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Serum HER2 levels determined by two methods in patients with metastatic breast cancer

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Abstract

Background

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).

Methods

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.

Results

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.

Conclusions

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.

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Acknowledgments

The authors thank Bibari Nakamura and Keiko Shimizu from St. Luke’s International Hospital for help in collecting clinical data; Yuji Shimoda, Masayuki Shimada, Takeshi Watanabe, and Yuki Matsuo from SRL Inc. for analysis of serum HER2 levels in the blood samples; and Sunita Patterson, Department of Scientific Publications, MD Anderson Cancer Center, for editorial review. This research is supported in part by the National Institutes of Health through MD Anderson’s Cancer Center Support Grant CA016672.

Conflict of interest

SRL Inc. provided analysis of serum HER2 levels in the blood samples at St. Luke’s International Hospital (N. Hayashi, S. Nakamura, A. Yoshida, and H. Yagata). G. N. Hortobagyi is a consultant to Allergan, Genentech, Merck, and SanofiAventis, and has received research funding from Novartis. All other coauthors have no conflict of interest.

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Authors and Affiliations

  1. Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 1354, Houston, TX, 77030, USA

    Naoki Hayashi, Gabriel N. Hortobagyi & Naoto T. Ueno

  2. Department of Breast Surgical Oncology, St. Luke’s International Hospital, 9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560, Japan

    Naoki Hayashi, Seigo Nakamura, Hiroshi Yagata & Atsushi Yoshida

  3. Second Department of Pathology, The Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan

    Naoki Hayashi & Hidekazu Ota

  4. Department of Breast Surgical Oncology, The Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan

    Seigo Nakamura

  5. Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan

    Yasuharu Tokuda

  6. Department of Medical Oncology, Fox Chase Cancer Center Philadelphia, 333 Cottman Avenue, Philadelphia, PA, 19111-2497, USA

    Massimo Cristofanilli

Authors
  1. Naoki Hayashi
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  2. Seigo Nakamura
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  3. Yasuharu Tokuda
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  4. Hiroshi Yagata
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  5. Atsushi Yoshida
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  7. Gabriel N. Hortobagyi
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  8. Massimo Cristofanilli
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  9. Naoto T. Ueno
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Correspondence to Naoto T. Ueno.

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Hayashi, N., Nakamura, S., Tokuda, Y. et al. Serum HER2 levels determined by two methods in patients with metastatic breast cancer. Int J Clin Oncol 17, 55–62 (2012). https://doi.org/10.1007/s10147-011-0253-z

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  • DOI: https://doi.org/10.1007/s10147-011-0253-z

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