BACKGROUND: We critically evaluated the available evidence on genomic tests in breast cancer to define their prognostic ability and likelihood to determine treatment benefit. DESIGN: Independent evaluation of six genomic tests [Oncotype Dx™, MammaPrint(®), Genomic Grade Index, PAM50 (ROR-S), Breast Cancer Index, and EndoPredict] was carried out by a panel of experts in three parameters: analytical validity, clinical validity, and clinical utility based on the principles of the EGAPP criteria. PANEL STATEMENTS: The majority of the working group members found the available evidence on the analytical and clinical validity of Oncotype Dx™ and MammaPrint(®) to be convincing. None of the genomic tests demonstrated robust evidence of clinical utility: it was not clear from the current evidence that modifying treatment decisions based on the results of a given genomic test could result in improving clinical outcome. CONCLUSIONS: The IMPAKT 2012 Working Group proposed the following recommendations: (i) a need to develop models that integrate clinicopathologic factors along with genomic tests; (ii) demonstration of clinical utility should be made in the context of a prospective randomized trial; and (iii) the creation of registries for patients who are subjected to genomic testing in the daily practice.
BACKGROUND: We critically evaluated the available evidence on genomic tests in breast cancer to define their prognostic ability and likelihood to determine treatment benefit. DESIGN: Independent evaluation of six genomic tests [Oncotype Dx™, MammaPrint(®), Genomic Grade Index, PAM50 (ROR-S), Breast Cancer Index, and EndoPredict] was carried out by a panel of experts in three parameters: analytical validity, clinical validity, and clinical utility based on the principles of the EGAPP criteria. PANEL STATEMENTS: The majority of the working group members found the available evidence on the analytical and clinical validity of Oncotype Dx™ and MammaPrint(®) to be convincing. None of the genomic tests demonstrated robust evidence of clinical utility: it was not clear from the current evidence that modifying treatment decisions based on the results of a given genomic test could result in improving clinical outcome. CONCLUSIONS: The IMPAKT 2012 Working Group proposed the following recommendations: (i) a need to develop models that integrate clinicopathologic factors along with genomic tests; (ii) demonstration of clinical utility should be made in the context of a prospective randomized trial; and (iii) the creation of registries for patients who are subjected to genomic testing in the daily practice.
Authors: Stella Mook; Marjanka K Schmidt; Giuseppe Viale; Giancarlo Pruneri; Inge Eekhout; Arno Floore; Annuska M Glas; Jan Bogaerts; Fatima Cardoso; Martine J Piccart-Gebhart; Emiel T Rutgers; Laura J Van't Veer Journal: Breast Cancer Res Treat Date: 2008-07-27 Impact factor: 4.872
Authors: John P A Ioannidis; David B Allison; Catherine A Ball; Issa Coulibaly; Xiangqin Cui; Aedín C Culhane; Mario Falchi; Cesare Furlanello; Laurence Game; Giuseppe Jurman; Jon Mangion; Tapan Mehta; Michael Nitzberg; Grier P Page; Enrico Petretto; Vera van Noort Journal: Nat Genet Date: 2008-01-28 Impact factor: 38.330
Authors: Martin Filipits; Margaretha Rudas; Raimund Jakesz; Peter Dubsky; Florian Fitzal; Christian F Singer; Otto Dietze; Richard Greil; Andrea Jelen; Paul Sevelda; Christa Freibauer; Volkmar Müller; Fritz Jänicke; Marcus Schmidt; Heinz Kölbl; Achim Rody; Manfred Kaufmann; Werner Schroth; Hiltrud Brauch; Matthias Schwab; Peter Fritz; Karsten E Weber; Inke S Feder; Guido Hennig; Ralf Kronenwett; Mathias Gehrmann; Michael Gnant Journal: Clin Cancer Res Date: 2011-08-01 Impact factor: 12.531
Authors: Eric Van Cutsem; Claus-Henning Köhne; István Láng; Gunnar Folprecht; Marek P Nowacki; Stefano Cascinu; Igor Shchepotin; Joan Maurel; David Cunningham; Sabine Tejpar; Michael Schlichting; Angela Zubel; Ilhan Celik; Philippe Rougier; Fortunato Ciardiello Journal: J Clin Oncol Date: 2011-04-18 Impact factor: 44.544
Authors: C M Perou; T Sørlie; M B Eisen; M van de Rijn; S S Jeffrey; C A Rees; J R Pollack; D T Ross; H Johnsen; L A Akslen; O Fluge; A Pergamenschikov; C Williams; S X Zhu; P E Lønning; A L Børresen-Dale; P O Brown; D Botstein Journal: Nature Date: 2000-08-17 Impact factor: 49.962
Authors: Joel S Parker; Michael Mullins; Maggie C U Cheang; Samuel Leung; David Voduc; Tammi Vickery; Sherri Davies; Christiane Fauron; Xiaping He; Zhiyuan Hu; John F Quackenbush; Inge J Stijleman; Juan Palazzo; J S Marron; Andrew B Nobel; Elaine Mardis; Torsten O Nielsen; Matthew J Ellis; Charles M Perou; Philip S Bernard Journal: J Clin Oncol Date: 2009-02-09 Impact factor: 44.544
Authors: Steven M Teutsch; Linda A Bradley; Glenn E Palomaki; James E Haddow; Margaret Piper; Ned Calonge; W David Dotson; Michael P Douglas; Alfred O Berg Journal: Genet Med Date: 2009-01 Impact factor: 8.822
Authors: Marc Buyse; Sherene Loi; Laura van't Veer; Giuseppe Viale; Mauro Delorenzi; Annuska M Glas; Mahasti Saghatchian d'Assignies; Jonas Bergh; Rosette Lidereau; Paul Ellis; Adrian Harris; Jan Bogaerts; Patrick Therasse; Arno Floore; Mohamed Amakrane; Fanny Piette; Emiel Rutgers; Christos Sotiriou; Fatima Cardoso; Martine J Piccart Journal: J Natl Cancer Inst Date: 2006-09-06 Impact factor: 13.506
Authors: Laurel A Habel; Steven Shak; Marlena K Jacobs; Angela Capra; Claire Alexander; Mylan Pho; Joffre Baker; Michael Walker; Drew Watson; James Hackett; Noelle T Blick; Deborah Greenberg; Louis Fehrenbacher; Bryan Langholz; Charles P Quesenberry Journal: Breast Cancer Res Date: 2006-05-31 Impact factor: 6.466
Authors: P Sinn; S Aulmann; R Wirtz; S Schott; F Marmé; Z Varga; A Lebeau; H Kreipe; A Schneeweiss Journal: Geburtshilfe Frauenheilkd Date: 2013-09 Impact factor: 2.915
Authors: Carol Sweeney; Philip S Bernard; Rachel E Factor; Marilyn L Kwan; Laurel A Habel; Charles P Quesenberry; Kaylynn Shakespear; Erin K Weltzien; Inge J Stijleman; Carole A Davis; Mark T W Ebbert; Adrienne Castillo; Lawrence H Kushi; Bette J Caan Journal: Cancer Epidemiol Biomarkers Prev Date: 2014-02-12 Impact factor: 4.254
Authors: Bette J Caan; Carol Sweeney; Laurel A Habel; Marilyn L Kwan; Candyce H Kroenke; Erin K Weltzien; Charles P Quesenberry; Adrienne Castillo; Rachel E Factor; Lawrence H Kushi; Philip S Bernard Journal: Cancer Epidemiol Biomarkers Prev Date: 2014-02-12 Impact factor: 4.254