AusPAR: Cabazitaxel - Therapeutic Goods Administration

Participant flow
AusPAR Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4
Final 9 February 2012
Therapeutic Goods Administration
A total of 755 patients were centrally randomized, with 377 patients in arm A
(mitoxantrone [MTX] + prednisone [pred]) and 378 patients in arm B (cabazitaxel [CBZ] +
pred). The median number of cycles was 4 in arm A and 6 in arm B. In all 13.5% of patients
in arm A and 29.4% in arm B completed all 10 treatment cycles. The most common reason
for treatment discontinuation was disease progression, 70.8% of patients in arm A and
47.6% in arm B. The second most common reason for treatment discontinuation was
completed study treatment (without progression), 12.2% of patients in arm A and 27.8%
in arm B. Six patients in arm A and 7 patients in arm B were randomized but not treated.
Of the 7 patients who discontinued treatment for 'other reasons' in arm A, 4 had protocol
violations, 2 had clinical progression and 1 was discontinued by the investigator. Of the 10
patients who discontinued treatment for 'other reasons' in arm B, 2 refused treatment, 2
had protocol violations, 2 had adverse events (abnormal liver function tests (LFTs), fever
with increased white blood cell (WBC) count, 1 had disease progression that was not
confirmed by standard means.
Baseline data
The demographic characteristics were well balanced between the two arms. Almost half
the patients in the two arms had non-measurable disease. As per protocol over 99% of the
patients had had prior hormone therapy and over 80% (MTX+pred: 87.3%; CBZ+pred:
87.8%) had received docetaxel as their first chemotherapy. The majority of patients in
each group were randomized within 6 months of docetaxel treatment. Overall, 75.6% of
patients in arm A and 72.2% of patients in arm B had relapsed within 3 months of
completing that docetaxel treatment. The majority of patients had 1 or 2 metastatic sites.
At baseline, anaemia was the most common haematological abnormality. Because of the
high incidence of bone metastases in this population, abnormal levels of alkaline
phosphatase (ALP) were common.
Concomitant medications included corticosteroids, antihistamines and H2 antagonists.
Results for the primary efficacy outcome
The median survival was 12.7 months in arm A and 15.1 months in arm B. The difference
was statistically significant (Table 5, Figure 2). The hazard ratio (HR) was 0.70 (95% CI:
0.59 - 0.83) in favour of cabazitaxel.
Table 5: Descriptive analysis of overall survival - ITT population
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