West German Study Group Phase III PlanB Trial: First Prospective Outcome Data for the 21-Gene Recurrence Score Assay and Concordance of Prognostic Markers by Central and Local Pathology Assessment.

Autor:	Gluz O; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA. oleg.gluz@wsg-online.com., Nitz UA; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Christgen M; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Kates RE; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Shak S; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Clemens M; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Kraemer S; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Aktas B; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Kuemmel S; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Reimer T; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Kusche M; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Heyl V; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Lorenz-Salehi F; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Just M; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Hofmann D; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Degenhardt T; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Liedtke C; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Svedman C; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Wuerstlein R; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Kreipe HH; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA., Harbeck N; Oleg Gluz, Ulrike A. Nitz, Ronald E. Kates, Daniel Hofmann, Cornelia Liedtke, Rachel Wuerstlein, and Nadia Harbeck, West German Study Group; Oleg Gluz and Ulrike A. Nitz, Evangelical Hospital Bethesda, Moenchengladbach; Matthias Christgen and Hans H. Kreipe, Medical School Hannover, Hannover; Michael Clemens, Mutterhaus der Borromäerinnen, Trier; Stefan Kraemer, University Clinics Cologne, Cologne; Bahriye Aktas, University Clinics Essen; Sherko Kuemmel, Clinics Essen-Mitte, Essen; Toralf Reimer, Clinics Suedstadt, Rostock; Manfred Kusche, Marienhospital Aachen, Aachen; Volker Heyl, Asklepios Paulinen Clinics; Fatemeh Lorenz-Salehi, Dr Horst-Schmidt Clinics, Wiesbaden; Marianne Just, Oncologic Practice, Bielefeld; Tom Degenhardt, Rachel Wuerstlein, and Nadia Harbeck, University of Munich, Munich; Cornelia Liedtke, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, Germany; and Steven Shak and Christer Svedman, Genomic Health, Redwood City, CA.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2016 Jul 10; Vol. 34 (20), pp. 2341-9. Date of Electronic Publication: 2016 Feb 29.
DOI:	10.1200/JCO.2015.63.5383
Abstrakt:	Purpose: The 21-gene Recurrence Score (RS) assay is a validated prognostic/predictive tool in early hormone receptor-positive breast cancer (BC); however, only a few prospective outcome results have been available so far. In the phase III PlanB trial, RS was prospectively used to define a subset of patients who received only endocrine therapy. We present 3-year outcome data and concordance analysis (among biomarkers/RS). Patients and Methods: Central tumor bank was established prospectively from PlanB (intermediate and high-risk, locally human epidermal growth factor receptor 2-negative BC). After an early amendment, HR-positive, pN0-1 patients with RS ≤ 11 were recommended to omit chemotherapy. Results: From 2009 to 2011, PlanB enrolled 3,198 patients with a median age of 56 years; 41.1% had node-positive and 32.5% grade 3 disease. In 348 patients (15.3%), chemotherapy was omitted based on RS ≤ 11. After 35 months median follow-up, 3-year disease-free survival in patients with RS ≤ 11 and endocrine therapy alone was 98% versus 92% and 98% in RS > 25 and RS 12 to 25 in chemotherapy-treated patients, respectively. Nodal status, central and local grade, the Ki-67 protein encoded by the MKI67 gene, estrogen receptor, progesterone receptor, tumor size, and RS were univariate prognostic factors for disease-free survival; only nodal status, both central and local grade, and RS were independent multivariate factors. Histologic grade was discordant between central and local laboratories in 44%. RS was positively but moderately correlated with the Ki-67 protein encoded by the MKI67 gene and grade and negatively correlated with progesterone receptor and estrogen receptor. Conclusion: In this prospective trial, patients with enhanced clinical risk and omitted chemotherapy on the basis of RS ≤ 11 had excellent 3-year survival. The substantial discordance observed between traditional prognostic markers and RS emphasizes the need for standardized assessment and supports the potential integration of standardized, well-validated genomic assays such as RS with clinicopathologic prognostic factors for chemotherapy indication in early hormone receptor-positive BC. (© 2016 by American Society of Clinical Oncology.)
Databáze:	MEDLINE
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