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Prosigna Package Insert

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Système d’analyse nCounter® Dx Manuel d‘utilisation

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Fiche technique du produit Prosigna®

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Rapport patient Prosigna®

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Liste des publications

Sous-types intrinsèques

Perou CM, Sørlie T, Eisen MB, et al. Molecular portraits of human breast tumours. Nature. 2000;406(6797):747-752. Voir l’article
Sørlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001;98(19):10869-10874. Voir l’article
Sørlie T, Tibshirani R, Parker J, et al. Repeated observation of breast tumor subtypes in independent gene expression data sets. Proc Natl Acad Sci U S A. 2003;100(14):8418-8423. Voir l’article
Fan C, Oh DS, Wessels L, et al. Concordance among gene-expression-based predictors for breast cancer. N Engl J Med. 2006;355(6):560-569. Voir l’article

PAM50

Parker JS, Mullins M, Cheang MC, et al. Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol. 2009;27(8):1160-1167. Voir l’article
Nielsen TO, Parker JS, Leung S, et al. A comparison of PAM50 intrinsic subtyping with immunohistochemistry and clinical prognostic factors in tamoxifen-treated estrogen receptor-positive breast cancer. Clin Cancer Res. 2010;16(21):5222-5232. Voir l’article
Chia SK, Bramwell VH, Tu D, et al. A 50-gene intrinsic subtype classifier for prognosis and prediction of benefit from adjuvant tamoxifen. Clin Cancer Res. 2012;18(16):4465-4472. Voir l’article
Cheang MC, Voduc KD, Tu D, et al. Responsiveness of intrinsic subtypes to adjuvant anthracycline substitution in the NCIC.CTG MA.5 randomized trial. Clin Cancer Res. 2012;18(8):2402-2412. Voir l’article
Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70. Voir l’article

Prosigna®

Dowsett M, Sestak I, Lopez-Knowles E, et al. Comparison of PAM50 risk of recurrence score with Oncotype DX and IHC4 for predicting risk of distant recurrence after endocrine therapy. J Clin Oncol. 2013;31(22):2783-2790. Voir l’article
Gnant M, Filipits M, Mlineritsch B, et al; Austrian Breast and Colorectal Cancer Study Group. Clinical validation of the PAM50 risk of recurrence (ROR) score for predicting residual risk of distant-recurrence (DR) after endocrine therapy in postmenopausal women with HR+ early breast cancer (EBC): an ABCSG study. Presented at: San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX. Abstract P2-10-02. Voir l’article
Gnant M, Filipits M, Dubsky P, et al. Predicting risk for late metastasis: the PAM50 risk of recurrence (ROR) score after 5 years of endocrine therapy in postmenopausal women with HR+ early breast cancer: a study on 1,478 patients from the ABCSG-8 trial. Presented at: European Society for Medical Oncology IMPAKT 2013 Breast Cancer Conference; May 2-4, 2013; Brussels, Belgium. Abstract 53O_PR. Voir l’article
Sestak I, Dowsett M, Sgroi D, et al. Comparison of five different scores for the prediction of late recurrence for oestrogen receptor-positive breast cancer. Presented at: European Society for Medical Oncology IMPAKT 2013 Breast Cancer Conference; May 2-4, 2013; Brussels, Belgium. Abstract 540_PR. Voir l’article
Sestak I, Dowsett M, Zabaglo L, et al. Factors predicting late recurrence for estrogen receptor–positive breast cancer. J Natl Cancer Inst. 2013;105(19):1504-1511. Voir l’article
Nielsen T, Wallden B, Schaper C, et al. Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens [published online ahead of print March 13, 2014]. BMC Cancer. doi:10.1186/1471-2407-14-177. Voir l’article
Gnant M, Dowsett M, Filipits M, et al. Identifying clinically relevant prognostic subgroups in node-positive postmenopausal HR+ early breast cancer patients treated with endocrine therapy: a combined analysis of 2,485 patients from ABCSG-8 and ATAC using the PAM50 risk of recurrence (ROR) score and intrinsic subtype. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL. Abstract 506. Voir l’article
Gnant M, Filipits M, Greil R, et al; Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014;25(2):339-345. Voir l’article
Filipits M, Nielsen TO, Rudas M, et al; Austrian Breast and Colorectal Cancer Study Group. The PAM50 risk-of-recurrence score predicts risk for late distant recurrence after endocrine therapy in postmenopausal women with endocrine-responsive early breast cancer [published online ahead of print February 11, 2014]. Clin Cancer Res. 2014;20(5):1298-1305. doi:10.1158/1078-0432.CCR-13-1845. Voir l’article
Sestak I, Cuzick J, Dowsett M, et al; Prediction of Late Distant Recurrence After 5 Years of Endocrine Treatment: A Combined Analysis of Patients From the Austrian Breast and Colorectal Cancer Study Group 8 and Arimidex, Tamoxifen Alone or in Combination Randomized Trials Using the PAM50 Risk of Recurrence Score. J Clin Oncol. 2014 Oct 20. pii: JCO.2014.55.6894. Voir l’article

Verification study

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Étude de validation clinique TransATAC

Cliquez ici pour accéder à l’article sur l’étude de validation clinique TransATAC publié dans Journal of Clinical Oncology..

Validation clinique

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Étude de validation clinique ABCSG-8

Cliquez ici pour accéder à l’article sur l’étude de validation clinique ABCSG-8 publié dans Annals of Oncology.

Validation analytique

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Cliquez ici pour accéder à l’article sur l’étude de validation analytique publié dans BMC Cancer.

Prosigna is indicated for use in postmenopausal women with hormone receptor-positive, node-negative (Stage I or II) or node-positive (Stage II or IIIA) early-stage breast cancer to be treated with adjuvant endocrine therapy.

 

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