Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group
Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group
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DOI：
10.1038/modpathol.2015.74
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发表时间：
2015-09-01
期刊：
影响因子：
7.5
通讯作者：
Symmans, W. Fraser
中科院分区：
文献类型：
--
作者：
Provenzano, Elena;Bossuyt, Veerle;Symmans, W. Fraser
新辅助全身治疗越来越多地用于早期乳腺癌的治疗。以病理学完全缓解形式出现的缓解是新辅助治疗后经验证和可评价的替代生存终点。因此，病理完全缓解已成为临床试验的主要终点。然而，目前病理完全缓解的定义缺乏统一性。对28项主要的新辅助乳腺癌试验和/或参与此类试验的25个研究中心使用的标准操作规程进行了审查，发现标本处理和组织学报告存在显著差异。召集了一个国际工作组，为乳腺癌新辅助治疗临床试验中残留疾病的病理评估和病理报告中预期的信息制定实用建议。通过标本的知情绘图和与放射学结果的密切相关性确定的区域的系统采样优于过度详尽的采样，并允许采集组织样本用于转化研究。有争议的领域进行了讨论，包括病灶大小的测量，报告淋巴血管间隙浸润和新辅助治疗后淋巴结中存在孤立的肿瘤细胞，以及治疗后重新检测标记物。如果有病理学完全缓解，必须明确说明，并描述是否存在残留导管原位癌。当有残留的浸润性癌时，必须对乳腺和淋巴结中是否存在化疗效果进行评论。残留癌症负担是乳腺癌新辅助治疗临床试验中定量残留疾病的首选方法;根据试验方案和地区偏好，可纳入其他方法。应包括使用肿瘤-淋巴结-转移系统进行的治疗后肿瘤分期。这些新辅助治疗乳腺癌标本的标准化病理学评价和报告建议应改善个体患者的诊断，并允许在临床试验内和临床试验间比较治疗结局。
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.