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研究分野生物医学と臨床科学腫瘍学とがん発生分子標的
パゾパニブ対プラセボのランダム化第2相試験進行性臓外神経内分泌腫瘍患者 (アライアンスA021202)

パゾパニブ対プラセボのランダム化第2相試験進行性臓外神経内分泌腫瘍患者 (アライアンスA021202)

Emily K Bergsland ¹, Susan Geyer ², Timothy R Asmis ³, Spencer C Behr ⁴, J Philip Kuebler ⁵, Priya Kumthekar ⁶, Gina Mazza ², Michael L Maitland ⁷, Donna Niedzwiecki ⁸, Andrew B Nixon ⁹, Lawrence Howard Schwartz ¹⁰, Jonathan R Strosberg ¹¹, Alan P Venook ¹, Eileen M O'Reilly ¹², Jeffrey A Meyerhardt ¹³

Emily K Bergsland ¹, Susan Geyer ², Timothy R Asmis ³

¹Department of Medicine, University of California San Francisco, San Francisco, CA.
²Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.
³Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.
⁴Department of Radiology, University of California San Francisco, San Francisco, CA.
⁵Columbus NCI Community Clinical Oncology Research Program, Columbus, OH.
⁶Northwestern Memorial Hospital, Chicago, IL.
⁷Inova Schar Cancer Institute and the University of Virginia Comprehensive Cancer Center, Falls Church, VA.
⁸Department of Biostatistics and Bioinformatics and Duke Cancer Institute-Biostatistics, Duke University, Durham, NC.
⁹Department of Medicine and Duke Cancer Institute, Duke University, Durham, NC.
¹⁰Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.
¹¹Moffitt Cancer Center, Tampa, FL.
¹²Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
¹³Dana-Farber Cancer Institute, Boston, MA.

⁰Department of Medicine, University of California San Francisco, San Francisco, CA.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology +

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2025年9月3日

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PubMedで要約を見る

まとめ

この要約は機械生成です。

パゾパニブは,進行した臓外神経内分泌腫瘍 (epNET) の患者に,進行性のない生存率を有意に改善しました. しかし,有害事象の増加は,この治療のさらなる開発を計画しなかった.

科学分野

腫瘍学
医学研究
臨床試験

背景

超臓神経内分泌腫瘍 (epNETs) は希少で,進行した,よく区別された疾患の全身治療の選択肢が限られていることが多い.
パゾパニブは,腫瘍の成長と血管新生における重要な経路を標的とした口服マルチキナーゼ阻害剤です.

研究の目的

パゾパニブの有効性と安全性を評価する.
この患者群でプラセボと比較して,パゾパニブが無進行生存期 (PFS) を改善するかどうかを判断する.

主な方法

パゾパニブ (800 mg/ 日) とプラセボを比較した多センター,ランダム化,ダブルブラインド,第2相試験.
患者は低度から中度までepNETを発症し,進行を記録した.
プライマリエンドポイントは,盲目の独立した中央レビューによって評価されたPFSでした.

主要な成果

パゾパニブはプラセボと比較してPFSの中央値 (11. 8ヶ月対7. 6ヶ月) の有意な改善を示した (危険比0. 54;P < . 001).
グレード3またはそれ以上の有害事象 (84%対47%) とグレード5の死亡 (8%対0%) がパゾパニブで観察されました.
総生存率の有意な差は認められなかった.

結論

パゾパニブは,進行性epNETにおけるPFSを著しく改善し,治療目標としてVEGF経路を検証した.
パゾパニブの有毒性プロファイルは,その利点に比べて,この環境でのさらなる開発を妨げています.

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