Discordant results obtained for different methods of HER-2/neu testing in breast cancer  a question of standardization, automation and timing

Lüftner, Diana; Henschke, P.; Kafka, Ariane; Anagnostopoulos, I; Wiechen, Kai; Geppert, R.; Stein, Harald; Wernecke, Klaus D.; Possinger, K.

doi:10.5301/jbm.2008.4693

Cited by 13 publications

(3 citation statements)

References 26 publications

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“…Studies have shown that serum HER2 levels, prior to treatment, positively correlate with tumor size, number of positive lymph nodes and histological scores [25]. In fact, serum HER2 levels were a better indicator for stage IV breast cancer than were IHC scores [26]. Serum HER2 levels were also an effective prognostic indicator for metastasis-free and disease-specific survival after treatment cessation [25].…”

Section: Her2mentioning

confidence: 99%

Non-invasive, ultra-sensitive, high-throughput assays to quantify rare biomarkers in the blood

Freudenberg

Bembas

Greene

et al. 2008

Methods

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Many diseases are easier to treat and control when detected at an early stage of disease progression. Often, disease-related antigens or biomarkers are shed from the primary site and present in the blood. Unfortunately, there are very few tests capable of detecting these rare biomarkers in the blood. A blood test would be very useful to diagnose the disease earlier, monitor effectiveness of treatments, predict recurrence, and monitor recurrence. There is certainly a need to develop assays that are ultrasensitive, non-invasive and high-throughput. Here we describe several highly sensitive immunological assays we have developed to detect rare serum antigens. Initially we created an assay named immunodetection amplified by T7 RNA polymerase (IDAT). To enhance the effectiveness and streamline the procedure, this assay was amended to the facile amplification system termed fluorescent amplification catalyzed by T7 polymerase technique (FACTT). These assays have been used to analyze the tumor antigen HER2 and the prion protein PrP Sc . They can also be applied to other tumor markers or antigens from a variety of diseases such as cardiovascular disease, rheumatoid arthritis, Alzheimer's disease, Parkinson's disease, and hepatitis. These tests are not limited to testing only serum, but may also be applicable to detecting biomarkers in tissue, saliva, urine, cerebrospinal fluid, etc. Clearly, the FACTT-based technology represents an important step in the detection of rare molecules in fluids or tissues for a variety of diseases.

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Section: Her2mentioning

confidence: 99%

Non-invasive, ultra-sensitive, high-throughput assays to quantify rare biomarkers in the blood

Freudenberg

Bembas

Greene

et al. 2008

Methods

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“…

When combined with estradiol or progesterone receptor status, patients with elevated serum ERBB2 ECD (sERBB2) and receptor-negative tumors had a significantly shorter disease-specific survival (4). The strong positive correlation observed between sERBB2 levels and ERBB2 amplification assessed by FISH technique have led researchers to conclude that patients with an elevated sERBB2 level and no tissue overexpression should be considered for retesting of tissue material or a new biopsy (5,6).One of the key roles of ERBB2 oncogene is in the modulation of the cellular response to cytotoxic and inflammatory cytokines (7), which are excessively produced by cancer tissues (8). Cytokines have been used as biomarkers in research for prognosis and have been associated with symptoms and adverse outcomes in breast cancer.

…”

mentioning

confidence: 99%

“…When combined with estradiol or progesterone receptor status, patients with elevated serum ERBB2 ECD (sERBB2) and receptor-negative tumors had a significantly shorter disease-specific survival (4). The strong positive correlation observed between sERBB2 levels and ERBB2 amplification assessed by FISH technique have led researchers to conclude that patients with an elevated sERBB2 level and no tissue overexpression should be considered for retesting of tissue material or a new biopsy (5,6).…”

mentioning

confidence: 99%

Serum Tumor Necrosis Factor-alpha and Interleukin-2 Concentrations in Newly Diagnosed ERBB2 (HER2/neu) Positive Breast Cancer Patients

2009

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Comparison of two antibodies for immunohistochemical evaluation of epidermal growth factor receptor expression in colorectal carcinomas, adenomas, and normal mucosa

Bhargava

Chen

Klimstra

et al. 2006

Cancer

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BACKGROUNDImmunohistochemical staining for epidermal growth factor receptor (EGFR) has been used as a criterion for the selection of patients with colon cancer for anti‐EGFR therapy. Two antibodies, the PharmDx kit and the 31G7 clone, are used commonly for immunohistochemistry by various laboratories. No comparative studies on the performance of these 2 antibodies are available.METHODSEGFR status was evaluated in 744 tissue microarray core samples from primary and metastatic colorectal carcinomas, colorectal adenomas, and normal colorectal mucosa with both the PharmDx kit and the clone 31G7 monoclonal antibodies. The stains were compared for staining intensity by using an automated image‐analysis system. The intensity of positive staining (brown color) was measured on a scale from 0 to 255.The staining intensity also was scored manually as 0, 1 +, 2 +, and 3 +.RESULTSStatistically, the median staining intensities scored by the automated system between the 2 antibodies did not differ significantly, although, within each category of samples (normal, adenoma, carcinoma, and metastases), the PharmDx antibody staining was slightly more intense than the clone 31G7 antibody staining. There was a linear correlation between automated image‐analysis and manual scoring categories. The median automated image‐analysis intensity scores for the 4 manual scoring categories with the PharmDx kit were as follows: 0 staining, 67.5; 1 + staining, 75.5; 2 + staining, 89.6; and 3 + staining, 106.0. The median automated image‐analysis intensity scores for the 4 manual scoring categories with the clone 31G7 antibody were as follows: 0 staining, 71.3; 1 + staining, 73.6; 2 + staining, 84.6; and 3 + staining, 99.1. The classification of tumors as EGFR‐negative (0 staining) or positive (1 +, 2 +, or 3 + staining) was concordant in 151 of 160 carcinomas (94.4%) with 2 antibodies using manual scoring. Five samples (3%) that scored 1 + with the PharmDx kit antibody scored 0 with the clone 31G7 antibody; whereas 4 samples (2.5%) that scored 1 + with the clone 31G7 antibody scored 0 with the PharmDx kit antibody.CONCLUSIONSThe EGFR expression results obtained by immunohistochemistry using both the EGFR PharmaDx kit and the 31G7 clone were comparable. Either antibody may be used for immunohistochemical detection of EGFR in colorectal carcinomas. In addition, manual scoring had an excellent correlation with automated scoring. Cancer 2006. © 2006 American Cancer Society.

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Discordant results obtained for different methods of HER-2/neu testing in breast cancer a question of standardization, automation and timing

Cited by 13 publications

References 26 publications

Non-invasive, ultra-sensitive, high-throughput assays to quantify rare biomarkers in the blood

Non-invasive, ultra-sensitive, high-throughput assays to quantify rare biomarkers in the blood

Serum Tumor Necrosis Factor-alpha and Interleukin-2 Concentrations in Newly Diagnosed ERBB2 (HER2/neu) Positive Breast Cancer Patients

Comparison of two antibodies for immunohistochemical evaluation of epidermal growth factor receptor expression in colorectal carcinomas, adenomas, and normal mucosa

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