This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Köstler, W. J. Articles by Zielinski, C. C. Search for Related Content PubMed PubMed Citation Articles by Köstler, W. J. Articles by Zielinski, C. C.

Monitoring of Serum Her-2/neu Predicts Response and Progression-Free Survival to Trastuzumab-Based Treatment in Patients with Metastatic Breast Cancer

¹ Clinical Division of Oncology, Department of Medicine I and ² Clinical Division of Special Gynaecology, Department of Gynaecology and Obstetrics, University Hospital of Vienna, Austria; ³ Bayer Vital GmbH, Leverkusen, Germany; ⁴ Statistical Analyses Methodical Consulting, Vienna, Austria; and ⁵ Ludwig Boltzmann Institute for Clinical Experimental Oncology, Vienna, Austria

ABSTRACT

Purpose: The present pilot study was performed to elucidate whether early changes in serum Her-2/neu extracellular domain (ECD) levels during trastuzumab-based treatment would predict the clinical course of disease in patients with metastatic breast cancer.

Experimental Design: Sera from 55 patients with Her-2/neu-overexpressing metastatic breast cancer obtained immediately before each weekly administration of trastuzumab were analyzed by a serum Her-2/neu ELISA.

Results: Whereas response rates were significantly higher in patients with elevated (15 ng/ml) ECD levels before initiation of treatment (35% versus 7%, P = 0.045), progression-free and overall survival did not differ significantly between patients with normal and elevated ECD levels. In patients responding to treatment, ECD levels decreased significantly as early as from day 8 of treatment onwards (all P for weekly measurements versus baseline <0.001). In contrast, no significant change in ECD levels was observed in patients with progressive disease. Multiple logistic regression analyses identified kinetics of ECD levels as the only factor that allowed for the accurate prediction of response likelihood as early as from day 8 of trastuzumab-based treatment onwards (P = 0.020). In addition, determination of serial ECD levels allowed for the prediction of the risk for disease progression within the observed period as early as day 15 of treatment (P = 0.010).

Conclusions: Serial monitoring of the ECD may represent a valuable tool for early prediction of the probability of response and progression-free survival to trastuzumab-based treatment and is thus likely to contribute to an optimization of treatment and resource allocation.

This article has been cited by other articles:

				A. Ardavanis, P. Kountourakis, F. Kyriakou, S. Malliou, I. Mantzaris, A. Garoufali, I. Yiotis, A. Scorilas, N. Baziotis, and G. Rigatos Trastuzumab plus Paclitaxel or Docetaxel in HER-2-Negative/HER-2 ECD-Positive Anthracycline- and Taxane-Refractory Advanced Breast Cancer Oncologist, April 1, 2008; 13(4): 361 - 369. [Abstract] [Full Text] [PDF]

				S. F. Shariat, K. Bensalah, J. A. Karam, C. G. Roehrborn, A. Gallina, Y. Lotan, K. M. Slawin, and P. I. Karakiewicz Preoperative Plasma HER2 and Epidermal Growth Factor Receptor for Staging and Prognostication in Patients with Clinically Localized Prostate Cancer Clin. Cancer Res., September 15, 2007; 13(18): 5377 - 5384. [Abstract] [Full Text] [PDF]

				G Valabrega, F Montemurro, and M Aglietta Trastuzumab: mechanism of action, resistance and future perspectives in HER2-overexpressing breast cancer Ann. Onc., June 1, 2007; 18(6): 977 - 984. [Abstract] [Full Text] [PDF]

				S. A. Perez, M. V. Karamouzis, D. V. Skarlos, A. Ardavanis, N. N. Sotiriadou, E. G. Iliopoulou, M. L. Salagianni, G. Orphanos, C. N. Baxevanis, G. Rigatos, et al. CD4+CD25+ Regulatory T-Cell Frequency in HER-2/neu (HER)-Positive and HER-Negative Advanced-Stage Breast Cancer Patients Clin. Cancer Res., May 1, 2007; 13(9): 2714 - 2721. [Abstract] [Full Text] [PDF]

				S.-Y. Kong, B.-H. Nam, K. S. Lee, Y. Kwon, E. S. Lee, M.-W. Seong, D. H. Lee, and J. Ro Predicting Tissue HER2 Status Using Serum HER2 Levels in Patients with Metastatic Breast Cancer Clin. Chem., August 1, 2006; 52(8): 1510 - 1515. [Abstract] [Full Text] [PDF]

				M. J. Duffy Serum Tumor Markers in Breast Cancer: Are They of Clinical Value? Clin. Chem., March 1, 2006; 52(3): 345 - 351. [Abstract] [Full Text] [PDF]

				C. Tse, D. Brault, J. Gligorov, M. Antoine, R. Neumann, J.-P. Lotz, and J. Capeau Evaluation of the Quantitative Analytical Methods Real-Time PCR for HER-2 Gene Quantification and ELISA of Serum HER-2 Protein and Comparison with Fluorescence in Situ Hybridization and Immunohistochemistry for Determining HER-2 Status in Breast Cancer Patients Clin. Chem., July 1, 2005; 51(7): 1093 - 1101. [Abstract] [Full Text] [PDF]

				M. N. Fornier, A. D. Seidman, M. K. Schwartz, F. Ghani, R. Thiel, L. Norton, and C. Hudis 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 Ann. Onc., February 1, 2005; 16(2): 234 - 239. [Abstract] [Full Text] [PDF]

				B. Salvadori, P. Pinzani, V. Distante, D. Casella, S. Bianchi, M. Paglierani, V. Vezzosi, R. Neumann, L. Cataliotti, M. Pazzagli, et al. Comparison of Pre- and Postsurgical Concentrations of Blood HER-2 mRNA and HER-2 Extracellular Domain Reflects HER-2 Status in Early Breast Cancer Clin. Chem., January 1, 2005; 51(1): 254 - 256. [Full Text] [PDF]