scholarly journals Comparison between Real-Time Quantitative PCR Detection of HER2 mRNA Copy Number in Peripheral Blood and ELISA of Serum HER2 Protein for Determining HER2 Status in Breast Cancer Patients

2009 ◽  
Vol 31 (3) ◽  
pp. 203-211 ◽  
Author(s):  
Maria Savino ◽  
Paola Parrella ◽  
Massimiliano Copetti ◽  
Raffaela Barbano ◽  
Roberto Murgo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Peripheral Blood ◽  
Her2 Status ◽  
Healthy Controls ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Her2 Protein ◽  
Real Time Quantitative Pcr ◽  
Her2 Mrna

Background: The development of non-invasive procedure to determine HER2 status may represent a powerful method for monitoring disease progression and response to the treatment.Methods: Serum samples and RNA from peripheral blood were evaluated in 85 breast cancer patients (49 HER2 positive and 36 HER2 negative) and 22 healthy controls. HER2 mRNA levels were measured by real-time quantitative PCR (QPCR) and serum HER2 protein by immunoenzimatic assay (EIA). ROC curve analyses were used to determine the optimal cut off values.Results: A statistically significant difference was detected for both QPCR and EIA in HER2 positive patients as compared with both healthy controls and HER2 negative tumours. QPCR showed a 91% (CI95%: 84%–98%) specificity and a 78% (CI95%: 68%–88%) sensitivity for an optimal cut off value of 4.74. The optimal cut off value for EIA was 22 ng/ml yielding a 95% (CI95%: 90%–100%) specificity and a 59% (CI95%: 48%–70%) sensitivity. The QPCR assay was slightly less specific than EIA in discriminating HER2 positive breast cancers from HER2 negative tumours (78% CI95%: 69%–87% versus 86% CI95%: 79%–93%), but it was more sensitive (76% CI95%: 67%–85% versus 55% CI95%: 44%–66%).Conclusions: Our results indicate that QPCR performs better than EIA in the determination of HER2 status of breast cancer patients and could be useful in monitoring the disease during follow up.

Comparison of HER2 Status by Fluorescence in Situ Hybridization and Immunohistochemistry to Predict Benefit From Dose Escalation of Adjuvant Doxorubicin-Based Therapy in Node-Positive Breast Cancer Patients

2005 ◽  
Vol 23 (19) ◽  
pp. 4287-4297 ◽  
Author(s):  
Lynn G. Dressler ◽  
Donald A. Berry ◽  
Gloria Broadwater ◽  
David Cowan ◽  
Kelly Cox ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Fluorescence In Situ Hybridization ◽  
Cancer Patients ◽  
Her2 Status ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Node Positive ◽  
Positive Breast Cancer

Purpose HER2 is a clinically important tumor marker in breast cancer; however, there is controversy regarding which method reliably measures HER2 status. We compared three HER2 laboratory methods: immunohistochemistry (IHC), fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR), to predict disease-free survival (DFS) and overall survival (OS) after adjuvant doxorubicin-based therapy in node-positive breast cancer patients. Methods This is a Cancer and Leukemia Group B (CALGB) study, using 524 tumor blocks collected from breast cancer patients registered to clinical trial CALGB 8541. IHC employed CB11 and AO-11-854 monoclonal antibodies; FISH used PathVysion HER2 DNA Probe kit; PCR utilized differential PCR (D-PCR) methodology. Results Cases HER2 positive by IHC, FISH and D-PCR were 24%, 17%, and 18%, respectively. FISH and IHC were clearly related (κ = 64.8%). All three methods demonstrated a similar relationship for DFS and OS. By any method, for patients with HER2-negative tumors, there was little or no effect of dose of adjuvant doxorubicin-based therapy. For patients with HER2-positive tumors, all three methods predicted a benefit from dose-intense (high-dose) compared with low- or moderate-dose adjuvant doxorubicin-based therapy. Conclusion FISH is a reliable method to predict clinical outcome following adjuvant doxorubicin-based therapy for stage II breast cancer patients. There is a moderate level of concordance among the three methods (IHC, FISH, PCR). None of the methods is clearly superior. Although IHC-positive/FISH-positive tumors yielded the greatest interaction with dose of therapy in predicting outcome, no combination of assays tested was statistically superior.

