New England Journal of Medicine publishes
positive results from one of the largest-ever adjuvant breast
cancer trials
TORONTO, Sept. 28, 2015 /CNW/ - Genomic Health today
announced the presentation of the first
results[i] from
the Trial Assigning IndividuaLized Options for
Treatment (Rx), or TAILORx, a large, multicentre, prospectively
conducted trial, including Canadian patients, sponsored by the
U.S. National Cancer Institute (NCI). The study
demonstrated that a group of early-stage breast cancer patients
with low Oncotype DX Recurrence Score results of 10 or
less who received hormonal therapy alone without chemotherapy had
less than a one percent chance of distant recurrence at five
years.
Presented at the 2015 European Cancer
Congress (ECC2015), results from a group of 1,626 patients
with a Recurrence Score result between 0 and 10 demonstrated that
99.3 percent of node-negative, estrogen receptor-positive,
HER2-negative patients who met accepted guidelines for recommending
chemotherapy in addition to hormonal therapy had no distant
recurrence at five years after treatment with hormonal therapy
alone. Outcomes were excellent irrespective of patient age, tumour
size, and tumour grade.
"TAILORx is a unique, large breast cancer trial that provides us
with information no other trial to date has offered," said
Kathleen Pritchard, MD, senior
scientist, Sunnybrook Health Sciences Centre in Toronto. "The
results of this trial highlight the clinical utility of Oncotype DX
and provide physicians and patients with greater confidence in
using this test to make chemotherapy treatment decisions."
The trial enrolled 10,273 patients across 1,182 sites and major
cancer centres in six countries, including Canada. TAILORx
used the Oncotype DX test on every patient to quantify
individual risk of recurrence in order to assign the appropriate
treatment. This study is evaluating the effect of chemotherapy only
for those with a mid-range Recurrence Score result, as previous
Oncotype DX studies have already confirmed the benefit
of adjuvant chemotherapy for those in the high Recurrence Score
range and minimal, if any, benefit for those in the low Recurrence
Score range. The data safety monitoring board of the trial, as
mandated by the study protocol, will continue to monitor outcomes
in patients with a Recurrence Score result of 11 to 25 randomized
to chemo-endocrine therapy or endocrine therapy alone.
"To date, more than 170,000 breast cancer patients have changed
their treatment decision based the Oncotype DX test. Many of
these women who received high Oncotype DX scores were able to
choose chemotherapy as a potentially life-saving treatment, while
the majority were able to effectively pursue hormonal therapy alone
and avoid the unnecessary side-effects of chemotherapy," said
Steven Shak, M.D., chief scientific
officer, Genomic Health. "The rigorous TAILORx trial led by
ECOG-ACRIN provides level 1A evidence supporting Oncotype DX as the
only multigene expression assay that can identify the tens of
thousands of patients each year who can effectively forego
chemotherapy."
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
early-stage cancer, one of the greatest issues in healthcare today.
The company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of massive
amounts of genomic data into clinically-actionable results for
treatment planning throughout the cancer patient's journey, from
diagnosis to treatment selection and monitoring. 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 to the benefits of the test to
physicians, patients and payers. 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 ability of test
results to change treatment decisions; the risks and uncertainties
associated with the regulation of the company's tests; the results
of clinical studies; the applicability of clinical study results to
actual outcomes; 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; 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 quarterly report on
Form 10-Q for the year ended June 30,
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,
Recurrence Score, and DCIS Score are trademarks or registered
trademarks of Genomic Health, Inc. All other trademarks and service
marks are the property of their respective owners.
SOURCE Genomic Health, Inc.