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
Authors’ conclusions:
Patients with
asymptomatic progressive
disease had a significantly
higher response rate when
treated with mitoxantrone
plus prednisone than when
treated with prednisone
alone, measured by a
≥ 50% decrease in PSA.
Time to treatment failure
in the I group was also
significantly longer but
survival rates were not
affected
Outcome 1: Overall survival (N = 119)
I: median = 23 months (range: 3–49)
C: median = 19 months (range: 2–50)
No significant difference
Number randomised: 120, 119
included in analysis
Authors: Berry
et al., (2002) 30
Disease characteristics:
Diagnosis stage
I: n (%) C: n (%)
Country: USA
Median survival for subgroup: PSA responders (response =
≥ 50% reduction in PSA levels for ≥ 2 months with
stabilisation or improvement of performance status for
≥ 2 weeks):
Primary source:
MEDLINE
I (months) C (months)
Responders 31.8 32.9
Non-responders 18.3 18.3
Intervention:
Mitoxantrone +
prednisone
No. randomised: 56
Route of administration:
Mitoxantrone, i.v.;
prednisone, orally
Dose: Mitoxantrone,
12 mg/m 2 every 3 weeks;
prednisone, 5 mg b.d.
No. of cycles: 6
Length per cycle: 3
weeks
Died within 4 years of study beginning
I, 43 (77%); C, 48 (76%)
Control: Prednisone
A 2 (4) 5 (8)
B1 4 (7) 2 (3)
B2 10 (18) 9 (14)
C1 3 (5) 9 (14)
C2 5 (9) 2 (3)
D1 9 (16) 13 (21)
D2 19 (33) 21 (34)
D3 1 (2) 0
Unknown 3 (5) 2 (3)
Aim: To compare
median time to
treatment failure of
men with
asymptomatic
progressive HRPC
treated with
mitoxantrone plus
prednisone versus
prednisone alone
Comments: Supported by
Immunex Corp. Lead
author has financial links to
Bristol Myers Squibb,
Immunex and Aventis
Survival at 12 months
I, 82%; C, 76%
No. randomised: 63
Route of administration:
orally
Dose: 5 mg b.d.
No. of cycles: Not stated
Length per cycle: Not
stated
Pretreatment tumour characteristics
Tumour I: n (%) C: n (%)
Trial ID: –
Phase: Phase III
Survival at 24 months
I, 45%, C, 44%
Outcome 2: Progression-free survival (N = 119)
After 12 months:
I, 36%; C, 15%
Measurable 8 (14) 9 (14)
PSA only 2 (4) 5 (8)
Non-measurable 46 (82) 49 (78)
and increased
PSA
Length of followup:
Median:
21.8 months (range:
2.4–50)
After 24 months:
I, 13%; C, 10%
Time to treatment failure; primary outcome of trial (aggregate
end-point of time to disease progression, removal from
study or time to initiation of alternative therapy from start of
treatment. Time to progression = time to treatment failure):
Comments about
intervention/control:
Prednisone continued even
after mitoxantrone
therapy was stopped.
Maximum of 2
25% dose reductions of
mitoxantrone allowed
Metastases I: n (%) C: n (%)
Maximum
planned: 4 years
Bone 48 (86) 50 (79)
Lymph 10 (18) 11 (18)
Lung 1 (2) 4 (6)
Liver 2 (4) 0
I: median: 8.1 months (range: 1–50)
C: median: 4.1 months (range: 1–37)
(p = 0.018)
From Gregurich et al.: 44
Median time to progression:
I, 10.5 months; C, 3.8 months (p < 0.001)
Supportive care was
administered at the
discretion of the
investigator.
Haematopoietic growth
factors were administered
according to ASCO
guidelines as needed
PSA at study entry:
I: median, 56.7 ng/ml (range:
3.7–2375)
C: median, 71.0 ng/ml (range:
1.1–1233 ng/ml)
Number and
times of follow-up
measurements:
Blood count/platelet
and liver function
every week for first
cycle and before
each subsequent
cycle. PSA every
other cycle through
cycle 6, every
continued