MedicalResearch.com Interview with:
Tara Sanft, MD
Assistant Professor of Medicine (Medical Oncology)
Medical Director of Adult Survivorship
Yale Cancer Center Survivorship Clinic
MedicalResearch.com: What is the background for this study?
Response: Previous studies have demonstrated the benefit of extended endocrine therapy (EET) for hormone receptor-positive (HR+) breast cancer in preventing late relapse, however that benefit is limited to 3-5% of women where late recurrence was prevented or staved off. However, EET has become common practice and as a result we are exposing many patients to risks of side effects and toxicities associated with anti-estrogen therapies when they may not be benefitting, and, conversely may not be treating the patients that might actually benefit. There is a real need to better identify the patients who are both at most risk of late distant recurrence, and most likely to benefit from EET.
This prospective study included 141 patients with a mean age of 62. In the study, 83% of patients were postmenopausal, 73% were stage I.
Breast Cancer Index (BCI) is a gene expression-based test and is the only currently available validated biomarker that is both prognostic for late distant recurrence and predictive for likelihood of benefit from EET. The purpose of this prospective 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.
MedicalResearch.com: What are the main findings?
Response: Key findings include:
- 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.
- With use of BCI, we were able to project cost savings of $5,190 per patient, 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.
MedicalResearch.com: What should readers take away from your report?
Response: These data showed that when incorporating BCI into the decision-making process for ER+ patients, physicians changed their treatment decisions in 30% of patients, and more physicians felt “strongly confident” in their recommendation after the test result than before.
It’s important that your readers understand the value of incorporating BCI into clinical practice – more confidence in treatment decisions for both the patient and the physician, and the potential to avoid recommending 5 more years of anti-estrogen therapy that may not be benefiting the patient, or conversely, ensuring those that stand to most benefit, receive the long-term treatment. BCI is important tool in the armamentarium.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future research will look to further validate the likelihood of response in other cohorts. Specifically, I think other future research should be focused on investigating if the BCI results influence compliance rates in those who go on to take EET. That has implications in recurrence as we know compliance drops off as time goes on.
Disclosures: I have served as a speaker and researcher for Biotheranostics, Inc., the maker of BCI.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
34th Annual Miami Breast Cancer Conference abstract discussing:
Use of Breast Cancer Index(SM) (BCI) Leads to Significant Changes in Physician Recommendations for Extended Endocrine Therapy in ER+ Breast Cancer Patients
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.