more on serum her 2 test

[Lani]

Clin Chem Lab Med. 2009;47(9):1117-23.

Serum HER-2 concentrations for monitoring women with breast cancer in a routine oncology setting.

Sørensen PD, Jakobsen EH, Langkjer ST, Bokmand S, Østergaard B, Olsen DA, Madsen JS, Brandslund I.
Department of Clinical Biochemistry, Lillebaelt Hospital, Vejle, Denmark. Patricia.Diana.Soerensen@slb.regionsyddanmark.dk
BACKGROUND: The purpose of this study was to determine the positive predictive value (PPV) of positive serum human epidermal growth factor receptor-2 (HER-2) for monitoring women with breast cancer following diagnosis and treatment in a routine clinical setting. METHODS: Serum HER-2 was measured in 1348 patients with breast cancer: 837 during routine oncology clinic visits and 511 following new diagnosis. All patients with positive serum HER-2, 1/5 of negative patients from the oncology clinic, and all the newly diagnosed were followed; a total of 862 patients. Serum HER-2 was measured using the Bayer ADVIA Centaur assay. Tissue HER-2 was determined using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). IHC +3 or IHC +2 and FISH>2.0 were positive. Patients were considered to have positive serum HER-2 when at least two values were >15 ng/mL. Recurrence, progression and regression were diagnosed according to usual clinical practice. Serum HER-2 concentrations did not contribute to diagnostic decision-making or selection of treatment. RESULTS: From January 2004 to January 2009, 149 patients were found to have positive serum HER-2. Of these, 35 were tissue HER-2 positive at surgery, 69 tissue-negative and 45 were not determined. Fifty-five of 149 that were serum HER-2 positive (37%, 95% CI: 29-45) had metastases. Among the 35 tissue-positive patients, 25 had recurrence in the form of metastases and there was good correlation between recurrence/progression and increase in serum HER-2 (p<0.0003). There was also a high correlation between effect of treatment and decline in serum HER-2 (p<0.0003). Of the 69 tissue-negative patients, 29 had recurrence in the form of metastases, and there was good correlation with serum HER-2 levels (p<0.000004). In this routine application of serum HER-2, the PPV for metastases recurrence detection in both tissue-positive and tissue-negative was 54 of 104 (52%, 95% CI: 42%-62%), in tissue-positive 25 of 35 (71%, 95% CI: 54%-85%), in tissue-negative 29 of 69 (42%, 95% CI: 30%-54%). The lead time of increases in serum HER-2 before recurrence could be determined in ten tissue-positive patients was 3-24 months (mean 11.3 months), when compared to standard clinical imaging methods. CONCLUSIONS: Serum HER-2 is a useful marker for the detection of recurrence of breast cancer and for monitoring the effect of treatment, especially in tissue HER-2 positive patients.
PMID: 19728854

[StephN]

Thank you, Lani.
I will continue to use this test to monitor my NED status, bring a stage IV. Seems reasonable on the basis of those findings.

[chicagoetc]

Lani or anyone,

Sorry to sound ignorant, but this is the first I've heard of a HER2 serum (apparently different from the actual HER2+ diagnosis itself). Would this be a way that doctors could monitor the effectiveness of treatment? [E.g. whether or not Taxol and/or Herceptin are working.] Or is this more like the other markers that indicate possible progression or lack thereof (I just had one run and it came back fine)? I would guess this would be most pertinent for Stage IV'ers but am interested in understanding more.

Melanie

[Joe]

Melanie,

More Info: Siemens HER2 Serum Test

Regards
Joe

[chicagoetc]

Thanks Joe. That helps a lot. Melanie

[Joe]

Melanie,

This test is rather inexpensive so most insurance companies will pay.

Joe