Longer Survival of Metastatic Prostate Cancer
Patients Using Docetaxel Prompts Data Release
Three-year survival rate of 69
percent when chemotherapy drug docetaxel given at start of standard
Dec. 6, 2013 - Men with
hormone-sensitive metastatic prostate cancer who received the
chemotherapy drug docetaxel at the start of standard hormone therapy
lived longer than patients who received hormone therapy alone. Due to
the success the results were released early from the National Institutes
of Health-supported randomized controlled clinical trial.
The independent Data and Safety
Monitoring Committee overseeing the trial recommended to the National
Cancer Institute (NCI), part of NIH, that the study results be made
public because a recent planned interim analysis showed the prolongation
in overall survival. Full details from this early analysis will be
presented at a scientific meeting in 2014 and in a peer-reviewed
The study enrolled 790 men with
metastatic prostate cancer between July 2006 and November 2012 in a
trial known as E3805. All patients started treatment by receiving a form
of hormone therapy known as ADT (androgen deprivation therapy).
Androgens regulate male sex characteristics and can stimulate prostate
Men received either ADT alone or
ADT with the chemotherapy drug docetaxel every three weeks over a period
of 18 weeks.
In addition to examining whether
the study participants lived longer with the addition of chemotherapy,
investigators looked at whether the extent of a patient’s metastatic
disease was high or low at the start of treatment. Approximately two
thirds of patients had a high extent of disease which, according to the
study, meant the disease had spread to major organs such as the liver,
had a spread resulting in four or more bone lesions, or both.
A significant improvement in the
overall survival was noted favoring the participants who had received
docetaxel chemotherapy in addition to the ADT compared to the ADT alone
(three-year survival rates of 69.0 percent vs. 52.5 percent
Further analysis showed that
patients with a high extent of metastatic disease accounted for most of
the benefit in the overall survival from docetaxel plus ADT (three-year
survival rates of 63.4 percent vs. 43.9 percent for ADT alone). Median
follow-up to date is two years.
Since docetaxel has been shown in
previous clinical trials to be beneficial in ADT-resistant disease and
is approved by the U.S. Food and Drug Administration for treatment of
late-stage prostate cancer, it is available for use now.
However, because it is a
chemotherapy drug associated with some toxicities, its use in
combination with ADT at this time should be restricted to patients with
high-extent metastatic prostate cancer who are candidates for treatment
with docetaxel, according to the trial investigators.
This is the group of patients who
experienced the most benefit in the current analysis. Further follow-up
will be performed on patients with less extensive metastatic disease who
participated in E3805 in order to define the effect of this treatment
combination on these patients.
“The results of this study are
practice-changing,” said lead investigator Christopher Sweeney, Dana
Farber Cancer Institute, Boston.
“We have strong scientific evidence
that patients with the most advanced metastatic prostate cancer benefit
from the early addition of docetaxel to ADT and not waiting until the
cancer has progressed on hormonal therapy. The findings of this study
are important both for improving the clinical care we deliver now and in
designing new clinical trials as we strive to further improve the lives
of men with metastatic prostate cancer.”
E3805 was sponsored by NCI and was
designed and conducted by the ECOG-ACRIN Cancer Research Group in
collaboration with SWOG, Alliance for Clinical Trials in Oncology, and
NRG Oncology. Sanofi, Paris, the drug manufacturer, provided the
docetaxel and supported this study under a Clinical Trials Agreement
“This trial would not have been
done in the United States without a large national network of
investigators brought together through the NCI-supported Cooperative
Group program that was capable of rapidly enrolling many patients,” said
Jeff Abrams, M.D., clinical director of NCI’s Division of Cancer
Treatment and Diagnosis.
“Additionally, these findings are
an example of how combining two approved and available treatments can
produce a significant improvement in clinical outcome.
It is estimated that over 238,000
men will be diagnosed with prostate cancer in the United States in 2013
and over 29,000 men will die of the disease.
NCI leads the National Cancer
Program and the NIH effort to dramatically reduce the prevalence of
cancer and improve the lives of cancer patients and their families,
through research into prevention and cancer biology, the development of
new interventions, and the training and mentoring of new researchers.
For more information about cancer,
please visit the NCI website at
http://www.cancer.gov or call NCI's Cancer Information Service at
About the National Institutes of Health (NIH):
NIH, the nation's medical research agency, includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and Human
Services. NIH is the primary federal agency conducting and supporting
basic, clinical, and translational medical research, and is
investigating the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit
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