sp;
Interim
27.3 (16.0 to 32.1)
6.4 (4.4 to 10.0)
0.329 (0.233 to 0.466)
<0.001
-
Final
26.6 (16.0 to 32.1)
6.4 (4.4 to 10.0 )
0.339 (0.244 to 0.472)
<0.001
10.4 (4.3 to 22.0)
Secondary
PFS (weeks) c
Interim
24.1 (11.1 to 28.3)
6.0 (4.4 to 9.9)
0.333 (0.238 to 0.467)
<0.001
-
Final
22.9 (10.9 to 28.0)
6.0 (4.4 to 9.7)
0.347 (0.253 to 0.475)
<0.001
-
ORR (%)d
Interim
6.8 (3.7 to 11.1)
0 (-)
NA
0.006
-
Final
6.6 (3.8 to 10.5)
0 (-)
NA
0.004
10.1 (5.0 to 17.8)
OS (weeks)e
Interim
-
-
0.491 (0.290 to 0.831)
0.007
-
Final
72.7 (61.3 to 83.0)
64.9 (45.7 to 96.0)
0.876 (0.679 to 1.129)
0.306
-
a Results of double-blind treatment are from the ITT population and using central radiologist measurement, as appropriate.
b Efficacy results for the 99 subjects who crossed over from placebo to SUTENT after unblinding. Baseline was reset at cross-over and efficacy analyses were based on investigators assessment
c The interim PFS numbers have been updated based on a recalculation of the original data
d Results for ORR are given as percent of subjects with confirmed response with the 95% CI.
e Median not achieved because the data were not yet mature.
Median overall survival (OS) in the ITT population was 72.7 weeks and 64.9 weeks (HR 0.876, 95% CI 0.679 – 1.129, p=0.306), in the SUTENT and placebo arms respectively. In this analysis, the placebo arm included those patients randomized to placebo who subsequently received open-label SUTENT treatment.
Treatment-naïve metastatic renal cell carcinoma (MRCC)
A phase 3 randomized, multicentre, international, study eva luating the efficacy and safety of sunitinib compared with interferon IFN-α in treatment-naïve MRCC patients was conducted. Seven hundred and fifty patients were randomized 1:1 to the treatment arms; they received treatment with either sunitinib in repeated 6-week cycles, consisting of 4 weeks of 50 mg daily oral administration followed by 2 weeks of rest (Schedule 4/2), or IFN-α, administered as a subcutaneous injection of 3 million units (MU) the first week, 6 MU the second week, and 9 MU the third week and thereafter on 3 non-consecutive days each week.
The median duration of treatment was 11.1 months (range: 0.4 – 46.1) for sunitinib treatment and 4.1 months (range: 0.1 – 45.6) for IFN- α treatment. Treatment-related serious adverse events (TRSAEs) were reported in 23.7% of patients receiving sunitinib and in 6.9% of patients receiving IFN-α. However, the discontinuation rates due to adverse events were 20% for sunitinib and 23% for IFN-α. Dose interruptions occurred in 202 patients (54 |
