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

these, 69 patients had measurable tumours. No
complete responses were observed in either group.
Partial responses were observed in eight (7%)
patients in the mitoxantrone group and five (4%)
patients in the hydrocortisone group. There was
no statistically significant difference in terms of
response rate between groups; RR for response =
1.65 (95% CI: 0.56 to 4.91, p = 0.375).
Health-related quality of life HRQoL was assessed
using five instruments. The Functional Living
Index – Cancer (FLIC) with scores ranging from 0
to 7 was used to provide a global assessment of
QoL. Four other HRQoL instruments were used to
provide in-depth evaluations of cancer-related
symptoms, sexual and urological issues, problems
with everyday activities and the impact of pain on
activities such as sleep and normal work.
A total of 155 (66%) patients were assessed at
baseline and at least one follow-up. The estimated
treatment effects showed that there was no
statistically significant benefit for the mitoxantrone
group compared with the hydrocortisone group in
terms of global QoL as assessed by the FLIC
questionnaire (p = 0.12). Some of the items of the
questionnaires did show statistically significant
benefits for the mitoxantrone group compared
with the hydrocortisone group in relation to
emotional state and family disruption (p = 0.04
and 0.02, respectively, as assessed by FLIC) and
severity of pain (p = 0.03 as assessed by the
symptom distress scale).
Pain Data on pain were measured and reported
with the HRQoL assessments. Specific items
assessed by the QoL instruments and reported
were the total impact of pain, frequency of pain,
severity of pain and pain from cancer; only the
last item showed a tendency for those in the
hydrocortisone group to have a better QoL than
those in the mitoxantrone group.
PSA decline PSA decline was defined as at least a
50% reduction and at least an 80% reduction in
serum PSA from baseline at a follow-up
examination between 4 and 8 weeks. A post hoc
Health Technology Assessment 2007; Vol. 11: No. 2
TABLE 13 Grade 3 or 4 haematopoietic adverse events for mitoxantrone plus hydrocortisone versus hydrocortisone
Adverse event Mitoxantrone group (%) Hydrocortisone group (%)
White blood count 59 1
Platelets 6 0
Granulocytes/bands 63 1
Lymphocytes 70 15
© Queen’s Printer and Controller of HMSO 2007. All rights reserved.
analysis was also performed to determine the
maximum PSA decrease over the duration of the
whole trial. The original analysis of PSA decline
included 187 patients for whom PSA
measurements were available and the post hoc
analysis included 228 participants.
Between 4 and 8 weeks, 18 (18.7%) patients in the
mitoxantrone group had achieved a PSA decline
of at least 50% and, of these, four (4.2%) achieved
a PSA decline of 80% or more. During the same
time interval, 13 (14.3%) patients in the
hydrocortisone group achieved a PSA decline of at
least 50% and, of these, four (4.3%) achieved a
PSA decline of 80% or more. These differences
were not statistically significant (p = 0.412).
The post hoc analysis of PSA decline over the
duration of the whole trial showed that 42 (37.5%)
patients in the mitoxantrone group achieved a 50%
or greater decline in PSA and, of these, 22 (19.6%)
experienced a decline of 80% or more. In the
hydrocortisone group, 25 (21.5%) patients had PSA
decreases of 50% or more and of these, 11 (9.5%)
had declines of 80% or more. There was a
statistically significant benefit for the mitoxantrone
group compared with the hydrocortisone group
with respect to PSA decline throughout the trial,
both for declines of at least 50% (p = 0.008) and
declines of at least 80% (p = 0.029).
Adverse effects of treatment Grade 3 and 4 specific
toxicities were reported for 206 (86%) patients.
There were no observed treatment-related deaths
in either group. The most common treatmentrelated
adverse event reported for the
mitoxantrone group was haematopoietic toxicity,
occurring in approximately 70% of patients. There
were statistically significant differences between
the two treatment groups in terms of the
haematopoietic toxicities reported (p < 0.01).
Table 13 shows the proportion of patients
experiencing grade 3 or 4 haematopoietic
toxicities.
Summary Summary results are given in Table 14.
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