SAN DIEGO, Calif., March 9, 2017 – Results from a new multi-institutional study assessing the role of Breast Cancer IndexSM (BCI) in treatment decision-making for ER+ breast cancer patients who are considering extended endocrine therapy (EET) showed that when incorporating BCI into clinical practice, physicians made significant changes in their treatment recommendations. The analysis also projected cost savings of $5,190 per patient with use of BCI, driven by reduced recurrence in patients receiving EET and a reduction in treatment and toxicity costs for those who did not receive EET after BCI. BCI is the only currently available validated biomarker that is both prognostic for late distant recurrence and predictive for likelihood of benefit from EET.
“Though some studies have demonstrated some ER+ breast cancer patients may benefit from EET, the reality is that only 3-5% of patients showed benefit where late recurrence was prevented or staved off. That means because EET has become common practice, we’re unnecessarily exposing many patients to the increased toxicity associated with anti-estrogen therapies, and we also may not be treating the patients that might actually benefit,” said Tara Sanft, MD, lead author and Assistant Professor of Medicine and Medical Director of Adult Survivorship for the Yale Cancer Center Survivorship Clinic. “This analysis further demonstrates the value of BCI in helping physicians make treatment decisions they can be confident about, and the potential for tangible cost savings for patients.”
The study also assessed BCI’s impact on patient satisfaction and anxiety finding that 53% of patients felt “strongly confident” with their decision after BCI, versus 29% before the test. Additionally, among the patients for whom EET was recommended following BCI testing, 81% reported that they are more likely to be compliant with the prescribed therapy.
These data will be presented at the 34th Annual Miami Breast Cancer Conference, in Miami, Florida. BCI is developed and marketed by Biotheranostics, Inc., a pioneer in molecular diagnostics for cancer.
“BCI is an important tool in the decision-making process for ER+ breast cancer patients because it is prognostic and predictive, both assessing the risk of the cancer coming back, as well as the likelihood that the patient will benefit from EET,” Dr. Sanft continued. “These data show that beyond helping patients and doctors make informed treatment decisions, BCI makes patients feel better about those decisions because it lessens their anxiety and increases their confidence that they’ve made the right choice.”
The poster, “A multi-institutional, prospective decision impact study and health economic analysis of incorporating the Breast Cancer Index (BCI) genomic test as a tool for decision-making regarding extended adjuvant endocrine therapy (EET),” demonstrated the findings of a prospective study of 141 patients with a mean age of 62. In the study, 83% of patients were postmenopausal, 73% were stage I.
The purpose of the study was to assess the impact of BCI on physician EET recommendations, physician confidence, patient satisfaction, anxiety, and decision-conflict; and the cost impact of BCI. In the study, patients with stage I-III HR+ breast cancer who had completed >3.5 years of adjuvant endocrine therapy were eligible. BCI was performed on FFPE samples from the original tumor sample, patients and physicians were asked to complete a standardized pre- and post-test questionnaire examining preferences for EET. Patients also completed anxiety (STAI) and decision-conflict (DCS) surveys. A fact-based economic model was developed, integrating decision-impact data from the prospective study, to project the cost impact of BCI.
Integration of BCI test results impacted physician changes to treatment decisions in 30% of patients. The proportion of patients recommended for EET decreased from 65% to 52%, while those not recommended for EET rose from 35% to 48% (OR=6.37, 95% CI 2.91-13.95; p<.0001). More physicians felt “strongly confident” in their recommendation after the test result (27%) than before (9%) (OR=3.65, 95% CI 1. 14-11.68; p=.022). More patients felt strongly comfortable with their decision after the test result (53%) than before (29%) (OR=2.13, 95% CI 1.0014-4.55; p=.047). Of patients recommended for EET following BCI testing, 81% stated they are more likely to be compliant with prescribed therapy. BCI use was projected to result in net cost savings of $5,190 per patient tested. Cost savings were projected to be achieved through reduced recurrence in patients receiving EET and decreased drug costs and toxicities for patients who did not receive EET following BCI.
About Breast Cancer IndexSM
BCI is a molecular, gene expression-based test uniquely positioned to help identify patients best suited for extended endocrine treatment. It is the only validated, commercially available test with data demonstrating prognostic risk of recurrence out to 15 years, as well as prediction of likelihood of benefit from extended endocrine therapy (treatment in years 5-10). The breakthrough test helps oncologists and patients navigate the difficult trade-off between wanting to take steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to extended endocrine therapy. For more information, visit breastcancerindex.com.
Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary genomics-based molecular diagnostics that allow treatment to be tailored to individual patients. The company's Breast Cancer IndexSM and CancerTYPE ID® tests address a variety of unmet medical needs in the management of cancer patients, and extensive clinical studies have confirmed the accuracy, clinical validity, clinical utility, and cost-effectiveness of the tests. Biotheranostics operates a CLIA-certified, CAP-accredited diagnostic laboratory in San Diego. Learn more at biotheranostics.com.
BCI provides a quantitative assessment of the likelihood of distant recurrence in patients diagnosed with ER+ node-negative breast cancer, and prediction of likelihood of benefit from extended (>5 year) endocrine therapy in patients who are recurrence-free after an initial 5 years of adjuvant endocrine therapy. Treatment decisions require correlation with all other clinical findings. This test was developed and its performance characteristics determined by Biotheranostics, Inc. lt has not been cleared or approved by the U.S. Food and Drug Administration. This test is used for clinical purposes. lt should not be regarded as investigational or for research. How this information is used to guide patient care is the responsibility of the physician. Biotheranostics is certified under the Clinical Laboratory lmprovement Amendments of 1988 to perform high-complexity clinical laboratory testing.