Genomic Health, Inc.
GHDX today announced strongly positive results from an additional
independent clinical validation study of the Oncotype DX® prostate cancer
test, conducted in collaboration with the Uniformed Services University of the
Health Sciences' (USU) Center for Prostate Disease Research (CPDR) supported
by a multi-disciplinary team of investigators under a cooperative research and
development agreement with USU. This new large study reconfirmed the
biopsy-based test's Genomic Prostate Score (GPS) as a predictor of adverse
pathology at surgery and, for the first time, validated GPS as a strong
independent predictor of a rise in prostate-specific antigen (PSA) following
surgery (biochemical recurrence). In meeting these two endpoints, the Oncotype
DX prostate cancer test provides both clinically actionable and long-term
outcomes information for men with newly diagnosed low- and intermediate-risk
prostate cancer. Furthermore, the study demonstrated that Oncotype DX is
similarly predictive of outcomes in both Caucasian and African-American men.
The key results of this large prospectively-designed study in 402 patients are
based on the CPDR multi-center national database, which has tracked men
treated for prostate cancer within the Department of Defense healthcare
system since 1990, and showed:
o The biopsy-based Oncotype DX GPS was a robust and independent measure of
multiple clinically relevant endpoints, including adverse surgical
pathology (p<0.001) and long-term risk of biochemical recurrence after
surgery (p<0.001);
o The Oncotype DX GPS was very similarly predictive of outcomes in Caucasian
and African-American men regardless of their race. African-American men
represented 20 percent of this study's patient population;
o The established multiple prostate cancer-specific pathways contributed to
the robust predictive value of the Oncotype DX GPS.
The Oncotype DX GPS was also significantly predictive of metastatic prostate
cancer recurrence (p = 0.032), a notable finding given the likelihood of
metastases in patients with low- and intermediate-risk prostate cancer is so
small.
"There is a clear need for more accurate risk stratification and treatment
optimization of men with newly diagnosed prostate cancer," said senior author
David McLeod, M.D., director of CPDR and a professor of Surgery at USU. "Our
rigorously conducted study provides further validation of the earlier studies
at Cleveland Clinic and University of California, San Francisco, which showed
the Oncotype DX prostate cancer test is an independent predictor of clinical
outcomes to inform decisions regarding active surveillance versus immediate
treatment in patients with low- and intermediate-risk disease."
In this study, GPS results were obtained using archival biopsy tumor tissue
from 402 men, including 82 African-American patients, treated with radical
prostatectomy for NCCN very low-, low- or intermediate-risk prostate cancer at
two U.S. military medical centers between 1990 and 2012. The analysis showed
that GPS distribution was very similar between African-American and Caucasian
patients. Additionally, specific gene groups incorporated in GPS – androgen
signaling and stromal response – were more strongly associated with
biochemical recurrence, while all four biologic pathways measured by GPS were
significant predictors of adverse pathology.
The CPDR is a multi-disciplinary prostate cancer research program of the
Department of Surgery at USU, the U.S. Department of Defense's federal health
sciences university. The center is a collaboration with The Henry M. Jackson
Foundation for the Advancement of Military Medicine, Inc., a private,
not-for-profit organization authorized by Congress to support medical
research and education at USU.
Developed and validated in collaboration with the University of California,
San Francisco and Cleveland Clinic, the Oncotype DX prostate cancer test
addresses the unique challenges in making treatment decisions for men with
low-risk, clinically localized prostate cancer by identifying patients who can
consider active surveillance with greater confidence and thus avoid
unnecessary treatment, as well as those men who have more aggressive disease
and should consider immediate treatment. This genomic test measures the level
of expression of 17 genes across four biological pathways to predict prostate
cancer aggressiveness. It provides a GPS result on a scale that ranges from 0
to 100, and is combined with other clinical factors to further clarify a man's
risk prior to treatment intervention.
"This new landmark study reconfirms the clinical validity of the Oncotype DX
prostate cancer test and adds to the recently published UCSF and Cleveland
Clinic studies," said Phil Febbo, M.D., chief medical officer, Genomic Health.
"These new results provide the first validation of our test's ability to
predict biochemical recurrence and a second, independent validation of its
ability to predict adverse pathology. By measuring biology associated with
both near- and long-term outcomes, the test provides important and
practice-changing information to patients and physicians."
Additional Oncotype DX data presented at the ESMO 2014 Congress included
previously presented studies in breast and renal cancers, highlighting further
evidence of the impact of the Oncotype DX test in breast cancer treatment
across multiple health care systems and the importance of assessing multiple,
disease relevant, biological pathways to predict tumor behavior and the best
course of treatment.
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