J Clin Oncol:Elacestrant vs 标准内分泌疗法治疗ER+/HER2-晚期乳腺癌

2022-05-20 MedSci原创 MedSci原创

ER+/HER2-晚期乳腺癌患者采用选择性ER降解剂Elacestrant治疗可获得优于标准内分泌疗法的无进展生存预后

内分泌疗法(芳香酶抑制剂或氟维司群+细胞周期依赖性激酶4/6抑制剂)是局部晚期或转移性激素受体(ER)阳性或人表皮生长因子受体2(HER2)阴性乳腺癌推荐的一线标准疗法。但目前经预处理的这类患者的预后仍较差。

Elacestrant是一种口服的新型选择性激素受体降解剂,可通过剂量依赖性方式降解ERα,抑制雌二醇依赖性ER定向基因转录和肿瘤生长,在早期研究中显示出抗肿瘤活性。

本研究是一项开放标签、随机的3期试验,招募了ER阳性/HER2阴性的既往接受过1-2线内分泌疗法的晚期乳腺癌患者,随机分成两组,予以Elacestrant(400mg/天,口服)或标准内分泌疗法(SOC)。主要终点是无进展生存期。


两组总人群和携带ESR1突变的患者的无进展生存率

共有477位患者被随机分至两组:Elacestrant组 239位,SOC组 238位。从47.8%的患者中检测到ESR1突变,43.4%的患者既往接受过两次内分泌疗法。与SOC组相比,Elacestrant组所有患者的无进展生存期均有所延长(HR 0.70, p=0.002),携带ESR1突变的患者延长更显著(0.55,p=0.005)。Elacestrant组和SOC组的6个月无进展生存率分别是34.3%和20.4%,12个月无进展生存率分别是22.3%和9.4%。


两组不良反应的发生情况

Elacestrant组和SOC组分别有7.2%和3.1%的患者经历了3/4级治疗相关不良反应,分别有3.4%和0.9%的患者因不良反应而中断治疗。最常见的所有级别的不良反应是恶心(Elacestrant组 35.0%,SOC组 18.8%)。

总之,Elacestrant是首个口服的选择性ER降解剂,在无论是否携带ESR1突变的ER+/HER2-晚期乳腺癌患者中展现出了优于标准内分泌疗法的无进展生存期,而且具有可控的安全性。

原始出处:

Francois-Clement Bidard, et al. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. Journal of Clinical Oncology. https://creativecommons.org/licenses/by-nc-nd/4.0/

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    2022-08-23 minlingfeng
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    2023-04-12 bsmagic9140
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    2022-11-11 gwc392
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    2023-01-07 shanyongle
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    2022-12-02 luwei00

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