Department of Radiotherapy, Henri Becquerel Center, Rouen, France.
Anticancer Res. 2012 Apr;32(4):1429-33.
To investigate in a prospective study the prognostic value of serum HER2 extracellular domain (ECD) level in patients with primary breast cancer overexpressing HER2 treated with adjuvant chemotherapy and trastuzumab.
All the patients treated for primary breast cancer with chemotherapy and adjuvant trastuzumab from April 1, 2005 to December 31, 2006 at the Centre de Lutte Contre le Cancer de Haute Normandie were enrolled in this prospective study. HER2 ECD was measured in frozen serum by a commercial kit with a cut-off value of 15 ng/ml.
Sixty-five patients were enrolled. Seven patients (11%) had an elevated serum HER2 ECD level (mean=25.1 ng/ml, range 15.1-38.9 ng/ml). During follow-up, 13 patients (20%) developed metastases and seven patients (11%) died. Death was related to breast cancer metastases in six patients (9%). Out of the seven patient with elevated serum HER2 ECD level, five (71%) developed metastases and three (43%) died of metastases during follow-up. Multivariate analysis showed that elevated serum HER2 ECD level was the unique factor for both disease-free survival (p<0.0006) and overall survival (p=0.008) in this series.
Elevated serum HER2 ECD level is a strong prognostic factor in primary breast cancer overexpressing HER2 treated with adjuvant therapy of trastuzumab. In addition, our results suggest that it could predict failure of adjuvant therapy of trastuzumab.
前瞻性研究探讨曲妥珠单抗辅助化疗治疗过表达 HER2 的原发性乳腺癌患者血清 HER2 细胞外域（ECD）水平的预后价值。
本前瞻性研究纳入了 2005 年 4 月 1 日至 2006 年 12 月 31 日在诺曼底癌症防治中心接受化疗和辅助曲妥珠单抗治疗的原发性乳腺癌患者。采用商业试剂盒检测冷冻血清中 HER2 ECD，截断值为 15ng/ml。
共纳入 65 例患者。7 例（11%）患者血清 HER2 ECD 水平升高（平均值=25.1ng/ml，范围 15.1-38.9ng/ml）。随访期间，13 例（20%）患者发生转移，7 例（11%）患者死亡。6 例患者（9%）的死亡与乳腺癌转移有关。在 7 例血清 HER2 ECD 水平升高的患者中，5 例（71%）发生转移，3 例（43%）在随访期间死于转移。多变量分析显示，血清 HER2 ECD 水平升高是该系列患者无病生存率（p<0.0006）和总生存率（p=0.008）的唯一相关因素。
曲妥珠单抗辅助治疗过表达 HER2 的原发性乳腺癌患者，血清 HER2 ECD 水平升高是一个强烈的预后因素。此外，我们的结果表明，它可能预测曲妥珠单抗辅助治疗的失败。
