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21 基因检测与早期乳腺癌患者循环肿瘤细胞检测的相关性:IRMA 试验结果。

Association between 21-gene-assay and detection of disseminated tumor cells in patients with early breast cancer: results from the IRMA trial.

机构信息

Department for Women's Health, University Medical Center Tübingen, 72076, Tübingen, Germany.

Department for Gynecology and Obstetrics, University Medical Center Heidelberg, 69120, Heidelberg, Germany.

出版信息

Breast Cancer Res Treat. 2023 Nov;202(1):67-72. doi: 10.1007/s10549-023-07031-w. Epub 2023 Aug 9.

DOI:10.1007/s10549-023-07031-w
PMID:37556015
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10504215/
Abstract

PURPOSE

Disseminated tumor cells (DTCs) in the bone marrow (BM) are known to be of prognostic value for patients with early breast cancer (EBC). In addition to histopathological features, multigene expression assays, such as the commercially available 21-gene Breast Recurrence Score® assay, have been validated for evaluating prognosis and making decisions concerning adjuvant treatment in EBC. In a previous retrospective study from our group, the 21-gene assay was shown to be associated with DTC-detection. A secondary endpoint of the prospective IRMA trial was to evaluate the association between Recurrence Score® (RS) result and tumor cell dissemination in patients with EBC.

METHODS

DTC-status and RS result were assessed in patients with ER-positive/HER2-negative EBC with 0-3 pathologic lymph nodes who underwent primary surgical treatment at the Department for Women's Health of Tuebingen University, Germany.

RESULTS

Patients with a high RS result (≥ 26) were more frequently DTC-positive (22.6%) than patients with a low RS result (8.6%, p = 0.034). The odds for DTC-positivity increased with rising RS values (p = 0.047).

CONCLUSION

We therefore confirm that a high genomic risk is associated with tumor cell dissemination into the BM. Further trials are needed to investigate whether therapeutic decisions could be further individualized by combining DTC-status and prognostic gene signature testing.

摘要

目的

已知骨髓(BM)中的播散性肿瘤细胞(DTC)对早期乳腺癌(EBC)患者具有预后价值。除了组织病理学特征外,多基因表达分析,如商业上可用的 21 基因乳腺癌复发评分(Breast Recurrence Score®assay),已被验证可用于评估预后并决定 EBC 的辅助治疗。在我们小组的先前回顾性研究中,21 基因检测与 DTC 检测相关。前瞻性 IRMA 试验的次要终点是评估 ER 阳性/HER2 阴性 EBC 患者中 Recurrence Score®(RS)结果与肿瘤细胞扩散之间的关联。

方法

在德国图宾根大学妇女健康系接受原发性手术治疗的 0-3 个病理性淋巴结的 ER 阳性/HER2 阴性 EBC 患者中评估 DTC 状态和 RS 结果。

结果

高 RS 结果(≥26)患者的 DTC 阳性率(22.6%)高于低 RS 结果患者(8.6%,p=0.034)。随着 RS 值的升高,DTC 阳性的可能性增加(p=0.047)。

结论

因此,我们证实高基因组风险与肿瘤细胞播散到 BM 相关。需要进一步的试验来研究是否可以通过结合 DTC 状态和预后基因特征检测进一步个体化治疗决策。

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2
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