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

Clinical evaluation
We identified one trial that directly assessed the
intervention under consideration: docetaxel plus
prednisone; this was in comparison with
mitoxantrone plus prednisone (TAX 327). No
other trials were found that assessed the clinical
effectiveness of docetaxel plus prednisone.
The results of this trial showed statistically
significant improvements with 3-weekly docetaxel
plus prednisone compared with mitoxantrone plus
prednisone, in terms of overall survival, QoL, pain
response and PSA decline. The response rate was
higher for the 3-weekly docetaxel plus prednisone
group than the mitoxantrone plus prednisone
group, but this difference was not statistically
significant. The improved outcomes for docetaxel
plus prednisone were associated with more grade
3–4 adverse events; however, this had no
detrimental effect on QoL, which was also
significantly improved in the 3-weekly docetaxel
group. Progression-free survival was not assessed
in this trial. This was a large, well-conducted RCT
and the results are likely to be reliable; however,
the lack of other studies available for the
evaluation of the efficacy of docetaxel plus
prednisone is a limitation of this review.
Since docetaxel plus prednisone has only been
directly compared with mitoxantrone plus
prednisone, we considered additional evidence
which would permit a comparison of docetaxel
plus prednisone with other chemotherapy-based
treatments and best supportive care. Therefore, we
searched for other treatments that were compared
with mitoxantrone plus a corticosteroid, in order
to allow a comparison across the full range of
relevant treatment options. We found three trials
that compared other chemotherapy regimens with
mitoxantrone plus prednisone: one trial that
compared mitoxantrone plus prednisone with
docetaxel plus prednisone plus estramustine, one
trial that compared mitoxantrone plus prednisone
with docetaxel plus estramustine and one trial that
compared mitoxantrone plus prednisone with
mitoxantrone plus prednisone plus clodronate.
Both treatments that included docetaxel were
superior to mitoxantrone plus prednisone in terms
of overall survival (although the difference was not
Chapter 7
Discussion
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Health Technology Assessment 2007; Vol. 11: No. 2
statistically significant for docetaxel plus
prednisone plus estramustine), response rate
(although the difference was not statistically
significant for docetaxel plus estramustine), and
progression-free survival (although this was only
assessed for docetaxel plus estramustine in
comparison with mitoxantrone plus prednisone).
Docetaxel plus estramustine was associated with
more adverse events compared with mitoxantrone
plus prednisone. No significant differences were
found between mitoxantrone plus prednisone
plus clodronate and mitoxantrone plus
prednisone without clodronate. A mixed
treatment comparison has been presented
incorporating these drug combinations. However,
since we only searched for trials which included
docetaxel plus prednisone/prednisolone or
mitoxantrone plus a corticosteroid as one of the
treatment arms, this should be interpreted with
caution as the search strategy did not include
searches for all available evidence that could
inform this comparison. It is possible that other
trials may exist that could inform this comparison
but which did not meet our review inclusion
criteria. Only the results for overall survival were
presented in the mixed treatment comparison,
because the definitions and measurements of the
other outcomes varied across the trials and
therefore it is impossible to make any comparisons
between trials for any other outcome, as discussed
previously.
In addition, three trials were found that compared
mitoxantrone plus a corticosteroid with best
supportive care, in the form of corticosteroids. No
trials were identified that compared other forms of
best supportive care with mitoxantrone plus a
corticosteroid. Two of the trials used prednisone
(5 mg twice daily) as the comparator and one
compared mitoxantrone plus hydrocortisone with
hydrocortisone (40 mg given in two divided doses
daily). One of the trials comparing mitoxantrone
plus a corticosteroid with a corticosteroid included
men with asymptomatic mHRPC, another
included men with symptomatic mHRPC and the
third included all men with progressive mHRPC.
This difference in disease severity between
patients included in the trials may have affected
the results, as mitoxantrone was more effective in
the trial of patients with symptoms of pain
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