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Oncotype DX乳腺复发评分检测对早期乳腺癌辅助化疗使用的影响:英国大曼彻斯特地区的真实世界经验

Impact of Oncotype DX breast Recurrence Score testing on adjuvant chemotherapy use in early breast cancer: Real world experience in Greater Manchester, UK.

作者信息

Loncaster J, Armstrong A, Howell S, Wilson G, Welch R, Chittalia A, Valentine W J, Bundred N J

机构信息

The Christie Hospital, Department of Medical Oncology, 550 Wilmslow Rd, Manchester, M20 4BX, UK.

The Christie Hospital, Department of Medical Oncology, 550 Wilmslow Rd, Manchester, M20 4BX, UK; Bolton Hospital NHS Foundation Trust, Bolton Breast Unit, Minerva Rd, Farnworth, Bolton, BL4 0JR, UK.

出版信息

Eur J Surg Oncol. 2017 May;43(5):931-937. doi: 10.1016/j.ejso.2016.12.010. Epub 2017 Jan 9.

Abstract

BACKGROUND

The National Institute for Health and Clinical Excellence (NICE) recommended the Oncotype DX Breast Recurrence Score (RS) assay as an option for informing adjuvant chemotherapy decisions in node-negative, oestrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer assessed to be at intermediate risk of recurrence based on clinicopathological factors. We evaluated the impact of RS testing on adjuvant chemotherapy decision-making in routine clinical practice in a UK Cancer Network.

METHODS

RS testing was performed in 201 females with newly diagnosed, ER+, HER2-negative, invasive breast cancer who underwent breast surgery with curative intent, were calculated to have a >3% overall survival benefit at 10 years from adjuvant chemotherapy based on PREDICT, and were considered for adjuvant chemotherapy. The impact of RS testing on adjuvant treatment decisions/associated cost was assessed.

RESULTS

In all patients, the multi-disciplinary team recommended chemotherapy but the RS result allowed 127/201 patients (63.2%) to avoid unnecessary adjuvant chemotherapy. Amongst ER+, HER2-negative, node-negative patients (eligible for Oncotype DX testing in UK guidelines), 60.3% were spared chemotherapy. In node-positive patients, the assay reduced the use of chemotherapy by 69.2%. The use of RS testing to guide treatment in these 201 patients was associated with significant cost saving (when considering the cost of RS testing for all patients plus chemotherapy and its associated cost for 74 patients).

CONCLUSIONS

Incorporating RS testing into routine clinical practice for selected node-negative and node-positive breast cancer patients significantly reduces the use of chemotherapy (p < 0.001) with its associated morbidity and costs.

摘要

背景

英国国家卫生与临床优化研究所(NICE)推荐使用21基因复发评分(RS)检测,作为一种辅助化疗决策的选择,用于那些经临床病理因素评估为复发风险中等的、淋巴结阴性、雌激素受体(ER)阳性、人表皮生长因子受体2(HER2)阴性的早期乳腺癌患者。我们评估了RS检测对英国某癌症网络常规临床实践中辅助化疗决策的影响。

方法

对201例新诊断为ER阳性、HER2阴性浸润性乳腺癌且接受了根治性乳房手术的女性进行了RS检测,根据PREDICT模型计算,这些患者接受辅助化疗在10年时总体生存获益>3%,并被考虑进行辅助化疗。评估了RS检测对辅助治疗决策/相关成本的影响。

结果

在所有患者中,多学科团队推荐进行化疗,但RS结果使127/201例患者(63.2%)避免了不必要的辅助化疗。在ER阳性、HER2阴性、淋巴结阴性的患者中(符合英国指南中21基因检测标准),60.3%的患者无需化疗。在淋巴结阳性患者中,该检测使化疗的使用减少了69.2%。在这201例患者中使用RS检测指导治疗可显著节省成本(考虑所有患者的RS检测成本加上74例患者的化疗及其相关成本)。

结论

将RS检测纳入选定的淋巴结阴性和淋巴结阳性乳腺癌患者的常规临床实践中,可显著减少化疗的使用(p < 0.001)及其相关的发病率和成本。

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