Joan Albanell1, Christer Svedman2, Joseph Gligorov3, Simon D H Holt4, Gianfilippo Bertelli5, Jens-Uwe Blohmer6, Roman Rouzier7, Ana Lluch8, Wolfgang Eiermann9. 1. Medical Oncology, Hospital del Mar, Passeig Maritim 25-29, 08003, Barcelona, Spain; CEXS Department, Pompeu Fabra University, Plaça de la Mercè, 10, 08002, Barcelona, Spain; Cancer Research Programme, Hospital del Mar Medical Research (IMIM) Institute, Carrer del Dr. Aiguader, 88, 08003, Barcelona, Spain. Electronic address: jalbanell@hospitaldelmar.cat. 2. Genomic Health, Inc., 301 Penobscot Dr, Redwood City, CA, 94063, USA. 3. Medical Oncology, APHP Tenon, IUC-UPMC Sorbonne University, Francilian Breast Intergroup, APREC, Paris. 4. Breast Cancer Unit, Prince Philip Hospital, Bryngwyn Mawr Dafen Road, Llanelli, Carmarthenshire, SA14 8QF, UK. 5. Oncology, Singleton Hospital, Sketty Lane, Sketty, Swansea, SA2 8QA, UK. 6. Department of Gynecology with Breast Center, Charité Hospital, Charitéplatz 1, 10117, Berlin, Germany. 7. Surgical Oncology, Institut Curie, 26 rue d'Ulm, 75248, Paris Cedex 05, France. 8. Hematology-Oncology, Hospital Clinico, INCLIVA, University of Valencia, Av. de Blasco Ibáñez, 17, 46010, València, Valencia, Spain. 9. Department of Gynecology and Oncology, Interdisciplinary Oncology Center, Nussbaumstr. 12, 80336, Munich, Germany.
Abstract
PURPOSE: The 21-gene Recurrence Score assay (Oncotype DX) provides prognostic/predictive information in oestrogen receptor positive (ER+) early breast cancer, but access/reimbursement has been limited in most European countries in the absence of prospective outcome data. Recently, two large prospective studies and a real-life 5-year outcome study have been reported. We performed a pooled analysis of prospective European impact studies to generate robust data on impact of use in different clinical subgroups. METHODS: The analysis included four studies (French, German, Spanish, and British) in ER+ human epidermal growth factor receptor 2-negative breast cancer patients (n = 527). Node-positive patients were excluded. RESULTS: The analysis demonstrated that treatment recommendations changed in 32% of patients post-testing; chemotherapy recommendation rate decreased from 55% to 34%. Change rates in the individual studies ranged from 30% to 37%. The highest change rates were in patients originally recommended chemotherapy and in grade II tumours; there was no subgroup without a treatment recommendation change. Notably, 31% of patients with an intermediate Recurrence Score result had a treatment recommendation change suggesting that testing provides actionable information in this group. With the exception of the German study (where chemotherapy rates remained high [41%] post-testing), between-study variability in treatment recommendations decreased post-testing (chemotherapy: from 36-52% to 26-29%; hormonal therapy: from 48-64% to 71-74%). Physicians' confidence regarding treatment recommendations improved in all the studies after testing. CONCLUSION: Recurrence Score testing led to changes in adjuvant chemotherapy use in approximately a third of patients, to an overall reduced chemotherapy use, and to more homogeneous decision making.
PURPOSE: The 21-gene Recurrence Score assay (Oncotype DX) provides prognostic/predictive information in oestrogen receptor positive (ER+) early breast cancer, but access/reimbursement has been limited in most European countries in the absence of prospective outcome data. Recently, two large prospective studies and a real-life 5-year outcome study have been reported. We performed a pooled analysis of prospective European impact studies to generate robust data on impact of use in different clinical subgroups. METHODS: The analysis included four studies (French, German, Spanish, and British) in ER+ humanepidermal growth factor receptor 2-negative breast cancerpatients (n = 527). Node-positive patients were excluded. RESULTS: The analysis demonstrated that treatment recommendations changed in 32% of patients post-testing; chemotherapy recommendation rate decreased from 55% to 34%. Change rates in the individual studies ranged from 30% to 37%. The highest change rates were in patients originally recommended chemotherapy and in grade II tumours; there was no subgroup without a treatment recommendation change. Notably, 31% of patients with an intermediate Recurrence Score result had a treatment recommendation change suggesting that testing provides actionable information in this group. With the exception of the German study (where chemotherapy rates remained high [41%] post-testing), between-study variability in treatment recommendations decreased post-testing (chemotherapy: from 36-52% to 26-29%; hormonal therapy: from 48-64% to 71-74%). Physicians' confidence regarding treatment recommendations improved in all the studies after testing. CONCLUSION: Recurrence Score testing led to changes in adjuvant chemotherapy use in approximately a third of patients, to an overall reduced chemotherapy use, and to more homogeneous decision making.
Authors: Paul Gaß; Peter A Fasching; Tanja Fehm; Johann de Waal; Mahdi Rezai; Bernd Baier; Gerold Baake; Hans-Christian Kolberg; Martin Guggenberger; Mathias Warm; Nadia Harbeck; Rachel Wuerstlein; Jörg-Uwe Deuker; Peter Dall; Barbara Richter; Grischa Wachsmann; Cosima Brucker; Jan W Siebers; Nikos Fersis; Thomas Kuhn; Christopher Wolf; Hans-Walter Vollert; Georg-Peter Breitbach; Wolfgang Janni; Robert Landthaler; Andreas Kohls; Daniela Rezek; Thomas Noesselt; Gunnar Fischer; Stephan Henschen; Thomas Praetz; Volker Heyl; Thorsten Kühn; Thomas Krauss; Christoph Thomssen; Andre Hohn; Hans Tesch; Christoph Mundhenke; Alexander Hein; Claudia Rauh; Christian M Bayer; Adib Jacob; Katja Schmidt; Erik Belleville; Peyman Hadji; Sara Y Brucker; Matthias W Beckmann; Diethelm Wallwiener; Sherko Kümmel; Christian R Löhberg Journal: Breast Care (Basel) Date: 2016-10-27 Impact factor: 2.860
Authors: L M McSorley; M Tharmabala; F Al Rahbi; K McSorley; S Chew; D Evoy; J G Geraghty; R S Prichard; J Rothwell; D P McCartan; E W McDermott; M Keane; M J Kennedy; S O'Reilly; S J Millen; J P Crown; L M Smyth; C M Kelly; C M Quinn; J M Walshe Journal: Breast Cancer Res Treat Date: 2021-04-09 Impact factor: 4.872
Authors: Mashuk Alam Khan; Laura Henderson; Dayalan Clarke; Simon Harries; Lucie Jones Journal: Breast Care (Basel) Date: 2018-07-13 Impact factor: 2.860