SAN DIEGO, June 5, 2017 /PRNewswire/ -- Biotheranostics, Inc. today announced new data further demonstrating the importance of BCI in clinical practice. In a study of more than 14,000 cases, the largest patient study for BCI, BCI identified 31.5% of patients with node-negative (LN-) breast cancer – those who are typically considered at lower risk for recurrence and who may not be recommended for extended endocrine therapy (EET) – as high risk of recurrence and high likelihood of benefit from an additional 5 years of therapy. Conversely, the study also identified 16% of node positive (LN+) patients who are typically considered at higher risk of recurrence and likely to be recommended extended therapy as low risk of recurrence between years 5-10 and low likelihood of benefit from extended endocrine therapy. A separate study of the BCI database stratified patients by age, and demonstrated that in patients aged 75 or older, for whom treatment considerations are often more complex, BCI identified similar rates of patients with HR+, LN–breast cancer as having high vs. low risk of late distant recurrence and high vs. low likelihood of benefit from EET.

The studies are being presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago this week.

"These clinical experience studies further underscore that BCI is an important tool to help physicians to better personalize EET recommendations -- informing patient selection for extended therapy, while potentially minimizing exposure to unnecessary side effects and toxicities for the patients who are at low risk of late distant recurrence and low likelihood of benefit from EET," said Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics.

In the largest BCI patient study to date (n=14,463), researchers evaluated data from the BCI Clinical Database for Correlative Studies – a de-identified database that contains more than 50 data points including tumor size, grade, LN status, and BCI results. The analysis was specifically designed to better understand how physicians are using BCI in the clinic, and to affirm its use across the patient spectrum. Of the patient cases evaluated, the median age was 58.2 years. 47 cases were Stage I, and the majority of cases had Grade 1 (29%) or Grade 2 (51%) tumors. Like previously presented BCI data, the study demonstrated that more than 30% of node negative patients were classified as high risk of late distant recurrence.

In consideration of the complexities of treating older patients, a second study compared cases of older patients (≥75y) vs. younger patients. Consistent with previous studies of BCI, BCI identified 31.9% of these patients who would typically be considered low risk and not prescribed extended endocrine therapy, as high risk of late distant recurrence and high likelihood of benefit from EET.

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