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  • Patients who may benefit from PARP inhibitors-Results from the I-SPY2 Trial | Agendia
    I SPY 2 TRIAL Investigators O Olapade H Rugo D Berry D M Wolf and C Yau June 1 2015 Background In I SPY 2 HER2 patients were adaptively randomized to receive standard chemotherapy or the PARP inhibitor veliparib with carboplatin V C and chemotherapy V C graduated in the triple negative TN subtype and we have previously shown that DNA repair deficiency signatures PARPi 7 and BRCAness may predict V C response Here we combine these signatures into a composite measure of DNA repair deficiency and investigate whether this measure can identify a subset of HR HER2 patients likely to respond to V C Conclusion Here HR Her2 tumors are identified as DNA repair deficient if carrying a BRCA1 2 mutation or BRCA like or PARPi7 high Our exploratory analysis suggests that 38 of HR HER2 patients in I SPY 2 are DNA repair deficient and may benefit from V C If validated DNA repair deficiency biomarkers may merit further investigation for selecting HR HER2 patients for future early phase PARP inhibitor trials Click here to view poster ASCO 2015 Abstract 521 About the I SPY 2 Trial Adaptive clinical trial for women with newly diagnosed locally advanced breast cancer to enrich for pre specified breast cancer subtypes defined by HR HER2 and MammaPrint showing highest efficacy Inclusion MammaPrint high risk or MammaPrint low risk and HR OR HER2 Goal To identify graduate regimens that have 85 predictive probability of success in a neoadjuvant 300 patient phase 3 trial of patients in 1 of 10 possible signatures defined by HR HER2 and MammaPrint High1 2 risk status I SPY 2 Biomarker component Designed to facilitate evaluation of novel biomarkers of response in conjunction with the pre defined signatures Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8

    Original URL path: http://www.agendia.com/asco_2015_ispy2-trial-poster/ (2016-05-01)
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  • molecular subtyping of breast cancer | Agendia
    Angela M Mislowsky Charles H Nash Paul D Richards Laura A Lee Lisette Stork Sloots Femke de Snoo Sarah Untch Mark Gittleman Stephanie Akbari Jennifer Beatty June 1 2015 Background and Aim Classification into molecular subtypes is important for the selection of therapy for patients with breast cancer Previous analyses demonstrated that breast cancer subtypes have distinct clinical outcome Glück BCRT 2013 The aim of the prospective NBRST study is to compare a multi gene classifier to conventional local IHC FISH subtyping to predict chemosensitivity as defined by pathological Complete Response pCR pCR ypT0 isN0 Conclusions Compared to conventional IHC FISH BluePrint functional subtyping reclassifies about 1 in 5 tumors yielding significantly better correlation with NCT responsiveness BP HER2 and Basal and resistance BP Luminal BluePrint identifies two distinct subgroups within the conventional HER2 ER group 50 of these tumors are BP Luminal and relatively resistant to NCT trastuzumab Pertuzumab overcame resistance to NCT trastuzumab in a substantial proportion of the IHC FISH HER2 BP Luminal subgroup indicated by a significantly increased pCR rate Click here to view poster ASCO 2015 Abstract 596 Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5 Cost Effectiveness 6 Development

    Original URL path: http://www.agendia.com/asco_2015_nbrst-poster/ (2016-05-01)
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  • Genomic Profile of Breast Cancer: Cost-effectiveness Analysis from the Spanish National Healthcare System Perspective | Agendia
    analysis of MammaPrint 70 gene signature in the diagnosis of early breast cancer as a prognosis assay to study the risk of tumor recurrence to administer adjuvant chemotherapy Methods Markov model assuming a cohort of 60 year old women with breast cancer Treatment costs and effects were assessed by comparing the 5 year 10 year and lifetime risk of recurrence using Adjuvant Online online algorithm 70 gene signature or Oncotype DX 21 gene assay Results 70 gene signature showed a life expectancy of 23 55 years at lifetime Life expectancy was lower for 21 gene assay and online algorithm with associated quality adjusted life year gains up to 0 23 and 0 75 respectively with 70 gene signature At year 5 the mean cost of 21 gene assay 70 gene signature and online algorithm was 7100 6380 and 4580 respectively 70 gene signature was dominant versus 21 gene assay at any time horizon and would be cost effective from year 7 versus online algorithm lifetime 1457 per quality adjusted life years gained Conclusions 70 gene signature was a dominant strategy over 21 gene assay and was highly cost effective versus online algorithm See Article Categories Abstract Poster 18 Accreditation 1

