CD30陽性外周T細胞リンパ腫 (ECHELON-2) に対する化学療法とブレントキシマブベドチン: 全球,ダブルブラインド,ランダム化,第3相試験
Steven Horwitz1, Owen A O'Connor2, Barbara Pro3
1Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Lancet (London, England)
|December 8, 2018
まとめ
標準のCHOP化学療法と比較して,ブレンツシマブベドチン,サイクロフォスファミド,ドクソルビシン,プレドニゾーン (A+CHP) は,CD30陽性外周T細胞リンパ腫の患者に進行性のない生存期間を有意に改善しました. この新しい治療法は 管理可能な安全性プロファイルを持つ優れた治療法です
科学分野:
- 血液学
- 腫瘍学
- 臨床試験
背景:
- CD30陽性外周T細胞リンパ腫 (PTCL) は攻撃的なノンホッジキンリンパ腫です.
- 以前の研究では,PTCLにおけるブレンツシマブベドチンの有望な作用が示された.
研究 の 目的:
- 以前治療を受けていないCD30陽性PTCL患者におけるA+CHPとCHOPの有効性と安全性の比較.
- 主要エンドポイントとして,不発症生存率 (PFS) を評価する.
主な方法:
- ECHELON-2は第3相,ダブルブラインド,ランダム化,プラセボ対照試験でした.
- 未治療のCD30陽性PTCL患者452人をランダムにA+CHPまたはCHOPに6~8サイクルに分けました.
- ヒストロジカルサブタイプとIPIスコアによる分層化が行われました.
主要な成果:
- CHOP (20. 8ヶ月) と比較すると,PFSの中央値はA+CHPで有意に長かった (HR 0. 71,p=0. 0110)
- 発熱性ニュートロペニアと周辺神経症を含む有害事象は,グループごとに類似していました.
- 致命的な有害事象は両腕で低かった (3% A+CHP 対 4% CHOP).
結論:
- 前線A+CHPは,CD30陽性PTCLにおいて,CHOPよりも優れた有効性を示しています.
- A+CHPは,管理可能な安全性プロファイルで,改善されたPFSと全生存率を提供します.
- ブレンツシマブ・ベドチンを含む治療法は,この患者群の治療における新しい標準です.
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