Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
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DOI：
10.1200/jco.2015.65.2289
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发表时间：
2016-04-01
影响因子：
45.3
通讯作者：
Hayes, Daniel F.
中科院分区：
文献类型：
--
作者：
Harris, Lyndsay N.;Ismaila, Nofisat;Hayes, Daniel F.
目的探讨乳腺肿瘤生物标志物检测结果的合理应用，为早期浸润性乳腺癌患者辅助全身治疗的决策提供指导。方法通过文献检索和前瞻性定义研究选择，对2006年至2014年发表的系统综述、荟萃分析、随机对照试验、前瞻性回顾性研究和前瞻性比较观察性研究进行了检索。关注的结果包括总生存期和无病或无复发生存期。专家小组成员采用非正式共识制定循证指南建议。结果检索到50篇相关研究。根据指南的定义，一项随机临床试验和18项前瞻性-回顾性研究评估了特定生物标志物在指导是否需要辅助全身治疗方面的临床效用。没有发现符合临床应用指南标准的研究来指导特定治疗或方案的选择。除了雌激素和孕激素受体和人表皮生长因子受体2外，该小组还发现了足够的证据，证明Oncotype DX、endopdict、PAM50、乳腺癌指数、尿激酶纤溶酶原激活剂和纤溶酶原激活剂抑制剂1型在乳腺癌特定亚组中的临床应用。除了雌激素受体、孕激素受体和人表皮生长因子受体2外，没有发现生物标志物可以指导特定治疗方案的选择。治疗决定还应考虑疾病分期、合并症和患者偏好。
PurposeTo provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer.MethodsA literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations.ResultsThe literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens.RecommendationsIn addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences.