atio = 1.16, 95% CI [0.73, 1.83] for DCarbH (TCH) vs ACD (ACT); hazard ratio 0.97, 95% CI [0.60, 1.55] for ACDH (ACTH) vs ACD).
In addition a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831 and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in the following table:
|
AC PH
(vs. ACP)
(NSABP B-31 and NCCTG N9831)
|
ACDH
(vs. ACD)
(BCIRG 006)
|
DCarbH
(vs. ACD)
(BCIRG 006)
|
|
Primary efficacy analysis
DFS Hazard ratios
(95% CI)
p-value
|
0.48
(0.39, 0.59)
p<0.0001
|
0.61
(0.49, 0.77)
p< 0.0001
|
0.67
(0.54, 0.83)
p=0.0003
|
|
Post-hoc exploratory analysis with DFS and symptomatic cardiac events
Hazard ratios
(95% CI)
|
0.64
(0.53, 0.77)
|
0.70
(0.57, 0.87)
|
0.71
(0.57, 0.87)
|
A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab
CI = confidence interval
MGC
Herceptin has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Chemotherapy was administered as follows:
- capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
or
- intravenous 5-fluorouracil - 800 mg/m2/day as a continuous i.v. infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle)
Either of which was administered with:
- cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
The efficacy results from study BO18225 are summarized in the following table:
|
Parameter
|
FP
N = 290
|
FP +H
N = 294
|
HR (95 % CI)
|
p-value
|
|
Overall Survival, Median months
|
11.1
|
13.8
|
0.74 (0.60-0.91)
|
0.0046
|
|
Progression-Free Survival, Median months
|
5.5
|
6.7
|
0.71 (0.59-0.85)
|
0.0002
|
|
Time to Disease Progression, Median months
|
5.6
|
7.1
|
0.70 (0.58-0.85)
|
0.0003
|
|
Overall Response Rate, %
|
34.5 %
|
4 |
|
