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Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group.

国际工作小组对乳腺癌新辅助治疗后标本病理评估和报告规范化的建议

Provenzano E,Bossuyt V,Viale G,Cameron D,Badve S,Denkert C,MacGrogan G,Penault-Llorca F,Boughey J,Curigliano G,Dixon JM,Esserman L,Fastner G,Kuehn T,Peintinger F,von Minckwitz G,White J,Yang W,Symmans WF
阅读:406 Modern PathologySep 2015; 28 (9): 1152 - 1281:1185-201 

Abstract

Neoadjuvant systemic therapy is being used increasingly in the treatment of early-stage breast cancer. Response, in the form of pathological complete response, is a validated and evaluable surrogate end point of survival after neoadjuvant therapy. Thus, pathological complete response has become a primary end point for clinical trials. However, there is a current lack of uniformity in the definition of pathological complete response. A review of standard operating procedures used by 28 major neoadjuvant breast cancer trials and/or 25 sites involved in such trials identified marked variability in specimen handling and histologic reporting. An international working group was convened to develop practical recommendations for the pathologic assessment of residual disease in neoadjuvant clinical trials of breast cancer and information expected from pathology reports. Systematic sampling of areas identified by informed mapping of the specimen and close correlation with radiological findings is preferable to overly exhaustive sampling, and permits taking tissue samples for translational research. Controversial areas are discussed, including measurement of lesion size, reporting of lymphovascular space invasion and the presence of isolated tumor cells in lymph nodes after neoadjuvant therapy, and retesting of markers after treatment. If there has been a pathological complete response, this must be clearly stated, and the presence/absence of residual ductal carcinoma in situ must be described. When there is residual invasive carcinoma, a comment must be made as to the presence/absence of chemotherapy effect in the breast and lymph nodes. The Residual Cancer Burden is the preferred method for quantifying residual disease in neoadjuvant clinical trials in breast cancer; other methods can be included per trial protocols and regional preference. Posttreatment tumor staging using the Tumor-Node-Metastasis system should be included. These recommendations for standardized pathological evaluation and reporting of neoadjuvant breast cancer specimens should improve prognostication for individual patients and allow comparison of treatment outcomes within and across clinical trials.

摘要

新辅助综合治疗越来越多地应用于治疗早期乳腺癌。病理完全缓解,是新辅助治疗后生存分析中经验证有预测价值的替代性指标。因此,病理完全缓解已成为乳腺癌新辅助试验的主要终点。但病理完全缓解的定义目前尚未统一。复习28项大型乳腺癌新辅助治疗试验的标准治疗过程,试验涉及25个不同区域医疗机构,发现标本处理和组织病理学报告有显著差异。国际工作小组召开会议,针对乳腺癌新辅助试验残留病变的病理评估和病理报告需提供的信息制定了切实可行的建议。推荐结合临床所做新辅助试验标本的示意图和放射学检查资料确定病变部位,进行全面系统取材,效果优于过度充分取材,还可以切取组织样本用于转化研究。国际工作小组讨论了一些有争议的问题,包括测量新辅助治疗后病变大小、报告淋巴管血管间隙是否侵犯、淋巴结是否存在孤立肿瘤细胞以及新辅助治疗后重新检测免疫标记。如果病理表现为完全缓解,必须病理报告中清楚地注明,必须描述是否存在残留的导管原位癌。残留浸润性癌时,必须加备注:乳腺和淋巴结中存在/缺乏化疗效果。残留瘤荷是乳腺癌新辅助试验中量化残留病变的首选方法,其它方法依每个试验方案和医疗机构对量化残留病变的偏好而不同,也包括新辅助治疗后肿瘤TNM分期。这些针对乳腺癌新辅助试验标本病理评估和报告规范化建议会有助于对个体患者的预后判定、临床试验内部和临床试验之间可以比较治疗效果。

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