|
Taken from WWW.pubmed.gov
Int J Radiat Oncol Biol Phys 2008; 72(1 Suppl)
Mortality in Men Age 70 or more with Localized Prostate Cancer Treated with Brachytherapy
with or without Neoadjuvant Hormonal Therapy
Dosoretz AM, et al
Harvard
BOSTON, Sept. 24 -- For men older than 70 with prostate cancer, neoadjuvant hormone therapy before
brachytherapy with radioactive seeds increases the risk of death, a researcher said here.
Such a therapeutic approach led to a 20% increase in the risk of all-cause mortality, compared with men
who got radioactive seeds alone, according to Amy Dosoretz, M.D., of Harvard.
The finding is the second major piece of evidence that the therapeutic approach is risky in older men with early-stage
cancer, Dr. Dosoretz said at the American Society for Therapeutic Radiology and Oncology meeting here.
"In older patients it's very important to weigh the risks and benefits of hormone therapy when designing a
treatment plan," she said.
The new data came after a 2005 study that found an increased risk and another published a year later than did
not see the effect, she said.
To help clarify the matter, Dr. Dosoretz and colleagues looked at 1,709 men at least 70 years old who were
treated at centers in an oncology consortium in Boston, Connecticut, and Florida between 1991 and 2005.
They were treated with brachytherapy with or without anti-androgen therapy (916 versus 786) but no external
beam radiation was used. The median duration of hormone therapy, when it was used, was 3.5 months and
the median follow-up was five years.
After adjusting for a range of factors, including age, prostate-specific antigen level, Gleason score, and
T-category, the study found:
> Neoadjuvant hormone therapy was significantly associated with an increased risk of death
from any cause. The hazard ratio was 1.2, with a 95% confidence interval from 1.0 to 1.4,
which was significant at P =0.04.
> Increasing age was also associated with an increased risk, with a hazard ratio of 1.1, which was significant at P<0.001.
> Men whose disease had a Gleason score of seven or higher had a hazard ratio for death from any
cause of 1.2, which was significant at P=0.05.
While anti-androgen therapy has been known to cause a range of adverse events, including some involving the
cardiovascular system, Dr. Dosoretz said the available data don't allow her to say exactly what caused the
increased risk in her study.
The risks of anti-androgen therapy have become better understood over the past five years, and include bone
health, cardiac death, and development of the metabolic syndrome, said Robert Lee, M.D., of Duke, who
was not involved in the study.
He said the study was a confirmatory analysis, "but what we don't have is an understanding of why these
patients died."
He said physicians may have chosen the combined therapy to treat more aggressive cancer, perhaps leading to
an increased death rate, or the treatment itself might have caused the increased risk.
"The design of the study doesn't allow us to say with confidence one way or the other," he said.
"In my practice, what (the study) does is make it less likely to consider hormone therapy prior to
brachytherapy," Dr. Lee added.
The study "challenges the standard paradigm (and is) potentially practice-changing," added Louis Harrison,
M.D., of Beth Israel Medical Center in New York, who is chairman of ASTRO's board of directors and
was not involved in the study.
"It will make physicians think twice and maybe even a third time" before starting with hormone therapy
in such cases, he said.
|
