Monitoring therapy by serum HER-2/neu
Monitoring therapy by serum HER-2/neu
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DOI：
10.1177/172460080001500409
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发表时间：
2000-10-01
影响因子：
2
通讯作者：
Neiman, I
中科院分区：
文献类型：
--
作者：
Schwartz, MK;Smith, C;Neiman, I
我们已经评估了Bayer Immune 1（TM）血清HER-2/neu测定的性能。精密度极佳，HER-2/neu值范围为16.8 ng/mL至108.6 ng/mL时，精密度在1.7%至2.1%之间变化。在每月随访的正常女性中，平均偏差为6%。正常女性的浓度（平均值+/- SD）为8.7 +/- 3.2 ng/mL。绝经前和绝经后妇女之间无差异。正常/异常临界值定义为大于15 ng/mL。在正常妇女和良性疾病的特异性在95%和100%之间变化。在乳腺癌女性中，I期疾病的敏感性为1.7%，II期为3.0%，III期为16.7%，IV期为35.5%。在总共285名乳腺癌妇女中，有56名（14.7%）升高。与微量滴定板法有很好的相关性（r = 0.9944）。纵向研究清楚地表明，在其组织中表达HER-2/neu的妇女血清水平升高，这些水平反映了患者的临床过程。需要更广泛的对照研究来确定HER-2/neu检测在乳腺癌女性管理中的作用。
We have evaluated the performance of the Bayer Immune 1(TM) serum HER-2/neu assay. The precision is excellent and varied between 1.7% and 2.1% at values of HER-2/neu ranging from 16.8 ng/mL to 108.6 ng/mL. In normal women who were followed on a monthly basis the average deviation was 6%. The concentration (mean +/- SD) in normal women was 8.7 +/- 3.2 ng/mL. There was no difference between pre and postmenopausal women. The normal/abnormal cutoff was defined as greater than 15 ng/mL. In normal women and those with benign disease the specificity varied between 95% and 100%. In women with breast cancer the sensitivity was 1.7% in stage I disease, 3.0% in stage II, 16.7 in stage III and 35.5% in stage IV. There were 56 elevations (14.7%) in the total group of 285 women with breast cancer. There was an excellent correlation with a microtitre plate method (r = 0.9944). Longitudinal studies showed clearly that women who expressed HER-2/neu in their tissue had elevated serum levels and these levels reflected the clinical course of the patient. More extensive control studies are required to establish the role of HER-2/neu assays in the management of women with breast cancer.