Serum HER2 extracellular domain in metastatic breast cancer patients treated with weekly trastuzumab and paclitaxel: Association with HER2 status by immunohistochemistry and fluorescence in situ hybridization and with response rate Journal Article


Authors: Fornier, M. N.; Seidman, A. D.; Schwartz, M. K.; Ghani, F.; Thiel, R.; Norton, L.; Hudis, C.
Article Title: Serum HER2 extracellular domain in metastatic breast cancer patients treated with weekly trastuzumab and paclitaxel: Association with HER2 status by immunohistochemistry and fluorescence in situ hybridization and with response rate
Abstract: Purpose: We explored the relationship between circulating HER2 extracellular domain (ECD) and tissue HER2 status as determined by inummohistochemistry (IHC) and fluorescence in situ hybridization (FISH). We also examined its predictive value in a cohort of metastatic breast cancer patients treated with weekly trastuzumab and paclitaxel. Methods: Eligible patients had pre- and post-treatment stored serum specimens and were treated on a previously reported phase II trial. Retrospective analysis evaluated: the association between pretreatment serum HER2 ECD and tissue HER2 status by IHC and FISH; and the association between change in serum HER2 ECD after 12 weeks of therapy and response proportion. Results: Stored serum samples were available for 55/95 (58%) patients. Statistically significant associations were found between HER2 status as assessed by IHC and FISH, and baseline serum HER2 ECD level. Patients whose ECD normalized after 12 weeks of therapy had a higher response proportion compared with patients with persistently high ECD levels (68% versus 15%, P=0.005). A relative decline of over 55% from baseline HER2 ECD predicted response to therapy. Conclusion: A statistically significant association was observed between pretreatment serum HER2 ECD and tissue HER2 status as assessed by IHC and FISH. A decrease in serum HER2 ECD level was a significant predictor of response to trastuzumab-based therapy. © 2005 European Society for Medical Oncology.
Keywords: immunohistochemistry; adult; human tissue; aged; middle aged; retrospective studies; major clinical study; paclitaxel; protein domain; protein localization; protein blood level; in situ hybridization, fluorescence; metastasis; cohort studies; breast cancer; antineoplastic combined chemotherapy protocols; epidermal growth factor receptor 2; tumor markers, biological; breast neoplasms; retrospective study; prediction; antibodies, monoclonal; fluorescence in situ hybridization; statistical significance; tissue distribution; blood sampling; neoplasm metastasis; receptor, erbb-2; trastuzumab; metastatic breast cancer; her2 ecd
Journal Title: Annals of Oncology
Volume: 16
Issue: 2
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2005-02-01
Start Page: 234
End Page: 239
Language: English
DOI: 10.1093/annonc/mdi059
PUBMED: 15668276
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 63" - "Export Date: 24 October 2012" - "CODEN: ANONE" - "Source: Scopus"
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MSK Authors
  1. Andrew D Seidman
    318 Seidman
  2. Clifford Hudis
    905 Hudis
  3. Larry Norton
    760 Norton
  4. Monica Nancy Fornier
    158 Fornier
  5. Morton Schwartz
    186 Schwartz