Study confirms the test's ability to accurately predict
clinical outcomes, reinforcing the unique value of Oncotype DX as
the only multi-gene breast cancer test with prospective outcomes
evidence in more than 50,000 patients
GENEVA, March 11, 2016 /PRNewswire/ -- Genomic Health
today announced the presentation of new, five-year results from a
large outcomes study with the Oncotype DX test at the
10th European Breast Cancer Conference
(EBCC-10)1. Results from the PlanB study showed that 94
percent of women with early-stage breast cancer and Recurrence
Score® results of 11 or less, who were treated with
hormonal therapy alone, were still alive and disease-free five
years after diagnosis.
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PlanB is the first study which provides prospective data with
the Oncotype DX breast cancer test in patients with high clinical
risk of recurrence including those with node-positive disease (up
to three nodes). The study was conducted by the West German Study
Group (WSG) at 93 centres across Germany and is one of Europe's largest contemporary adjuvant breast
cancer trials.
"Our study shows the unique value of adding biologic information
provided by the Oncotype DX test in order to identify low-risk
breast cancer patients - among patients with 0-3 involved lymph
nodes - who can safely be spared the toxicity and side effects of
chemotherapy without compromising outcomes," said Prof.
Nadia Harbeck, WSG Scientific
Director and Head of the breast center at University of
Munich (LMU). "This is especially
important for patients who would be considered as intermediate to
high risk of recurrence based on traditional clinical parameters.
These results confirm previous retrospective studies with Oncotype
DX as well as the prospective TAILORx trial which already provided
results for the node-negative population."
The PlanB study enrolled more than 3,100 patients who were
considered candidates for chemotherapy by traditional parameters.
Participants with Recurrence Score results of 11 or less were
offered hormonal therapy alone, and patients with Recurrence Score
results of 12 or higher were randomised to different chemotherapy
regimens.
In women with Recurrence Score results of 11 or less who were
treated with hormonal therapy alone, five-year disease free
survival (DFS) was estimated as 94 percent after a median follow-up
of 55 months. Patients with Recurrence Score results of 12 to 25
who were treated with adjuvant chemotherapy also had high DFS rates
of 94 percent, while in patients with Recurrence Score results
above 25 who had also received chemotherapy, DFS rates were 84
percent.
Further analysis from PlanB shows that Recurrence Score results
provided independent value in addition to traditional
clinical-pathological markers such as tumour grade and size.
"Value in health care depends on results and outcomes, which are
vital to the patient. Results from this study clearly show the
benefit of a personalised approach to breast cancer treatment,"
said Denis Horgan, executive
director of the European Alliance for Personalised Medicine (EAPM).
"We hope to see more healthcare systems across Europe provide access to molecular diagnostics
that are supported by a high level of scientific evidence and
proven clinical utility."
These new PlanB study results with five-year outcomes provide
information beyond the three-year outcomes published recently in
the Journal of Clinical Oncology. The findings are
consistent with conclusions of the Trial Assigning
IndividuaLized Options for Treatment
(Rx), or TAILORx, published in The New England Journal of
Medicine. They add to an unprecedented body of evidence which
now includes prospective outcomes in more than 50,000 patients
across four large independently run international studies and
provide unequivocal evidence supporting the expert clinical
practice guidelines on the utility of Oncotype DX in node-negative
and node-positive early breast cancer beyond the standard measures
used alone for many years.
About the Oncotype DX test
The Oncotype DX
breast cancer test is the only genomic test validated for its
ability to predict the likelihood of chemotherapy benefit as well
as risk of recurrence in early-stage breast cancer.
Healthcare systems across Europe are recognising the value of the test,
which is incorporated in all major international clinical
guidelines. Following assessment and recommendation by NICE in
2013, the Oncotype DX test is now widely available to patients
across the UK. Other European countries that reimburse the test
include Switzerland, Ireland, Greece and Spain. To learn more about the Oncotype DX
test, visit: www.OncotypeDX.com
About Genomic Health
Genomic Health, Inc.
(NASDAQ: GHDX) is the world's leading provider of genomic-based
diagnostic tests that address both the overtreatment and optimal
treatment of cancer, one of the greatest issues in healthcare
today. With its Oncotype IQ™ Genomic Intelligence Platform, the
company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of clinical
and genomic big data into actionable results for treatment
planning throughout the cancer patient journey, from diagnosis to
treatment selection and monitoring. The Oncotype IQ portfolio
of genomic tests and services currently consists of the company's
flagship line of Oncotype DX gene expression tests that have been
used to guide treatment decisions for more than 600,000 cancer
patients worldwide. Genomic Health is expanding its test
portfolio to include additional liquid and tissue-based tests. The
company is based in Redwood City, California, with
international headquarters in Geneva, Switzerland. For
more information, please visit, www.GenomicHealth.com and
follow the company on Twitter:
@GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating the company's beliefs regarding
its liquid biopsy platform and the timing of a liquid biopsy test;
the company's intent to continue its investments in DCIS, prostate
cancer and international markets; the company's full year 2015
results; the attributes and focus of the company's product
pipeline; the ability of any potential tests the company may
develop to optimize cancer treatment; and the ability of the
company to develop and commercialize additional tests in the
future. Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially,
and reported results should not be considered as an indication of
future performance. These risks and uncertainties include, but are
not limited to: the risks and uncertainties associated with the
regulation of the company's tests; the results of clinical studies
and their impact on reimbursement and adoption; the applicability
of clinical study results to actual outcomes; the company's ability
to develop and commercialize new tests and expand into new markets
domestically and internationally; the risk that the company may not
obtain or maintain sufficient levels of reimbursement, domestically
or abroad, for its existing tests and any future tests it may
develop; the risks of competition; unanticipated costs or delays in
research and development efforts; the company's ability to obtain
capital when needed and the other risks set forth in the company's
filings with the Securities and Exchange Commission, including the
risks set forth in the company's yearly report on Form 10-K for the
year ended December 31, 2015. These
forward-looking statements speak only as of the date hereof.
Genomic Health disclaims any obligation to update these
forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX and
Recurrence Score are trademarks or registered trademarks of Genomic
Health, Inc. All other trademarks and service marks are the
property of their respective owners.
1Abstract no: 8 LBA. "Prospective WSG Phase III PlanB
trial: Clinical outcome at 5-year follow up and impact of 21 Gene
Recurrence Score result, central/local-pathological review of
grade, ER, PR and Ki67 in HR+/HER2- high risk node-negative and
–positive breast cancer", Friday, Plenary session: oral and late
breaking abstracts, 09.45-11.15 hrs, Elicium.