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将MINDACT转化为日常临床实践:70基因检测在腔面型早期乳腺癌中的应用——奥地利医学肿瘤治疗协作组(AGMT)前瞻性注册研究结果

Transferring MINDACT to Daily Routine: Implementation of the 70-Gene Signature in Luminal Early Breast Cancer - Results from a Prospective Registry of the Austrian Group Medical Tumor Therapy (AGMT).

作者信息

Westphal Theresa, Gampenrieder Simon P, Rinnerthaler Gabriel, Balic Marija, Posch Florian, Dandachi Nadia, Hauser-Kronberger Cornelia, Reitsamer Roland, Sotlar Karl, Radl Bianca, Suppan Christoph, Stöger Herbert, Greil Richard

机构信息

IIIrd Medical Department with Hematology and Medical Oncology, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg, Austria.

Salzburg Cancer Research Institute with Laboratory of Immunological and Molecular Cancer Research and Center for Clinical Cancer and Immunology Trials, Salzburg, Austria.

出版信息

Breast Care (Basel). 2022 Feb;17(1):1-9. doi: 10.1159/000512467. Epub 2021 Mar 30.

DOI:10.1159/000512467
PMID:35355702
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8914232/
Abstract

BACKGROUND

For hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC), adjuvant chemotherapy (ACT) is recommended in the case of high-risk features only. The MINDACT trial showed that patients with high clinical risk (CR) but low genomic risk (GR) defined by the 70-gene signature (MammaPrint®; 70-GS) did not benefit from ACT. In this registry, we investigated the frequency and feasibility of 70-GS and concurrent 80-gene subtyping (BluePrint®) use in HR-positive, HER2-negative EBC. Furthermore, we recorded the frequency of ACT recommendation and the adherence to it when the "MINDACT strategy" was used.

METHODS

This prospective registry included patients from 2 Austrian cancer centers. Similar to MINDACT, a modified version of Adjuvant!Online was used to determine CR, and 70-GC was used to determine GR in high-CR patients. ACT was recommended to patients with high CR and high GR.

RESULTS

Of 224 enrolled patients, 76 (33.9%) had high CR and 67 (88.2%) received genomic testing. Of those, 43 (64.2%) were classified as low and 24 (35.8%) as high GR, respectively. All 24 patients with high CR and GR (10.7% of all patients) received the recommendation for ACT, but ACT was started in only 15 patients (62.5%). The median time from surgery to the start of ACT was 45 days (range 32-68), and the median time from test decision to the test result was 15 days (range 9-56).

CONCLUSION

We showed that the results of the MINDACT trial are reproducible in an Austrian population. Incorporating 70-GS into the daily clinical routine is feasible and mostly accepted by physicians for the guidance of treatment recommendations.

摘要

背景

对于激素受体(HR)阳性/人表皮生长因子受体2(HER2)阴性早期乳腺癌(EBC),仅在具有高危特征的情况下推荐辅助化疗(ACT)。MINDACT试验表明,临床高危(CR)但由70基因检测(MammaPrint®;70-GS)定义为基因组低危(GR)的患者不能从ACT中获益。在本登记研究中,我们调查了在HR阳性、HER2阴性EBC中使用70-GS及同时进行80基因亚型分析(BluePrint®)的频率和可行性。此外,我们记录了使用“MINDACT策略”时ACT推荐的频率及其依从性。

方法

这项前瞻性登记研究纳入了来自奥地利两个癌症中心的患者。与MINDACT类似,使用改良版的Adjuvant!Online来确定CR,并使用70-GC来确定高CR患者的GR。向高CR和高GR的患者推荐ACT。

结果

在224例入组患者中,76例(33.9%)具有高CR,67例(88.2%)接受了基因检测。其中,分别有43例(64.2%)被分类为低GR和24例(35.8%)为高GR。所有24例高CR和高GR的患者(占所有患者的10.7%)都收到了ACT的推荐,但只有15例患者(62.5%)开始接受ACT。从手术到开始ACT的中位时间为45天(范围32 - 68天),从检测决定到检测结果的中位时间为15天(范围9 - 56天)。

结论

我们表明MINDACT试验的结果在奥地利人群中具有可重复性。将70-GS纳入日常临床实践是可行的,并且大多被医生接受用于指导治疗推荐。

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