Excess Mortality Seen Among Prostate Cancer Patients on Long Term Androgen
Deprivation Therapy: Presented at ASTRO
By Ed Susman

PHILADELPHIA, PA -- November 9, 2006 -- In a surprise finding, a
retrospective study suggests long-term use of anti-male hormone drugs
increase the risk of mortality among patients who were at high risk for
recurrence of prostate cancer, doctors said here at the American Society of
Therapeutic Radiology and Oncology (ASTRO) 48th annual meeting.

"More than 6 months' treatment with these androgen deprivation drugs appears
to double the risk of mortality in these patients," said Cliff Robinson, MD,
resident in oncology, The Cleveland Clinic, Cleveland, Ohio.

Dr. Robinson and colleagues reviewed the charts of 579 men treated for
prostate cancer at the Cleveland Clinic between the years 1998 and 2003.

"Specifically, we were looking for ways to improve outcomes of high risk
patients," said study co-author Chandama Reddy, MS, biostatistician, The
Cleveland Clinic. "We weren't looking to find something wrong with
anti-hormone treatment, but these numbers just jumped out."

Dr. Robinson said that the 5-year survival after definitive treatment for
prostate cancer among the 153 high-risk individuals who had not received any
post-procedure treatment was 92%.

Among the 351 patients who received anti-hormone treatment for 1 to 6
months, the survival rate was also 92%. But among the 74 patients who took
the anti-hormone treatment for longer than 6 months, the survival was 76% (P
= .0007). "That's a significant difference," Dr. Robinson said.

In addition, Jay Ciezki, MD, staff physician, The Cleveland Clinic, and
another co-author of the study, said that with or without hormone therapy
there did not appear to be any impact on prostate cancer recurrence.

The group's poster was presented November 8th.

Patients in the study had all undergone surgery to remove the prostate or
radiation therapy to kill the cancer, either with external beam radiation
sources or brachytherapy, the insertion of radioactive pellets into the
prostate gland.

Before any treatment was performed, the men who were considered to be at
high risk for prostate cancer recurrence had to have the following: a
prostate specific antigen (PSA) level higher than 20 ng/mL; a cancer that
was judged by pathologists to be highly aggressive; or cancer that had
already extended through the wall of the prostate. They could also be judged
at high risk if they had both a PSA score of 10 ng/mL and a moderately
aggressive cancer.

The Cleveland Clinic researchers are now looking to determine the cause of
death of the study patients to determine if the use or lack of use of the
monthly injections of androgen deprivation drugs prevents prostate cancer
deaths, Dr. Robinson said.

[Presentation title: Greater Than 6 Months of Androgen Deprivation Therapy
Does Not Improve Overall Survival for High-risk Prostate Cancer Patients
Treated with Radiotherapy or Prostatectomy. Abstract