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

22
Results
TABLE 6 Summary results table for docetaxel plus prednisone plus estramustine versus mitoxantrone plus prednisone
the mitoxantrone group. The baseline
characteristics of patients across the two groups
appear to have been well balanced in terms of
performance status, serum PSA level, grade of
bone pain, type of progression, sites of secondary
disease, race and age.
For inclusion in the trial, patients had to have
progressive metastatic disease, despite androgenablative
therapy and cessation of anti-androgen
treatment; progression of a bi-dimensionally
measurable lesion as assessed within 28 days
before study registration, progression of disease
that could be evaluated but not measured as
assessed within 42 days before registration, or an
increase in serum PSA level over the baseline level
in at least two consecutive samples obtained at
least 7 days apart.
Patients were also required to have a SWOG
performance status score of 0–2 (3 was allowed if
due to bone pain) and adequate renal, hepatic and
cardiac function.
The median length of follow-up was 32 months.
Six patients in the docetaxel group and four
patients in the mitoxantrone group did not receive
the assigned treatment. One patient in the
One-dose Two-dose Mitoxantrone Comparison
docetaxel (A) docetaxel (B) (C)
Mortality A vs C: HR = 0.94
(95% CI: 0.29 to 1.02)
B vs C: HR = 0.86
(95% CI: 0.68 to 1.08)
Progression-free survival Not enough data
Response rate 9 3 1 Significant difference – not
enough data
QoL response Not reported
Pain response 14/43 (33%) 10/42 (24%) 9/42 (21%) A vs C: RR = 1.52
(95% CI: 0.74 to 3.13)
B vs C: RR = 1.11
(95% CI: 0.50 to 2.45)
PSA decline 29/43 (67%) 26/42 (63%) 7/42 (18%) A vs C: RR = 4.05
(95% CI: 1.99 to 8.21)
B vs C: RR = 3.71
(95% CI: 1.82 to 7.58)
Adverse events:
Discontinued 4 in total
Grade 3/4 25 a 4 a 27 a
Died 1
a May not be mutually exclusive.
mitoxantrone group also received intermittent
radiotherapy, which was a major protocol
deviation. Two patients in the docetaxel group and
four patients in the mitoxantrone group
discontinued treatment within 1 week.
Quality of the trial comparing docetaxel plus
estramustine with mitoxantrone plus prednisone
This was a randomised open-label comparative
trial. However, the methods of randomisation and
concealment of allocation were not reported and
therefore cannot be assessed for adequacy. The
evaluation of the trial in relation to study quality is
shown in Appendix 7.
Effectiveness of docetaxel plus estramustine
versus mitoxantrone plus prednisone
Overall survival
Overall survival was the primary end-point for the
trial and was defined as the time from the date of
randomisation to the date of death from any cause
or censored at the date of last contact. After a
median follow-up of 32 months, 217/338 (64%)
patients receiving docetaxel and 235/336 (70%)
patients receiving mitoxantrone had died.
There was a statistically significant benefit in terms
of overall survival observed for the docetaxel group