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

Tara Sanft, Bilge Aktas, Brock Schroeder, Veerle Bossuyt, Michael DiGiovanna, Maysa Abu-Khalaf, Gina Chung, Andrea Silber, Erin Hofstatter, Sarah Mougalian, Lianne Epstein, Christos Hatzis, Cathy Schnabel, Lajos Pusztai, Tara Sanft, Bilge Aktas, Brock Schroeder, Veerle Bossuyt, Michael DiGiovanna, Maysa Abu-Khalaf, Gina Chung, Andrea Silber, Erin Hofstatter, Sarah Mougalian, Lianne Epstein, Christos Hatzis, Cathy Schnabel, Lajos Pusztai

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.

Trial registration: ClinicalTrials.gov NCT02057029.

Keywords: Anxiety; Hormone therapy; Late recurrence; Risk assessment; Satisfaction; Survivorship.

Figures

Fig. 1
Fig. 1
Consort diagram of the participants
Fig. 2
Fig. 2
Medical oncologists’ pre- and post-test recommendation for extended adjuvant endocrine treatment
Fig. 3
Fig. 3
Medical oncologists’ pre-test and post-test level of confidence in treatment recommendation stratified based on whether extended endocrine treatment was recommended in the pre-test and post-test setting (a). Patients’ pre-test and post-test levels of comfort with the decision for extended adjuvant endocrine treatment stratified based on whether patients preferred extended endocrine treatment in the pre-test and post-test setting (b)
Fig. 4
Fig. 4
STAI (a) and DCS (b) scores for individual patients before and after BCI assay. Each line connects the pre- and post-test STAI and DCS scores for an individual (n = 96 patients). Increasing values post-test are shown in blue and decreasing values are shown in red. n number of the patients, STAI state trait anxiety index, DCS decision conflict scale, BCI Breast Cancer Index

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