Prosigna检测对早期激素受体阳性/人表皮生长因子受体2阴性乳腺癌患者新辅助治疗决策的影响：一项单中心前瞻性观察研究

Impact of the Prosigna assay on neoadjuvant treatment decision-making in patients with early-stage HR-positive/HER2-negative breast cancer: a single-center prospective observational study.

作者信息

Corti C, Chu X, Exman P, Kline D M, Priedigkeit N M, Mayer E L, Waks A G, Hughes M E, Abravanel D L, Giordano A, Curigliano G, Lin N U, King T A, Jeselsohn R M, Manning D K, Dillon D A, Mittendorf E A, Tayob N, Tolaney S M

机构信息

Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Cancer Institute, Boston, USA; Harvard Medical School, Boston, USA; Division of New Drugs and Early Drug Development, European Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hematology-Oncology (DIPO), University of Milan, Milan, Italy. Electronic address: https://twitter.com/CCortiMD.

Department of Data Science, Dana-Farber Cancer Institute, Boston, USA.

出版信息

ESMO Open. 2025 Jul 25;10(8):105521. doi: 10.1016/j.esmoop.2025.105521.

DOI:10.1016/j.esmoop.2025.105521

PMID:40714511

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12314373/

Abstract

BACKGROUND

The 50-gene assay Prosigna is cleared by the United States Food and Drug Administration only in postoperative hormone receptor-positive (HR-positive) breast cancer (BC) specimens. Given studies showing that Prosigna may identify chemo-sensitive tumors, this decision-impact study evaluated whether the assay could influence physicians' choices and patients' confidence in the neoadjuvant treatment plan.

PATIENTS AND METHODS

This single-center prospective observational study included patients with early-stage HR-positive/HER2-negative BC measuring ≥0.5 cm, any nodal status, deemed as possible candidates for neoadjuvant treatment per physician's choice. Formalin-fixed, paraffin-embedded core biopsy specimens were centrally analyzed using Prosigna. Physicians and patients were surveyed before and after Prosigna testing. The primary endpoint was the proportion of patients whose treatment differed from the pre-Prosigna recommendation. Secondary endpoints included assessing (i) reasons for treatment changes, (ii) physicians' and patients' confidence in the treatment recommendation and (iii) the association of residual cancer burden (RCB) with risk of recurrence (ROR) risk groups (RG).

RESULTS

Fifty-four patients were enrolled between March 2019 and April 2023. Tumors were luminal A, luminal B, HER2-enriched and basal-like in 27.8%, 63.0%, 5.6% and 3.7% of cases, respectively. ROR RG was low, intermediate, and high in 18.5%, 20.4% and 61.1% of cases, respectively. A change in the treatment plan occurred in 35.2% of cases [95% confidence interval (CI) 23.1%-50.2%]. Among 14 questionnaires regarding reasons for treatment changes, ROR RG alone and both ROR RG and intrinsic subtype were reported in 35.7% and 64.3% of cases, respectively. Of treating physicians, 83.7% felt their confidence in the appropriateness of the treatment plan remained stable or improved, and 62.5% of patients reported reduced anxiety. No association between RCB and ROR RG was found.

CONCLUSIONS

Performing Prosigna on upfront core biopsies may influence the neoadjuvant treatment decision-making in early-stage HR-positive/HER2-negative BC.

CLINICALTRIALS

gov number, NCT03749421.

摘要

背景

50基因检测法Prosigna仅在美国食品药品监督管理局获批用于术后激素受体阳性（HR阳性）乳腺癌（BC）标本检测。鉴于有研究表明Prosigna可能识别出对化疗敏感的肿瘤，本决策影响研究评估了该检测法是否会影响医生的选择以及患者对新辅助治疗方案的信心。

患者与方法

这项单中心前瞻性观察性研究纳入了早期HR阳性/人表皮生长因子受体2阴性（HER2阴性）、肿瘤大小≥0.5 cm、任何淋巴结状态、经医生判断可能适合新辅助治疗的BC患者。使用Prosigna对福尔马林固定、石蜡包埋的核心活检标本进行集中分析。在Prosigna检测前后对医生和患者进行调查。主要终点是治疗方案与Prosigna检测前建议不同的患者比例。次要终点包括评估（i）治疗方案改变的原因，（ii）医生和患者对治疗建议的信心，以及（iii）残余癌负担（RCB）与复发风险（ROR）风险组（RG）的关联。

结果

2019年3月至2023年4月期间共纳入54例患者。肿瘤分别为腔面A型、腔面B型、HER2富集型和基底样型的病例占比分别为27.8%、63.0%、5.6%和3.7%。ROR RG为低、中、高风险组的病例分别占18.5%、20.4%和61.1%。35.2%的病例（95%置信区间[CI] 23.1% - 50.2%）治疗方案发生了改变。在14份关于治疗方案改变原因的问卷中，分别有35.7%和64.3%的病例报告仅因ROR RG以及同时因ROR RG和内在亚型而改变治疗方案。在参与治疗的医生中，83.7%认为他们对治疗方案适宜性的信心保持稳定或增强，62.5%的患者报告焦虑减轻。未发现RCB与ROR RG之间存在关联。