Utilization of anti-HER2 regimens among HER2-positive metastatic breast cancer patients.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 282-282
Author(s):  
Sandhya Mehta ◽  
Jinlin Song ◽  
Melissa Pavilack ◽  
Jipan Xie ◽  
Xiaoyu Nie ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Targeted Therapies ◽  
Metastatic Breast ◽  
Cancer Registries ◽  
Additional Treatment ◽  
Her2 Status ◽  
Breast Cancer Patients ◽  
Her2 Positive

282 Background: HER2-positive (+) metastatic breast cancer (mBC) has a poor prognosis and many patients require multiple lines of HER2 targeted regimens. This study aims to examine the treatment sequencing of anti-HER2 regimens for HER2+ mBC among Medicare beneficiaries. Methods: A retrospective study was conducted using linked 1999-2016 Surveillance, Epidemiology, and End Results (SEER) cancer registries and Medicare claims. Adults patients who had mBC diagnosis, HER2+ status documented in SEER or claims of ≥1 anti-HER2 drug, continuous enrollment in Medicare from the date of mBC diagnosis until end of study period/death, and 2 anti-HER2 regimens with or without chemotherapy (Ch) or hormonal therapy (HT) were included. Discontinuation of anti-HER2 regimen was defined as the absence of claims for all anti-HER2 drugs for >60 days, or initiation of a different anti-HER2 drug. Re-initiation of the same regimen after >60 days was considered as a new regimen. The first two anti-HER2 regimens and subsequent therapies were summarized. Results: 804 patients with 2 anti-HER2 regimens were included. Trastuzumab (T) based regimen (defined as: T±Ch/HT; without other anti-HER2 drugs) was the most common 1st regimen (82%), followed by T+ pertuzumab (P) (14%) and lapatinib (L) (3%). For the 2nd regimen, T (52%) was most common, followed by T+P (18%), L (11%), trastuzumab emtansine (T-DM1) (11%) and T+L (7%). After a 2nd regimen, 578 (72%) initiated a subsequent therapy, with over half switching to non-targeted therapies [52%; HT alone (35%), Ch±HT (17%)] followed by T (17%), T-DM1 (12%) and T+P (7%). Among those with subsequent therapy, 2 T-based regimens followed by HT alone (21%) was the most common sequence. After the 1st regimen, 52% patients reused the same anti-HER2 drugs in the 2nd regimen, 21% added another anti-HER2 drug and 27% switched to a different anti-HER2 regimen. After the 2nd regimen, 14% reused anti-HER2 drugs and 6% added another anti-HER2 drug, 25% switched to a different anti-HER2 regimen; 15% reused anti-HER2 drugs from the 1st regimen. Conclusions: Trastuzumab based regimen was the mainstay of anti-HER2 drug regimens during the study timeframe. Despite availability of multiple anti-HER2 drugs, reuse of prior anti-HER2 drugs and switching to non-targeted therapies alone were common after using 2 anti-HER2 regimens. These findings underscore the unmet needs in later lines of therapy. Recently approved anti-HER2 agents may provide additional treatment options for pre-treated HER2+ metastatic breast cancer patients.

scholarly journals Utilization of Intravenous (IV) Curcumin, Genistein, and Trastuzumab to Reduce HER2 receptors in Breast Cancer Patients

2021 ◽  
Vol 8 (4) ◽  
Author(s):  
Shreya Bhandari ◽  
Hasmitha Kamineni
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Kinase Inhibitors ◽  
The Novel ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Her2 Protein ◽  
Protein Receptors ◽  
Novel Method ◽  
Future Work

