Savitha Badada Ananthamurthy, Shrivastava Payal, Bhagat Rahul, Krishnamoorthy Naveen, Shivashimpi Deepti K, Bakre Manjiri M
Technical and Analytical Division, OncoStem Diagnostics Pvt. Ltd, Bengaluru, IND.
Design and Development, OncoStem Diagnostics Pvt. Ltd, Bengaluru, IND.
Cureus. 2024 Sep 23;16(9):e70054. doi: 10.7759/cureus.70054. eCollection 2024 Sep.
Introduction Core needle biopsies (CNB) are being increasingly utilized for biomarker, prognostic, and predictive testing in breast cancer (BC). CanAssist Breast (CAB) is a prognostic test performed to assess the 'risk of breast cancer recurrence' in early-stage hormone receptor-positive, Her2-negative BC patients. CAB segregates tumors as 'low risk' or 'high risk' for distant recurrence. Risk assessment done by CAB aids in planning and making adjuvant chemotherapy or hormone therapy decisions. CAB is typically performed on surgical specimens (SS). However, performing it on CNB does offer additional insights into tumor biology leading to different strategies for treatment planning; hence, we aimed to compare the risk stratification performance of CAB using CNB versus SS. Method We analyzed 103 paired formalin-fixed paraffin-embedded CNB and SS samples from hormone receptor-positive, Her2-negative early BC tissue samples submitted for performing CAB at OncoStem Diagnostics between November 2021 and September 2023. Concordance on 'risk categories' of CAB performed on CNB versus SS was reported using overall percentage agreement and Pearson correlation coefficient. Results We found excellent overall concordance of 92.2% for CAB risk stratification between paired CNB and SS tumor samples with a strong Pearson correlation coefficient of r= 0.8351 (p< 0.0001) when either SS or CNB was used as the gold standard. In prognostic testing patients with a 'low risk' of recurrence may avoid chemotherapy and hence it is crucial to assess the accuracy of CAB in the low-risk category. Additionally, in a real-world scenario, it is more likely that CAB will be performed on CNB first. Conclusion CAB when performed on CNB samples showed high concordance with SS thus demonstrating that CNB was a suitable sample for the CanAssist Breast test. The accuracy in the low-risk category is 97.5%, which ensures that physicians can reliably use prognostic information by testing CNB to guide adjuvant therapy decisions.
引言
在乳腺癌（BC）的生物标志物、预后和预测检测中，核心针吸活检（CNB）的应用越来越广泛。CanAssist Breast（CAB）是一项预后检测，用于评估早期激素受体阳性、人表皮生长因子受体2（Her2）阴性的BC患者的“乳腺癌复发风险”。CAB将肿瘤分为远处复发的“低风险”或“高风险”。CAB进行的风险评估有助于辅助化疗或激素治疗决策的规划和制定。CAB通常在手术标本（SS）上进行。然而，在CNB上进行该检测确实能为肿瘤生物学提供更多见解，从而为治疗规划带来不同策略；因此，我们旨在比较使用CNB与SS进行CAB风险分层的性能。
方法
我们分析了2021年11月至2023年9月期间在OncoStem诊断公司提交进行CAB检测的103对激素受体阳性、Her2阴性早期BC组织样本的福尔马林固定石蜡包埋CNB和SS样本。使用总体百分比一致性和Pearson相关系数报告在CNB与SS上进行的CAB“风险类别”的一致性。
结果
当以SS或CNB作为金标准时，我们发现配对的CNB和SS肿瘤样本之间CAB风险分层的总体一致性极佳，为92.2%，Pearson相关系数r = 0.8351（p < 0.0001）。在预后检测中，复发“低风险”的患者可能避免化疗，因此评估CAB在低风险类别中的准确性至关重要。此外，在实际情况中，更有可能首先在CNB上进行CAB检测。
结论
在CNB样本上进行CAB检测时与SS显示出高度一致性，从而表明CNB是CanAssist Breast检测的合适样本。低风险类别的准确性为97.5%，这确保医生可以通过检测CNB可靠地使用预后信息来指导辅助治疗决策。
