New research suggests that two months of "androgen deprivation" therap

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c palmer - 04 Jan 2008 07:56 GMT

Posted: January 3, 2008NEW YORK

(Reuters Health) - New research suggests that two months of "androgen
deprivation" therapy, which reduces levels of the androgen, a male
hormone, can help slow the growth of locally advanced prostate cancer
when given before and during radiotherapy. Plus, the short course of
androgen deprivation therapy does not increase the risk of death from
cardiovascular disease, which had been a concern.

"The benefits of short-term hormonal therapy for men receiving radiation
therapy for prostate cancer far outweigh the risks," lead author Dr.
Mack Roach, from the University of California at San Francisco, said in
a statement.

As reported in the Journal of Clinical Oncology, the researchers
assessed the outcomes of 456 men with prostate cancer who were randomly
assigned to receive radiotherapy alone or in combination with androgen
deprivation therapy.

The androgen deprivation therapy included goserelin (every 4 weeks) and
flutamide (3-times daily) given before and during radiotherapy.

The overall survival rates after 10 years were 43 percent with the
combination regimen and 34 percent with radiotherapy alone; the
corresponding average survival times were 8.7 and 7.3 years. Still, the
authors point out that none of these differences were statistically
significant.

The combination therapy, however, did result in a statistically
significant improvement in mortality from prostate cancer after 10
years, at 23 percent compared with 36 percent in the radiation
therapy-only group.

The rates of metastatic disease -- cancer spread to distant parts of the
body -- (35 percent vs. 47 percent) and disease-free survival (11
percent vs. 3 percent) were also significantly improved in the
combination therapy group.

Furthermore, adding androgen deprivation therapy to radiotherapy did not
increase the risk of death from cardiovascular disease, the findings
indicate.

"While four months of hormonal therapy isn't enough to cause significant
side effects, we found that it can delay the development of bone
metastasis by as many as 8 years, which is very significant," Roach
stated.

knowledge is power - growing old is mandatory - growing wise is optional
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc

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J - 04 Jan 2008 19:33 GMT

> Posted: January 3, 2008NEW YORK
>
[quoted text clipped - 42 lines]
> metastasis by as many as 8 years, which is very significant," Roach
> stated.

http://jco.ascopubs.org/cgi/content/abstract/JCO.2007.13.9881v1
JCO Early Release, published online ahead of print Jan 2 2008
Journal of Clinical Oncology, 10.1200/JCO.2007.13.9881
PubMed
Right arrow Articles by Roach, M., III
Right arrow Articles by Pilepich, M. V.

Received August 14, 2007
Accepted October 26, 2007
Short-Term Neoadjuvant Androgen Deprivation Therapy and External-Beam
Radiotherapy for Locally Advanced Prostate Cancer: Long-Term Results of RTOG
8610
Mack Roach III,* Kyounghwa Bae, Joycelyn Speight, Harvey B. Wolkov, Phillip
Rubin, R. Jeffrey Lee, Colleen Lawton, Richard Valicenti, David Grignon, and
Miljenko V. Pilepich

From the Departments of Radiation Oncology and Urology, University of
California San Francisco, San Francisco; Radiation Oncology Center, Sutter
Cancer Center, Sacramento; Department of Radiation Oncology, University of
California Los Angeles, Los Angeles, CA; University of Rochester, Medical
Center, Rochester, NY; Latter-Day Saints Hospital Radiation Center, Salt
Lake City, UT; Medical College of Wisconsin Department of Radiation
Oncology, Milwaukee, WI; Radiation Therapy Oncology Group Department of
Statistics; and Department of Radiation Oncology, Thomas Jefferson
University Hospital, Bodine Cancer Center, Philadelphia, PA; and Department
of Pathology and Laboratory Medicine, Indiana University School of Medicine,
Indianapolis, IN.

* To whom correspondence should be addressed. E-mail: <see web page>

Purpose: Radiation Therapy Oncology Group (RTOG) 8610 was the first phase
III randomized trial to evaluate neoadjuvant androgen deprivation therapy
(ADT) in combination with external-beam radiotherapy (EBRT) in men with
locally advanced prostate cancer. This report summarizes long-term follow-up
results.

Materials and Methods:
Between 1987 and 1991, 456 assessable patients (median age, 70 years) were
enrolled.

Eligible patients had bulky (5 times; 5 cm) tumors (T2-4) with or without
pelvic lymph node involvement according to the 1988 American Joint Committee
on Cancer TNM staging system. Patients received combined ADT that consisted
of goserelin 3.6 mg every 4 weeks and flutamide 250 mg tid for 2 months
before and concurrent with EBRT, or they received EBRT alone.

Study end points included overall survival (OS), disease-specific mortality
(DSM), distant metastasis (DM), disease-free survival (DFS), and biochemical
failure (BF).

Results: Ten-year OS estimates (43% v 34%) and median survival times (8.7 v
7.3 years) favored ADT and EBRT, respectively; however, these differences
did not reach statistical significance (P = .12).

There was a statistically significant improvement in 10-year DSM (23% v 36%;
P = .01), DM (35% v 47% P = .006), DFS (11% v 3%; P < .0001), and BF (65% v
80% P < .0001) with the addition of ADT, but no differences were observed in
the risk of fatal cardiac events.

Conclusion: The addition of 4 months of ADT to EBRT appears to have a
dramatic impact on clinically meaningful end points in men with locally
advanced disease with no statistically significant impact on the risk of
fatal cardiac events.

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