指南标题：Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
发布机构：美国临床肿瘤学会(ASCO, American Society of Clinical Oncology)
指南发表：J Clin Oncol. 2015 Jul 20.
本指南旨在为合理使用乳腺肿瘤生物标志物检测结果指导女性转移性乳腺癌系统性治疗提供推荐建议。
指南关键信息：
可获取组织标本的新诊断转移性乳腺癌患者，应予活检以确认疾病进展，并检测ER、PR和HER2状态。患者还需告知，若原发灶和转移灶检测结果不一致，目前尚缺乏证据说明依据哪种标本决定治疗方案预后更好。鉴于原发灶和转移灶的结果存在不一致性，若符合临床状况及患者治疗目标，共识建议优先检测转移灶的ER、PR和HER2状态以指导治疗。（证据来源：基于原发灶与转移灶之间的生物标志物转变的证据，尚无证据说明生物标志物的改变与系统治疗的选择影响预后。证据级别：欠充分。推荐等级：中度。）
转移性乳腺癌系统治疗决策应基于临床评估、判断和患者意愿。目前尚无证据显示单独依据除ER、PR、HER2外的生物标志物进行初始治疗可改善患者预后。（来源：循证证据。证据级别：低。推荐等级：中等。）
对组织生物标志物的建议：已接受系统治疗的转移性乳腺癌患者，应该基于临床评估、病情进展或治疗反应的判断、患者的治疗目标来决定是否更换新药或治疗方案，或中断治疗。目前尚无证据显示单独基于除ER、PR、HER2外的生物标志物改变治疗方案可改善预后、生活质量或成本效益。（来源：循证证据。证据级别：低。推荐等级：中等）
对循环肿瘤标志物的建议：已接受系统治疗的转移性乳腺癌患者，应该基于临床评估、病情进展或治疗反应的判断、患者的治疗目标来决定是否更换新药或治疗方案，或中断治疗。目前尚无证据显示单独基于除循环肿瘤标志物外的生物标志物改变治疗方案可改善预后、生活质量或成本效益。（来源：循证证据。证据级别：中等。推荐等级：中等）
CEA、CA15-3和C27-29可用作辅助评价指标以帮助转移性乳腺癌治疗的临床决策。目前的数据尚不足以建议单独使用CEA、CA15-3和CA27-29检测治疗反应。由于缺乏评价标志物临床应用的研究设计，该建议为基于临床经验的非正式共识，因此，临床医生不使用这些标志物作为辅助评估手段也是合理的。（来源：非正式共识。证据级别：不充分。推荐等级：中等）
To provide recommendations on the appropriate use of breast tumorbiomarker assay results to guide decisions on systemic therapy for metastatic breast cancer.
Key Points
Patients with accessible, newly diagnosed metastases from primary breast cancer should be offered biopsy for confirmation of disease process and testing of ER, PR, and HER2 status. They should also be informed that if discordances are found, evidence is lacking to determine whether outcomes are better with treatment regimens based on receptor status in theme tastases or the primary tumor. With discordance of results between primary and metastatic tissues, the Panel consensus is to preferentially use the ER, PR,and HER2 status from the metastasis to direct therapy, if supported by the clinical scenario and the patient's goals for care. (Type: evidence based for biomarker change from primary to metastasis, but noevidence to address systemic therapy choices affecting health outcome when biomarker changeoccurs. Evidence quality: insufficient. Strength of recommendation: moderate.)
Decisions on initiating systemic therapy for metastaticbreast cancer should be based on clinical evaluation, judgment, and patient preferences. There is no evidence at this time that initiating therapy solely on the basis of biomarker results beyond those of ER, PR, and HER2 improves health outcomes. (Type: evidence based. Evidence quality: low. Strength ofrecommendation: moderate.)
Recommendations for tissue biomarkers: In patients already receiving systemic therapy for metastatic breast cancer, decisions on changing to a new drug or regimen or discontinuing treatment should be based on clinical evaluation, judgment of disease progression or response, and the patient’s goals for care. There is no evidence at this time that changing therapy based solely on biomarker results beyond ER, PR, and HER2 improves health outcomes, quality of life, or cost effectiveness. (Type: evidence based. Evidence quality: low. Strength of recommendation: moderate.)
Recommendations for circulating tumor markers: In patients already receiving systemic therapy for metastatic breast cancer, decisions on changing to a new drug or regimen or discontinuing treatment should be based on clinical evaluation, judgment of disease progression or response, and the patient’s goals for care. There is no evidence at this time that changing therapy based solely on circulating biomarker results improves health outcomes, quality of life, or cost effectiveness. (Type: evidence based. Evidence quality: intermediate. Strength of recommendation: moderate.)
CEA, CA 15-3, and CA 27-29 may be used as adjunctive assessments to contribute to decisions regarding therapy form etastatic breast cancer. Data are insufficient to recommend use of CEA, CA 15-3, and CA 27-29 alone for monitoring response to treatment. The recommendation for use is based on clinical experience and Panel informal consensus in the absence of studies designed to evaluate the clinical utility of the markers. As such, it is also reasonable for clinicians to not use these markers as adjunctive assessments. (Type: informal consensus. Evidence quality: insufficient. Strength of recommendation: moderate.)
