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  • Gene Expression Signature to Improve Prognosis Prediction of Stage II and III Colorectal Cancer | Agendia
    23 2010 Purpose This study aims to develop a robust gene expression classifier that can predict disease relapse in patients with early stage colorectal cancer CRC Patients and Methods Fresh frozen tumor tissue from 188 patients with stage I to IV CRC undergoing surgery was analyzed using Agilent 44K oligonucleotide arrays Median follow up time was 65 1 months and the majority of patients 83 6 did not receive adjuvant chemotherapy A nearest mean classifier was developed using a cross validation procedure to score all genes for their association with 5 year distant metastasis free survival Results An optimal set of 18 genes was identified and used to construct a prognostic classifier ColoPrint The signature was validated on an independent set of 206 samples from patients with stage I II and III CRC The signature classified 60 of patients as low risk and 40 as high risk Five year relapse free survival rates were 87 6 95 CI 81 5 to 93 7 and 67 2 95 CI 55 4 to 79 0 for low and high risk patients respectively with a hazard ratio HR of 2 5 95 CI 1 33 to 4 73 P 005 In multivariate analysis the signature remained one of the most significant prognostic factors with an HR of 2 69 95 CI 1 41 to 5 14 P 003 In patients with stage II CRC the signature had an HR of 3 34 P 017 and was superior to American Society of Clinical Oncology criteria in assessing the risk of cancer recurrence without prescreening for microsatellite instability MSI Conclusion ColoPrint significantly improves the prognostic accuracy of pathologic factors and MSI in patients with stage II and III CRC and facilitates the identification of patients with stage II disease who may be safely managed without

    Original URL path: http://www.agendia.com/gene-expression-signature-to-improve-prognosis-prediction-of-stage-ii-and-iii-colorectal-cancer/ (2016-05-01)
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  • Identification of a low-risk subgroup of HER-2-positive breast cancer by the 70-gene prognosis signature | Agendia
    September 20 2010 BACKGROUND Overexpression of HER 2 is observed in 15 25 of breast cancers and is associated with increased risk of recurrence Current guidelines recommend trastuzumab and chemotherapy for most HER 2 positive patients However the majority of patients does not recur and might thus be overtreated with adjuvant systemic therapy We investigated whether the 70 gene MammaPrint signature identifies HER 2 positive patients with favourable outcome METHODS In all 168 T1 3 N0 1 HER 2 positive patients were identified from a pooled database classified by the 70 gene signature as good or poor prognosis and correlated with long term outcome A total of 89 of these patients did not receive adjuvant chemotherapy RESULTS In the group of 89 chemotherapy naive patients after a median follow up of 7 4 years 35 39 distant recurrences and 29 33 breast cancer specific deaths occurred The 70 gene signature classified 20 22 patients as good prognosis with 10 year distant disease free survival DDFS of 84 compared with 69 78 poor prognosis patients with 10 year DDFS of 55 The estimated hazard ratios HRs were 4 5 95 confidence interval CI 1 1 18 7 P¼0 04 and 3 8 95 CI 0 9 15 8 P¼0 07 for DDFS and breast cancer specific survival BCSS respectively In multivariate analysis adjusted for known prognostic factors and hormonal therapy HRs were 5 8 95 CI 1 3 26 7 P¼0 03 and 4 7 95 CI 1 0 21 7 P¼0 05 for DDFS and BCSS respectively INTERPRETATION The 70 gene prognosis signature is an independent prognostic indicator that identifies a subgroup of HER 2 positive early breast cancer with a favourable long term outcome See article Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5

