title: Pooled analysis of prospective European studies assessing the impact of using the 21-gene Recurrence Score assay on clinical decision making in women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.affiliation: 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.
authors.forename: Joan
authors.initials: J
authors.lastname: Albanell
authors.affiliation: Genomic Health, Inc., 301 Penobscot Dr, Redwood City, CA, 94063, USA.
authors.forename: Christer
authors.initials: C
authors.lastname: Svedman
authors.affiliation: Medical Oncology, APHP Tenon, IUC-UPMC Sorbonne University, Francilian Breast Intergroup, APREC, Paris.
authors.forename: Joseph
authors.initials: J
authors.lastname: Gligorov
authors.affiliation: Breast Cancer Unit, Prince Philip Hospital, Bryngwyn Mawr Dafen Road, Llanelli, Carmarthenshire, SA14 8QF, UK.
authors.forename: Simon D H
authors.initials: SD
authors.lastname: Holt
authors.affiliation: Oncology, Singleton Hospital, Sketty Lane, Sketty, Swansea, SA2 8QA, UK.
authors.forename: Gianfilippo
authors.initials: G
authors.lastname: Bertelli
authors.affiliation: Department of Gynecology with Breast Center, Charité Hospital, Charitéplatz 1, 10117, Berlin, Germany.
authors.forename: Jens-Uwe
authors.initials: JU
authors.lastname: Blohmer
authors.affiliation: Surgical Oncology, Institut Curie, 26 rue d'Ulm, 75248, Paris Cedex 05, France.
authors.forename: Roman
authors.initials: R
authors.lastname: Rouzier
authors.affiliation: Hematology-Oncology, Hospital Clinico, INCLIVA, University of Valencia, Av. de Blasco Ibáñez, 17, 46010, València, Valencia, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Lluch
authors.affiliation: Department of Gynecology and Oncology, Interdisciplinary Oncology Center, Nussbaumstr. 12, 80336, Munich, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Eiermann
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy; D000066491:Clinical Decision-Making / Q000379:methods*; D005060:Europe; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D057285:Precision Medicine / Q000379:methods; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011960:Receptors, Estrogen / Q000378:metabolism; D018570:Risk Assessment; D012720:Severity of Illness Index; D047368:Tumor Burden
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; C508053:ERBB2 protein, human
keywords: Adjuvant chemotherapy; Breast cancer; Clinical decision making; Individualised medicine