    Original URL path: http://www.agendia.com/genomic-profile-of-breast-cancer-cost-effectiveness-analysis-from-the-spanish-national-healthcare-system-perspective/ (2016-05-01)
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  • Chemosensitivity predicted by BluePrint 80-gene functional subtype and MammaPrint in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST) | Agendia
    Beitsch PD October 21 2014 PURPOSE The purpose of the NBRST study is to compare a multigene classifier to conventional immunohistochemistry IHC fluorescence in situ hybridization FISH subtyping to predict chemosensitivity as defined by pathological complete response pCR or endocrine sensitivity as defined by partial response METHODS The study includes women with histologically proven breast cancer who will receive neoadjuvant chemotherapy NCT or neoadjuvant endocrine therapy BluePrint in combination with MammaPrint classifies patients into four molecular subgroups Luminal A Luminal B HER2 and Basal RESULTS A total of 426 patients had definitive surgery Thirty seven of 211 18 IHC FISH hormone receptor HR HER2 patients were reclassified by Blueprint as Basal n 35 or HER2 n 2 Fifty three of 123 43 IHC FISH HER2 patients were reclassified as Luminal n 36 or Basal n 17 Four of 92 4 IHC FISH triple negative TN patients were reclassified as Luminal n 2 or HER2 n 2 NCT pCR rates were 2 in Luminal A and 7 Luminal B patients versus 10 pCR in IHC FISH HR HER2 patients The NCT pCR rate was 53 in BluePrint HER2 patients This is significantly superior p 0 047 to the pCR rate in IHC FISH HER2 patients 38 The pCR rate of 36 of 75 IHC FISH HER2 HR patients reclassified as BPLuminal is 3 NCT pCR for BluePrint Basal patients was 49 of 140 35 comparable to the 34 of 92 pCR rate 37 in IHC FISH TN patients CONCLUSIONS BluePrint molecular subtyping reclassifies 22 94 426 of tumors reassigning more responsive patients to the HER2 and Basal categories while reassigning less responsive patients to the Luminal category These findings suggest that compared with IHC FISH BluePrint more accurately identifies patients likely to respond or not respond to NCT See Article Categories

    Original URL path: http://www.agendia.com/chemosensitivity-predicted-by-blueprint-80-gene-functional-subtype-and-mammaprint-in-the-prospective-neoadjuvant-breast-registry-symphony-trial-nbrst/ (2016-05-01)
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  • European Inter-Institutional Impact Study of MammaPrint | Agendia
    Lifrange G Jerusalem J Klaase F de Snoo L Stork Sloots L Dekker Vroling M Lutke Holzik March 31 2014 Aim To measure the impact of MammaPrint on adjuvant treatment decisions and to analyze the agreement in treatment decisions between hospitals from 4 European countries for the same patient cohort Methods Breast cancer patients were prospectively enrolled and MammaPrint was assessed Patients clinical data without and then with MammaPrint results were sent to the different multidisciplinary teams and treatment advice was provided for each patient Results Using MammaPrint chemotherapy treatment advice for ER HER2 breast cancer patients was changed in 37 of patients by the Dutch 24 by the Belgian 28 by the Italian and 35 by the Spanish teams MammaPrint increased the inter institutional agreement in treatment advice chemotherapy or no chemotherapy from 51 to 75 Conclusion The results of this study indicate that MammaPrint impacts adjuvant chemotherapy recommendation MammaPrint can decrease inter institutional and inter country variability in adjuvant treatment advice for breast cancer patients 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

