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.