Objectives: There is high interest in blood-based assays for tracking treatment efficacy and detecting recurrence among breast cancer patients. This preliminary feasibility study assessed the performance of the Early Detection Serum-based Assay for Breast Cancer (EDSA-BC), which measures a novel protein biomarker (BF-09), in (neo)adjuvant and metastatic treatment follow-up.Methods: In total, 313 serial serum samples collected retrospectively from 72 BC patients (72.2% stage I–III, 27.8% stage IV) during disease management (median 33.4 months) were analyzed for BF-09 serum level at different time points before and/or after surgery and treatment (3 to 9 samples per patient). Serial dynamics of BF-09 were correlated with clinically recorded outcomes.Results:Per-sample performance of EDSA-BC for progressive disease or recurrence was 74% sensitivity at 85% specificity with 49.4% positive predictive value, 94.3% negative predictive value and 83% accuracy. Median lead time in detecting relapse was 9.4 months (range 0.8–27 months).Conclusions: Results showed the clinical validity of BF-09 in reflecting relative tumor burden and were comparable to tumor-naïve ctDNA liquid biopsy, especially as a single-marker test. These findings indicate that EDSA-BC has potential as a scalable and cost-efficient assay to aid in breast cancer management. Prospective studies are needed to clarify sampling tempo, clinical utility and benefit.
目的：基于血液的检测方法在乳腺癌患者治疗疗效追踪及复发监测方面备受关注。本研究为初步可行性评估，旨在探讨早期乳腺癌血清检测法（EDSA-BC）在（新）辅助治疗及转移性治疗随访中的表现。该检测通过测量新型蛋白生物标志物（BF-09）实现。 方法：回顾性分析72例乳腺癌患者（I–III期占72.2%，IV期占27.8%）在疾病管理期间（中位时间33.4个月）采集的313份连续血清样本。检测患者手术和/或治疗前后不同时间点（每例患者3-9份样本）的BF-09血清水平，并将BF-09的动态变化与临床记录结果进行关联分析。 结果：EDSA-BC对疾病进展或复发的单样本检测性能表现为：在85%特异性下灵敏度达74%，阳性预测值49.4%，阴性预测值94.3%，准确率83%。检测复发的中位提前时间为9.4个月（范围0.8-27个月）。 结论：研究结果证实BF-09在反映相对肿瘤负荷方面具有临床有效性，其表现与不依赖肿瘤组织的ctDNA液体活检相当，尤其作为单一标志物检测时。这些发现表明EDSA-BC有望成为可扩展且经济高效的检测方法，辅助乳腺癌临床管理。未来需开展前瞻性研究以明确采样频率、临床效用及实际获益。
肿瘤(癌症)患者之家