乳腺癌NCCN2015v3指南——病理学评估原则

Pathology Assessment

A central component of the treatment of breast cancer is full knowledge of extent of disease and biologic features.

These factors contribute to the determination of the stage of disease, assist in the estimation of the risk that the cancer will recur, and provide information that predicts response to therapy (eg, estrogen receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor 2 [HER2]).山东省肿瘤医院呼吸肿瘤内科张品良

These factors are determined by examination of excised tissue and are provided in a written pathology report.

Accurate pathology reporting requires communication between the clinician and the pathologist relating to relevant patient history, prior breast biopsies, prior irradiation to the chest, pregnancy status, characteristics of the abnormality biopsied (eg, palpable, mammographically detected microcalcifications), clinical state of lymph nodes, presence of inflammatory change or other skin abnormality, and any prior treatment administered (eg, chemotherapy, radiation therapy).

The specimens should be oriented for the pathologist, and specific requests for determination of biomarkers should be stated (eg, ER, PR, and HER2 status).

The use of consistent, unambiguous standards for reporting is strongly encouraged.

Data from both national and local surveys show that as many as 50% of pathology reports for breast cancer are missing some elements critical to patient management.

Significant omissions include failure to orient and report surgical margins and failure to report tumor grade consistently.

The College of American Pathologists (CAP) has developed pathology reporting protocols to promote complete and standardized reporting of malignant specimens.

CAP provides a protocol for each disease site that includes cancer case summaries (checklists) along with background documentation.

These checklists form the basis for a synoptic, standardized reporting of pathologic findings.

The checklists are available without charge through the CAP website at www.cap.org.

Consistent, unambiguous, and complete pathology reporting is a cornerstone of quality breast cancer care, and the NCCN Breast Cancer Panel endorses the use of the CAP protocols for reporting the pathologic analysis of all breast cancer specimens.

ER status should be determined for all samples of ductal carcinoma in situ (DCIS), and ER and PR tumor status should be determined for all samples of invasive breast cancer.

ER and PR tumor status is normally determined by immunohistochemistry (IHC) testing.

Although this method is considered reliable when performed by experienced pathology personnel, there have been several reports indicating that the reliability of ER and PR determinations can vary widely from one laboratory to another.

These inter-laboratory differences may be attributable to the diverse methodologies and diverse interpretation schema used to evaluate tumor hormonal status.

An NCCN Task Force and a panel of ASCO and CAP members have reviewed this topic and issued recommendations on ER and PR testing in breast cancer.

Breast cancers that have at least 1% of cells staining positive for ER should be considered ER-positive.

病理学评估 

乳腺癌治疗的一个最重要的部分是对病变范围与生物学特征的充分认识

这些因素有助于确定疾病的分期、帮助判断癌症复发的风险以及提供预测治疗应答的信息(例如雌激素受体[ER]、孕激素受体[PR]、人类表皮生长因子受体2[HER2])。

这些因素通过检查切除的组织确定并以书面病理学报告的方式提供。

准确的病理学报告需要临床医师与病理学家之间交流相应患者的信息：病史、既往乳腺活检、既往胸部照射、妊娠情况、该异常活检的特点(如可触知、乳房摄影检出微小钙化)、临床上淋巴结情况、存在炎性改变或其它的皮肤异常以及既往给予的任何治疗(例如化疗、放疗)。

应该为病理学家定位标本，且应当说明生物标志物测定的具体要求(例如ER、PR和HER2状态)。

强烈鼓励使用一致、明确的报告标准。

来自国家与地方的调查数据均显示多达50%的乳腺癌病理报告缺乏病人管理的某些关键因素。

重要的遗漏包括没有定位并记录手术切缘以及没有坚持记录肿瘤分级。

为促进完善并统一恶性标本的报告美国病理医师学会(CAP)已经开发出了病理报告协议。

CAP为每一疾病部位都提供了一个协议流程即包括癌症病例摘要(清单)以及背景资料记录。

这些清单构成摘要、病理结果标准化报告的基础。

清单可从CAP网址www.cap.org.免费获得。

一致、明确且完善的病理学报告是乳腺癌管理质量的基石，NCCN乳腺癌小组支持对所有的乳腺癌标本使用CAP病理检查报告协议。

对于所有的导管原位癌(DCIS)标本均应该测定ER状态，对于所有的侵袭性乳腺癌标本均应该测定肿瘤ER和PR状态。

肿瘤ER和PR状态通常用免疫组化(IHC)检测测定。

尽管当由有经验的病理学人员完成时该方法被认为是可靠的，但是已有若干报告提示ER和PR测定的可靠性从一个实验室到另一个实验室可以变化很大。

这些实验室之间的差异也许可归因于评估肿瘤激素状态所使用的方法与判读模式各种各样。

NCCN工作组与ASCO小组以及CAP成员已经综述了乳腺癌ER与PR检测课题与推荐的论点。

至少有1%的细胞ER染色阳性的乳腺癌应该考虑ER阳性。