Ghosh Susmita, Durgekar Tejal Deepak, Sunder Manvi, Savitha Badada Ananthamurthy, Shrivastava Payal, Krishnamoorthy Naveen, Shivashimpi Deepti K, Bakre Manjiri M
OncoStem Diagnostics Private Limited, Bangalore, Karnataka, India.
OncoStem Diagnostics Private Limited, 4, Raja Ram Mohan Roy Road, Aanand Towers, 2nd Floor, Bangalore, Karnataka 560027, India.
Ther Adv Med Oncol. 2025 May 24;17:17588359251342218. doi: 10.1177/17588359251342218. eCollection 2025.
The estrogen receptor (ER) is one of the key biomarkers in breast cancer (BC), and therapy decisions are based on ER expression levels. However, the benefit of endocrine therapy in patients with ER expression (ER) is debatable. Owing to aggressive tumor biology, like triple-negative BC patients, many ER patients are considered to have worse outcomes and may benefit from additional drugs. This treatment dilemma in ER patients can be addressed by prognostication for risk of recurrence, which remains underexplored.
The study aims to assess whether CanAssist Breast (CAB), an immunohistochemistry-based prognostic test validated globally in ER+/PR+/HER2- early-stage breast cancer (EBC) patients, would help prognosticate ER patients and thereby aid in treatment planning.
We conducted secondary data analyses of previously published retrospective studies to evaluate CAB prognostication in ER and ER subgroups across different clinical parameters.
Analysis of CAB-based risk stratification was conducted on 2896 ER+/PR+/HER2- EBC patients with a known percentage of ER staining in both ER and ER subgroups. Kaplan-Meier survival curves were used to evaluate distant recurrence-free interval (DRFI).
ER patients constituted 6% of the total cohort. Overall, CAB significantly identified 65% of ER patients as low risk (LR) with acceptable DRFI of 91% and 35% as high risk (HR) with worse DRFI of 61% ( < 0.0001; hazard ratio (HR/LR), 5.175). ER patients are mostly younger, with T2, grade 3, lymph node positive tumors, and have a twofold higher incidence of distant recurrence than ER patients. CAB-based prognostication was significant in these subgroups analyzed with acceptable DRFI in LR patients of ~90% and a drop in DRFI in HR patients to ⩽66% ( = 0.01 to < 0.0001).
CAB-based risk stratification of ER patients is significant and would add value in treatment decisions for additional targeted treatments to HR patients.
雌激素受体(ER)是乳腺癌(BC)的关键生物标志物之一,治疗决策基于ER表达水平。然而,内分泌治疗对ER表达(ER)患者的益处存在争议。由于肿瘤生物学行为侵袭性强,如三阴性乳腺癌患者,许多ER患者被认为预后较差,可能从额外的药物治疗中获益。ER患者的这种治疗困境可通过预测复发风险来解决,但这方面仍未得到充分探索。
本研究旨在评估CanAssist Breast(CAB),一种在全球范围内针对ER+/PR+/HER2-早期乳腺癌(EBC)患者进行验证的基于免疫组织化学的预后检测方法,是否有助于对ER患者进行预后评估,从而辅助治疗规划。
我们对先前发表的回顾性研究进行了二次数据分析,以评估CAB在不同临床参数的ER和ER亚组中的预后情况。
对2896例ER+/PR+/HER2- EBC患者进行基于CAB的风险分层分析,这些患者在ER和ER亚组中均有已知的ER染色百分比。采用Kaplan-Meier生存曲线评估远处无复发生存期(DRFI)。
ER患者占总队列的6%。总体而言,CAB显著将65%的ER患者识别为低风险(LR),其可接受的DRFI为91%,35%为高风险(HR),DRFI较差,为61%(<0.0001;风险比(HR/LR),5.175)。ER患者大多较年轻,肿瘤为T2、3级、淋巴结阳性,远处复发发生率是ER患者的两倍。在这些亚组中,基于CAB的预后评估具有显著性,LR患者的DRFI约为90%,HR患者的DRFI降至≤66%(=0.01至<0.0001)。
基于CAB的ER患者风险分层具有显著性,可为HR患者的额外靶向治疗决策增加价值。