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关键生物标志物合理应用的通路临床决策支持

Pathways Clinical Decision Support for Appropriate Use of Key Biomarkers.

作者信息

Ellis Peter G, Brufsky Adam M, Beriwal Sushil, Lokay Kathleen G, Benson Hans O, McCutcheon Stephanie B, Krebs Melinda

机构信息

UPMC CancerCenter; University of Pittsburgh Cancer Center; and Via Oncology, Pittsburgh, PA.

UPMC CancerCenter; University of Pittsburgh Cancer Center; and Via Oncology, Pittsburgh, PA

出版信息

J Oncol Pract. 2016 Jun;12(6):e681-7. doi: 10.1200/JOP.2015.010546. Epub 2016 May 24.

Abstract

PURPOSE

Breast cancer diagnostics have the ability to predict disease recurrence and the benefit of chemotherapy. This study measures the use of a diagnostic assay, Oncotype DX, when embedded in a breast cancer decision support algorithm and, on the basis of the assay results, the use of chemotherapy in the adjuvant setting.

METHODS

UPMC CancerCenter retrospectively reviewed patients with estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)Neu-negative disease with zero to three positive nodes navigated in the Via Pathways decision support portal during a 12-month period. The breast algorithm prompted input of the assay recurrence score (RS) and then recommended hormonal therapy alone (HT) for low RS, or chemotherapy followed by HT for high RS. The patient's RS was correlated with the treatment decision.

RESULTS

During this time period, 643 patients had ER-positive, HER2Neu-negative disease with zero to three positive nodes. Of those, 596 (92.7%) had diagnostic testing to determine chemotherapy plus HT versus HT alone, and 47 had chemotherapy followed by HT without an RS. For node-negative patients classified with low or high RS, pathway treatment adherence rates were 99.7% and 96.6%, respectively; node-positive patients had 95.7% and 87.5% adherence rates, respectively.

CONCLUSION

This analysis demonstrates the use of a clinical pathway to measure the adoption of a diagnostic test, the Oncotype DX breast assay, and the use of the appropriate therapy on the basis of the RS. As more diagnostics are established to aid in the personalized treatment of diseases, pathways may be important in maintaining clinician awareness of the appropriate disease presentations where these tests should be used, measuring usage of these tests, and tracking the treatment decisions on the basis of test results.

摘要

目的

乳腺癌诊断能够预测疾病复发及化疗的益处。本研究评估了一种诊断检测方法——Oncotype DX,将其嵌入乳腺癌决策支持算法中,并根据检测结果评估辅助治疗中化疗的使用情况。

方法

UPMC癌症中心回顾性分析了在12个月期间通过Via Pathways决策支持门户就诊的雌激素受体阳性、人表皮生长因子受体2(HER2)Neu阴性且腋窝淋巴结转移0至3个的患者。乳腺算法提示输入检测复发评分(RS),然后对于低RS推荐单纯激素治疗(HT),对于高RS推荐化疗后序贯HT。将患者的RS与治疗决策进行关联。

结果

在此期间,643例患者为ER阳性、HER2Neu阴性且腋窝淋巴结转移0至3个。其中,596例(92.7%)进行了诊断检测以确定是化疗联合HT还是单纯HT,47例接受了化疗后序贯HT但未获得RS。对于RS分类为低或高的淋巴结阴性患者,路径治疗依从率分别为99.7%和96.6%;淋巴结阳性患者的依从率分别为95.7%和87.5%。

结论

本分析表明使用临床路径可评估诊断检测方法Oncotype DX乳腺检测的采用情况,以及根据RS使用适当治疗方法的情况。随着越来越多的诊断方法用于辅助疾病的个体化治疗,路径对于维持临床医生对应使用这些检测的适当疾病表现的认识、评估这些检测的使用情况以及追踪基于检测结果的治疗决策可能具有重要意义。

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