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  • Validation and Clinical Utility of a 70-Gene Prognostic Signature for Women With Node-Negative Breast Cancer | Agendia
    cancer Our goal was to validate the signature in an independent group of patients Methods Patients n 307 with 137 events after a median follow up of 13 6 years from five European centers were divided into high and low risk groups based on the gene signature classification and on clinical risk classifications Patients were assigned to the gene signature low risk group if their 5 year distant metastasis free survival probability as estimated by the gene signature was greater than 90 Patients were assigned to the clinicopathologic low risk group if their 10 year survival probability as estimated by Adjuvant software was greater than 88 for estrogen receptor ER positive patients or 92 for ER negative patients Hazard ratios HRs were estimated to compare time to distant metastases disease free survival and overall survival in high versus low risk groups Results The 70 gene signature outperformed the clinicopathologic risk assessment in predicting all endpoints For time to distant metastases the gene signature yielded HR 2 32 95 confidence interval CI 1 35 to 4 00 without adjustment for clinical risk and hazard ratios ranging from 2 13 to 2 15 after adjustment for various estimates of clinical risk clinicopathologic risk using Adjuvant software yielded an unadjusted HR 1 68 95 CI 0 92 to 3 07 For overall survival the gene signature yielded an unadjusted HR 2 79 95 CI 1 60 to 4 87 and adjusted hazard ratios ranging from 2 63 to 2 89 clinicopathologic risk yielded an unadjusted HR 1 67 95 CI 0 93 to 2 98 For patients in the gene signature high risk group 10 year overall survival was 0 69 for patients in both the low and high clinical risk groups for patients in the gene signature low risk group the 10

    Original URL path: http://www.agendia.com/validation-and-clinical-utility-of-a-70-gene-prognostic-signature-for-women-with-node-negative-breast-cancer/ (2016-05-01)
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  • Frequency and Cost of Chemotherapy-Related Serious Adverse Effects in a Population Sample of Women With Breast Cancer | Agendia
    of clinical trials are unknown Methods From a database of medical claims made by individuals with employer provided health insurance between January 1998 and December 2002 we identified 12 239 women 63 years of age or younger with newly diagnosed breast cancer of whom 4 075 received chemotherapy during the 12 months after the initial breast cancer diagnosis and 8 164 did not Diagnostic codes for eight chemotherapy related adverse effects were identified Total hospitalizations for all causes hospitalizations or emergency room visits for adverse effects that are typically related to chemotherapy and health care expenditures were compared between the two groups of women All statistical tests were two sided Results Women who received chemotherapy were more likely than those who did not to be hospitalized or to visit the emergency room for all causes 61 versus 42 mean difference 19 95 confidence interval CI 16 7 to 21 3 P 001 and for chemotherapy related serious adverse effects 16 versus 5 mean difference 11 95 CI 9 6 to 12 4 P 001 The percentages of chemotherapy recipients who were hospitalized or visited the emergency room during the year after their breast cancer diagnosis were 8 4 for fever or infection 5 5 for neutropenia or thrombocytopenia 2 5 for dehydration or electrolyte disorders 2 4 for nausea emesis or diarrhea 2 2 for anemia 2 for constitutional symptoms 1 2 for deep venous thrombosis or pulmonary embolus and 0 9 for malnutrition Chemotherapy recipients incurred large incremental expenditures for chemotherapy related serious adverse effects 1 271 dollars per person per year and ambulatory encounters 17 617 dollars per person per year Conclusions Chemotherapy related serious adverse effects among younger commercially insured women with breast cancer may be more common than reported by large clinical trials and lead to

    Original URL path: http://www.agendia.com/frequency-and-cost-of-chemotherapy-related-serious-adverse-effects-in-a-population-sample-of-women-with-breast-cancer/ (2016-05-01)
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  • Microarray analysis and tumor classification. | Agendia
    Us Search for Search More Publications Microarray analysis and tumor classification Publication Name New England Journal of Medicine Author s J Quackenbush Ph D June 8 2006 DNA microarray analysis was first described in the mid 1990s as a means to probe the expression of thousands of genes simultaneously 1 2 and was quickly adopted by the research community for the study of a wide range of biologic processes Most of the early studies had a simple and powerful design to compare two biologic classes in order to identify the differential expression of the genes in them genes with potential relevance to a wide range of biologic processes such as the progression of cancer 3 6 the causes of asthma 7 9 heart disease 10 12 and neuropsychiatric disorders 13 17 and the analysis of factors associated 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/microarray-analysis-and-tumor-classification/ (2016-05-01)
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  • Concordance among Gene-Expression– Based Predictors for Breast Cancer | Agendia
    primary breast tumors performed by different laboratories have resulted in the identification of a number of distinct prognostic profiles or gene sets with little overlap in terms of gene identity Methods To compare the predictions derived from these gene sets for individual samples we obtained a single data set of 295 samples and applied five gene expression based models intrinsic subtypes 70 gene profile wound response recurrence score and the two gene ratio for patients who had been treated with tamoxifen Results We found that most models had high rates of concordance in their outcome predictions for the individual samples In particular almost all tumors identified as having an intrinsic subtype of basal like HER2 positive and estrogen receptor negative or luminal B associated with a poor prognosis were also classified as having a poor 70 gene profile activated wound response and high recurrence score The 70 gene and recurrence score models which are beginning to be used in the clinical setting showed 77 to 81 percent agreement in outcome classification Conclusions Even though different gene sets were used for prognostication in patients with breast cancer four of the five tested showed significant agreement in the outcome predictions for individual

