Department of Oncology Box 193, University of Cambridge, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK.
Br J Cancer. 2013 Mar 5;108(4):866-72. doi: 10.1038/bjc.2012.547. Epub 2013 Jan 8.
Neo-tAnGo, a National Cancer Research Network (NCRN) multicentre randomised neoadjuvant chemotherapy trial in early breast cancer, enroled 831 patients in the United Kingdom. We report a central review of post-chemotherapy histopathology reports on the surgical specimens, to assess the presence and degree of response.
A central independent two-reader review (EP and HME) of histopathology reports from post-treatment surgical specimens was performed. The quality and completeness of pathology reporting across all centres was assessed. The reviews included pathological response to chemotherapy (pathological complete response (pCR); minimal residual disease (MRD); and lesser degrees of response), laterality, the number of axillary metastases and axillary nodes, and the type of surgery. A consensus was reached after discussion.
In all, 825 surgical reports from 816 patients were available for review. Out of 4125 data items there were 347 discrepant results (8.4% of classifications), which involved 281 patients. These involved grading of breast response (169 but only 9 involving pCR vs MRD); laterality (6); presence of axillary metastasis (35); lymph node counts (108); and type of axillary surgery (29). Excluding cases with pCR, only 45% of reports included any comment regarding response in the breast and 30% in the axillary lymph nodes.
We found considerable variability in the completeness of reporting of surgical specimens within this national neoadjuvant breast cancer trial. This highlights the need for consensus guidelines among trial groups on histopathology reporting, and the participation of histopathologists throughout the development and analysis of neoadjuvant trials.
Neo-tAnGo 是英国国家癌症研究网络 (NCRN) 进行的一项早期乳腺癌新辅助化疗多中心随机临床试验,共纳入 831 例患者。我们报告了一项针对手术后标本化疗后组织病理学报告的中心审查,以评估其反应的存在和程度。
对手术后标本的组织病理学报告进行了中央独立的两位读者(EP 和 HME)审查。评估了所有中心的病理学报告的质量和完整性。审查包括对化疗的病理反应(病理完全缓解(pCR);微小残留病(MRD);以及较低程度的反应)、侧别、腋窝转移和腋窝淋巴结的数量以及手术类型。经过讨论达成了共识。
共获得 816 例患者的 825 份手术报告进行审查。在 4125 个数据项中,有 347 个不一致的结果(8.4%的分类),涉及 281 例患者。这些涉及乳腺反应的分级(169 例,但仅 9 例涉及 pCR 与 MRD 相比);侧别(6);腋窝转移的存在(35);淋巴结计数(108);腋窝手术类型(29)。排除 pCR 病例后,仅 45%的报告包括乳腺反应的任何评论,30%的报告包括腋窝淋巴结的任何评论。
我们发现该全国新辅助乳腺癌试验中,手术标本报告的完整性存在相当大的差异。这突出表明,需要在试验组之间就组织病理学报告达成共识指南,并需要组织病理学家参与新辅助试验的开发和分析。