Advanced refractory prostate cancer: new treatment trial

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c palmer - 17 Jan 2005 23:39 GMT

Original article

Docetaxel and estramustine compared with mitoxantrone and prednisone for
advanced refractory prostate cancer. N Engl J Med 351: 15131520
PubMed

Men with metastatic, androgen-independent prostate cancer have a median
survival of 1 year or less. Current treatment with mitoxantrone plus
prednisone or hydrocortisone palliates bone pain in some patients, but
no available therapies prolong survival. Phase I and II studies have
shown improved survival in patients receiving docetaxel plus
estramustine; Petrylak and colleagues have investigated this in a
randomized, phase III trial.

A total of 770 men with metastatic, hormone-independent prostate cancer
were prospectively enrolled in the study. Of 674 eligible patients, half
were assigned to receive docetaxel plus estramustine and half to receive
mitoxantrone plus prednisone. Overall survival was compared in the two
treatment groups during a median follow-up of 32 months.

The median overall survival was significantly longer in patients treated
with docetaxel plus estramustine compared with those in the mitoxantrone
plus prednisone group (17.5 months vs 15.6 months, P = 0.02). The median
time to progression was also significantly longer in the docetaxel plus
estramustine group, and post-treatment declines in serum PSA levels of
50% were more common in these patients. Pain relief was similar in both
treatment groups. Adverse events (grade 3 or 4 neutropenic fevers,
nausea and vomiting, and cardiovascular events) were significantly more
frequent, however, in the docetaxel plus estramustine group than in the
mitoxantrone plus prednisone group.

The authors conclude that docetaxel plus estramustine treatment
moderately increased survival in these patients, but that this must be
balanced against the increased rate of adverse events.

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 - 18 Jan 2005 12:02 GMT

> Original article
>
[quoted text clipped - 9 lines]
> estramustine; Petrylak and colleagues have investigated this in a
> randomized, phase III trial.

I wonder if Steve or others know of some here who were in it?
J
http://content.nejm.org/cgi/content/short/351/15/1513
Volume 351:1513-1520 October 7, 2004

Abstract

Background Mitoxantrone-based chemotherapy palliates pain without extending
survival in men with progressive androgen-independent prostate cancer. We
compared docetaxel plus estramustine with mitoxantrone plus prednisone in
men with metastatic, hormone-independent prostate cancer.

Methods We randomly assigned 770 men to one of two treatments, each given in
21-day cycles: 280 mg of estramustine three times daily on days 1 through 5,
60 mg of docetaxel per square meter of body-surface area on day 2, and 60 mg
of dexamethasone in three divided doses before docetaxel, or 12 mg of
mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily.
The primary end point was overall survival; secondary end points were
progression-free survival, objective response rates, and post-treatment
declines of at least 50 percent in serum prostate-specific antigen (PSA)
levels.

Results Of 674 eligible patients, 338 were assigned to receive docetaxel and
estramustine and 336 to receive mitoxantrone and prednisone. In an
intention-to-treat analysis, the median overall survival was longer in the
group given docetaxel and estramustine than in the group given mitoxantrone
and prednisone (17.5 months vs. 15.6 months, P=0.02 by the log-rank test),
and the corresponding hazard ratio for death was 0.80 (95 percent confidence
interval, 0.67 to 0.97). The median time to progression was 6.3 months in
the group given docetaxel and estramustine and 3.2 months in the group given
mitoxantrone and prednisone (P<0.001 by the log-rank test). PSA declines of
at least 50 percent occurred in 50 percent and 27 percent of patients,
respectively (P<0.001), and objective tumor responses were observed in 17
percent and 11 percent of patients with bidimensionally measurable disease,
respectively (P=0.30). Grade 3 or 4 neutropenic fevers (P=0.01), nausea and
vomiting (P<0.001), and cardiovascular events (P=0.001) were more common
among patients receiving docetaxel and estramustine than among those
receiving mitoxantrone and prednisone. Pain relief was similar in both
groups.

Conclusions The improvement in median survival of nearly two months with
docetaxel and estramustine, as compared with mitoxantrone and prednisone,
provides support for this approach in men with metastatic,
androgen-independent prostate cancer.

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