Breast:HER2低表达对激素受体阳性早期乳腺癌预后的影响

2021-09-16 MedSci原创 MedSci原创

HER-2低表达有可能成为影响治疗决策的生物标志物吗?

雌激素受体(ER)阳性,人表皮生长因子受体2 (HER2)阴性,是早期乳腺癌最常见的亚型。现时21基因复发评分(RS)分析可以提供关于辅助化疗治疗益处的预后和预测信息。独立于基因组风险,组织病理学特征,如肿瘤大小、淋巴结受累度和分级有重要的预后价值,也是治疗的决策依据。

我们将原位杂交 (IHC )结果 +1 或 +2/ISH 阴性的肿瘤,定义为"HER2-low"。大约55%-60%的乳腺癌HER2-low,其中80%是luminal样,15%-20%是三阴性乳腺癌。现时关于HER2低表达肿瘤的预后意义临床数据尚不一致。一些研究表明,早期和晚期都与较差的预后有关。其他研究则报道与HER2-0相比,HER2-low具有相似或较佳的临床结局。目前,HER2低表达尚未被认为是ER阳性患者辅助化疗潜在益处的独立预后或预测因素。

本研究旨在研究HER2在早期、ER阳性、HER2阴性疾病中的表达是否对临床病理特征有影响,并通过基因组风险检验HER2表达在整个人群中的预后作用。

本次研究部共对705名患者进行了筛查,最终分析包括608名患者,其中包括304名HER2-0型患者和304名HER2-low型患者。与HER-low疾病相比,HER2-0疾病中浸润性小叶癌更为普遍(分别为17%和8%,p = 0.005)。其他组织病理学特征包括肿瘤大小、淋巴结受累、分级、增殖指数Ki-67%、激素受体染色强度、血管淋巴细胞浸润等均类似。

根据HER2表达状态的基线临床和病理特征

中位随访时间为10.3年。在研究队列中,HER2表达与预后无关。

整个研究队列的OS、DFS和DDFS以及按基因组风险分列数据

HER2-low的10年预期OS率为91%,HER2-0疾病的10年OS率为88%(下图,图1A),HR=0.66,95% CI 0.40-1.08,P=0.10。对于HER2-low和HER2-0,10年预期DFS分别为87%和82%(图1B),HR=0.72,95% CI 0.49-1.06 P=0.09。对于HER2-low和HER2-0,10年预期DDFS分别为90%和85%(图1C), HR=0.71,95% CI 0.45-1.1 P=0.13。

总体而言,497例患者(82%)具有低基因组风险(RS为0-25),其中245例HER2-low患者和252例HER2-0患者。对低基因风险女性的分析发现相似的OS、DFS和DDFS,见表2和图2-C(下图)。

111名患者的复发评分为26分或以上,其中52例HER2-0,59例HER2-low。高基因组风险妇女的临床病理特征在HER2-低和HER2-0疾病之间相似。与HER2-0相比, HER2-low与OS(10年生存率89%vs68%,HR=0.31,95% CI 0.11-0.78, P=0.01),DFS(10年生存率80%vs59%,HR=0.40,95% CI 0.20-0.82;P < 0.01)和DDFS(10年比率分别为86%和59%,HR=0.26 95% CI 0.11-0.63,P=0.002)改善相关,具有统计学意义(见下图,图3A-C)。

大多数基因组风险较高的女性接受辅助化疗:40名(78.4%)为HER2-0和45名(78.9%)为HER2-low。与HER-0疾病相比,无论是否给予辅助化疗,HER2-low都出现了良好的结果。这些患者中绝大多数(97%)接受了初始辅助激素治疗,其中55例(98%)HER2-low患者和45例(96%))HER2-0患者接受了辅助激素治疗。由于高基因组风险和侵袭性小叶癌患者的数量很少(n¼8),没有对肿瘤亚型、基因组风险和预后之间的相互作用进行分析。然而,无论her2-低疾病的组织学亚型如何,有利于改善预后的信号仍然存在。在多变量分析中,HER2-low、更年轻、肿瘤较小和基因组风险低都与统计学上显著改善的DFS独立相关,DDFS 的多变量分析结果类似,但 HER2-low 与 HER2-0 之间的差异未达到统计意义阈值(p = 0.084)。

疾病复发时的HER2状态见图4。总的来说,有68例复发事件,其中33例经活检证实。其中10/14 (71%) HER2-0和12/19(63%)HER2-low的患者,复发部位活检的HER2表达与基线一致。复发时,免疫组化(+3)或ISH检测HER2阳性4例(12%)。与Oncotype DX评分较低、倾向于保持HER2原始水平的肿瘤相比,Oncotype DX评分较高的肿瘤在复发时倾向于过度表达HER2受体。

综上,本次研究表明,在Oncotype DX风险组中HER2-low预后意义不同,只有在高基因组风险患者中HER2-low肿瘤的预后良好。未来有必要进行更大规模的研究,以明确HER2-low是否代表可能影响治疗决策的生物标志物。

 

原文来源:

Raz Mutai,et al.Prognostic impact of HER2-low expression in hormone receptor positive early breast cancer.

The Breast 60(2021)62-69.https://doi.org/10.1016/j.breast.2021.08.016

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    2021-09-16 JZ Yang

    感谢分享,学习了

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    2021-09-17 zhaojie88

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