HER2 评分和组织学评估的挑战与改进:中国乳腺癌诊断国家能力验证计划的启示。

IF 7.4 1区 医学 Q1 Medicine Breast Cancer Research Pub Date : 2024-09-03 DOI:10.1186/s13058-024-01884-9
Xuemin Xue, Lei Guo, Changyuan Guo, Liwei Xu, Lin Li, Lin Yang, Xin Wang, Wei Rao, Pei Yuan, Jiali Mu, Jiangtao Li, Bingning Wang, Quan Zhou, Weicheng Xue, Fei Ma, Wenjing Yang, Jianming Ying
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引用次数: 0

摘要

背景:2022年,我们的团队率先启动了全国乳腺癌病理诊断能力验证(PT)计划,并迅速在全国建立了公信力。为持续监测和提高中国病理医师的乳腺病理诊断能力,2023 年,我们启动了第二轮能力验证计划,将扩大参与机构的数量,并在全国范围内开展 HER2 0、1+ 和 2+/FISH- 分类解读的调查:本轮能力验证计划所采用的方法与2022年的上一轮能力验证计划密切相关,是根据《合格评定能力验证通用要求》(GB/T27043-2012/ISO/IEC 17043:2010)设计和实施的。更重要的是,我们采用了基于统计的方法来生成分配值,以增强其稳健性和可信度:国家癌症质控中心网站(http://117.133.40.88:3927)公布的最终检测结果显示,所有参与者均通过了检测。然而,少数机构在对 HER2 0、1+ 和 2+/FISH- 进行评分时出现了系统性偏差,准确率低于 59%,不能令人满意。特别是,HER2 0 病例的吻合率仅为 78.1%,表明在区分 HER2 0 和 HER2 低表达方面存在挑战。同时,在组织学类型和分级解释方面也有改进:结论:我们的 PT 方案在诊断中国乳腺癌方面表现出了很高的熟练程度。结论:我们的 PT 方案显示了中国乳腺癌诊断的高熟练度,但也发现了一些机构在对 HER2 0、1+ 和 2+/FISH- 进行评分时存在系统性偏差。更重要的是,我们的研究凸显了在 HER2 染色谱极低端进行评估的挑战,这是一个有待进一步研究的关键领域。同时,研究还揭示了在解释组织学类型和分级方面需要改进的地方。这些发现增强了健全的质量保证机制(如本研究中开展的全国性 PT 计划)的重要性,以保持较高的诊断标准,并确定需要进一步培训和提高的领域。
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Challenges and improvements in HER2 scoring and histologic evaluation: insights from a national proficiency testing scheme for breast cancer diagnosis in China.

Background: In 2022, our team launched the pioneering national proficiency testing (PT) scheme for the pathological diagnosis of breast cancer, rapidly establishing its credibility throughout China. Aiming to continuously monitor and improve the proficiency of Chinese pathologists in breast pathology, the second round of the PT scheme was initiated in 2023, which will expand the number of participating institutions, and will conduct a nationwide investigation into the interpretation of HER2 0, 1+, and 2+/FISH- categories in China.

Methods: The methodology employed in the current round of PT scheme closely mirrors that of the preceding cycle in 2022, which is designed and implemented according to the "Conformity assessment-General requirements for proficiency testing"(GB/T27043-2012/ISO/IEC 17043:2010). More importantly, we utilized a statistics-based method to generate assigned values to enhance their robustness and credibility.

Results: The final PT results, published on the website of the National Quality Control Center for Cancer ( http://117.133.40.88:3927 ), showed that all participants passed the testing. However, a few institutions demonstrated systemic biases in scoring HER2 0, 1+, and 2+/FISH- with accuracy levels below 59%, considered unsatisfactory. Especially, the concordance rate for HER2 0 cases was only 78.1%, indicating challenges in distinguishing HER2 0 from low HER2 expression. Meanwhile, areas for histologic type and grade interpretation improvement were also noted.

Conclusions: Our PT scheme demonstrated high proficiency in diagnosing breast cancer in China. But it also identified systemic biases in scoring HER2 0, 1+, and 2+/FISH- at some institutions. More importantly, our study highlighted challenges in the evaluation at the extreme lower end of the HER2 staining spectrum, a crucial area for further research. Meanwhile, it also revealed the need for improvements in interpreting histologic types and grades. These findings strengthened the importance of robust quality assurance mechanisms, like the nationwide PT scheme conducted in this study, to maintain high diagnostic standards and identify areas requiring further training and enhancement.

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来源期刊
CiteScore
12.00
自引率
0.00%
发文量
76
审稿时长
12 weeks
期刊介绍: Breast Cancer Research, an international, peer-reviewed online journal, publishes original research, reviews, editorials, and reports. It features open-access research articles of exceptional interest across all areas of biology and medicine relevant to breast cancer. This includes normal mammary gland biology, with a special emphasis on the genetic, biochemical, and cellular basis of breast cancer. In addition to basic research, the journal covers preclinical, translational, and clinical studies with a biological basis, including Phase I and Phase II trials.
期刊最新文献
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