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  • Gene Expression profiling: Decoding breast cancer. | Agendia
    review discusses the development of these arrays summarizes the validation of those that are commercially available and indicates how the information provided by these assays can help in the care of patients The review also provides an extensive overview of commercially available assays focusing on MammaPrint the first and only assay for breast cancer management that has been cleared by the FDA See article Categories Abstract Poster 18 Accreditation 1

    Original URL path: http://www.agendia.com/gene-expression-profiling-decoding-breast-cancer/ (2016-05-01)
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  • Microarray-Based Determination of Estrogen Receptor, Progesterone Receptor, and HER2 Receptor Status in Breast Cancer | Agendia
    Vijver November 3 2009 Purpose The level of estrogen receptor ER progesterone receptor PR and HER2 aids in the determination of prognosis and treatment of breast cancer Immunohistochemistry is currently the predominant method for assessment but differences in methods and interpretation can substantially affect the accuracy resulting in misclassification Here we investigated the association of microarray based mRNA expression levels compared with immunohistochemistry Experimental Design Microarray mRNA quantification of ER PR and HER2 was done by the developed TargetPrint test and compared with immunohistochemical assessment for breast tumors from 636 patients Immunohistochemistry was done in a central laboratory and in an independent reference laboratory according to American Society of Clinical Oncology College of American Pathologists guidelines for 100 cases For HER2 immunohistochemistry 2 cases additional chromogenic in situ hybridization CISH was used to determine the final status Results ER concordance between microarray and central immunohistochemistry was 93 95 confidence interval 95 CI 91 95 Only 4 of immunohistochemistrypositive samples were classified negative using microarray whereas 18 of immunohistochemistry negative samples showed a positive microarray ER status Concordance for PR was 83 95 CI 80 86 and 96 of all samples showed an identical classification of HER2 status by microarray and immunohistochemistry CISH 95 CI 94 98 Nine percent of immunohistochemistry HER2 positive samples showed a negative microarray classification Detailed review of 11 cases with discordant classifications by American Society of Clinical Oncology College of American Pathologists and central immunohistochemistry indicated that microarray assessment was likely to add additional information in 5 cases Conclusion Microarray based readout of ER PR and HER2 shows a high concordance with immunohistochemistry CISH and provides an additional objective and quantitative assessment of tumor receptor status in breast cancer Clin Cancer Res 2009 15 22 7003 11 See article Categories Abstract Poster 18 Accreditation 1 BluePrint

    Original URL path: http://www.agendia.com/microarray-based-determination-of-estrogen-receptor-progesterone-receptor-and-her2-receptor-status-in-breast-cancer/ (2016-05-01)
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  • The 70-gene prognosis signature predicts early metastasis in breast cancer patients between 55 and 70 years of age. | Agendia
    the beneficial effect of chemotherapy in postmenopausal patients predominantly occurs in the first 5 years after diagnosis a prognostic marker for early events can be of use for adjuvant treatment decision making The aim of this study was to evaluate the prognostic value of the 70 gene prognosis signature for early events in postmenopausal patients Methods Frozen tumor samples from 148 patients aged 55 70 years were selected T1 2 N0 and classified by the 70 gene prognosis signature MammaPrintä into good or poor prognosis Eighteen percent received hormonal therapy Results Breast cancer specific survival BCSS at 5 years was 99 for the good prognosis signature versus 80 for the poor prognosis signature group P 0 036 The 70 gene prognosis signature was a significant and independent predictor of BCCS during the first 5 years of follow up with an adjusted hazard ratio of 14 4 95 confidence interval 1 7 122 2 P 0 01 at 5 years Conclusion The 70 gene prognosis signature can accurately select postmenopausal patients at low risk of breast cancer related death within 5 years of diagnosis and can be of clinical use in selecting postmenopausal women for adjuvant chemotherapy See article Categories Abstract

    Original URL path: http://www.agendia.com/the-70-gene-prognosis-signature-predicts-early-metastasis-in-breast-cancer-patients-between-55-and-70-years-of-age/ (2016-05-01)
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  • Validation of 70-gene prognosis signature in node-negative breast cancer | Agendia
    and we therefore wished to evaluate the prognostic value of the 70 gene prognosis signature in a series of relatively recently diagnosed lymph node negative breast cancer patients Methods We evaluated the 70 gene prognosis signature in an independent representative series of patients with invasive breast cancer N 123 55 years pT1 2N0 diagnosed between 1996 and 1999 median follow up 5 8 years by classifying these patients as having a good or poor prognosis signature In addition we updated the follow up of the node negative patients of the previously published validation series Van de Vijver et al N Engl J Med 347 25 1999 2009 2002 N 151 median follow up 10 2 years The prognostic value of the 70 gene prognosis signature was compared with that of four commonly used clinicopathological risk indexes The endpoints were distant metastasis as first event free percentage DMFP and overall survival OS Results The 5 year OS was 82 5 in poor 48 and 97 2 in good prognosis signature 52 patients HR 3 4 95 CI 1 2 9 6 P 0 021 The 5 years DMFP was 78 6 in poor and 98 2 in good prognosis signature patients HR 5 7 95 CI 1 6 20 P 0 007 In the updated series N 151 60 poor vs 40 good the 10 year OS was 51 5 and 94 3 HR 10 7 95 CI 3 9 30 P 0 01 respectively The DMFP was 50 6 in poor and 86 5 in good prognosis signature patients HR 5 5 95 CI 2 5 12 P 0 01 In multivariate analysis the prognosis signature was a strong independent prognostic factor in both series outperforming the clinicopathological risk indexes Conclusion The 70 gene prognosis signature is also an independent

