通过标准参数评估生物学行为不确定的早期ER阳性HER2阴性乳腺癌患者复发风险的Oncotype DX®测定及其对治疗建议的影响的前瞻性研究：POST试验。

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2024-10-31 DOI:10.1016/j.ejca.2024.115108

Luca Livraghi , Francesca Martella , Matteo Ghilli , Catia Angiolini , Simonetta Magnanini , Erica Moretti , Carmelo Bengala , Emanuela Risi , Elena Molinara , Ilaria Pazzagli , Luca Malorni , Sara Donati , Stefano Gabellini , Angelo Martignetti , Piergiorgio Giannessi , Giuseppina Sanna , Leonardo Barellini , Chiara Biagioni , Luca Boni , Simonetta Bianchi , Laura Biganzoli

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引用次数: 0

摘要

背景：2015年公布的数据显示，早期乳腺癌（EBC）患者和21基因Oncotype DX®检测（"检测"）结果为低风险（LR）复发评分®（RS）的患者在内分泌治疗（HT）的基础上加用化疗（CT）并不能获益，而结果为高风险（HR）RS的患者则能获益。然而，CT在中危（IR）癌症患者中的作用仍不确定。我们设计了一项研究，以评估该检验将生物学行为不确定的EBC患者分为LR和HR两组的能力，从而确定额外化疗的价值：POST试验是一项多中心、前瞻性队列研究，在意大利托斯卡纳地区的14家乳腺中心进行。根据标准参数，pT1-2 pN0-N1mi 激素受体阳性/HER2 阴性 EBC 患者的生物学行为不确定。如果RS结果为25，则根据RS结果将患者分别分为LR组、IR组和HR组。在RS结果出来之前和之后，由多学科会议评估治疗建议：结果：在 246 份检测样本中，78 人被分为 LR 或 HR 组，其中大部分患者（65.4%）为 IR 组。检测结果出来后，15.9%的病例改变了建议。在最初被建议进行 CT 或讨论 CT 作用的患者中，分别有 64.3% 和 75.9% 最终被建议仅进行 HT：我们的研究表明，对于最初被建议或考虑进行 CT 检查的生物学行为不确定的 EBC 患者，RS 结果可以完善他们的治疗决策。(250/250).

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Prospective study on Oncotype DX® assay to assess recurrence risk in early ER-positive HER2-negative breast cancer patients with uncertain biological behavior by standard parameters and its impact on treatment recommendation: The POST trial

Background

Data published in 2015 showed that patients with early breast cancer (EBC) and a low-risk (LR) Recurrence Score® (RS) result by the 21-gene Oncotype DX® assay (“the test”) did not derive benefit from adding chemotherapy (CT) to endocrine therapy (HT), while those with a high-risk (HR) RS result did. However, the role of CT remained uncertain in patients with intermediate-risk (IR) cancers. We designed a study to assess the test’s ability to categorize patients with EBC with uncertain biological behavior into the groups (LR and HR) for which the value of additional chemotherapy was defined.

Methods

The POST trial was a multicenter, prospective cohort study conducted in 14 Breast Centers of the Tuscany region of Italy. Consecutive patients with pT1–2 pN0-N1mi hormone receptor-positive/HER2-negative EBC and uncertain biological behavior based on standard parameters were enrolled. Patients were categorized based on RS results into LR, IR, and HR groups if RS result was < 11, 11–25, and > 25, respectively. Treatment recommendations by multidisciplinary meeting assessed before and after RS results were available.

Results

Of 246 tested samples, 78 were classified as LR or HR, with most of the patients (65.4 %) being at IR. Following test results, the recommendation changed in 15.9 % of cases. Among patients initially recommended for CT or for discussion about the role of CT, respectively 64.3 % and 75.9 % ultimately received recommendation for HT alone.

Conclusions

Our study suggests that RS results can refine treatment decisions for patients with EBC exhibiting uncertain biological behavior initially recommended or considered for CT.

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.