Studies Presented at 2015 ASCO Meeting Demonstrate Predictive Power of bioTheranostics’ Breast Cancer Index℠ Molecular Te...
May 30 2015 - 8:00AM
Business Wire
Ability to Predict Benefit from Extended
Endocrine Therapy Impacts Treatment & Reduces Patient
Anxiety
bioTheranostics, Inc., today announced results from studies
being presented at the 2015 American Society of Clinical Oncology
(ASCO) meeting reinforcing the role its Breast Cancer IndexSM (BCI)
molecular test plays in informing decisions about extending
endocrine therapy beyond five years post-diagnosis for patients
with early stage, estrogen receptor-positive (ER+) breast cancer.
The meeting runs May 29–June 2, 2015, in Chicago.
In the first prospective trial investigating the impact of BCI
in clinical practice, BCI results led to changes in treatment
decisions in 27 percent of patients tested, and significantly
reduced patient anxiety regarding decisions about whether to extend
endocrine therapy to 10 years. Other studies further clarify the
role of BCI in informing treatment decisions in clinically relevant
subsets of patients (e.g., HER2 positive patients) and at various
time points along patients’ breast cancer journeys. In addition,
new predictive data from the TransATAC randomized trial cohort
build on the test’s predictive ability with tamoxifen shown in an
adjuvant setting (Stockholm randomized trial cohort), and aromatase
inhibitors in the extended endocrine treatment setting (MA-17
randomized trial cohort).
Nicolas Barthelemy, president and CEO of bioTheranostics, said
these milestone studies demonstrate how the prognostic and
predictive powers of BCI influence important decisions about
duration of endocrine treatment. “BCI is a unique predictive
indicator of endocrine therapy benefit with growing evidence of
utility across both the adjuvant and extended settings. It also has
been shown to identify a higher risk of recurrence and an increased
likelihood of benefit from extended endocrine therapy in some
patients who would be considered low risk using traditional tools.
Taken together, these studies continue to show that BCI provides
critical information about patient biology that translates into
more individualized treatment recommendations and improved patient
care.”
Yale Study Reveals Impact of BCI on Extended Endocrine
Treatment Decisions
In a prospective study of the decision-making impact of BCI led
by Yale University Smilow Cancer Hospital, researchers evaluated
how BCI testing in patients with early stage ER+ breast cancer
impacted the decision of whether to extend endocrine therapy to 10
years versus five years. Integration of BCI led to change in
treatment recommendations for 27 percent of patients, with a
majority of changes based on identification of patients with low
risk of late recurrence and low likelihood of benefit from extended
endocrine therapy. Extended therapy was recommended for 75 percent
of patients pre-testing and 55 percent post-testing. The study also
demonstrated that patient satisfaction increased and patients
experienced significantly less anxiety and conflict with treatment
decisions when BCI testing was incorporated. The study (abstract
No. 538) is being presented as a poster May 30.
BCI Predicted Benefit of Anastrozole Versus Tamoxifen
In a retrospective study of patients from the prospective,
randomized TransATAC trial, BCI Predictive was compared with
quantitative estrogen receptor, progesterone receptor, and human
epidermal growth factor receptor 2 (HER2) expression in assessing
the ability to predict benefit from anastrozole versus tamoxifen in
742 patients treated with five years of adjuvant endocrine therapy.
Only BCI predicted differential benefit of anastrozole versus
tamoxifen. These results support the test’s generalizability as a
biomarker of benefit from endocrine therapies. The study (abstract
No. 526) is being presented as a poster May 30.
Clinical Utility of BCI in Clinical Practice
A large retrospective analysis in collaboration with Beth Israel
Medical Center showed the clinical utility of BCI to stratify
patients based on risk of late recurrence and likelihood of benefit
from extended endocrine therapy. Results showed that there was
pronounced use of the test approaching the five-year anniversary,
but also substantial use both earlier and later than the
anniversary. In this large, real-world study, BCI identified a
majority of patients as having a low likelihood of benefit from
extended endocrine therapy. Notably, however, in the subset of
patients who would be considered low risk by clinicopathologic
criteria and who may have been less likely to be recommended
extended endocrine therapy, BCI identified a substantial number as
having a higher risk of recurrence and high likelihood of
benefitting from extended therapy. The study (abstract No. 545) is
being presented as a poster May 30.
Predicting Benefit from Extended Endocrine Therapy in
HER2+/HR+ Patients
A study done in conjunction with the University of Wisconsin
School of Medicine investigated BCI results in patients with HER2+
versus HER2- early stage breast cancer. BCI classified a higher
proportion of HER2+ patients as having high risk for late
recurrence and a high likelihood of benefit from extended endocrine
therapy compared with HER2- patients. This indicates that a higher
proportion of HER2+ patients could be offered extended endocrine
treatment. The study (abstract No. 595) is being presented as a
poster May 30.
About BCI
BCI is a molecular, gene expression-based test uniquely
positioned to identify patients best suited for extended
endocrine treatment. It is the only validated, commercially
available test that provides prognostic risk of late recurrence
(5-10 years post-diagnosis), as well as prediction of extended
endocrine therapy benefit. 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. BCI was granted
Medicare coverage in October 2014.
About bioTheranostics
bioTheranostics, Inc., is a leader in helping physicians improve
the care of cancer patients, offering a suite of proprietary
molecular diagnostic tests that allow treatment to be tailored to
individual patients. The company’s Breast Cancer IndexSM helps
oncologists make difficult decisions about extended endocrine
therapy for ER+ breast cancer patients beyond five years. Its bioT3
Metastatic Cancer Solution combines accurate diagnosis with
comprehensive biomarker information that allows improved treatment
for metastatic cancer patients. bioTheranostics, a bioMérieux
company, is based in San Diego. For more information, visit
www.biotheranostics.com or www.AnswersBeyond5.com. Follow BCI on
Twitter at @AnswersByond5.
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Sullivan & AssociatesBarbara Sullivan,
714-374–6174bsullivan@sullivanpr.com