Abstract P2-09-15: A multi-institutional, prospective study of incorporating the genomic platform breast cancer index as a tool for decision-making regarding extension of adjuvant endocrine therapy
Authors: Sanft T , Berkowitz A , Schroeder B , Hatzis C , Schnabel C , Aktas B , Brufsky A , Pusztai L , vanLonden GJ 
Published: March 2017

Abstract
Background: Extending adjuvant endocrine therapy (AET) for hormone responsive breast cancer (HRBC) from 5 to 10 years is beneficial for many in preventing late relapse. Current decision-making regarding extension relies on a decision-making process that weighs non-personalized recurrence risks against risks and benefits of extended AET. The Breast Cancer Index (BCI, BioTheranostics Inc) has been validated to quantify the risk of late recurrence and to predict likelihood of benefit from AET extension based on an individual's tumor genomic profile. The purpose of this study was to conduct a multi-institutional study to prospectively assess the impact of BCI i) on provider's recommendation using the BCI results; 2) the confidence with decision-making; and 3) patient's satisfaction regarding extension of AET.
Methods: Patients with stage I-III HRBC treated at Yale Cancer Center and University of Pittsburgh Medical Center (UPMC), who had completed at least 3.5 years of AET were eligible. BCI was performed on FFPE samples from the original tumor sample (bioTheranostics Inc.). Patients and physicians completed pre- and post-test questionnaires examining preferences for extending AET, patients also completed anxiety and decision-conflict surveys.
Results: 140 patients [mean age 61, 80% postmenopausal, 73% stage I] were included. No extended AET was recommended for 35.3% patients' pre-testing. Reasons physicians did not recommend extended AET were perceived low risk of recurrence (87%), risk of osteoporosis (25%) and side effects (13%). Extended therapy was recommended for 65.7% patients pre-testing. Integration of BCI resulted in a change in physician treatment recommendation in 29% of patients. The recommendation for no extended AET rose to 48% and recommendation for extended AET dropped to 52% (OR=1.76 95% CI 1.08-2.85; p=.003). Of the recommendations that changed (N=41), the majority (73%) was for not extending endocrine therapy. However, 27% of recommendations were to extend endocrine therapy because of high risk or high likelihood of benefit results. More physicians felt strongly confident in their recommendation after the test result (26.4%) than before (9.3%) (OR= 3.5 95% CI 1.77-6.95; p&lt;.0001). Satisfaction of decision increased in 23% of patients (OR=2.72 95% CI 1.66-4.46; p&lt;.0001). Patient reported concerns including the cost, safety and benefit of extended AET decreased from pre- to post-testing (p=.025; p&lt;.0001; p=.0012 respectively)
Conclusions: Overall, incorporation of BCI into clinical practice resulted in significant changes in physician recommendations regarding AET duration, with the majority of recommendations for no extended AET. Physicians reported increased confidence for their recommendation when incorporating the test result. There was also a significant increase in patient satisfaction and decrease in patient reported concerns regarding cost, safety and benefit of extended AET. The BCI is a tool that could be incorporated into decision-making algorithms to enhance physician confidence and patient satisfaction with recommendations for extending AET.
Citation Format: Sanft T, Berkowitz A, Schroeder B, Hatzis C, Schnabel C, Aktas B, Brufsky A, Pusztai L, vanLonden GJ. A multi-institutional, prospective study of incorporating the genomic platform breast cancer index as a tool for decision-making regarding extension of adjuvant endocrine therapy [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-09-15.