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HER2陽性転移性乳がんに対するパルボシクリブとトラストズマブ: SOLTI-1303- PATRICIA試験のコホートAとBの最終的な全生存結果

T Pascual ¹, G Villacampa ², M Oliveira ³

¹SOLTI Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Cancer Institute and Blood Disorders, Hospital Clínic de Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Medicine Department, University of Barcelona, Barcelona, Spain.
²SOLTI Cancer Research Group, Barcelona, Spain; Statistics Unit, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
³SOLTI Cancer Research Group, Barcelona, Spain; Medical Oncology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Breast Cancer Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
⁴SOLTI Cancer Research Group, Barcelona, Spain; Institut Catala d'Oncologia-IDIBELL, L'Hospitalet, Barcelona, Spain.
⁵SOLTI Cancer Research Group, Barcelona, Spain; Reveal Genomics, Barcelona, Spain.
⁶Department of Medical Oncology, Cancer Institute and Blood Disorders, Hospital Clínic de Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
⁷Department of Medical Oncology, Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Castellón, Spain.
⁸International Breast Cancer Center (IBCC), Pangaea Oncology, Quiron Group, Barcelona, Spain.
⁹Department of Medical Oncology, Hospital Son Espases, Palma, Spain.
¹⁰Department of Medical Oncology, Hospital Son Llàtzer, Palma, Spain.
¹¹Department of Medical Oncology, Hospital Sant Joan, Reus, Spain.
¹²SOLTI Cancer Research Group, Barcelona, Spain.
¹³SOLTI Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, 12 de Octubre University Hospital, Madrid, Spain; Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Madrid, Spain.
¹⁴Department of Pathology, Biomedical Diagnostic Center, Hospital Clinic of Barcelona, Barcelona, Spain.
¹⁵Translational Genomics and Targeted Therapies in Solid Tumors, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
¹⁶Molecular Oncology Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
¹⁷SOLTI Cancer Research Group, Barcelona, Spain; Institut Oncològic Dr. Rosell, Barcelona, Spain; Hospital General de Catalunya, Sant Cugat del Vallès, Barcelona, Spain; Universitat Internacional de Catalunya, Sant Cugat del Vallès, Barcelona, Spain.
¹⁸Department of Medical Oncology, Cancer Institute and Blood Disorders, Hospital Clínic de Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Medicine Department, University of Barcelona, Barcelona, Spain; Reveal Genomics, Barcelona, Spain; Institute of Oncology (IOB)-Quirón, Barcelona, Spain.
¹⁹SOLTI Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, 12 de Octubre University Hospital, Madrid, Spain; Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), Madrid, Spain; Medical Oncology Department, HM Hospitales, Madrid, Spain.

⁰SOLTI Cancer Research Group, Barcelona, Spain; Department of Medical Oncology, Cancer Institute and Blood Disorders, Hospital Clínic de Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain; Medicine Department, University of Barcelona, Barcelona, Spain.

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2025年9月2日

PubMedで要約を見る

まとめ

PATRICIA試験では,ホルモン受容体陽性/ HER2陽性転移性乳がんにおいて,パルボシクリブとトラストズマブが有望な全生存率を示した. 遺伝子発現プロファイリングにより,より良い患者選択と治療戦略のためのバイオマーカーが特定されました.

科学分野

医療腫瘍学
翻訳研究
乳がんの治療法

背景

SOLTI-1303- PATRICIA試験では,HR+/ HER2+転移性乳がん (MBC) のパルボシクリブとトラストズマブを研究した.
この第2相試験は,内分泌療法による治療の有効性を評価することを目的とした.
最終的な全生存率 (OS) とバイオマーカーのデータが示されています.

研究の目的

PATRICIA試験の最終的な全生存率 (OS) を提示する.
治療反応と生存に関するバイオマーカーを分析する.
HR+/HER2+ MBCにおける遺伝子発現プロファイルの役割を調査する.

主な方法

前治療を受けたHR+/ HER2+ MBC患者における第2相臨床試験 (NCT02448420)
患者は,ER陰性 (コホートA) またはER陽性 (コホートB1/ B2) により層分けされた.
ER陽性患者はレトロゾールと併用したパルボシクリブ/ トラストズマブにランダムに分けられ,OSとPFSはKaplan- MeierとCoxモデルを用いて評価された.

主要な成果

4年間の生存率はコホートによって異なる (13. 3%A,35. 7%B1,32. 3%B2).
PAM50 ルーミナルサブタイプは,ルーミナルでないサブタイプと比較して優れたOSを示しました (38. 0 vs 26. 6ヶ月).
ルーミナル関連遺伝子は生存率の向上と相関し,基礎/増殖遺伝子は抵抗性を示し,ルーミナルA/Bと化学内分泌のスコアは好ましい予後を予測した.

結論

HER2陽性乳がんの患者の選択には,遺伝子発現プロフィールが重要です.
バイオマーカーベースのアプローチは,HR+/HER2+ MBCの治療戦略を向上させることができます.
PATRICIAの長期的結果は,この患者集団における非化学療法による治療を支持している.

キーワード:

HR陽性/HER2陽性バイオマーカー遺伝子発現プロファイリング転移した乳がんパルボシクリブトラストズマブ

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