経口メルファランとプレドニゾンの化学療法とタリドミドを併用し,マルチ骨髄腫の高齢患者におけるメルファランとプレドニゾンの単独投与と比較:ランダム化比較試験
Antonio Palumbo1, Sara Bringhen, Tommaso Caravita
1Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S Giovanni Battista, 10126 Torino, Italy. appalumbo@yahoo.com
Lancet (London, England)
|March 15, 2006
まとめ
経口メルファランとプレドニゾン (MPT) にタリドミドを添加すると,高齢の多発性骨髄腫患者の応答率と無事生存率が著しく改善されます. 抗凝固剤の予防は,血栓形成のリスクを低減するために極めて重要です.
科学分野:
- 血液学 ヘマトロジ
- 腫瘍学 腫瘍学
- クリニック・トライアル 臨床試験
背景:
- 経口メルファランとプレドニゾン (MP) は1960年以来,高齢の多発性骨髄腫患者の標準治療法となっています.
- この研究では,標準的なMPレジメンにタリドミドを添加する効果を調査しました.
研究 の 目的:
- 経口メルファラン,プレドニゾン,タリドミド (MPT) と,経口メルファランとプレドニゾン (MP) の効果と安全性を比較する.
- 新たに多発性骨髄腫と診断された高齢患者の応答率と無事生存率を評価する.
主な方法:
- 多中心のランダム化試験では,60歳から85歳までの患者に,口服MPTまたはMP単独の投与を6回の4週間のサイクルで割り当てました.
- タリドマイドは,疾患の進行または再発まで1日100mgで投与されました.
- 治療意図の分析が行われ,この試験はNCT00232934.4に登録されています.
主要な成果:
- MPTは,MPのみと比較して,著しく高い応答率 (76.0%対47.6%) と,2年イベントフリー生存率の改善 (54%対27%) を示した.
- ほぼ完全または完全な応答率は,MPTアームでかなり高かった (27.9%対7.2%).
- グレード3または4の有害事象は,MPTグループではより頻繁 (48%対25%) であったが,エノキサパリン予防法は,血栓塞栓症の発生率を20%から3%まで減少させた.
結論:
- 口服MPTは,多発性骨髄腫の高齢患者に対する効果的な第一線治療法であり,重要な有効性エンドポイントを改善します.
- 抗凝固剤の予防の使用は,MPTに関連した血栓形成のリスクの増加を軽減するために不可欠です.
- MPTが全生存期に与える長期的な影響を確かめるために,さらなるフォローアップが必要である.
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