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

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Appendix 6
Study details and Participant details Intervention details Results Conclusion and
design comments
Median duration of PSA response, in months (defined as the
time interval between the first 50% decline in PSA levels
until PSA increased to 50% above the nadir):
Protocol deviations:
3 patients never started
treatment (1 stroke and 2
withdrawals of consent)
Other previous anticancer therapy:
I(1) I(2) C
n (%) n (%) n (%)
Per protocol
analysis
performed: Not
stated
I(1), 8; I(2), 8.3 ; C, 6.4
Outcome 5: Adverse events (n = 127)
Scored according to the revised NCI CTC, version 1.
Surgery 6 10 8
(14) (24) (19)
Radiotherapy 10 9 7
(23) (21) (17)
Severe adverse events (grade 3 or 4):
I(1): n (%) I(2): n (%) C: n (%)
Median age of participants:
I(1), 68; I(2), 68; C, 70 years
Granulocytopenia 16 (37) 0 20 (48)
Granulocytopenic 0 0 3 (7)
fever
Anaemia 1 (2) 0 3 (7)
Thrombocytopenia 0 1 (2) 1 (2)
Nausea 1 (2) 0 0
Vomiting 1 (2) 0 0
Diarrhoea 3 (7) 0 0
Thrombosis (caused
by estramustine) 3 (7) 3 (7) 0
Age IQ range of participants:
I(1), 52–91; I(2), 51–79; C, 52–85
Comments:
A Simon design was
used to calculate
that a sample size of
130 was required to
distinguish a 60%
PSA response from
a 30% response
with 80% power
and a Type 1 error
of 0.05
Other participant characteristics:
Time from diagnosis to random
assignment (median months, IQ
range):
I(1): 33, 3–219
I(2): 33, 5–151
C: 47, 6–150
I(1): 1 corticosteroid premedication-related death reported
Baseline
comparability: Yes,
non-significant trend
for I(2) to have
better ECOG
performance status
(p = 0.18)
Other adverse events:
Asthenia:
Time from start of hormonal
treatment to random assignment
(median months, IQ range):
I(1): 16, 2–116
I(2): 27, 2–89
C: 25, 1–118
Eligibility criteria
specified: Yes
I(1), 47%; I(2), 41%; C, 26%
p = 0.30
Nail and skin toxicities:
I(1) + I(2): 14%
Decrease in LVEF (grade 1 or 2):
C: 4 (10%)
Comments about participants:
Inclusion/exclusion criteria:
Histologically proven metastatic
adenocarcinoma of the prostate with
progressive disease, despite
androgen deprivation. Anti-androgen
withdrawal and documented disease
progression were required before
study entry. Disease progression was
defined as appearance of new
Co-interventions:
Premedication with
oral prednisolone,
300 mg total dose
and oral warfarin
2 mg/day
administered
continuously in I(1)
and I(2)
Outcome 6: Pain (n = 127)
‘Clinical benefit’ was measured using the pain control and
analgesic consumption indices of the McGill pain
questionnaire and ECOG performance status. Pain control
was scored from 0 (no pain) to 4 (uncontrollable pain) and
the analgesic consumption was scored from 0 (no
requirement) to 4 (regular, narcotic analgesic use). Clinical
From Oudard
et al.: 38,39 coumadin
(2 mg orally) given
continued