Cook G B, Neaman I E, Goldblatt J L, Cambetas D R, Hussain M, Lüftner D, Yeung K K, Chan D W, Schwartz M K, Allard W J
Bayer Corporation, Diagnostics Division, 511 Benedict Avenue, Tarrytown, NY 10591-5097, USA.
Anticancer Res. 2001 Mar-Apr;21(2B):1465-70.
The clinical utility of automated serum HER-2/neu measurements in breast cancer run on the Bayer random analyzer Immuno 1 was analyzed in several steps: [a] The reference interval was determined for 242 normal healthy pre- and postmenopausal females. [b] The clinical specificity of serum HER-2/neu to separate healthy controls from 210 patients with non-malignant breast--and non-breast diseases was calculated. [c] The clinical sensitivity of cross-sectional serum HER-2/neu values for 204 patients (pts) with stage I-IV breast cancer was established. [d] Specimens from 103 stage IV breast cancer pts were tested for their parallel between serial serum HER-2/neu results and disease course.
[a] The value of 13.03 ng/ml exceeded 95% of the results from the healthy female population. Based on the mean +2 standard deviations value of 14.7 ng/dl, the upper limit of normal was established at 15 ng/ml. [b] The specificity for benign breast diseases and other benign non-breast diseases was 98.0% and 94.6%, respectively. [c] The correlation of increased serum HER-2/neu levels and stage of breast cancer revealed the best sensitivity of 40% for stage IV disease. [4] Thirty-eight (36.9%) of 103 stage IV patients had initial HER-2/neu values > 15 ng/ml, 33 of whom showed longitudinal HER-2/neu concentrations which paralleled the clinical course of the disease giving a sensitivity of 86.8%.
对在拜耳随机分析仪Immuno 1上进行的乳腺癌自动化血清HER-2/neu检测的临床效用分几步进行了分析：[a] 确定了242名绝经前和绝经后正常健康女性的参考区间。[b] 计算了血清HER-2/neu区分210例患有非恶性乳腺及非乳腺疾病的健康对照者的临床特异性。[c] 确定了204例I-IV期乳腺癌患者横断面血清HER-2/neu值的临床敏感性。[d] 对103例IV期乳腺癌患者的样本进行检测，以观察血清HER-2/neu系列结果与病程之间的相关性。
[a] 13.03 ng/ml的值超过了健康女性人群95%的检测结果。基于均值加2个标准差14.7 ng/dl的值，正常上限设定为15 ng/ml。[b] 对良性乳腺疾病和其他良性非乳腺疾病的特异性分别为98.0%和94.6%。[c] 血清HER-2/neu水平升高与乳腺癌分期的相关性显示，IV期疾病的最佳敏感性为40%。[d] 103例IV期患者中有38例（36.9%）初始HER-2/neu值>15 ng/ml，其中33例显示HER-2/neu浓度纵向变化与疾病临床病程相符，敏感性为86.8%。
