Wludarski Sheila Cristina Lordelo, Lopes Lisandro Ferreira, Berto E Silva Tácio R, Carvalho Filomena M, Weiss Lawrence M, Bacchi Carlos E
Consultoria em Patologia, Rua Major Leonidas Cardoso, 739, Botucatu, SP 18602-010, Brazil.
Appl Immunohistochem Mol Morphol. 2011 Mar;19(2):112-8. doi: 10.1097/PAI.0b013e3181f0b044.
Breast cancer accounts for approximately one quarter of all cancers in females. HER2 gene amplification or HER2 protein overexpression, detected in about 20% of breast carcinomas, predicts a more aggressive clinical course and determines eligibility for targeted therapy with trastuzumab. HER2 testing has become an essential part of the clinical evaluation of all breast carcinoma patients, and accurate HER2 results are critical in identifying patients who may be benefited from targeted therapy. This study investigated the concordance in the results of HER2 immunohistochemistry assays performed in 500 invasive breast carcinomas between a reference laboratory and 149 local laboratories from all geographic regions of Brazil. Our results showed an overall poor concordance (171 of 500 cases, 34.2%) regarding HER2 results between local and reference laboratories, which may be related to the low-volume load of HER2 assays, inexperience with HER2 scoring system, and/or technical issues related to immunohistochemistry in local laboratories. Standardization of HER2 testing with rigorous quality control measures by local laboratories is highly recommended to avoid erroneous treatment of breast cancer patients.
乳腺癌约占女性所有癌症的四分之一。在约20%的乳腺癌中检测到的HER2基因扩增或HER2蛋白过表达，预示着更具侵袭性的临床病程，并决定了使用曲妥珠单抗进行靶向治疗的资格。HER2检测已成为所有乳腺癌患者临床评估的重要组成部分，准确的HER2检测结果对于识别可能从靶向治疗中获益的患者至关重要。本研究调查了巴西所有地理区域的一家参考实验室与149家当地实验室对500例浸润性乳腺癌进行HER2免疫组织化学检测结果的一致性。我们的结果显示，当地实验室与参考实验室之间在HER2检测结果方面总体一致性较差（500例中的171例，34.2%），这可能与HER2检测的低样本量、对HER2评分系统缺乏经验和/或当地实验室与免疫组织化学相关的技术问题有关。强烈建议当地实验室通过严格的质量控制措施对HER2检测进行标准化，以避免对乳腺癌患者的错误治疗。
