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爱尔兰对21基因Oncotype DX®检测在早期、1-3个淋巴结阳性、雌激素受体阳性、人表皮生长因子受体2阴性乳腺癌中的临床和经济影响的全国性真实世界分析。

Irish national real-world analysis of the clinical and economic impact of 21-gene oncotype DX® testing in early-stage, 1-3 lymph node-positive, oestrogen receptor-positive, HER2-negative, breast cancer.

作者信息

Browne I M, McLaughlin R A, Weadick C S, O'Sullivan S, McSorley L M, Hadi D K, Millen S J, Higgins M J, Crown J P, Prichard R S, McCartan D P, Hill A Dk, Connolly R M, Noonan S A, O'Mahony D, Murray C, O'Hanlon-Brown C, Hennessy B T, Quinn C M, Kelly C M, O'Reilly S, Morris P G, Walshe J M

机构信息

Department of Medical Oncology, St Vincent's University Hospital, Dublin 4, Ireland.

Department of Medical Oncology, Beaumont Hospital, Beaumont, Dublin, Ireland.

出版信息

Breast Cancer Res Treat. 2025 Jan;209(1):189-199. doi: 10.1007/s10549-024-07486-5. Epub 2024 Oct 4.

Abstract

PURPOSE

The treatment landscape of Oestrogen receptor-positive (ER-positive) breast cancer is evolving, with declining chemotherapy use as a result of Oncotype DX Breast Recurrence Score® testing. Results from the SWOG S1007 RxPONDER trial suggest that adjuvant chemotherapy may benefit some premenopausal women with ER-positive, HER2-negative disease with 1-3 positive lymph nodes (N1), and a Recurrence Score® (RS) of ≤ 25. Postmenopausal women with similar characteristics did not benefit from adjuvant chemotherapy. We examine the clinical and economic impact of Oncotype DX® testing on treatment decisions in patients with N1 disease in Ireland using real world data.

METHODS

From March 2011 to October 2022, a retrospective, cross-sectional observational study was performed of patients with ER-positive, HER2-negative N1 breast cancer, who had Oncotype DX testing across 5 of Ireland's largest cancer centres. Patients were classified into low risk (RS 0-13), intermediate risk (RS 14-25) and high risk (RS > 25). Data were collected via electronic patient records. Information regarding costing was provided primarily by pre-published sources.

RESULTS

A total of 828 N1 patients were included in this study. Post Oncotype DX testing, 480 patients (58%) were spared chemotherapy. Of the patients who had a change in chemotherapy recommendation based on Oncotype DX testing, 271 (56%), 205 (43%), 4 (1%) had a RS result of 0-13, 14-25 and > 25 respectively. Use of Oncotype DX testing was associated with a 58% reduction in chemotherapy administration overall. This resulted in estimated savings of over €6 million in treatment costs. Deducting the assay cost, estimated net savings of over €3.3 million were achieved. Changes in the ordering demographics of Oncotype DX tests were identified after RxPONDER data were presented, with increased testing in women ≥ 50 years and a reduction in proportion of tests ordered for women < 50 years.

CONCLUSION

Between 2011 and 2022, assay use resulted in a 58% reduction in chemotherapy administration and net savings of over €3.3 million.

摘要

目的

雌激素受体阳性(ER阳性)乳腺癌的治疗格局正在演变,由于Oncotype DX乳腺癌复发评分检测,化疗的使用有所减少。SWOG S1007 RxPONDER试验的结果表明,辅助化疗可能使一些ER阳性、人表皮生长因子受体2阴性且有1 - 3个阳性淋巴结(N1)且复发评分(RS)≤25的绝经前女性受益。具有相似特征的绝经后女性未从辅助化疗中获益。我们使用真实世界数据研究Oncotype DX检测对爱尔兰N1期疾病患者治疗决策的临床和经济影响。

方法

2011年3月至2022年10月,对爱尔兰5家最大癌症中心接受Oncotype DX检测的ER阳性、人表皮生长因子受体2阴性N1期乳腺癌患者进行了一项回顾性横断面观察研究。患者被分为低风险(RS 0 - 13)、中风险(RS 14 - 25)和高风险(RS > 25)。数据通过电子病历收集。成本核算信息主要来自预先发表的资料。

结果

本研究共纳入828例N1期患者。Oncotype DX检测后,480例患者(58%)免于化疗。在因Oncotype DX检测而改变化疗建议的患者中,RS结果为0 - 13、14 - 25和> 25的分别有271例(56%)、205例(43%)、4例(1%)。Oncotype DX检测的使用使总体化疗给药减少了58%。这导致估计节省治疗成本超过600万欧元。扣除检测成本后,估计实现净节省超过330万欧元。在呈现RxPONDER数据后,发现Oncotype DX检测的订购人群发生了变化,50岁及以上女性的检测增加,50岁以下女性的检测比例降低。

结论

2011年至2022年期间,检测的使用使化疗给药减少了58%,净节省超过330万欧元。

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