Lancet Oncol:CDKI联合氟维司群有望成为激素受体阳性、HER2阴性的晚期乳腺癌的标准治疗方案!

2021-10-23 Nebula MedSci原创

将CDKI和氟维司群的联合方案或可成为激素受体阳性、HER2阴性晚期乳腺癌患者的标准治疗方案

细胞周期蛋白依赖性激酶 4/6 抑制剂 (CDKI) 是口服靶向药物,已获批与内分泌疗法联合作为激素受体阳性、HER2阴性的晚期或转移性乳腺癌的一线或二线治疗。Jennifer J Gao等人既往报道了特定临床病理亚组患者的无进展生存期的汇总分析,所有这些患者都从激素+CDKI治疗中获得了一致的益处。本文汇报了接受 CDKI 和氟维司群联合治疗的患者的汇总总生存期结果

在这项探索性分析中,研究人员汇总了2020年8月1日前获批的三项关于CDKI或安慰剂联合氟维司群治疗乳腺癌的3期试验的患者数据。所有分析患者都是年满18岁、ECOG表现状态0-1分、激素受体阳性、HER2阴性、晚期或转移性乳腺癌患者,都至少接受了一剂CDKI或安慰剂联合氟维司群治疗。

汇总的总生存期分析

从2013年10月7日至2016年6月10日,三项试验共有1960位患者被随机分组(12位患者未接受研究治疗,1296位[66%]被分至CDKI组,652位[33%]被分至安慰剂组)。在所有接受治疗的患者(n=1948)中,中位随访了43.7个月,总生存期的估计风险比(HR)为0.77(95% CI 0.68-0.88),935位(48%)患者死亡。CDKI组和安慰剂组的估计中位总生存期相差7.1个月,支持CDKI的治疗效益。

在接受CDKI或安慰剂联合氟维司群作为一线系统内分泌治疗的患者中(两项试验,n=396),中位随访了39.4个月,总生存期的HR是0.74(95% CI 0.52-1.07)。123位(31%)患者死亡。CDKI组的中位总生存期未达到(95% CI 50.9-未达到;安慰剂组中位总生存期为45.7个月[41.7-未达到]),因此无法估算两组间的中位总生存期差异。

在接受CDKI或安慰剂联合氟维司群作为二线或后线系统内分泌治疗的患者(三项试验;n=1552)中,中位随访了45.1个月,总生存期的估计HR为0.77(95% CI 0.67-0.89)。812位(52%)患者死亡。CDKI组和安慰剂组的中位总生存期相差7.0个月,支持CDKI的疗效。

综上所述,在该研究患者中,氟维司群联合CDKI无论是作为一线治疗方案还是二线或后线治疗方案,都可使患者获得显著的生存期延长效果。该研究发现支持将CDKI和氟维司群的联合方案作为激素受体阳性、HER2阴性晚期乳腺癌患者的标准治疗方案。

原始出处:

Jennifer J Gao, et al. Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis. The Lancet Oncology. October 14, 2021. https://doi.org/10.1016/S1470-2045(21)00472-1

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    2022-03-08 howi
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    2021-10-25 zhouqu_8
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    2021-10-24 查查佳佳

    临床和神经病理学研究表明,灰质萎缩

    0

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