Docetaxel with prednisone or prednisolone for the treatment of ...

Study details and Participant details Intervention details Results Conclusion and
design comments
Authors’ conclusions:
The improvement in
median survival of nearly
2 months with docetaxel
and estramustine,
compared with
mitoxantrone plus
prednisone, provides
support for this approach
in men with metastatic
androgen-independent
prostate cancer
Outcome 1: Overall survival
Time from the date of randomisation to the date of death
from any cause or censored at the date of last contact
Number randomised:
770 men, 674 eligible
Authors: Petrylak
et al., 2004 29
Country: USA
Median survival. (N = 674):
I: 17.5 months (p = 0.02)
C: 15.6 months
HR for death: 0.80 (95% CI: 0.67 to 0.97)
Intervention:
280 mg estramustine
3 × daily on days 1–5,
+60 mg docetaxel per m 2
body surface area i.v. on
day 2, preceded by 60 mg
dexamethasone orally in
3 doses
Sites of disease:
Bone: I = 84%; C = 88%
Lymph node: I = 24%; C = 26%
Liver: I = 8%; C = 9%
Lung: I = 10%; C = 10%
Primary source:
Handsearching
After median follow-up of 32 months:
I: 217/338 (64%) died
C: 235/336 (70%) died
Disease characteristics:
SWOG performance status:
I: 0–1 = 90%; 2–3 = 10%
C: 0–1 = 88%; 2–3 = 12%
PSA (ng/ml), median (range):
I: 84 (0.1–10,820)
C: 90 (0.1–8,378)
Aim:
To determine
whether docetaxel
plus estramustine
improves survival
over that afforded
by mitoxantrone
plus prednisone in
men with androgenindependent
prostate cancer
Bone pain, grade