶ月の治療に劣らない.
- 短い期間は重度の有害事象と心臓毒性を減少させる.
- トラストズマブの期間を短縮することは,特定の患者にとって有効な選択肢です.
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