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<p>Currently, there are no clinically actionable biomarkers to predict patient to cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i) plus endocrine therapy for hormone receptor (HR)[+]/ human epidermal growth factor receptor 2 <b>(</b>HER2)[-] advanced breast cancer (ABC). Herein, we report an exploratory biomarker substudy (transFAL) from a subset of patients included in PARSIFAL, a phase II randomized clinical trial that evaluated first-line palbociclib plus fulvestrant or letrozole for HR[+]/HER2[−] ABC. No definitive biomarkers were discovered, however, worse outcomes were found with CDK6 postivity (<i>p</i> = 0.008), ER negativity (<i>p</i> = 0.008), high Ki67 (<i>p</i> = 0.04), and <i>TP53</i> mutation (<i>p</i> = 0.04). ctDNA density (<i>p</i> = 0.036) and number of mutations (<i>p</i> = 0.033) at baseline were significantly higher for resistant patients. Our study reveals future directions to explore in the goal to determine biomarkers of response to CDK4/6i.</p>

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Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月20日

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  • Joan Albanell,
  • Angelo Gámez Pozo,
  • Carlos L. Arteaga,
  • Meritxell Bellet,
  • Federico Rojo,
  • Abel González,
  • Beatriz Bellosillo,
  • Violeta Serra,
  • Petra Gener,
  • José Antonio Guerrero,
  • Eileen Shimizu,
  • Mario Mancino,
  • Jose Rodríguez-Morató,
  • Leonardo Mina,
  • José Manuel Pérez-García,
  • Javier Cortés,
  • Antonio Llombart-Cussac

摘要

Currently, there are no clinically actionable biomarkers to predict patient to cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i) plus endocrine therapy for hormone receptor (HR)[+]/ human epidermal growth factor receptor 2 (HER2)[-] advanced breast cancer (ABC). Herein, we report an exploratory biomarker substudy (transFAL) from a subset of patients included in PARSIFAL, a phase II randomized clinical trial that evaluated first-line palbociclib plus fulvestrant or letrozole for HR[+]/HER2[−] ABC. No definitive biomarkers were discovered, however, worse outcomes were found with CDK6 postivity (p = 0.008), ER negativity (p = 0.008), high Ki67 (p = 0.04), and TP53 mutation (p = 0.04). ctDNA density (p = 0.036) and number of mutations (p = 0.033) at baseline were significantly higher for resistant patients. Our study reveals future directions to explore in the goal to determine biomarkers of response to CDK4/6i.