    Original URL path: http://www.agendia.com/identification-of-a-low-risk-subgroup-of-her-2-positive-breast-cancer-by-the-70-gene-prognosis-signature/ (2016-05-01)
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  • Comparison of MammaPrint and TargetPrint results with clinical parameters in German patients with early stage breast cancer | Agendia
    guidelines The microarray based test TargetPrint further provides reliable quantitative assessment of mRNA expression levels of estrogen receptor ER progesterone receptor PR and human epidermal growth factor receptor 2 HER2 This study was performed as a validation of MammaPrint and TargetPrint in an unselected German breast cancer population and was designed to determine the degree of concordance with currently applied clinical parameters One hundred and forty cases of breast cancer stage I and II were classified as being low orhigh risk for distant metastasis using MammaPrint Results were compared to current clinical risk classifications and adjuvant treatment management Immunohistochemistry IHC and fluorescent in situhybridization FISH chromogenic insitu hybridization CISH assessments of ER PR and HER2were further compared with gene expression read outs using TargetPrint Thirty two percent of patients 19 59 with a poor prognosis signature identified via MammaPrint did not receive adjuvant systemic treatment apart from endocrine therapy and were potentially undertreated whereas 42 35 77 of patients with a good prognosis signature received chemotherapy and were potentially overtreated Comparison of microarray receptor results with IHC and FISH CISH were concordant in 97 for ER 86 for PR and 94 for HER2 In this German study population MammaPrint would

    Original URL path: http://www.agendia.com/comparison-of-mammaprint-and-targetprint-results-with-clinical-parameters-in-german-patients-with-early-stage-breast-cancer/ (2016-05-01)
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  • Clinical Utility of the 70-gene MammaPrint Profile in a Japanese Population | Agendia
    profile known as MammaPrint to identify breast cancer patients who were at low risk of developing metastases We evaluated the prognostic value of the 70 gene MammaPrint profile in Japanese women with node negative breast cancer Methods Frozen tumour samples from 102 eligible node negative breast cancer patients aged 70 or younger were characterized with the MammaPrint array The patients were treated with breast conserving therapy or mastectomy with axillary lymph node dissection between December 1998 and August 2001 About 73 percent received adjuvant hormonal therapy and 28 percent received adjuvant chemotherapy The gene expression profiles obtained by MammaPrint classified the patients as high or low genomic risk The median follow up was 7 1 years Results Among the 102 patients 20 20 were classified as low genomic risk and 82 80 were classified as high genomic risk The probability of distant metastasis free survival at five years was 100 for the low risk group and 94 for the high risk group Conclusions The 70 gene MammaPrint prognosis profile accurately identified Japanese breast cancer patients at low risk of developing recurrences In fact 100 of the individuals in the low risk category remained metastasis free for the duration of the

    Original URL path: http://www.agendia.com/validation-of-the-70-gene-mammaprint-profile-in-a-japanese-population/ (2016-05-01)
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  • Cost-effectiveness of the 70-gene signature versus St. Gallen guidelines and Adjuvant Online for early breast cancer | Agendia
    guide adjuvant treatment decisions in patients with node negative breast cancer In order to decide upon its use a systematic comparative analysis of the effects of the 70 gene signature the Saint Gallen guidelines and the Adjuvant Online Software for these patients on survival quality of life and costs is warranted Methods A Markov decision model was used to simulate the 20 year costs and outcomes survival and quality of life adjusted survival QALYs in a hypothetical cohort of nodenegative estrogen receptor positive breast cancer patients Sensitivity and specificity of the three prognostic tools were based on 5 and 10 years breast cancer specific survival and distant metastasis as first event derived from a pooled analysis consisting of 305 tumour samples from 3 previously reported validation studies concerning the 70 gene signature Results Small differences in survival but substantial differences in quality adjusted survival between the prognostic tools were observed Quality adjusted survival was highest when using the 70 gene signature Based on costs per QALY the 70 gene has the highest probability of being cost effective for a willingness to pay for a QALY higher than 4600 0959 8049 See article Categories Abstract Poster 18 Accreditation 1 BluePrint 9

