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
Duration (median months):
I(1), 7.7 (95% CI: 7.1 to 8.6)
I(2), 8.2 (95% CI: 6.3 to 11.5)
C, 7.8 (95% CI: 5.4 to 10.5)
Outcome 5: adverse events (%)
(measured using the NCI CTC, version 2) (N = 997):
I(1) I(2) C
(n = 332) (n = 330) (n = 335)
No. randomised: 334
Route of administration:
docetaxel, i.v.;
prednisone, orally
Dose: 30 mg docetaxel
+5 mg prednisone
No. of cycles: Up to 5
Length per cycle:
6 weeks
Staging at diagnosis (from Dagher
et al. 34 ):
Stage I:
I(1), 0%; I(2), 0%; C, 0%
Stage II:
I(1), 16%; I(2), 15%; C, 17%
Stage III:
I(1), 18%; I(2), 14%; C, 15%
Stage IV:
I(1), 57%; I(2), 58%; C, 54%
Missing:
I(1), 9%; I(2), 13%; C, 14%
compared with
mitoxantrone and
both docetaxel
groups (combined)
compared with
mitoxantrone.
(Bon-ferroni
method used)
Grade 3–4 anaemia 5 5 2
Grade 3–4 1 0 1
Control:
12 mg mitoxantrone per
m 2 (for 30 minutes) on day
1 every 21 days + 5 mg
prednisone (or
prednisolone, if
prednisone unavailable)
orally twice daily from day
1. Up to 10 cycles of
treatment were planned,
and treatment delays of up
to 2 weeks and up to 2
dose reductions were
allowed. Dose reductions
were required in the
presence of grade 4
neutropenia for at least
7 days, an infection or
grade 3–4 neutropenia
with an oral temperature
≥ 38.5°C. Dose reduction
or treatment delay was
also stipulated for patients
with an absolute
neutrophil count of