    Original URL path: http://www.agendia.com/validation-of-70-gene-prognosis-signature-in-node-negative-breast-cancer/ (2016-05-01)
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  • Gene expression profiling in breast cancer – design of a pooled database to address open questions | Agendia
    J van t Veer September 7 2009 BACKGROUND The Netherlands Cancer Institute used DNA microarray analyses to identify a 70 gene expression profile strongly predictive of a short interval to distant metastases in breast cancer For patients with small tumors the signature is not yet adequately validated Furthermore 95 of estrogen receptor or triple negative tumors are assigned to poor prognosis by the profile METHODS A pooled database was constructed containing clinical pathological and microarray data of 1696 patients The database will be used to study the performance of the 70 gene profile in patients with small sized T1 tumors In addition patients with triple negative tumors will be identified and whole genome microarray analysis will be performed of these tumors to develop a new prognostic gene expression profile for this subgroup RESULTS AND CONCLUSIONS If the 70 gene profile is accurate for small tumors patients at risk may be assigned to adjuvant treatment A new prognostic classifier for triple negative tumors may help to identify women in whom adjuvant treatment may safely be omitted See article Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5 Cost Effectiveness 6 Development 8 Impact Study 2 MammaPrint 40

    Original URL path: http://www.agendia.com/gene-expression-profiling-in-breast-cancer-design-of-a-pooled-database-to-address-open-questions/ (2016-05-01)
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  • The 70-gene prognosis-profile predicts disease outcome in breast cancer patients with 1-3 positive lymph nodes in an independent validation study | Agendia
    will remain free of distant metastases even without adjuvant systemic therapy We therefore investigated whether the 70 gene prognosis signature can accurately identify patients with 1 3 positive lymph nodes who have an excellent disease outcome Methods Frozen tumour samples from 241 patients with operable T1 3 breast cancer and 1 3 positive axillary lymph nodes with a median follow up of 7 8 years were selected from 2 institutes Using a customized microarray tumour samples were analysed for the 70 gene tumour expression signature In addition we reanalysed part of a previously described cohort n 106 with extended follow up Results The 10 year distant metastasis free DMFS and breast cancer specific survival BCSS probabilities were 91 SE 4 and 96 SE 2 respectively for the good prognosis signature group 99 patients and 76 SE 4 and 76 SE 4 respectively for the poor prognosis signature group 142 patients The 70 gene signature was significantly superior to the traditional prognostic factors in predicting BCSS with a multivariate hazard ratio HR of 7 17 95 CI 1 81 to 28 43 P 0 005 Conclusions The 70 gene prognosis signature outperforms traditional prognostic factors in predicting disease outcome in patients

    Original URL path: http://www.agendia.com/the-70-gene-prognosis-profile-predicts-disease-outcome-in-breast-cancer-patients-with-1-3-positive-lymph-nodes-in-an-independent-validation-study/ (2016-05-01)
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  • Thresholds for therapies: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer. | Agendia
    A Ingle JN Gelber RD et al June 17 2009 The 11th St Gallen Switzerland expert consensus meeting on the primary treatment of early breast cancer in March 2009 maintained an emphasis on targeting adjuvant systemic therapies according to subgroups defined by predictive markers Any positive level of estrogen receptor ER expression is considered sufficient to justify the use of endocrine adjuvant therapy in almost all patients Overexpression or amplification of HER2 by standard criteria is an indication for anti HER2 therapy for all but the very lowest risk invasive tumours The corollary is that ER and HER2 must be reliably and accurately measured Indications for cytotoxic adjuvant therapy were refined acknowledging the role of risk factors with the caveat that risk per se is not a target Proliferation markers including those identified in multigene array analyses were recognised as important in this regard The threshold for indication of each systemic treatment modality thus depends on different criteria which have been separately listed to clarify the therapeutic decision making algorithm See article Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5 Cost Effectiveness 6 Development 8 Impact Study 2 MammaPrint 40 MINDACT 5 News 56 Predictive

    Original URL path: http://www.agendia.com/thresholds-fo-therapies-highlights-of-the-st-gallen-international-expert-consensus-on-the-primary-therapy-of-early-breast-cancer/ (2016-05-01)
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  • I-SPY 2 – An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy | Agendia
    Us Search for Search More Publications I SPY 2 An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy Publication Name Clinical Pharmacology Therapeutics Author s Barker AD Sigman CC Kelloff GJ Hylton NM Berry DA Esserman LJ May 13 2009 I SPY 2 investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2 is a process targeting the rapid focused clinical development of paired oncologic therapies and biomarkers The framework is an adaptive phase II clinical trial design in the neoadjuvant setting for women with locally advanced breast cancer I SPY 2 is a collaborative effort among academic investigators the National Cancer Institute the US Food and Drug Administration and the pharmaceutical and biotechnology industries under the auspices of the Foundation for the National Institutes of Health Biomarkers Consortium See article Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5 Cost Effectiveness 6 Development 8 Impact Study 2 MammaPrint 40 MINDACT 5 News 56 Predictive 3 Press Release 53 Publications 58 Review Article 10 St Gallen Guidelines 2 TargetPrint 4 Treatment Impacts 5 Validation 18 Video 3 Physician Education Breast Cancer Colon Cancer Publications Client Login Ordering Patient

    Original URL path: http://www.agendia.com/i-spy-2-an-adaptive-breast-cancer-trial-design-in-the-setting-of-neoadjuvant-chemotherapy/ (2016-05-01)
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