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

12
Results
● Docetaxel plus prednisone versus mitoxantrone
plus prednisone for the treatment of mHRPC. 27
One RCT used docetaxel at two different dosages
in combination with estramustine and prednisone:
● Docetaxel plus prednisone plus estramustine
versus mitoxantrone plus prednisone for the
treatment of mHRPC. 28
One RCT used docetaxel with estramustine, but
without prednisone/prednisolone:
● Docetaxel plus estramustine versus
mitoxantrone plus prednisone for the treatment
of mHRPC. 29
Four trials used mitoxantrone, which is licensed in
the UK, but not for patients with mHRPC. These
trials were:
● Mitoxantrone plus prednisone versus
prednisone alone for the treatment of
mHRPC. 30,31
● Mitoxantrone plus hydrocortisone versus
hydrocortisone alone for the treatment of
mHRPC. 32
● Mitoxantrone plus prednisone plus clodronate
versus mitoxantrone plus prednisone plus
placebo for the treatment of mHRPC. 33
Clodronate is a medicine used to treat a high
level of calcium in the blood caused by changes
in the body that happen with cancer.
Clodronate also treats the weakening in the
bones when cancer has spread to the bones
from another part of the body.
A summary of the seven included RCTs is
presented in Table 1 and full data extraction tables
are presented in Appendix 6.
Relevant studies reported in abstract
form only
In addition to the seven included trials for which
there was a full publication available, a further two
RCTs were identified that were reported in abstract
form only. No further details of the studies were
obtainable from the trialists and therefore the trials
were excluded from the review. The interventions
that were assessed in these trials were:
● docetaxel plus estramustine versus docetaxel;
Eymard and colleagues (2004) 54
● docetaxel versus docetaxel plus thalidomide;
Salimichokami (2003). 55
These trials are described in Appendix 3.
Systematic reviews/meta-analyses
One systematic review was identified, but was
reported only in abstract form. No further details
of the review were obtainable from the reviewers.
The review assessed:
● Chemotherapy efficacy from controlled trials in
HRPC patients; Casciano and colleagues
(2001). 56
Ongoing studies
Four ongoing studies were identified. No further
details of the studies were obtainable from the
trialists. The interventions that were assessed in
these trials were:
● docetaxel plus prednisone plus placebo versus
docetaxel plus prednisone plus bevacizumab;
National Cancer Institute (2005) 57
● docetaxel plus prednisone versus GVAX ®
prostate cancer vaccine; Cell Genesys 58
● docetaxel plus prednisolone versus docetaxel
plus prednisolone plus zoledronic acid versus
docetaxel plus prednisolone plus or minus
zoledronic acid plus strontium-89 (Trapeze
trial); James59 ● mitoxantrone versus paclitaxel plus carboplatin;
Cabrespine and colleagues (2005). 60
Excluded studies
A total of 220 records were excluded as they did
not meet the inclusion criteria for the review.
However, of these, 65 papers were used as
background articles for the review. The majority of
the other excluded articles were non-systematic
reviews and commentaries or non-randomised
studies. A full list of the excluded studies with the
reasons for exclusion is presented in Appendix 2.
Description of included studies
The following section of the report provides a
summary of the seven included RCTs. For each
included study a summary of the trial has been
provided followed by a description of the trial
quality and the results of the trial. Table 2
summarises the pattern of comparisons for the
seven included RCTs.
It can be seen that there are no head-to-head
comparisons of docetaxel versus best supportive
care (corticosteroids). However, all trials include a
comparison with mitoxantrone plus a
corticosteroid. Therefore, indirect comparisons
using mitoxantrone plus a corticosteroid as a
common comparator can be used to estimate the