通过循环肿瘤 DNA 分析检测 HER2 阳性早期乳腺癌微小残留病灶并配合新辅助化疗的多中心前瞻性研究:HARMONY 研究。

IF 1.8 Q3 ONCOLOGY Breast Cancer : Basic and Clinical Research Pub Date : 2024-10-27 eCollection Date: 2024-01-01 DOI:10.1177/11782234241288671
Momoko Tokura, Mark Malalay Ando, Yuki Kojima, Rui Kitadai, Shu Yazaki, Cyrielle Marie N Atutubo, Rubi K Li, Minda Z Perez, Agnes E Gorospe, Manuelito A Madrid, Mel Valerie C Ordinario, Marcelo Severino B Imasa, Kazuki Sudo, Tatsunori Shimoi, Akihiko Suto, Shinji Kohsaka, Ryunosuke Machida, Ryo Sadachi, Masayuki Yoshida, Yasushi Yatabe, Tomomi Hata, Kenichi Nakamura, Kan Yonemori, Sho Shiino
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引用次数: 0

摘要

背景:预测复发风险的生物标志物是优化围手术期治疗所必需的。人类表皮生长因子 2 阳性(HER2 阳性)早期乳腺癌患者的辅助化疗是根据新辅助化疗(NAC)的病理反应决定的。然而,病理反应是否是适当的生物标志物尚不清楚。目前,有几项研究将最小残留病灶(MRD)作为实体瘤预后的预测指标。然而,目前还没有检测MRD的标准方法:本研究旨在前瞻性评估亚洲 HER2 阳性早期乳腺癌患者 MRD 检测与复发之间的关系:设计:前瞻性、观察性、单组和探索性。本研究将包括来自日本和菲律宾两家机构的 60 名患者。比较接受 NAC 后接受手术的 HER2 阳性早期乳腺癌患者中 MRD 阳性组和 MRD 阴性组的侵袭性无病生存率(IDFS):将对患者的循环肿瘤DNA(ctDNA)水平进行6次评估:NAC前、NAC后、手术后以及手术后3年内的每年评估。我们将使用 Todai OncoPanel(TOP)分析血液和组织样本的基因图谱以及 DNA 的甲基化水平。主要终点是 IDFS。次要终点包括总生存期(OS)和无病生存期(DFS)。患者招募始于 2022 年 6 月,目前仍在招募新的参与者:本研究已于2022年3月获得国家癌症中心医院认证审查委员会的批准,并已获得参与中心研究伦理委员会的批准:我们的研究结果将有助于确定使用TOP检测MRD是否有助于预测HER2阳性早期乳腺癌的复发。如果这一点得到证实,那么在下一次干预试验中,TOP检测到的MRD可作为一种生物标志物,协助治疗策略的去级/升级,从而避免低危患者的过度治疗,并为高危患者增加强化治疗模式。
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Multicenter Prospective Study in HER2-Positive Early Breast Cancer for Detecting Minimal Residual Disease by Circulating Tumor DNA Analysis With Neoadjuvant Chemotherapy: HARMONY Study.

Background: Biomarkers to predict the recurrence risk are required to optimize perioperative treatment. Adjuvant chemotherapy for patients with human epidermal growth factor 2-positive (HER2-positive) early breast cancer is decided by pathological responses of neoadjuvant chemotherapy (NAC). However, whether pathological responses are appropriate biomarkers is unclear. Currently, there are several studies using minimal residual disease (MRD) as a predictor of prognosis in solid tumors. However, there is no standard method for detecting MRD.

Objectives: This study aimed at prospectively evaluating the relationship between MRD detection and recurrence in Asian patients with HER2-positive early breast cancer.

Design: Prospective, observational, single-group, and exploratory. This study will include 60 patients from 2 institutions in Japan and the Philippines. The invasive disease-free survival (IDFS) rates of the MRD-positive and MRD-negative groups are compared in patients with HER2-positive early breast cancer who undergo surgery after receiving NAC.

Methods and analysis: Circulating tumor DNA (ctDNA) levels of patients will be evaluated 6 times: before NAC, after NAC, after surgery, and annually after surgery for 3 years. We will analyze the genetic profile of blood and tissue samples using the Todai OncoPanel (TOP) and the methylation level of DNA. The primary endpoint is IDFS. Secondary endpoints include overall survival (OS) and disease-free survival (DFS). Patient enrollment began in June 2022, and new participants are still being recruited.

Ethics: This study has been approved by the National Cancer Center Hospital Certified Review Board in March 2022 and has been approved by the Research Ethics Board of the participating center.

Discussion: Our findings will contribute to determining whether MRD detection using TOP is useful for predicting the recurrence of HER2-positive early breast cancer. If this is proven, MRD detected by TOP could be used in the future as a biomarker to assist in the de-/escalation of treatment strategies in the next interventional trial, thereby avoiding overtreatment in patients at low risk, and in the addition of intensive treatment modalities for those in patients at high risk.

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来源期刊
CiteScore
5.10
自引率
3.40%
发文量
22
审稿时长
8 weeks
期刊介绍: Breast Cancer: Basic and Clinical Research is an international, open access, peer-reviewed, journal which considers manuscripts on all areas of breast cancer research and treatment. We welcome original research, short notes, case studies and review articles related to breast cancer-related research. Specific areas of interest include, but are not limited to, breast cancer sub types, pathobiology, metastasis, genetics and epigenetics, mammary gland biology, breast cancer models, prevention, detection, therapy and clinical interventions, and epidemiology and population genetics.
期刊最新文献
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