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Breast CancerThe Serum HER-2/neu Test and Metastatic Breast Cancer

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Serum HER-2

Serum HER-2/neu: Aiuta le donne affette da Cancro Metastatico al seno

 

Serum HER-2/neu test è un semplice esame del sangue per 150.000 donne che vivono con un cancro metastatico al seno.1Per migliaia di donne con una diagnosi di cancro metastatico al seno ogni anno, il Serum HER-2/neu test di Siemens è l'unico test disponibile per il monitoraggio dei livelli di Serum HER-2/neu durante la terapia.
Il test Serum HER-2/neu test è indicato per il monitoraggio delle pazienti con cancro metastatico al seno, dal livello di partenza: >15 ng/ml.
 

Livello di Serum HER-2/neu: Fornisce importanti informazioni per la valutazione del cancro metastatico

La diminuzione del livello di Serum HER-2/neu riflette la risposta al trattamento o la stabilizzazione della malattia. L'aumento dei livelli di Serum HER-2/neu riflette la progressione della malattia.*

Il monitoraggio del livelli Serum HER-2/neu da importanti informazioni sulla rispostaalle terapie e alla progressione del cancro, e puo' supportare i medici nel prendere le corrette decisioni nello sviluppo e nella modifica del regime di trattamento della paziente. 2-4

 

*Nei sistemi ADVIA Centaur® system l'aumento o diminuzione punto-punto del 15% riflette la risposta al trattamento o la progressione della malttia.

 


1. Silent Voices: Women with Advanced (Metastatic) Breast Cancer Share Their Needs and Preferences for Information, Support and Practical Resources.. Living Beyond Breast Cancer. 2006. Pg. 1.
2. Schwartz MK, et al. International Journal of Biological Markers 2000;15(4):324.
3. Lipton A, et al. Journal of Clinical Oncology 2002;20(6):1467.
4. Esteva FJ, et al. Journal of Clinical Oncology 2002.
 

Patients & Caregivers

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Serum HER-2/neu testing monitors your HER-2 status in real time

  • Serum HER-2/neu is a simple blood test with reliable and easily interpreted results.
  • If you have metastatic breast cancer, your doctor can use the Serum HER-2/neu test to monitor changes in your HER-2/neu status.
  • If you are on a HER-2 treatment, your Serum HER-2/neu status can tell you and your doctor if your treatment is effective or not.

 

 What are the HER-2/neu tissue tests?

  • A HER-2/neu tissue test is required to qualify for HER-2 targeted therapies, such as Herceptin® and Tykerb®.
  • To establish HER-2/neu positivity, a biopsy is taken. The tissue sample is then evaluated using approved IHC or FISH testing methods to determine HER-2/neu status.


How is the Serum HER-2/neu test different from HER-2/neu tissue tests?

  • The Serum HER-2/neu test is a simple blood test for monitoring real-time HER-2/neu status after initial metastatic breast cancer diagnosis.
  • The Serum HER-2/neu test is used to monitor changes in HER-2/neu levels that reflect response to treatment or disease progression.
  • All patients diagnosed with metastatic breast cancer should have a baseline Serum HER-2/neu established, regardless of HER-2/neu tissue status.

 

Where is Serum HER-2/neu testing performed?

Your doctor will order the test from a lab, and may combine it with your routine blood work. The time it takes to get results can vary between laboratories.

 

Laboratorians

Lab

Extensive studies have shown that HER-2/neu (c-erbB-2) positive breast cancer represents 20 to 30 percent of all breast cancers. Studies have shown that up to 90% of metastatic breast cancer patients can have an elevated Serum HER-2/neu level. In HER-2/neu positive breast cancer, the cancer cells have an abnormal level of HER-2/neu genes per cell, which leads to abnormally high levels of the HER-2/neu cancer-causing proteins called oncoproteins (overexpression). This causes the cancer cells to grow and divide quickly into more cancer cells. Overexpression of HER-2/neu has been shown to be an indicator of poor prognosis with patients exhibiting aggressive disease, decreased overall survival, and a higher probability of recurrence.2-3

The Siemens HER-2/neu test is the only Serum HER-2/neu test available for sale in the U.S. for measuring circulating levels of the HER-2/neu oncoprotein in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu is greater than 15 ng/mL. It is the only serum test available to monitor HER-2/neu baseline values and Serum HER-2/neu level changes over the course of the disease. Monitoring Serum HER-2/neu levels yields important information about response to therapy and cancer progression, and may help physicians make more informed decisions when developing and modifying patient treatment regimens.4-6
 

The HER-2/neu Oncoprotein

  • HER-2/neu is an oncoprotein, a class of proteins that are linked to tumor growth
  • 20 to 30 percent of all breast cancers are HER-2/neu (c-erbB-2) positive 2
  • HER-2/neu positive breast cancer cells have an abnormal number of HER-2/neu genes per cell, which leads to the production of abnormally high levels of HER-2/neu

 

Tissue and Serum HER-2/neu Testing

  • Traditional HER-2/neu status assessment has been generally limited to testing tissue from primary breast cancer
  • Serum HER-2/neu testing provides current or real-time assessment of a patient’s Serum HER-2/neu status with a minimally invasive procedure
  • Serum HER-2/neu testing enables physicians to:

        - Monitor changes in HER-2/neu levels over the course of metastatic disease
        - Assess response to treatment

 

Clinical Testing Algorithm

The Serum HER-2/neu test is for patients with metastatic breast cancer whose initial Serum HER-2/neu is greater than 15 ng/mL regardless of HER-2 positivity determined by tissue.
 

