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Breast Cancer Research

Open Access

Serological Her2/neu-determination in patients receiving Herceptin®

  • A Thomas1,
  • M Hoopmann1,
  • T Schöndorf1,
  • R Neumann2,
  • P Mallmann1,
  • U-J Göhring1,
  • CM Kurbacher1,
  • C Eisberg1,
  • T Tanasale1 and
  • M Warm1
Breast Cancer Research20013(Suppl 1):A63

Received: 10 May 2001

Published: 31 May 2001


Treatment with Herceptin® is one of the most promising therapies for patients with metastatic breast cancer whose tumors overexpress the HER2/neu protein. Recent studies provide evidence that patients receiving herceptin have a significant benefit. Taking into account this clinical success and, additionally, the favorable side-effect pattern, addition of Herceptin in first-line treatment of metastatic breast cancer is considered the most encouraging therapeutic option. However, prognostic and/or predictive markers justifying the therapy have not been available until now. Therefore, we designed a retrospective study in order to evaluate the serological Her2/neu determination accompanying a Herceptin therapy.


The sera samples of 10 Herceptin-patients were collected immediately after standard hematological investigation. Serological Her2/neu was quantified using the Her2/neu Kit (Bayer Diagnostics, Munich, Germany). Automatical determination was performed on the immunoanalyzer Bayer Immuno1™. The valueswere analyzed in terms of the clinical course of each patient. Each assay was performed in duplicate.


The 10 patients were observed 15 months (median), range 6-21. Two patients had visceral metastases, two patients bone metastases and six patients developed multiple occult metastases. Seven patients had suffered a relapse. In all these seven patients the serological Her2/neu concentration increased strikingly at time of progress. The Her2/neu levels of the three patients with stable disease did not change during the observation period.


Serological Her2/neu concentrations paralleled the clinical course of a patient with metastatic breast cancer receiving Herceptin therapy. Prospective studies should be designed in order to demonstrate the prognostic/predictive value of serological Her2/neu determination.

Authors’ Affiliations

Department of Gynecology and Obstetrics, University of Cologne, Cologne, Germany
Bayer Vital GmbH, Leverkusen, Germany


© BioMed Central Ltd 2001