Evidence Grows that Observation is Safe, Cost
Effective for Low-Risk Prostate Cancer Patients
Study focused on men age 65 to 75 when diagnosed; 70%
of prostate cancer is low-risk, but 60% of these get treatment
June 18, 2013 - Many men with low-risk, localized
prostate cancers can safely choose active surveillance or “watchful
waiting” instead of undergoing immediate treatment and have better
quality of life while reducing health care costs, according to a study
by researchers at Dana-Farber Cancer Institute and Massachusetts General
Writing in the June 18 issue of the Annals of
Internal Medicine, the authors said their statistical models showed that
“observation is a reasonable and, in some situations, cost-saving
alternative to initial treatment” for the estimated 70 percent of men
whose cancer is classified as low-risk at diagnosis.
The researchers, led by
Julia Hayes, MD, a
medical oncologist in the
Lank Center for Genitourinary
Oncology at Dana-Farber, said their findings support
observation - active surveillance and watchful waiting - as a reasonable
and underused option for men with low-risk disease.
“About 70 percent of men in this country have
low-risk prostate cancer, and it’s estimated that 60 percent of them are
treated unnecessarily” with various forms of radiation or having the
disease removed with radical prostatectomy surgery, said Hayes, who is
also a senior scientist at MGH’s Institute for Technology Assessment.
clinical trial called PIVOT reported that such men had about the same
small risk of death over a 12-year period whether they underwent radical
prostatectomy or simply observation.
Hayes and her co-authors created mathematical
models to construct a variety of scenarios, focusing on men ages 65 or
75 at diagnosis, and including estimated costs associated with treatment
and different forms of observation.
In active surveillance (AS), patient undergo blood
tests for prostate specific antigen (PSA) every three months, rectal
examinations every six months, and a prostate gland biopsy at one year
and then every three years. If the tests find the cancer is more
aggressive than originally thought, the patients begin treatment aimed
at curing the disease. “This approach could also be described as
deferred treatment,” said Hayes.
A patient who chooses watchful waiting (WW) is
observed without intensive monitoring and is given palliative treatment
when the cancer becomes symptomatic.
Treatments for low-risk prostate cancer include
radical prostatectomy, intensity-modulated radiation therapy (IMRT) or
brachytherapy (radioactive seed implants.)
The investigators calculated the quality-adjusted
life expectancy, or QALE, for the different strategies. (QALE takes into
account both the years of life gained and factors that reduce quality of
life, such as undergoing invasive tests, the impact of treatment and
complications, and disease recurrence.) The researchers also estimated
the lifetime costs of each strategy, which ranged from $18,302 for
watchful waiting for men aged 75 to $48,699 for a 65-year-old patient
treated with IMRT therapy.
Bottom line result
The bottom line result was that observation was
more effective and in some cases less costly than initial treatment for
low-risk prostate cancers. Watchful waiting yielded 11 months additional
QALE over brachytherapy – the most effective treatment – and 13 months
additional QALE over radical prostatectomy, the least effective
Hayes acknowledged that the study made assumptions
based on limited research data on these issues. Nevertheless, “it
appears that active surveillance and watchful waiting are safe
alternatives to initial treatment for prostate cancer based on these
assumptions. But it’s important to emphasize that these decisions are
very much a matter of individual choice.”
Philip Kantoff, MD,
director of the Lank Center for Genitourinary Oncology at Dana-Farber
and a professor of medicine at Harvard Medical School, commented: “This
study delineates the cost benefit of active surveillance as well as
watchful waiting - the less aggressive assessment strategy.
“A previous study by Dr. Hayes and colleagues
demonstrated that active surveillance is a reasonable option for men
with low-risk disease and associated with a better quality of life,”
Kantoff added. “As non-treatment becomes a more accepted option for
these patients, selecting those who require less aggressive assessment
including biopsy will become important.”
The study’s senior author is Pamela McMahon, PhD,
at MGH’s Institute for Technology Assessment. Others include Daniel
Ollendorf, MPH, and Steven Pearson, MD, MSc, of the Institute for
Clinical and Economic Review; Michael Barry, MD, of MGH; and Pablo Lee,
BS, of MGH’s Institute for Technology Assessment.
The research was supported by National Cancer
Institute grant CA92203-08, Department of Defense grant W81XWH-09-0512,
and a grant from the Prostate Cancer Foundation.
About Dana-Farber Cancer Institute
Dana-Farber Cancer Institute (www.dana-farber.org)
is a principal teaching affiliate of the Harvard Medical School and is
among the leading cancer research and care centers in the United States.
It is a founding member of the Dana-Farber/Harvard Cancer Center,
designated a comprehensive cancer center by the National Cancer
Institute. It provides adult cancer care with Brigham and Women’s
Hospital as Dana-Farber/Brigham and Women’s Cancer Center and it
provides pediatric care with Boston Children’s Hospital as
Dana-Farber/Boston Children’s Cancer and Blood Disorders Center.
Dana-Farber is the top ranked cancer center in New England, according to
U.S. News & World Report, and one of the largest recipients among
independent hospitals of National Cancer Institute and National
Institutes of Health grant funding. Follow Dana-Farber on Facebook:
www.facebook.com/danafarbercancerinstitute and on Twitter: @danafarber.
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