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

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Results
11–324 days). There was one discontinuation in
the prednisone only group due to toxicity.
CALGB 9182 32
This RCT included 242 men with mHRPC; 119
patients were randomised to receive an
intravenous infusion of mitoxantrone (14 mg/m 2
every 21 days) plus oral hydrocortisone (40 mg in
two divided doses every day), herein referred to as
the mitoxantrone group, and 123 patients were
randomised to receive oral hydrocortisone (40 mg
in two divided doses every day) only, herein
referred to as the hydrocortisone group. Patients
were stratified by baseline disease status
(measurable versus assessable) and ECOG
performance status score. After the accrual of 60
patients, a third stratification by number of prior
endocrine manipulations was added.
The baseline characteristics of patients across
the groups appear to have been reasonably well
balanced in terms of age, race, sites of
metastases, years since diagnosis, PSA level and
QoL. However, there was a tendency for the
patients in the hydrocortisone group to have
received more treatments with a progesterone
agent than the patients in the mitoxantrone group
(18% of patients in the hydrocortisone group
compared with 7% of patients in the mitoxantrone
group).
For inclusion in the trial, patients had to have
metastatic adenocarcinoma of the prostate, with
documented disease progression, and had to have
received no more than one prior endocrine
manipulation. However, the latter criterion was
removed after the accrual of 60 patients for the
trial, allowing patients with potentially poorer
prognoses to be eligible for inclusion in the trial.
Patients were also required to have adequate
hepatic, renal and bone marrow functions.
Two patients in each treatment arm never started
treatment and were excluded from the analyses.
Four further participants, three in the
hydrocortisone group and one in the
mitoxantrone group, were ruled ineligible for
inclusion, but were included in the survival
analysis only.
The median number of cycles of mitoxantrone
administered was five. No crossovers were
permitted, although alternative chemotherapy
regimes were allowed after disease progression.
Hydrocortisone treatment was continued in all
patients, until disease progression or treatment
failure, and was encouraged until death.
Quality of the trials comparing mitoxantrone plus
a corticosteroid with a corticosteroid
Berry and colleagues 30
This was a small, randomised, open-label,
comparative trial. The methods used to assign
patients to treatment groups and concealment of
allocation were not reported, so the adequacy of
these procedures cannot be assessed. Baseline
comparability between the two groups appears to
have been achieved. The evaluation of the trial in
relation to study quality is shown in Appendix 7.
CCI-NOV22 31
This was a reasonably small, open-label,
comparative trial. The method used to assign
participants to treatment groups was not reported,
so the randomisation procedure cannot be
assessed for adequacy. The two treatment groups
were not completely comparable at baseline. The
evaluation of the trial in relation to study quality is
shown in Appendix 7.
CALGB 9182 32
This was a randomised, open-label, comparative
trial. The methods of randomisation and
concealment of allocation were not reported and
therefore cannot be assessed for adequacy, and the
number of prior treatments with a progesterone
agent was not comparable at baseline between the
two groups. The evaluation of the trial in relation
to study quality is shown in Appendix 7.
Effectiveness of mitoxantrone plus a
corticosteroid versus a corticosteroid
Berry and colleagues 30
Overall survival Among the 119 patients analysed
in this trial, 91 (76%) died within 4 years of the
start of the study, 43 (77%) in the mitoxantrone
group and 48 (76%) in the prednisone group. At
12 months, survival was 82% in the mitoxantrone
group and 76% in the prednisone group. At
24 months, survival was 45% for the mitoxantrone
group and 44% for the prednisone group.
Estimated overall survival from the start of
treatment was 23 months (range: 3–49 months) in
the mitoxantrone group compared with 19 months
(range: 2–50 months) in the prednisone group.
This difference in overall survival was not
statistically significant, with an estimated HR for
death (calculated from numbers of events and
p-value presented in the trial publication) of 1.127
(95% CI: 0.747 to 1.7, p = 0.569).
Progression-free survival Time to treatment failure
(an aggregate end-point defined by the time
between start of treatment and occurrence of
progression, removal from study or initiation of