腎臓細胞癌 (EVEREST) の手術後の補助エベロリムス: ダブルブラインド,プラセボ対照,ランダム化,第3相試験
Christopher W Ryan1, Catherine M Tangen2, Elisabeth I Heath3
1Oregon Health and Science University Knight Cancer Institute, Portland, OR, USA.
Lancet (London, England)
|July 31, 2023
まとめ
手術後の腎臓細胞がん患者における補助的なエベロリムス (標的治療) は,リクリエーションフリー生存率を有意に改善しなかった. この研究では,エベロリムスは,この患者集団において補助剤として使用することが推奨されていないことが示されています.
科学分野:
- 腫瘍学
- 薬理学について
- 臨床試験
背景:
- 腎臓細胞癌 (RCC) の患者は,手術後の再発リスクに直面しています.
- RCC切除後の補助療法としてmTOR阻害剤エヴェロリムスの評価
研究 の 目的:
- 腎臓細胞癌の手術後の再発を予防するエヴェロリムスの有効性を評価する.
- 高リスクのRCC患者の再発のない生存率を改善するかどうかを判断する.
主な方法:
- ステージ3 ランダム化 ダブルブラインド プラセボ対照試験
- 中高または非常に高い再発リスクを有する切除されたRCC患者.
- 患者は54週間にわたって毎日口服エベロリムス10mgまたはプラセボを投与された.
主要な成果:
- エベロリムスとプラセボでは,再発のない生存率が統計的に有意に改善されなかった (p=0. 051).
- エベロリムスは,非常に高いリスクのサブグループ (p=0. 022) で効果を示したが,中等リスクのサブグループでは効果を示さなかった.
- プラセボ群 (11%),エベロリムス群 (46%) の3度以上の有害事象の発生率が高かった.
結論:
- 術後のエベロリムスは,再発リスクの高い腎臓細胞がん患者の再発なし生存率を有意に改善しませんでした.
- 発見は,手術後の腎臓細胞癌に対するエベロリムスの補助的な使用を支持しません.
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