Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China.
Department of Medical Affairs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Breast Cancer Res. 2024 Sep 3;26(1):128. doi: 10.1186/s13058-024-01884-9.
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.
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.
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.
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.
2022 年，我们团队开创性地推出了全国乳腺癌病理诊断能力验证（PT）计划，迅速在全国范围内建立了其可信度。为了持续监测和提高中国病理学家在乳腺病理学方面的能力，我们于 2023 年启动了第二轮 PT 计划，该计划将扩大参与机构的数量，并对中国 HER20、1+和 2+/FISH-类别的解读进行全国性调查。
本轮 PT 计划所采用的方法与 2022 年的上一轮计划相似，是根据《合格评定 能力验证的通用要求》（GB/T27043-2012/ISO/IEC 17043:2010）设计和实施的。更重要的是，我们利用基于统计学的方法生成赋值，以提高其稳健性和可信度。
最终的 PT 结果发布在国家癌症质量控制中心的网站上（http://117.133.40.88:3927），所有参与者都通过了测试。然而，一些机构在评分 HER20、1+和 2+/FISH-时存在系统性偏差，准确率低于 59%，这被认为是不理想的。特别是，HER20 病例的一致性率仅为 78.1%，表明在区分 HER20 与低 HER2 表达方面存在挑战。同时，还注意到在组织学类型和分级解释方面需要改进。
我们的 PT 计划表明中国在诊断乳腺癌方面具有很高的能力。但它也发现了一些机构在评分 HER20、1+和 2+/FISH-时存在系统性偏差。更重要的是，我们的研究强调了在 HER2 染色谱的极低端评估方面存在挑战，这是进一步研究的关键领域。同时，也揭示了在解释组织学类型和分级方面需要改进。这些发现强调了建立强大的质量保证机制的重要性，例如本研究中进行的全国性 PT 计划，以保持高标准的诊断，并确定需要进一步培训和加强的领域。
