which was followed by:
- carboplatin – at target AUC = 6 mg/mL/min administered by IV infusion over 30-60 minutes repeated every 3 weeks for a total of six cycles
Herceptin was administered weekly with chemotherapy and 3 weekly thereafter for a total of 52 weeks.
The efficacy results from the BCIRG 006 are summarized in the tables below. The median duration of follow up was 2.9 years in the ACD arm and 3.0 years in each of the ACDH and DCarbH arms.
Overview of Efficacy Analyses BCIRG 006 ACD versus ACDH
|
Parameter
|
AC D
(n=1073)
|
ACDH
(n=1074)
|
Hazard Ratio vs ACD
(95% CI)
p-value
|
|
Disease-free survival
|
|
No. patients with event
|
195
|
134
|
0.61 (0.49, 0.77)
p<0.0001
|
|
Distant recurrence
|
|
No. patients with event
|
144
|
95
|
0.59 (0.46, 0.77)
p<0.0001
|
|
Death (OS event)
|
|
No. patients with event
|
80
|
49
|
0.58 (0.40, 0.83)
p=0.0024
|
ACD = doxorubicin plus cyclophosphamide, followed by docetaxel; ACDH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval
Overview of Efficacy Analyses BCIRG 006 ACD versus DCarbH
|
Parameter
|
ACD
(n=1073)
|
DCarbH
(n=1074)
|
Hazard Ratio vs ACD
(95% CI)
|
|
Disease-free survival
|
|
No. patients with event
|
195
|
145
|
0.67 (0.54, 0.83)
p=0.0003
|
|
Distant recurrence
|
|
No. patients with event
|
144
|
103
|
0.65 (0.50, 0.84)
p=0.0008
|
|
Death (OS event)
|
|
No. patients with event
|
80
|
56
|
0.66 (0.47, 0.93)
p=0.0182
|
ACD = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7 % vs 80.9 %) in favour of the ACDH (Herceptin) arm and 4.6 percentage points (85.5 % vs 80.9 %) in favour of the DCarbH (Herceptin) arm compared to ACD.
In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the ACDH (ACTH) arm, and 217/1073 in the ACD (ACT) arm had a Karnofsky performance status 90 (either 80 or 90). No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard r |