    Original URL path: http://www.agendia.com/cost-effectiveness-of-the-70-gene-signature-for-node-negative-breast-cancer/ (2016-05-01)
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  • Use of a genomic test (MammaPrint) in daily clinical practice to assist in risk stratification of young breast cancer patients | Agendia
    tools in order to identify those patients who most likely will benefit from receiving adjuvant treatment such as chemotherapy MATERIALS AND METHODS The MammaPrint test was established on the basis of a 70 gene expression profile In this prospective study the adaptation of MammaPrint into clinical work up procedures was investigated in 56 patients with an average age of 45 years treated at a general hospital in Germany between 2004 and 2008 To assess the accuracy of MammaPrint in this younger patient group a meta analysis was performed on a subgroup from previously described retrospective studies n 689 RESULTS 44 patients had MammaPrint results and were eligible for the analysis The results revealed a low risk result in 29 patients and a high risk result in 15 patients Using St Gallen 2007 guidelines for risk assessment the numbers were 4 for low risk and 6 for high risk respectively while 34 patients were classified as intermediate risk In the group of women with intermediate risk MammaPrint assigned 23 patients to low risk and 11 to the high risk group In the meta analysis of retrospective studies 10 year overall survival for the low and high MammaPrint groups was 90 2 and 65 2 respectively CONCLUSIONS Using gene expression analysis as additional tool patients with an intermediate clinical risk can be accurately separated into low and high risk groups The gene expression analysis provides more accurate information on recurrence risk compared to conventional clinicopathological criteria and thus may provide additional guidance in daily clinical practice in future Results of further prospectively designed studies like the MINDACT trial will confirm the retrospective analysis and will determine how both low and high risk patients can best be treated See article Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5

    Original URL path: http://www.agendia.com/use-of-a-genomic-test-mammaprinttm-in-daily-clinical-practice-to-assist-in-risk-stratification-of-young-breast-cancer-patients/ (2016-05-01)
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  • The predictive value of the 70-gene signature for adjuvant chemotherapy in early breast cancer | Agendia
    5 2010 Multigene assays have been developed and validated to determine the prognosis of breast cancer In this study we assessed the additional predictive value of the 70 gene MammaPrint signature for chemotherapy CT benefit in addition to endocrine therapy ET from pooled study series For 541 patients who received either ET n 315 or ET CT n 226 breast cancer specific survival BCSS and distant disease free survival DDFS at 5 years were assessed separately for the 70 gene high and low risk groups The 70 gene signature classified 252 patients 47 as low risk and 289 53 as high risk Within the 70 gene low risk group BCSS was 97 for the ET group and 99 for the ET CT group at 5 years with a non significant univariate hazard ratio HR of 0 58 95 CI 0 07 4 98 P 0 62 In the 70 gene high risk group BCSS was 81 ET group and 94 ET CT group at 5 years with a significant HR of 0 21 95 CI 0 07 0 59 P 01 DDFS was 93 ET versus 99 ET CT respectively in the 70 gene low risk group HR 0 26 95 CI 0 03 2 02 P 0 20 In the high risk group DDFS was 76 versus 88 HR of 0 35 95 CI 0 17 0 71 P 01 Results were similar in multivariate analysis showing significant survival benefit by adding CT in the 70 gene high risk group A significant and clinically meaningful benefit was observed by adding chemotherapy to endocrine treatment in 70 gene high risk patients This benefit was not significant in low risk patients who were at such low risk for recurrence and cancer related death that adding CT does not appear to be

    Original URL path: http://www.agendia.com/the-predictive-value-of-the-70-gene-signature-for-adjuvant-chemotherapy-in-early-breast-cancer/ (2016-05-01)
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  • MammaPrint 70-gene profile quantifies the likelihood of recurrence for early breast cancer. | Agendia
    Phillipe L Bedard Stella Mook Martine J Piccart Gebhart Emiel T Rutgers Laura J van t Veer and Fatima Cardoso December 31 2009 Background Over the past few years a variety of multigene expression profiles have been developed to improve prognostication for early stage breast cancer and reduce overtreatment with chemotherapy MammaPrint is the only test cleared by the US Food and Drug Administration for the prognostication of early breast cancer The MammaPrint assay examines the expression of 70 genes in the primary tumor to stratify patients diagnosed with early stage breast cancer into good and poor prognosis groups Objective This evaluation reviews the development of the 70 gene profile including validation studies involving patients with node negative and 1 3 node positive disease the conversion of the 70 gene profile to a high throughput diagnostic test and the continuing prospective MINDACT clinical trial Conclusion The MammaPrint assay should help to determine which women with early breast cancer could be spared adjuvant chemotherapy 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

    Original URL path: http://www.agendia.com/mammaprint-70-gene-profile-quantifies-the-likelihood-of-recurrence-for-early-breast-cancer/ (2016-05-01)
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