title: Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer.
abstract: BACKGROUND
  This study examined the impact of the Recurrence Score (RS) in Spanish breast cancer patients and explored the associations between clinicopathological markers and likelihood of change in treatment recommendations.
  
  
  METHODS
  Enrollment was offered consecutively to eligible women with estrogen receptor-positive; human epidermal growth factor receptor 2-negative, node-negative breast cancer. Oncologists recorded treatment recommendation and confidence in it before and after knowing the patient's RS.
  
  
  RESULTS
  Treatment recommendation changed in 32% of 107 patients enrolled: in 21% from chemohormonal (CHT) to hormonal therapy (HT) and in 11% from HT to CHT. RS was associated with the likelihood of change from HT to CHT (P < 0.001) and from CHT to HT (P < 0.001). Confidence of oncologists in treatment recommendations increased for 60% of cases. Higher tumor grade (P = 0.007) and a high proliferative index (Ki-67) (P = 0.023) were significantly associated with a greater chance of changing from HT to CHT, while positive progesterone receptor status (P = 0.002) with a greater probability of changing from CHT to HT.
  
  
  CONCLUSIONS
  Results from the first prospective European study are consistent with published experience and use of the RS as proposed in European clinical practice guidelines and provide evidence on how Oncotype DX and clinicopathological factors are complementary and patient selection may be improved.
authors.affiliation: Medical Oncology Service, Hospital del Mar, Barcelona; Cancer Research Program, IMIM (Hospital del Mar Research Institute), Barcelona; Department of Medicine, Autonomous University of Barcelona, Barcelona. Electronic address: jalbanell@hospitaldelmar.cat.
authors.forename: J
authors.initials: J
authors.lastname: Albanell
authors.affiliation: Medical Oncology Service, MD Anderson, Madrid.
authors.forename: A
authors.initials: A
authors.lastname: González
authors.affiliation: Medical Oncology Service, Hospital Virgen del Rocío, Sevilla.
authors.forename: M
authors.initials: M
authors.lastname: Ruiz-Borrego
authors.affiliation: Medical Oncology Service, Hospital Virgen de la Victoria, Málaga.
authors.forename: E
authors.initials: E
authors.lastname: Alba
authors.affiliation: Medical Oncology Service, Hospital Clínico, Madrid.
authors.forename: J A
authors.initials: JA
authors.lastname: García-Saenz
authors.affiliation: Cancer Research Program, IMIM (Hospital del Mar Research Institute), Barcelona; Department of Medicine, Autonomous University of Barcelona, Barcelona; Pathology Service, Hospital del Mar, Barcelona.
authors.forename: J M
authors.initials: JM
authors.lastname: Corominas
authors.affiliation: Pathology Service, Hospital Clínico, Valencia.
authors.forename: O
authors.initials: O
authors.lastname: Burgues
authors.affiliation: Pathology Service, Hospital Clínico, Madrid.
authors.forename: V
authors.initials: V
authors.lastname: Furio
authors.affiliation: Pathology Service, MD Anderson, Madrid.
authors.forename: A
authors.initials: A
authors.lastname: Rojo
authors.affiliation: Pathology Service, Hospital Virgen del Rocío, Sevilla.
authors.forename: J
authors.initials: J
authors.lastname: Palacios
authors.affiliation: Department of Hematology and Oncology, Hospital Clínico de Valencia, Valencia.
authors.forename: B
authors.initials: B
authors.lastname: Bermejo
authors.affiliation: Medical Oncology Service, Hospital del Mar, Barcelona; Cancer Research Program, IMIM (Hospital del Mar Research Institute), Barcelona.
authors.forename: M
authors.initials: M
authors.lastname: Martínez-García
authors.affiliation: Medical Oncology Service, Hospital Virgen del Rocío, Sevilla.
authors.forename: M L
authors.initials: ML
authors.lastname: Limon
authors.affiliation: Medical Oncology Service, Hospital Virgen de la Victoria, Málaga.
authors.forename: A S
authors.initials: AS
authors.lastname: Muñoz
authors.affiliation: Medical Oncology Service, Hospital Gregorio Marañón Madrid, Madrid.
authors.forename: M
authors.initials: M
authors.lastname: Martín
authors.affiliation: Medical Oncology Service, Hospital del Mar, Barcelona; Cancer Research Program, IMIM (Hospital del Mar Research Institute), Barcelona.
authors.forename: I
authors.initials: I
authors.lastname: Tusquets
authors.affiliation: Cancer Research Program, IMIM (Hospital del Mar Research Institute), Barcelona; Pathology Service, Fundación Jiménez Díaz, Madrid.
authors.forename: F
authors.initials: F
authors.lastname: Rojo
authors.affiliation: Medical Oncology Service, MD Anderson, Madrid.
authors.forename: R
authors.initials: R
authors.lastname: Colomer
authors.affiliation: LiveMedix, Barcelona, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Faull
authors.affiliation: Department of Hematology and Oncology, Hospital Clínico de Valencia, Valencia.
authors.forename: A
authors.initials: A
authors.lastname: Lluch
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology*; D017024:Chemotherapy, Adjuvant / Q000706:statistics & numerical data; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data; D006727:Hormone Antagonists / Q000627:therapeutic use; D006801:Humans; D008495:Medical Oncology / Q000592:standards / Q000706:statistics & numerical data; D008875:Middle Aged; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000235:genetics; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011960:Receptors, Estrogen / Q000096:biosynthesis / Q000235:genetics; D012307:Risk Factors
chemical_list: D000970:Antineoplastic Agents; D006727:Hormone Antagonists; D011960:Receptors, Estrogen