VIENNA and PHILADELPHIA and REDWOOD CITY, Calif., Sept. 28, 2015 /PRNewswire/ -- Initial
results were announced today from the Trial Assigning
IndividuaLized Options for Treatment
(Rx), or TAILORx, a multi-center prospectively conducted
trial of more than 10,000 women with early stage breast cancer
sponsored by the National Cancer Institute (NCI), part of the
National Institutes of Health, and led by the ECOG-ACRIN Cancer
Research Group (ECOG-ACRIN) with support from Genomic Health, Inc.
The study demonstrated that a group of trial participants with low
21-gene recurrence score (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.
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This finding, published online today by the New England
Journal of Medicine, provides evidence that other women in the
future may effectively use hormonal therapy alone if the Recurrence
Score is 10 or less. Second primary cancers exceeded recurrences of
the original breast cancer, resulting in 93.8 percent five year
disease free survival, the primary trial endpoint.
These results, also presented at the 2015 European Cancer
Congress (ECC2015, abstract #5BA) today, which involve the group of
1,626 patients with a Recurrence Score between 0 and 10,
demonstrated that 99.3 percent of node-negative, estrogen receptor
(ER)-positive, human epidermal growth factor receptor 2
(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
at diagnosis, tumor size, and tumor grade.
TAILORx was designed and conducted by ECOG-ACRIN in association
with all of the cancer research groups of the NCI-sponsored
National Clinical Trials Network that address cancer in
adults; these include the Alliance for Clinical Trials in Oncology,
NCIC-Clinical Trials Group, NRG Oncology, and SWOG. Together, these
groups enrolled 10,273 patients across 1,182 sites in the United States and five additional
countries (Australia, Canada, Ireland, New
Zealand, and Peru).
"The compelling results seen in this global study provide
unequivocal evidence supporting the clinical utility of Oncotype DX
to risk-stratify patients with early stage breast cancer, and
indicate that the findings are generalizable to everyday clinical
practice," said lead author Joseph A.
Sparano, MD, vice-chairman of medical oncology at Montefiore
Einstein Center for Cancer Care, and professor of medicine and of
obstetrics, gynecology, women's health at Albert Einstein College
of Medicine.
Dr. Sparano continued: "This is the first prospectively
conducted clinical trial evaluating this assay—or any multigene
expression assay for that matter—in which patients with early stage
breast cancer were uniformly treated based on their assay results.
The findings provide the highest level of evidence supporting
expert-derived clinical practice guidelines which have recommended
Oncotype DX in patients with early stage ER-positive breast cancer.
The risk of developing a second primary cancer was about three-fold
greater than having a recurrence of the original breast cancer, but
we wouldn't expect chemotherapy to prevent these cancers from
developing. Further follow-up of the trial is ongoing to determine
whether chemotherapy may also be effectively spared in patients who
have a mid-range Recurrence Score between 11 and 25."
The trial used the Oncotype DX test on every patient to quantify
individual risk of recurrence in order to assign them to treatment.
This trial continues to evaluate the effect of chemotherapy only
for those with a mid-range Recurrence Score, as previous Oncotype
DX studies have already confirmed the benefit of adjuvant
chemotherapy for those in the high Recurrence Score
range.
In the TAILORx trial, women with a Recurrence Score of 10 or
less received hormonal therapy alone; women with a Recurrence Score
greater than 25 received hormonal therapy plus chemotherapy; and
those with a mid-range Recurrence Score from 11 to 25, the primary
study group, were randomized to receive hormonal therapy with or
without chemotherapy. The data safety monitoring board of the
trial, as mandated by the study protocol, continues to monitor
outcomes in patients with a Recurrence Score 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, MD, 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."
Oncotype DX is the only test that has been validated to predict
the likelihood of chemotherapy benefit and the only test
incorporated in all major international clinical guidelines
including those of the American Society of Clinical Oncology,
National Comprehensive Cancer Network, St. Gallen, and the European
Society of Medical Oncology.
"These findings will give women with early stage breast cancer
greater certainty that anti-estrogen therapy will decrease their
risk of recurrence and increase their chance for survival whereas
chemotherapy will not," said breast cancer survivor Mary Lou Smith, JD, MBA, who helped design the
study as a leader in the ECOG-ACRIN Cancer Research Advocates
Committee.
About the ECOG-ACRIN Cancer Research Group
The
ECOG-ACRIN Cancer Research Group is a membership-based scientific
organization that designs and conducts cancer research involving
adults who have or are at risk of developing cancer. ECOG-ACRIN
comprises nearly 1100 member institutions in the United States and around the world.
Approximately 12,000 physicians, translational scientists, and
associated research professionals from the member institutions are
involved in Group research, which is organized into three
scientific programs: Cancer Control and Outcomes, Therapeutic
Studies, and Biomarker Sciences. ECOG-ACRIN is supported primarily
through National Cancer Institute research grant funding, but also
receives funding from private sector organizations through
philanthropy and collaborations. It is headquartered in
Philadelphia, Pa. For more
information, visit www.ecog-acrin.org, call 215.789.3631, and
follow the organization on Twitter: @eaonc.
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, Calif.,
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 payors. 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.
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SOURCE Genomic Health, Inc.; ECOG-ACRIN Cancer Research
Group