Comparison of Methods of Measuring  HER-2  in Metastatic Breast Cancer Patients Treated With High-Dose Chemotherapy

Harris, Lyndsay N.; Liotcheva, Vlayka; Broadwater, Gloria; Ramirez, Michael J.; Maimonis, Peter; Anderson, Steven M.; Everett, Tajuana; Harpole, David; Moore, Mary B.; Berry, Donald A.; Rizzeri, David; Vredenburgh, James J.; Bentley, Rex C.

doi:10.1200/jco.2001.19.6.1698

Cited by 84 publications

(70 citation statements)

References 29 publications

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“…[18][19] Kim et al 20 reported similar results in assessing HER2 status by IHC. In contrast to our and the previously quoted studies, comparing ECD and HER2 status evaluated by IHC and FISH on primary tumors in patients treated with HD alkylating agents after anthracycline-based induction chemotherapy, Harris et al 22 concluded that ECD only can identify a subset of patients at worse prognosis, while IHC and FISH were not correlated with outcome.…”

Section: Discussioncontrasting

confidence: 99%

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HER2 overexpression as a prognostic factor in metastatic breast cancer patients treated with high-dose chemotherapy and autologous stem cell support

Guarneri

Bengala²,

Orlandini³

et al. 2004

Bone Marrow Transplant

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Summary:We retrospectively evaluated the predictive and prognostic role of HER2 expression in 44 metastatic breast cancer (MBC) patients treated with high-dose consolidation chemotherapy (HDCT) and autologous stem cell support after induction chemotherapy (IC) with six courses of epirubicin þ paclitaxel (22 patients) or gemcitabine þ epirubicin þ paclitaxel (22 patients). HER2 expression was evaluated by an immunohistochemical method (Herceptest, Dako). A total of 13 patients (29.5%) showed a HER2 overexpression (score 3 þ ). After IC, nine patients were in complete response (CR), 30 in partial response (PR), and five in stable disease (SD); after HDCT, 20 (45.5%) obtained a CR, and 23 were in PR, for a conversion rate of 48.5%. Conversion rate for HER2-positive patients was 87.5 vs 37% for HER2-negative patients (P ¼ 0.018). The median progressionfree (PFS) and overall survivals (OS) were 17.6 (95% CI 13.2-22.0) and 44 (95% CI 25.9-62.3) months, respectively. Patients with HER2 overexpression experienced a significantly (P ¼ 0.0042) shorter median PFS (15.3 months, 95% CI 11.1-19.5) compared to HER2-negative patients (21.3 months,). The median OS was 27.6 months (95% CI 4.5-50.7) in HER2-positive patients and 50.3 months (95% CI 38.7-62.0) in HER2-negative patients (P ¼ 0.345). These results indicate that HER2 overexpression predicts a worse outcome for patients with MBC treated with HDCT, despite the high CR rate obtained in this subset of patients.

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Section: Discussioncontrasting

confidence: 99%

“…The majority of these studies showed a worse outcome for HER2-positive patients. [18][19][20][21][22] Overall, these studies included 274 patients with HER2 assessed on the tumor, and the patients were treated with a variety of induction regimens, not including taxanes.…”

Section: Metastatic Breast Cancermentioning

confidence: 99%

HER2 overexpression as a prognostic factor in metastatic breast cancer patients treated with high-dose chemotherapy and autologous stem cell support

Guarneri

Bengala²,

Orlandini³

et al. 2004

Bone Marrow Transplant

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“…Studies of breast cancer prognosis based on the serum ECD test have been conflicting, with some finding significant correlation [116] and others finding weak or no correlation [230]. In 22 published studies on 4,088 patients, 16 (73%) studies involving 3,458 (85%) of the patients reported a significant correlation of serum HER-2 protein levels with disease recurrence, metastasis, or shorter survival [231][232][233][234][235][236][237][238][239][240][241][242][243][244][245][246][247]. Two studies involving 379 patients reported no significant association of serum levels with prognosis [248,249].…”

Section: Tissue and Serum Enzyme-linked Immunosorbentmentioning

confidence: 99%

“…Two studies involving 379 patients reported no significant association of serum levels with prognosis [248,249]. Of the 11 studies in which serum HER-2 protein levels were tested for their ability to predict response to therapy, eight (73%) of the studies found that elevated serum HER-2 protein levels predicted therapy resistance [234,[242][243][244][247][248][249], whereas three additional studies did not demonstrate this association [234,249,250]. Serum HER-2 levels have been correlated with shorter survival and the absence of clinical response to hormonal therapy in ER-positive tumors in some studies [239,247], but not in others [249].…”

