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Clin Cancer Res:Ribociclib+氟维司群±PI3K抑制剂治疗HR+晚期乳腺癌

2020-09-04 MedSci原创 MedSci原创

HR+HER2-晚期乳腺癌(ABC)患者对内分泌疗法耐药较常见,CDK4/6和PI3K通路的双重抑制或可延缓该类患者耐药性的发展。本研究旨在评估包含CDK4/6抑制剂瑞博西尼(ribociclib)的

HR+HER2-晚期乳腺癌(ABC)患者对内分泌疗法耐药较常见,CDK4/6和PI3K通路的双重抑制或可延缓该类患者耐药性的发展。本研究旨在评估包含CDK4/6抑制剂瑞博西尼(ribociclib)的三重或双重方案的安全性和耐受性。

该研究是一项开放标签的多中心Ib期试验,招募了70位绝经后的HR+HER2-的ABC患者,予以瑞博西尼(1/日,用3周停一周)+氟维司群、瑞博西尼(持续用药)+氟维司群、瑞博西尼+alpelisib+氟维司群或瑞博西尼+buparlisib+氟维司群治疗。

瑞博西尼推荐的II期剂量(RP2D)为600 mg(用3周、停1周)和400 mg(持续用药),联合氟维司群 500 mg。对于联合buparlisib的三联疗法,RP2D为瑞博西尼 400 mg +buparlisib 30 mg + 氟维司群 500 mg。三联疗法的招募因意料之外的毒性作用而终止。Alpelisib联合方案的RP2D未明确。瑞博西尼和氟维司群联合方案的安全性与既往研究一致。瑞博西尼在三联方案组中的暴露量无显著差异。Buparlisib三联治疗组的总体缓解率最高(25%)。

结论:瑞博西尼联合氟维司群治疗HR+HER2-ABC患者的安全性良好。包含alpelisib或buparlisib的三联方案不推荐进行II期试验。

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    2020-10-16 jklm09
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