1Yale School of Medicine, New Haven, CT.
2Biotheranostics, A Hologic Company, San Diego, CA.
J Natl Compr Canc Netw. 2024 Mar 4;22(2):99-107. doi: 10.6004/jnccn.2023.7087.
The Breast Cancer Index (BCI) test assay provides an individualized risk of late distant recurrence (5-10 years) and predicts the likelihood of benefitting from extended endocrine therapy (EET) in hormone receptor-positive early-stage breast cancer. This analysis aimed to assess the impact of BCI on EET decision-making in current clinical practice.
The BCI Registry study evaluates long-term outcomes, decision impact, and medication adherence in patients receiving BCI testing as part of routine clinical care. Physicians and patients completed pre-BCI and post-BCI test questionnaires to assess a range of questions, including physician decision-making and confidence regarding EET; patient preferences and concerns about the cost, side effects, drug safety, and benefit of EET; and patient satisfaction regarding treatment recommendations. Pre-BCI and post-BCI test responses were compared using McNemar's test and Wilcoxon signed rank test.
Pre-BCI and post-BCI questionnaires were completed for 843 physicians and 823 patients. The mean age at enrollment was 65 years, and 88.4% of patients were postmenopausal. Of the tumors, 74.7% were T1, 53.4% were grade 2, 76.0% were N0, and 13.8% were HER2-positive. Following BCI testing, physicians changed EET recommendations in 40.1% of patients (P<.0001), and 45.1% of patients changed their preferences for EET (P<.0001). In addition, 38.8% of physicians felt more confident in their recommendation (P<.0001), and 41.4% of patients felt more comfortable with their EET decision (P<.0001). Compared with baseline, significantly more patients were less concerned about the cost (20.9%; P<.0001), drug safety (25.4%; P=.0014), and benefit of EET (29.3%; P=.0002).
This analysis in a large patient cohort of the BCI Registry confirms and extends previous findings on the significant decision-making impact of BCI on EET. Incorporating BCI into clinical practice resulted in changes in physician recommendations, increased physician confidence, improved patient satisfaction, and reduced patient concerns regarding the cost, drug safety, and benefit of EET.
乳腺癌指数（BCI）检测可提供晚期远处复发（5-10 年）的个体化风险，并预测激素受体阳性早期乳腺癌患者从延长内分泌治疗（EET）中获益的可能性。本分析旨在评估 BCI 对当前临床实践中 EET 决策的影响。
BCI 注册研究评估了接受 BCI 检测作为常规临床护理一部分的患者的长期结果、决策影响和药物依从性。医生和患者在接受 BCI 检测前和检测后完成问卷，以评估一系列问题，包括医生对 EET 的决策和信心；患者对 EET 的成本、副作用、药物安全性和获益的偏好和关注；以及患者对治疗建议的满意度。使用 McNemar 检验和 Wilcoxon 符号秩检验比较接受 BCI 检测前和检测后的问卷回答。
843 名医生和 823 名患者完成了接受 BCI 检测前和检测后的问卷。入组时的平均年龄为 65 岁，88.4%的患者处于绝经后状态。肿瘤方面，74.7%为 T1，53.4%为 2 级，76.0%为 N0，13.8%为 HER2 阳性。接受 BCI 检测后，医生改变了 40.1%患者的 EET 推荐（P<.0001），45.1%的患者改变了他们对 EET 的偏好（P<.0001）。此外，38.8%的医生对他们的建议更有信心（P<.0001），41.4%的患者对他们的 EET 决策更放心（P<.0001）。与基线相比，有更多的患者不太担心 EET 的成本（20.9%；P<.0001）、药物安全性（25.4%；P=.0014）和获益（29.3%；P=.0002）。
本分析纳入了 BCI 注册研究中的大量患者队列，证实并扩展了之前关于 BCI 对 EET 的显著决策影响的发现。将 BCI 纳入临床实践导致了医生建议的改变、医生信心的增加、患者满意度的提高，以及患者对 EET 的成本、药物安全性和获益的担忧的减少。
