Single Vial Docetaxel Injection - ION Solutions

Table 13 - Response and TTP Analysis of Docetaxel in Combination Therapy for Chemotherapy-
Naïve NSCLC
Endpoint Docetaxel+Cisplatin Vinorelbine+Cisplatin p-value
Objective Response Rate
31.6%
24.4% Not Significant
(95% CI) a (26.5%, 36.8%) (19.8%, 29.2%)
Median Time to Progression b
(95% CI) a 21.4 weeks
(19.3, 24.6)
a Adjusted for multiple comparisons.
b Kaplan-Meier estimates.
22.1 weeks
(18.1, 25.6)
Not Significant
14.4 Hormone Refractory Prostate Cancer
The safety and efficacy of docetaxel in combination with prednisone in patients with androgen
independent (hormone refractory) metastatic prostate cancer were evaluated in a randomized multicenter
active control trial. A total of 1006 patients with Karnofsky Performance Status (KPS) ≥60 were
randomized to the following treatment groups:
• Docetaxel 75 mg/m 2 every 3 weeks for 10 cycles.
• Docetaxel 30 mg/m 2 administered weekly for the first 5 weeks in a 6-week cycle for 5 cycles.
• Mitoxantrone 12 mg/m 2 every 3 weeks for 10 cycles.
All 3 regimens were administered in combination with prednisone 5 mg twice daily, continuously.
In the docetaxel every three week arm, a statistically significant overall survival advantage was
demonstrated compared to mitoxantrone. In the docetaxel weekly arm, no overall survival advantage was
demonstrated compared to the mitoxantrone controlarm. Efficacy results for the docetaxel every 3 week
arm versus the control arm are summarized in Table 14 and Figure 5.
Table 14 - Efficacy of Docetaxel in the Treatment of Patients with Androgen Independent
(Hormone Refractory) Metastatic Prostate Cancer (Intent-to-Treat Analysis)
Docetaxel+Prednisone
every 3 weeks
Mitoxantrone+Prednisone
every 3 weeks
Number of patients
Median survival (months)
95% CI
Hazard ratio
335
18.9
(17.0-21.2)
0.761
337
16.5
(14.4-18.6)
—
95% CI
(0.619-0.936)
—
p-value*
0.0094
—
*Stratified log rank test. Threshold for statistical significance = 0.0175 because of 3 arms.
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