ne arm crossed over to a Herceptin containing regimen after progression of disease.
Three -weekly dosing in MBC
The efficacy results from the non-comparative
|
Parameter
|
Monotherapy
|
Combination Therapy
|
|
|
Herceptin1
N=105
|
Herceptin2
N=72
|
Herceptin plus paclitaxel 3
N=32
|
Herceptin plus docetaxel4
N=110
|
|
Response rate
(95 %CI)
|
24 %
(15 - 35)
|
27 %
(14 - 43)
|
59 %
(41-76)
|
73 %
(63-81)
|
|
Median duration of response (months)
(range)
|
10.1
(2.8-35.6)
|
7.9
(2.1-18.8)
|
10.5
(1.8-21)
|
13.4
(2.1-55.1)
|
|
Median TTP (months)
(95 %CI)
|
3.4
(2.8-4.1)
|
7.7
(4.2-8.3)
|
12.2
(6.2-ne)
|
13.6
(11-16)
|
|
Median Survival (months)
(95 %CI)
|
ne
|
ne
|
ne
|
47.3
(32-ne)
|
TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
1. Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule
2. Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule
3. Study BO15935
4. Study MO16419
Sites of progression
The frequency of progression in the liver was significantly reduced in patients treated with the combination of Herceptin and paclitaxel, compared to paclitaxel alone (21.8 % vs. 45.7 %; p=0.004). More patients treated with Herceptin and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6 % vs. 6.5 %; p=0.377).
EBC
Early breast cancer is defined as non-metastatic primary invasive carcinoma of the breast.
In the adjuvant setting, Herceptin was investigated in 4 large multicentre, randomised, trials.
- The HERA study was designed to compare one year of three-weekly Herceptin treatment versus observation in patients with HER2 positive early breast cancer following surgery, established chemotherapy and radiotherapy (if applicable). Patients assigned to receive Herceptin were given an initial loading dose of 8 mg/kg, followed by 6 mg/kg every three weeks for one year.
- The NCCTG N9831 and NSABP B-31 studies that comprise the joint analysis were designed to investigate the clinical utility of combining Herceptin treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding Herceptin sequen |
