PMID- 19728854
OWN - NLM
STAT- MEDLINE
DCOM- 20091112
LR  - 20161018
IS  - 1437-4331 (Electronic)
IS  - 1434-6621 (Linking)
VI  - 47
IP  - 9
DP  - 2009
TI  - Serum HER-2 concentrations for monitoring women with breast cancer in a routine 
      oncology setting.
PG  - 1117-23
LID - 10.1515/CCLM.2009.241 [doi]
AB  - 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.
FAU - Sorensen, Patricia Diana
AU  - Sorensen PD
AD  - Department of Clinical Biochemistry, Lillebaelt Hospital, Vejle, Denmark. 
      Patricia.Diana.Soerensen@slb.regionsyddanmark.dk
FAU - Jakobsen, Erik Hugger
AU  - Jakobsen EH
FAU - Langkjer, Sven Tyge
AU  - Langkjer ST
FAU - Bokmand, Susanne
AU  - Bokmand S
FAU - Ostergaard, Birthe
AU  - Ostergaard B
FAU - Olsen, Dorte Aalund
AU  - Olsen DA
FAU - Madsen, Jonna Skov
AU  - Madsen JS
FAU - Brandslund, Ivan
AU  - Brandslund I
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Clin Chem Lab Med
JT  - Clinical chemistry and laboratory medicine
JID - 9806306
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Breast Neoplasms/*diagnosis/pathology
MH  - Disease Progression
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Neoplasm Recurrence, Local/diagnosis
MH  - Receptor, ErbB-2/*blood
EDAT- 2009/09/05 06:00
MHDA- 2009/11/13 06:00
CRDT- 2009/09/05 06:00
PHST- 2009/09/05 06:00 [entrez]
PHST- 2009/09/05 06:00 [pubmed]
PHST- 2009/11/13 06:00 [medline]
AID - 10.1515/CCLM.2009.241 [doi]
PST - ppublish
SO  - Clin Chem Lab Med. 2009;47(9):1117-23. doi: 10.1515/CCLM.2009.241.