In recent decades, due to the increased growth, spread, and onset of cancer, interest has arisen in studying the methods that could be used to combat it. Breast cancer is the most prevalent form of cancer in the world. Due to the growing pervasiveness of this issue, a larger body of research is forming in the area of breast cancer with the intent to contain the spread of the potentially ravaging disease or diagnose it earlier. This research is intended to propose an alternative, possibly more efficient method to inhibit the chances of metastasis and continued prevalence of breast cancer in a patient. The related work discusses similar research being done and builds on it to incorporate the novel method being proposed while explaining the components of the proposed treatment in question. The proposed method aims to deplete HER2 protein receptors in breast cancer patients through the intravenous (IV) administration of the tyrosine kinase inhibitors (TKIs) curcumin and genistein, as well as trastuzumab, which is more commonly known under the brand name Herceptin. Depleting HER2 protein receptors can potentially cause the severity of HER2-positive breast cancer to decrease substantially, as well as reduce the probability of metastasis and recurrence, the rate of which is considerably higher in HER2-positive cases when compared to that of HER2-negative cases. The future work deals with alternate methods that could be explored with a similar intent as this research study and describes the potential implications of the study.

Need for systematic de-escalation of care in HER2+ breast cancer patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12657-e12657
Author(s):  
Tushar Pandey ◽  
Tyler M Earnest ◽  
John A Cole ◽  
Eduardo Braun
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
In Silico ◽  
Treatment Plan ◽  
Standard Of Care ◽  
Her2 Status ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Her2 Breast Cancer

e12657 Background: Over the last decade, there has been incredible progress in HER2-positive breast cancer patients with the adoption of targeted therapies like Trastuzumab and Pertuzumab to complement existing chemotherapies. Increasingly neoadjuvant therapy is the preferred method of therapy as it is better able to predict prognosis via pCR as well as guide adjuvant therapeutic strategy in cases with residual tumor. There are now a variety of combination therapies recommended for HER2-positive patients. As new therapies are developed, the standard-of-care shifts towards the regimen with highest pCR rate. The latest regimen being TCHP which produced pCR rates over 60% in clinical trials. While the improvement in pCR rates at a population level is encouraging, there is a growing sentiment among physicians that we may be over treating patients impacting both costs and resulting toxicity. Methods: We performed an analysis of Breast Cancer trials with pCR as the primary end point and stratification available based on HER2+ status. The cost (median insurance reimbursement) was also referenced from a recent ASCO observational study as a proxy for direct costs of drugs. Toxicities were referenced and each regimen scored (TS) from NCCN Evidence Blocks and adverse events from clinical trials. Potential savings were evaluated if a clinician had the ability to individualize regimen choice by patient. We utilized the SimBioSys TumorScope platform to perform in silico simulations to predict response to alternate therapies as it had previously used to analyze potential deescalate between AC-T vs TC in a HER2- cohort. Results: The following regimens were evaluated HP (pCR:17%,TS:1), TH (pCR: 29%,TS: 2) THP (pCR: 46%, TS: 3), TCH (pCR: 43%, TS: 4), TCHP (pCR: 64%, TS: 5), AC-TH (pCR: 43%, TS: 6), AC-THP(pCR: 55%, TS: 7). Based on an in-silico analysis and selection (where pCR was likely with multiple regimens), the lowest cost & toxicity regimen was selected. The estimated average saving per case of over $100,000 for the overall treatment plan . The calculated toxicity score was also reduced by this method to under 4 from the TCHP(5) standard of care. Conclusions: While the results above are estimates and perfection in such individualization may not be possible, an in-silico approach provides a promising solution.

scholarly journals The Prevalence of HER2 Positivity In HER2 Borderline Tumors In Iranian Breast Cancer Patients And Predictive Variables

2021 ◽  
Author(s):  
Ramesh Omranipour ◽  
Newsha Nazarian ◽  
Sadaf Alipour ◽  
Amirpasha Ebrahimi ◽  
Bita Eslami
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Lobular Carcinoma ◽  
Her2 Status ◽  
Breast Cancer Patients ◽  
Her2 Gene ◽  
Her2 Positive ◽  
Correct Treatment ◽  
Significance Level ◽  
Her2 Positivity