    Original URL path: http://www.agendia.com/european-inter-institutional-impact-study-of-mammaprint/ (2016-05-01)
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  • Risk estimations and treatment decisions in early stage breast cancer: Agreement among oncologists and the impact of the 70-gene signature. | Agendia
    by medical oncologists This survey evaluates the agreement among oncologists on risk estimations and adjuvant systemic treatment AST decisions and the impact of adding the 70 gene signature to known clinico pathological factors METHODS Twelve medical oncologists assessed 37 breast cancer cases cT1 3N0M0 and estimated their risk of recurrence high or low and gave a recommendation for AST Cases were presented in two written questionnaires sent 4weeks apart Only the second questionnaire included the 70 gene signature result RESULTS The level of agreement among oncologists in risk estimation κ 0 57 and AST recommendation κ 0 57 was moderate in the first questionnaire Adding the 70 gene signature result significantly increased the agreement in risk estimation to substantial κ 0 61 while agreement in AST recommendations remained moderate κ 0 56 Overall the proportion of high risk was reduced with 7 4 range 6 9 22 9 p 0 001 and the proportion of chemotherapy that was recommended was reduced with 12 2 range 5 4 29 5 p 0 001 CONCLUSION Oncologists risk estimations and AST recommendations vary greatly Even though the number of participating oncologists is low our results underline the need for a better standardisation tool

    Original URL path: http://www.agendia.com/risk-estimations-and-treatment-decisions-in-early-stage-breast-cancer-agreement-among-oncologists-and-the-impact-of-the-70-gene-signature/ (2016-05-01)
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  • Mammographic screening detects low-risk tumor biology breast cancers | Agendia
    or death became more prevalent with the implementation of population based screening Only rough estimates have been made of the proportion of patients that are overdiagnosed and identification of those patients is difficult Therefore the aim of this study is to evaluate whether tumor biology can help identify patients with screen detected tumors at such a low risk of recurrence that they are likely to be overdiagnosed Furthermore we wish to evaluate the impact of the transition from film screen mammography FSM to the more sensitive full field digital mammography FFDM on the biology of the tumors detected by each screening modality All Dutch breast cancer patients enrolled in the MINDACT trial EORTC 10041 accrued 2007 2011 who participated in the national screening program biennial screening ages 50 75 were included n 1 165 We calculated the proportions of high low and among those the ultralow risk tumors according to the 70 gene signature for patients with screen detected n 775 and interval n 390 cancers for FSM and FFDM Screen detected cancers had significantly more often a low risk tumor biology 68 of which 54 even an ultralow risk compared to interval cancers 53 low of which 45 ultralow risk p 0 001 with an OR of 2 33 p 0 0001 95 CI 1 73 3 15 FFDM detected significantly more high risk tumors 35 compared to FSM 27 p 0 011 Aside from favorable clinico pathological factors screen detected cancers were also more likely to have a biologically low risk or even ultralow risk tumor Especially for patients with screen detected cancers the use of tools such as the 70 gene signature to differentiate breast cancers by risk of recurrence may minimize overtreatment The recent transition in screening modalities led to an increase in the detection of

    Original URL path: http://www.agendia.com/%ef%bb%bfmammographic-screening-detects-low-risk-tumor-biology-breast-cancers/ (2016-05-01)
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  • Long-term impact of the 70-gene signature on breast cancer outcome | Agendia
    validated the prognostic value of the 70 gene prognosis signature MammaPrintR but long term outcome prediction of these patients has not been previously reported The follow up of the consecutively treated cohort of 295 patients 53 years with invasive breast cancer T1 2N0 1M0 n 151 N0 n 144 N1 diagnosed between 1984 and 1995 in which the 70 gene signature was previously validated was updated The median follow up for this series is now extended to 18 5 years A significant difference is seen in long term distant metastasis free survival DMFS for the patients with a low and a high risk 70 gene signature DMFS p 0001 as well as separately for node negative DMFS p 0 0001 and node positive patients DMFS p 0 0004 The 25 year hazard ratios HRs for all patients for DMFS and OS were 3 1 95 CI 2 02 4 86 and 2 9 95 CI 1 90 4 28 respectively The HRs for DMFS and OS were largest in the first 5 years after diagnosis 9 6 95 CI 4 2 22 1 and 11 3 95 CI 3 5 36 4 respectively The 25 year HRs in the subgroup of node negative patients for DMFS and OS were 4 57 95 CI 2 31 9 04 and 4 73 95 CI 2 46 9 07 respectively and for node positive patients for DMFS and OS were 2 24 95 CI 1 25 4 00 and 1 83 95 CI 1 07 3 11 respectively The 70 gene signature remains prognostic at longer follow up in patients53 years of age with stage I and II breast cancer The 70 gene signature s strongest prognostic power is seen in the first 5 years after diagnosis See article Categories Abstract Poster 18

    Original URL path: http://www.agendia.com/long-term-impact-of-the-70-gene-signature-on-breast-cancer-outcome/ (2016-05-01)
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