title: Prospective assessment of the decision-making impact of the Breast Cancer Index in recommending extended adjuvant endocrine therapy for patients with early-stage ER-positive breast cancer.
abstract: Extended adjuvant endocrine therapy (10 vs. 5 years) trials have demonstrated improved outcomes in early-stage estrogen receptor (ER)-positive breast cancer; however, the absolute benefit is modest, and toxicity and tolerability challenges remain. Predictive and prognostic information from genomic analysis may help inform this clinical decision. The purpose of this study was to assess the impact of the Breast Cancer Index (BCI) on physician recommendations for extended endocrine therapy and on patient anxiety and decision conflict. Patients with stage I-III, ER-positive breast cancer who completed at least 3.5 years of adjuvant endocrine therapy were offered participation. Genomic classification with BCI was performed on archived tumor tissues and the results were reported to the treating physician who discussed results with the patient. Patients and physicians completed pre- and post-test questionnaires regarding preferences for extended endocrine therapy. Patients also completed the validated traditional Decisional Conflict Scale (DCS) and State Trait Anxiety Inventory forms (STAI-Y1) pre- and post-test. 96 patients were enrolled at the Yale Cancer Center [median age 60.5 years (range 45-87), 79% postmenopausal, 60% stage I). BCI predicted a low risk of late recurrence in 59% of patients versus intermediate/high in 24 and 17%, respectively. Physician recommendations for extended endocrine therapy changed for 26% of patients after considering BCI results, with a net decrease in recommendations for extended endocrine therapy from 74 to 54%. After testing, fewer patients wanted to continue extended therapy and decision conflict and anxiety also decreased. Mean STAI and DCS scores were 31.3 versus 29.1 (p = 0.031) and 20.9 versus 10.8 (p < 0.001) pre- and post-test, respectively. Incorporation of BCI into risk/benefit discussions regarding extended endocrine therapy resulted in changes in treatment recommendations and improved patient satisfaction.
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. tara.sanft@yale.edu.
authors.forename: Tara
authors.initials: T
authors.lastname: Sanft
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. bilge.aktas@yale.edu.
authors.forename: Bilge
authors.initials: B
authors.lastname: Aktas
authors.affiliation: BioTheranostics, Inc., 9640 Towne Centre Drive, Suite 200, San Diego, CA, 92121, USA. brock.schroeder@biotheranostics.com.
authors.forename: Brock
authors.initials: B
authors.lastname: Schroeder
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. veerle.bossuyt@yale.edu.
authors.forename: Veerle
authors.initials: V
authors.lastname: Bossuyt
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. michaeal.digiovanna@yale.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: DiGiovanna
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. maysa.abu-khalaf@yale.edu.
authors.forename: Maysa
authors.initials: M
authors.lastname: Abu-Khalaf
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. gina.chung@yale.edu.
authors.forename: Gina
authors.initials: G
authors.lastname: Chung
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. andrea.silber@yale.edu.
authors.forename: Andrea
authors.initials: A
authors.lastname: Silber
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. erin.hofstatter@yale.edu.
authors.forename: Erin
authors.initials: E
authors.lastname: Hofstatter
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. sarah.mougalian@yale.edu.
authors.forename: Sarah
authors.initials: S
authors.lastname: Mougalian
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. lianne.epstein@yale.edu.
authors.forename: Lianne
authors.initials: L
authors.lastname: Epstein
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. christos.hatzis@yale.edu.
authors.forename: Christos
authors.initials: C
authors.lastname: Hatzis
authors.affiliation: BioTheranostics, Inc., 9640 Towne Centre Drive, Suite 200, San Diego, CA, 92121, USA. cathy.schnabel@biotheranostics.com.
authors.forename: Cathy
authors.initials: C
authors.lastname: Schnabel
authors.affiliation: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, PO Box 208032, 333 Cedar St, New Haven, CT, 06520-8032, USA. lajos.pusztai@yale.edu.
authors.forename: Lajos
authors.initials: L
authors.lastname: Pusztai
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001007:Anxiety / Q000523:psychology; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D017024:Chemotherapy, Adjuvant; D003657:Decision Making; D005260:Female; D015972:Gene Expression Regulation, Neoplastic; D005820:Genetic Testing; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011379:Prognosis; D011446:Prospective Studies; D011960:Receptors, Estrogen / Q000378:metabolism; D011795:Surveys and Questionnaires; D013629:Tamoxifen / Q000627:therapeutic use
chemical_list: D018931:Antineoplastic Agents, Hormonal; D011960:Receptors, Estrogen; D013629:Tamoxifen
keywords: Anxiety; Hormone therapy; Late recurrence; Risk assessment; Satisfaction; Survivorship