高用量イマチニブによる胃腸筋腫瘍の進行性生存率:ランダム化試験
Jaap Verweij1, Paolo G Casali, John Zalcberg
1Department of Medical Oncology, Erasmus University Medical Centre, Groene Hilledijk 301, 3075 EA Rotterdam, Netherlands. j.verweij@erasmusmc.nl
Lancet (London, England)
|September 29, 2004
まとめ
400mgのイマチニブの一日用量は,胃腸筋腫瘍 (GIST) の初期応答に十分である. しかし,1日2回投与は,転移性GIST患者の進行性生存率を大幅に改善します.
科学分野:
- 腫瘍学 腫瘍学
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- イマチニブは,消化器系ストロマル腫瘍 (GIST) の世界的に承認された治療法です.
- この研究では,転移性GIST.ISTにおけるイマチニブの治療応答と進行性生存期に対する用量依存の効果を調査した.
研究 の 目的:
- 転移性GISTにおけるイマチニブ投与量と患者のアウトカムとの関係を評価する.
- より高いイマチニブ投与量により,無進行生存率と応答率が改善されるかどうかを判断する.
主な方法:
- 946人の転移性GIST患者を含むランダム化試験.
- 患者は400mgのイマチニブを1日1回または2日1回投与された.
- 前進性無生存率は,治療意図分析による主要なエンドポイントであり,進行性無生存率は,治療意図分析による主要なエンドポイントであった.
主要な成果:
- イマチニブを1日2回投与した患者は,著しく延長された無進行生存期 (HR 0.82; p=0.026) を有しました.
- 2つのグループでは,応答率 (完全,部分,安定した疾患) の有意な差は認められなかった.
- 治療は一般的に良好に耐えており,毎日2回投与されたグループでは,より多くの投与量削減と中断がありました.
結論:
- GISTにおける初期応答を達成するには,毎日400mgのイマチニブが十分です.
- 400mgのイマチニブを1日2回投与すると,転移性GIST.の進行フリー生存期間を延長するのに有意な効果が得られます.
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