Chart

Serum HER-2/neu Testing Algorithm for Metastatic Breast Cancer (MBC) 7-11

Serum HER-2/neu Test Utility at a Glance

The Serum HER-2/neu test is used to monitor a patient’s HER-2/neu status once a diagnosis of metastatic breast cancer has been established. The chart above shows how the Serum HER-2/neu test is typically used as a monitoring tool complementary to tissue testing.
 

Complement Your Laboratory Menu with Serum HER-2/neu

The Serum HER-2/neu test from Siemens Healthcare Diagnostics measures circulating levels of the HER-2/neu oncoprotein. It is a simple blood test, with reliable and easily interpreted results. This assay is available on the automated ADVIA Centaur® System.
 

Performance Summary and Test Specificatons: ADVIA Centaur System

  • Sandwich immunoassay
  • Direct chemiluminescence technology
  • Normal cutoff value of 15 ng/mL
  • Two monoclonal antibodies that are specific for unique epitopes on the extracellular domain of the HER-2/neu oncoprotein
     

Sample Type

Sample Test Volume

Assay Range

Analytical Sensitivity

Calibration Interval

Onboard Stability

Serum

20 µL

0.5-350 ng/mL

0.5 ng/mL

14 days

41 days

High Degree of Assay Performance and Clinical Reliability

  • Confidence in test results due to excellent precision and resistance to interference from HER-2/neu-based therapy6
  • Improved long-term patient monitoring due to low reagent lot-to-lot variability7
  • Broad assay range of 0.5 to 350 ng/mL
  • Excellent reproducibility with a Total % CV Range of 3.2% – 5.7%
  • 95% of normal patients have serum HER-2/neu levels below 15.2 ng/mL
  • Serial changes in HER-2/neu were correlated with changes in clinical status for all patients whose pre-treatment HER-2/neu values exceeded 15 ng/mL. For each pair of serial measurements, an increase of equal or greater than 15% was considered to indicate progression (predictive value of 67%). For each pair of serial measurements, a decrease of less than 15% was considered to indicate a lack of progression (predictive value of 71%).

Footnotes:

1. Valero V, Roche H, Pienkowski T, et al. BCIRG 007: Serum HER-2/neu levels in women with metastatic HER-2/neu-amplified breast cancer. J Clin Oncol. ASCO Annual Meeting Proceedings 2007, Abstract No: 1020.
2. Slamon DJ, et al. Science 1987;235:177.
3. http://www.mayoclinic.com/health/Herceptin/BR00012
4. Schwartz MK, et al. International Journal of Biological Markers 2000;15(4):324.
5. Lipton A, et al. Journal of Clinical Oncology 2002;20(6):1467.
6. Esteva FJ, et al. Journal of Clinical Oncology 2002;20(7):1800.
7. Ali SM, Carney WP, Esteva FJ, et al. Serum HER-2/neu and relative resistance to trastuzumab-based therapy in patients with metastatic breast cancer. Cancer. 2008 Sep 15;113(6):1294-301.
8. Lipton A, Leitzel K, Chaudri-Ross HA, et al. Decrease in serum extracellular domain of HER2 at 4 and 8 weeks is associated with prolonged progression-free survival on lapatinib monotherapy. Proceedings of the 31st Annual CTRC-AACR San Antonio Breast Cancer Symposium, 2008. December: Abstract No. 3140.
9. Zidan J, Dashkovsky I, Stayerman C, et al. Comparison of HER-2 overexpression in primary breast cancer and metastatic sites and its effect on biological targeting therapy of metastatic disease. Br J Cancer. 2005 Sep 5;93(5):552-6.
10. Lower EE, Glass E, Blau R, Harman S. HER-2/neu expression in primary and metastatic breast cancer. 1: Breast Cancer Res Treat. 2009 Jan;113(2):301-6. Epub 2008 Feb 14.
11. Carney WP, Brown-Shimer S, Hamer PJ. Serum HER-2/neu testing can identify HER-2/neu positive patients previously classified as negative by tissue testing. American Association for Clinical Chemistry Annual Meeting Proceedings, 2008. Clin Chem Vol 54(56) Suppl, pg A130: Abstract No. C-96.