Breast Cancer Index Identifies a Subset of Clinically Low Risk Patients Who May Require Longer Therapy

A recent publication in npj Breast Cancer reports that Breast Cancer Index (BCI), a genomic test performed by Biotheranostics, Inc., identifies patients with early-stage estrogen receptor-positive (ER+) breast cancer who are low risk by clinicopathological features that are at increased risk for late disease recurrence and are likely to benefit from an extension of endocrine therapy.

"To date, most treating oncologists agree that lymph node negative patients with T1-sized tumors less than 2 cm (T1N0) are generally regarded as having an overall favorable prognosis, and are often times not recommended for extended endocrine therapy," said Adam M. Brufsky, MD, PhD, Professor of Medicine, University of Pittsburgh Medical Center and co-author of the study. "However, this new study demonstrated that traditional clinicopathological factors of tumor size and lymph node status may not provide the resolution offered by genomic tools to identify more women at risk of late recurrence and in need of continued therapy. These recent results indicate that Breast Cancer Index can help identify up to 25 percent of patients in this low clinicopathological risk category as being at a high genomic risk of late recurrence who may likely benefit from extended endocrine therapy."

Dr. Brufsky, who is also the medical director of the Women's Cancer Center at Magee-Womens Hospital of UPMC, has served as a paid consultant for Biotheranostics.

A multi-institutional, international group of Investigators conducted analyses of nearly 500 patients from two cohorts with a clinical outcome where the risk of distant recurrence was assessed specifically in lymph node negative patients with small tumors (T1N0) -- features that have traditionally been associated with a low risk of disease relapse.

In this study, BCI identified 32 percent and 36 percent of T1N0 patients within the two cohorts as high risk of late recurrence despite their small tumors size. Distant recurrence free survival (DRFS) of T1N0 patients between years 5-15 were significantly stratified by BCI (88 percent DRFS for BCI High-Risk vs. 95 percent for BCI low risk, P
In these cohorts, ~25 percent of patients classified as high risk by BCI had the smallest of the tumors evaluated, T1a/b, less than one centimeter.

"These analyses further support the growing understanding that tumor biology provides potentially meaningful information to individualizing patient care," added Catherine Schnabel, Ph.D., Chief Scientific Officer, Biotheranostics, Inc. "The data suggest that adding Breast Cancer Index to traditional clinical and pathological factors to assess prognosis as well as identify patients who may benefit from continued therapy, could be the difference between lasting remission and tumor recurrence for as many as one in every three early stage patients with ER+ tumors."

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 a prognostic risk of recurrence out to 15 years, as well as prediction of the 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.

Biotheranostics, Inc., is a leader in helping physicians improve the care of cancer patients, offering a suite of proprietary genomics-based molecular diagnostics that provide information to allow physicians to tailor treatment 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.