Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Int J Clin Oncol. 2012 Feb;17(1):55-62. doi: 10.1007/s10147-011-0253-z. Epub 2011 May 25.
The role and the optimal measurement method of serum HER2 levels are not defined in patients with metastatic breast cancer (MBC). We prospectively assessed the prognostic value of serum HER2 levels in MBC using two methods, enzyme immunoassay (EIA) and chemiluminescence immunoassay (CLIA).
We collected blood samples from patients with MBC at baseline and at subsequent 3- to 4-week intervals up to 12 weeks. Samples were divided, and serum HER2 levels were determined using EIA and CLIA. We also determined whether serum HER2 levels had decreased by ≥20% at first follow-up. These results were evaluated against overall survival, progression-free survival, and tumor response.
We obtained 196 samples from 52 patients. In 59 samples from patients who received trastuzumab, serum HER2 positivity rates were significantly lower for EIA (n = 22) than for CLIA (n = 33, P = 0.042); in 137 samples from patients who did not receive trastuzumab, there was no significant difference in rates of serum HER2 positivity for CLIA (n = 83) and EIA (n = 80). Serum HER2 level at baseline, the level at first follow-up, and a decrease of ≥20% between baseline and first follow-up were not associated with overall survival, progression-free survival, and tumor response.
Chemiluminescence immunoassay was a more sensitive method than EIA for measuring serum HER2 levels in patients who received trastuzumab. However, because serum HER2 levels did not correlate with patient outcome, we do not currently recommend measuring serum HER2 levels by either method for prognostic evaluation in patients with MBC.
在转移性乳腺癌（MBC）患者中，血清 HER2 水平的作用和最佳测量方法尚未明确。我们前瞻性地使用酶免疫分析法（EIA）和化学发光免疫分析法（CLIA）评估了 MBC 患者血清 HER2 水平的预后价值。
我们在基线和随后的 3 至 4 周间隔内采集 MBC 患者的血液样本，直至 12 周。将样本进行分组，使用 EIA 和 CLIA 测定血清 HER2 水平。我们还确定了首次随访时血清 HER2 水平是否降低了≥20%。这些结果与总生存期、无进展生存期和肿瘤反应进行了评估。
我们从 52 名患者中获得了 196 个样本。在接受曲妥珠单抗治疗的 59 个患者的样本中，EIA 检测的血清 HER2 阳性率明显低于 CLIA（n=22 与 n=33，P=0.042）；在未接受曲妥珠单抗治疗的 137 个患者的样本中，CLIA（n=83）和 EIA（n=80）检测的血清 HER2 阳性率无显著差异。基线时的血清 HER2 水平、首次随访时的水平以及基线和首次随访之间降低≥20%与总生存期、无进展生存期和肿瘤反应均无相关性。
与 EIA 相比，CLIA 是一种更敏感的方法，可用于测量接受曲妥珠单抗治疗的患者的血清 HER2 水平。然而，由于血清 HER2 水平与患者预后无相关性，目前我们不建议使用这两种方法中的任何一种来评估 MBC 患者的预后。