Abstract Background: Human epidermal growth receptor-2 (HER2) gene amplification is an important predictive and prognostic factor in breast cancer treatment. However, the expression of HER2 by immunohistochemistry (IHC) is determined as borderline in some cases and confirmation of the HER2 status by in situ hybridization either fluorescent (FISH) or bright field chromogenic (CISH) is necessary for correct treatment decision-making. Considering the high cost of FISH and CISH, we aimed to investigate whether the HER2 status could be predicted by other histological and cellular characteristics of the tumor by evaluating the association of these characteristics with the actual tumor HER2 status. Methods: Data of 438 breast cancer patients with IHC-determined HER-2 borderline disease was evaluated retrospectively. FISH or CISH results, pathologic tumor size and type, node involvement, Ki67%, presence of estrogen and progesterone receptor (ER, PR), HER2 status, lymphovascular invasion (LVI), perineural invasion (PNI), and stage were retrieved from clinic records. Results: Seventy-four (16.9%) patients had positive results for HER2 status with FISH or CISH. Logistic regression analysis showed that the pathologic size had a positive association with HER2 positivity with an OR equal to 1.03 (Odds ratio (OR):1.03, 95% CI: 1.01-1.05). In addition, the adjusted OR illustrated a statistically significant association between HER2 positivity and PR negativity (OR=2.14, 95% CI: 1.14-4.02). The invasive lobular carcinoma histology had a reverse association with HER2 positive status, with a borderline significance level (OR=0.15, 95% CI: 0.02-1.18).Conclusion: We could not find an applicable model to predict the actual status of HER2 in borderline cases and still, we have to recommend further assay by FISH or CISH in these patients.

Prognostic role of HER2 loss after neoadjuvant therapy in patients with HER2-positive operable breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 631-631
Author(s):  
Valentina Guarneri ◽  
Elena Barbieri ◽  
Federico Piacentini ◽  
Maria Vittoria Dieci ◽  
Claudia Omarini ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Therapy ◽  
Cancer Patients ◽  
Hormone Receptor ◽  
Her2 Status ◽  
Prognostic Impact ◽  
Her2 Expression ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Surgical Specimen

631 Background: Emerging literature data are consistently showing that a change in HER2 status adversely affect the prognosis of breast cancer patients. Aim of the present analysis is to evaluate the prognostic impact of HER2 loss in breast cancer patients with HER2 positive disease treated with neoadjuvant therapy with or without anti-HER2 agents. Methods: A total of 94 HER2 positive patients were identified from a prospectively maintained database. The first cohort (A) includes 40 patients treated with chemotherapy alone (enrolled before 2005). The second cohort (B) includes 54 patients treated with neoadjuvant chemotherapy in combination with anti-HER2 agents (trastuzumab and/or lapatinib). HER2 expression was evaluated by IHC or FISH on pre-treatment core biopsy and on surgical specimen after neoadjuvant therapy. Patients were considered as having HER2 positive disease in case of IHC 3+ or FISH amplification. Results: No imbalance in terms of age, stage at diagnosis, tumor grade and expression of hormone receptor was observed in the two cohorts. In detail, 67% and 61% of the patients have a co-expression of HER2 and hormone receptor in cohort A and B, respectively. The rate of breast conservation was significantly higher in cohort B (chemotherapy+anti-HER2 agents) as compared to cohort A (chemotherapy alone) (59% vs 38%, p=0.048). Similarly, the rate of pathologic complete response (pCR) was significantly higher in cohort B (42.6% vs 7.5% in cohort A, p<0.001). A change in HER2 expression from biopsy to post-therapy samples was observed in 35% of the patients in cohort A vs 9% of the patients in cohort B (p=0.04). No patients achieving a pCR have recurred so far vs 25% of the patients with less than pCR (p=0.005). The rate of recurrence was significantly higher for patients experiencing a change in HER2 expression (47% vs 15% in patients with no change, p=0.007). At 5 years, 53% of the patients with Her2 change and 75% of the patients without Her2 change were alive and free of recurrence (log rank test: p=0.03). Conclusions: The rate of HER2 loss was significantly higher in patients not receiving anti-HER2 agents as a part of the neoadjuvant therapy. In this series, the change in HER2 status has a negative prognostic impact.

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