Wludarski Sheila Cristina Lordelo, Lopes Lisandro Ferreira, Duarte Ivison Xavier, Carvalho Filomena Marino, Weiss Lawrence, Bacchi Carlos Eduardo
Pathology Consultancy, Botucatu, São Paulo, Brazil.
Sao Paulo Med J. 2011;129(4):236-42. doi: 10.1590/s1516-31802011000400007.
Breast cancer accounts for approximately one quarter of all cancers in females. Estrogen and progesterone receptor testing has become an essential part of the clinical evaluation of breast carcinoma patients, and accurate results are critical in identifying patients who may benefit from hormone therapy. The present study had the aim of investigating the concordance of the results from hormone receptor tests between a reference laboratory and local (or community) laboratories in Brazil.
Retrospective study at a reference pathology laboratory.
The concordance in the results from hormone receptor tests between a reference laboratory and 146 local laboratories in Brazil was compared in relation to 500 invasive breast carcinoma cases, using immunohistochemistry.
There was concordance in 89.4% (447/500 cases) and 85.0% (425/500 cases) of the results from estrogen (κ = 0.744, P < 0.001) and progesterone (κ = 0.688, P < 0.001) receptor tests, respectively, between local and reference laboratories. This was similar to findings in other countries. The false negative rates from estrogen and progesterone receptor tests in local laboratories were 8.7% and 14.4%, respectively. The false positive rates from estrogen and progesterone receptor tests in local laboratories were 15.5% and 16.0%, respectively.
Technical and result interpretation issues may explain most of the discordances in hormone receptor testing in local laboratories. Validation of estrogen and progesterone receptor tests at local laboratories, with rigorous quality control measures, is strongly recommended in order to avoid erroneous treatment of breast cancer patients.
乳腺癌约占女性所有癌症的四分之一。雌激素和孕激素受体检测已成为乳腺癌患者临床评估的重要组成部分,准确的检测结果对于确定可能从激素治疗中获益的患者至关重要。本研究旨在调查巴西一家参考实验室与当地(或社区)实验室之间激素受体检测结果的一致性。
在一家参考病理实验室进行的回顾性研究。
采用免疫组织化学方法,比较了一家参考实验室与巴西146家当地实验室对500例浸润性乳腺癌病例激素受体检测结果的一致性。
当地实验室与参考实验室之间雌激素受体检测结果的一致性为89.4%(447/500例),孕激素受体检测结果的一致性为85.0%(425/500例),雌激素受体检测结果的κ值为0.744(P<0.001),孕激素受体检测结果的κ值为0.688(P<0.001)。这与其他国家的研究结果相似。当地实验室雌激素和孕激素受体检测的假阴性率分别为8.7%和14.4%。当地实验室雌激素和孕激素受体检测的假阳性率分别为15.5%和16.0%。
技术和结果解读问题可能是当地实验室激素受体检测结果不一致的主要原因。强烈建议对当地实验室的雌激素和孕激素受体检测进行验证,并采取严格的质量控制措施,以避免对乳腺癌患者进行错误治疗。