NEJM:21基因检测为淋巴结阳性乳腺癌患者化疗获益提供了预后信息

2021-12-16 MedSci原创 MedSci原创

在有1到3个淋巴结阳性且复发评分为25或更低的绝经前女性中,接受化学内分泌治疗的女性无侵袭性疾病生存期和无远处复发生存期比单纯内分泌治疗的女性更长。

基于21基因乳腺癌检测的复发评分在临床上可用于预测激素受体阳性、人表皮生长因子受体2(HER2)阴性、腋窝淋巴结阴性乳腺癌的化疗获益情况。在淋巴结疾病阳性的女性中,复发评分在预测辅助化疗获益方面的作用尚未明确。

近日,顶级医学期刊NEJM上发表了一篇研究文章,在这项前瞻性试验中,研究人员随机分配了激素受体阳性、HER2阴性乳腺癌、1到3个腋窝淋巴结阳性、复发评分为25或更低(评分范围为0到100,评分较高表明预后较差)的患者仅接受内分泌治疗或化疗加内分泌(化学内分泌)治疗。该研究的主要目的是明确化疗对无侵袭性疾病生存期的效应,以及这种效应是否受复发评分的影响。该研究的次要终点包括无远处复发生存情况。

该研究共纳入了5083名女性(33.2%为绝经前女性和66.8%为绝经后女性)被随机分组,5018名女性参与了试验。在预先指定的第三次中期分析中,在增加无侵袭性疾病生存率方面的化疗益处因绝经状态而异(比较绝经前和绝经后参与者的化疗益处P=0.008),并进行了单独的预先指定分析。在绝经后女性中,仅内分泌组的5年无侵袭性疾病生存率为91.9%,化学内分泌组为91.3%,没有化疗获益(侵袭性疾病复发的风险比、新原发癌[乳腺癌或其他类型]或死亡为1.02;95%置信区间[CI]为0.82至1.26;P=0.89)。

在绝经前妇女中,仅内分泌治疗组的5年无侵袭性疾病生存率为89.0%,化学内分泌治疗组为93.9%(风险比为0.60;95%CI为0.43至0.83;P=0.002),在无远处复发生存率具有类似程度地升高(风险比为0.58;95%CI为0.39至0.87;P=0.009)。随着复发评分的增加,相对化疗获益并未增加。

由此可见,在有1到3个淋巴结阳性且复发评分为25或更低的绝经前女性中,接受化学内分泌治疗的女性无侵袭性疾病生存期和无远处复发生存期比单纯内分泌治疗的女性更长,而绝经后女性的无侵袭性疾病生存期和无远处复发生存期类似,且并未从辅助化疗中获益。

原始出处:
 
Kevin Kalinsky,et al.21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer.NEJM.2021.https://www.nejm.org/doi/full/10.1056/NEJMoa2108873

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    2021-12-18 sodoo
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