    Original URL path: http://www.agendia.com/concordance-among-gene-expression%c2%96-based-predictors-for-breast-cancer/ (2016-05-01)
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  • Molecular Portraits and 70-Gene Prognosis Signature Are Preserved throughout the Metastatic Process of Breast Cancer | Agendia
    Zhiyuan Hu Xiaping He Chad Livasy Lisa A Carey Matthew G Ewend Annuska M Glas Charles M Perou and Laura J van t Veer January 1 2005 Microarray analysis has been shown to improve risk stratification of breast cancer Breast tumors analyzed by hierarchical clustering of expression patterns of intrinsic genes have been reported to subdivide into at least four molecular subtypes that are associated with distinct patient outcomes Using a supervised method a 70 gene expression profile has been identified that predicts the later appearance or absence of clinical metastasis in young breast cancer patients Here we show that distant metastases display both the same molecular breast cancer subtype as well as the 70 gene prognosis signature as their primary tumors Our results suggest that the capacity to metastasize is an inherent feature of most breast cancers Furthermore our data imply that poor prognosis breast carcinomas classified either by the intrinsic gene set or the 70 prognosis genes represent distinct disease entities that seem sustained throughout the metastatic process 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/molecular-portraits-and-70-gene-prognosis-signature-are-preserved-throughout-the-metastatic-process-of-breast-cancer-5/ (2016-05-01)
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  • Molecular profiling of breast cancer: clinical implications | Agendia
    profiling of breast cancer clinical implications Publication Name British Journal of Cancer Author s S Cleator A Ashworth January 1 2004 Breast cancers are routinely subcategorised on the basis of clinical stage cellular morphology and immunohistochemical analysis of a small number of markers The recent development of gene expression microarray and related technologies provides an opportunity to perform more detailed profiling of the disease It is anticipated that the molecular classification arising from such studies will be more powerful than its pathological predecessor at confining treatment to those patients who are most likely to benefit It is likely that this will result in a much less frequent use of adjuvant chemotherapy Furthermore of those who do receive it a higher proportion will benefit If adopted this will offer considerable patient benefits in terms of reducing unnecessary toxicity and have major health economic implications 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

    Original URL path: http://www.agendia.com/molecular-profiling-of-breast-cancer-clinical-implications/ (2016-05-01)
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  • A Gene-Expression Signature as a Predictor of Survival in Breast Cancer. | Agendia
    Leonie Delahaye Tony van der Velde Harry Bartelink M D Ph D Sjoerd Rodenhuis M D Ph D Emiel T Rutgers M D Ph D Stephen H Friend M D Ph D and René Bernards Ph D December 19 2002 Background A more accurate means of prognostication in breast cancer will improve the selection of patients for adjuvant systemic therapy Methods Using microarray analysis to evaluate our previously established 70 gene prognosis profile we classified a series of 295 consecutive patients with primary breast carcinomas as having a gene expression signature associated with either a poor prognosis or a good prognosis All patients had stage I or II breast cancer and were younger than 53 years old 151 had lymph node negative disease and 144 had lymph node positive disease We evaluated the predictive power of the prognosis profile using univariable and multivariable statistical analyses Results Among the 295 patients 180 had a poor prognosis signature and 115 had a good prognosis signature and the mean SE overall 10 year survival rates were 54 6 4 4 percent and 94 5 2 6 percent respectively At 10 years the probability of remaining free of distant metastases was 50 6 4 5 percent in the group with a poor prognosis signature and 85 2 4 3 percent in the group with a good prognosis signature The estimated hazard ratio for distant metastases in the group with a poor prognosis signature as compared with the group with the good prognosis signature was 5 1 95 percent confidence interval 2 9 to 9 0 P 0 001 This ratio remained significant when the groups were analyzed according to lymph node status Multivariable Cox regression analysis showed that the prognosis profile was a strong independent factor in predicting disease outcome Conclusions The gene expression

    Original URL path: http://www.agendia.com/a-gene-expression-signature-as-a-predictor-of-survival-in-breast-cancer/ (2016-05-01)
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  • Gene expression profiling predicts clinical outcome of breast cancer | Agendia
    Linsley René Bernards Stephen H Friend January 31 2002 Breast cancer patients with the same stage of disease can have markedly different treatment responses and overall outcome The strongest predictors for metastases for example lymph node status and histological grade fail to classify accurately breast tumors according to their clinical behaviour Chemotherapy or hormonal therapy reduces the risk of distant metastases by approximately one third however 70 80 of patients receiving this treatment would have survived without it None of the signatures of breast cancer gene expression reported to date allow for patient tailored therapy strategies Here we used DNA microarray analysis on primary breast tumors of 117 young patients and applied supervised classification to identify a gene expression signature strongly predictive of a short interval to distant metastases poor prognosis signature in patients without tumor cells in local lymph nodes at diagnosis lymph node negative In addition we established a signature that identifies tumours of BRCA1 carriers The poor prognosis signature consists of genes regulating cell cycle invasion metastasis and angiogenesis This gene expression profile will outperform all currently used clinical parameters in predicting disease outcome Our findings provide a strategy to select patients who would benefit from adjuvant

    Original URL path: http://www.agendia.com/gene-expression-profiling-predicts-clinical-outcome-of-breast-cancer/ (2016-05-01)
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