Section: Tissue and Serum Enzyme-linked Immunosorbentmentioning

confidence: 99%

“…Serum HER-2 levels have been correlated with shorter survival and the absence of clinical response to hormonal therapy in ER-positive tumors in some studies [239,247], but not in others [249]. Serum HER-2 protein measurements have successfully predicted resistance to high-dose chemotherapy [242][243][244], bone marrow transplantation [243], and response to trastuzumab single-agent and combination treatment for metastatic HER-2-positive disease [251,252]. In general, the test is advocated by some oncologists for the continuous monitoring of patients with HER-2-positive disease undergoing anti-HER-2 targeted therapy [231].…”

Section: Tissue and Serum Enzyme-linked Immunosorbentmentioning

confidence: 99%

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The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti–HER-2 Therapy and Personalized Medicine

et al. 2009

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1. Contrast the current strengths and limitations of the three main slide-based techniques (IHC, FISH, and CISH) currently in clinical use for testing breast cancer tissues for HER-2 status.2. Compare the efficacy of trastuzumab-and lapatinib-based regimens in the adjuvant and metastatic settings as reported in published clinical trials and regulatory approval databases.3. Contrast the list of biomarkers that have been associated with clinical resistance to trastuzumab and lapatinib and describe their current level of validation.This article is available for continuing medical education credit at CME.TheOncologist.com. CME CME ABSTRACTThe human epidermal growth factor receptor (HER-2) oncogene encodes a transmembrane tyrosine kinase receptor that has evolved as a major classifier of invasive breast cancer and target of therapy for the disease. The validation of the general prognostic significance of HER-2 gene amplification and protein overexpression in the absence of anti-HER-2 targeted therapy is discussed in a study of 107 published studies involving 39,730 patients, which produced an overall HER-2-positive rate of 22.2% and a mean relative risk for overall survival (OS) of 2.74. The issue of HER-2 status in primary versus metastatic breast cancer is considered along with a section on the features of metastatic HER-2-positive disease. The major marketed slide-based HER-2 testing approaches, immunohistochemistry, fluorescence in situ hybridization, and chromogenic in situ

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Quantitative diagnosis of HER2 protein expressing breast cancer by single‐particle quantum dot imaging

et al. 2016

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Overexpression of HER2 is one of the major causes of breast cancer, and therefore precise diagnosis of its protein expression level is important. However, current methods estimating the HER2‐expression level are insufficient due to problem with the lack of quantification. This might result in a gap between diagnostics and therapeutics targeting HER2. Therefore, a new effective diagnostic method is needed. We developed a new immunohistochemical (IHC) technique with quantum dots (QD)‐conjugated trastuzumab using single‐particle imaging to quantitatively measure the HER2 expression level. Tissues from 37 breast cancer patients with available detailed clinical information were tested by IHC with QDs (IHC‐QD) and the correlation with IHC with 3,3′‐diaminobenzidine (DAB), fluorescence in situ hybridization (FISH), and IHC‐QD was examined. The number of QD‐conjugated trastuzumab particles binding specifically to a cancer cell was precisely calculated as the IHC‐QD score. The IHC‐QD score in 37 cases was correlated proportionally with the score of HER2 gene copy number as assessed by FISH (R = 0.83). When HER2 positivity was judged to be positive, the IHC‐QD score with our cut‐off level was exactly concordant with the FISH score with a cut‐off value of 2.0. Furthermore, IHC‐QDs score and time to progression (TTP) of trastuzumab therapy were well correlated in HER2‐positive cases (R = 0.69). Conversely, the correlation between FISH score and TTP was not observed. We developed a precisely quantitative IHC method using trastuzumab‐conjugated QDs and single‐particle imaging analysis and propose the possibility of using IHC‐QDs score as a predictive factor for trastuzumab therapy.

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Comparison of Methods of Measuring HER-2 in Metastatic Breast Cancer Patients Treated With High-Dose Chemotherapy

Cited by 84 publications

References 29 publications

HER2 overexpression as a prognostic factor in metastatic breast cancer patients treated with high-dose chemotherapy and autologous stem cell support

HER2 overexpression as a prognostic factor in metastatic breast cancer patients treated with high-dose chemotherapy and autologous stem cell support

The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti–HER-2 Therapy and Personalized Medicine

Quantitative diagnosis of HER2 protein expressing breast cancer by single‐particle quantum dot imaging

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