爱尔兰早期乳腺癌（ESBC）中 21 基因复发评分（RS）检测的临床和经济影响的真实世界分析。
Real-world analysis of clinical and economic impact of 21-gene recurrence score (RS) testing in early-stage breast cancer (ESBC) in Ireland.
机构信息
Department of Medical Oncology, St Vincent's University Hospital, Dublin 4, Ireland.
Department of Pathology, St. Vincent's University Hospital, Dublin, Ireland.
出版信息
Breast Cancer Res Treat. 2021 Aug;188(3):789-798. doi: 10.1007/s10549-021-06211-w. Epub 2021 Apr 9.
PURPOSE
Results from TAILOR-X suggest that up to 70% of hormone receptor-positive (HR+) node-negative (N0) ESBC patients (pts) may avoid chemotherapy (CT) with RS ≤ 25. We assess clinical and economic impacts of RS testing on treatment using real-world data.
METHODS
From October 2011 to February 2019, a retrospective, cross-sectional observational study was conducted of HR+ N0 ESBC pts who had RS testing in Ireland. Pts were classified low risk (RS ≤ 25) and high risk (RS > 25). Clinical risk was calculated. Data were collected via electronic patient records. Cost data were supplied by the National Healthcare Pricing Regulatory Authority.
RESULTS
963 pts. Mean age is 56 years. Mean tumour size is 1.7 cm. 114 (11.8%), 635 (66%), 211 (22%), 3 (0.2%) pts had G1, G2, G3 and unknown G, respectively. 796 pts (82.8%) low RS, 159 (16.5%) high RS and 8 pts (0.7%) unknown RS. 263 pts (26%) were aged ≤ 50 at diagnosis; 117 (45%) had RS 0-15, 63 (24.5%) 16-20, 39 (15.3%) 21-25 and 40 (15.2%) RS 26-100. 4 pts (1.5%) had unknown RS. Post-RS testing, 602 pts (62.5%) had a change in CT decision; 593 changed to hormone therapy (HT) alone. In total, 262 pts received CT. Of pts receiving CT; 138 (53%) had RS > 25, 124 (47%) had RS ≤ 25. Of pts aged ≤ 50, 153 (58%) had high clinical risk, of whom 28 had RS 16-20. Assay use achieved a 62.5% change in treatment with 73% of pts avoiding CT. This resulted in savings of €4 million in treatment costs. Deducting assay costs, savings of €1.9 million were achieved.
CONCLUSION
Over the 8 years of the study, a 62.5% reduction in CT use was achieved with savings of over €1,900,000.
目的
TAILOR-X 研究结果表明，多达 70%的激素受体阳性（HR+）淋巴结阴性（N0）ESBC 患者（pts）可能避免化疗（CT），RS≤25。我们使用真实世界数据评估 RS 检测对治疗的临床和经济影响。
方法
从 2011 年 10 月至 2019 年 2 月，对爱尔兰进行 RS 检测的 HR+N0 ESBC pts 进行了回顾性、横断面观察性研究。pts 分为低风险（RS≤25）和高风险（RS＞25）。计算临床风险。数据通过电子病历收集。成本数据由国家医疗保健定价监管局提供。
结果
共 963 例 pts。平均年龄 56 岁。平均肿瘤大小 1.7cm。G1、G2、G3 和未知 G 的 pts 分别为 114（11.8%）、635（66%）、211（22%）和 3（0.2%）。796 例（82.8%）低 RS，159 例（16.5%）高 RS，8 例（0.7%）未知 RS。263 例（26%）诊断时年龄≤50 岁；117 例（45%）RS0-15，63 例（24.5%）16-20，39 例（15.3%）21-25，40 例（15.2%）RS26-100。4 例（1.5%）RS 未知。RS 检测后，602 例（62.5%）CT 决策发生变化；593 例改为单独激素治疗（HT）。共 262 例接受 CT。接受 CT 的 pts 中；138 例（53%）RS＞25，124 例（47%）RS≤25。年龄≤50 岁的 pts 中，153 例（58%）临床风险高，其中 28 例 RS 为 16-20。检测使用使治疗改变率达到 62.5%，73%的 pts 避免 CT。这导致治疗费用节省 400 万欧元。扣除检测费用，节省 190 万欧元。
结论
在研究的 8 年中，CT 使用率降低了 62.5%，节省了超过 190 万欧元。
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