|
Herceptin150 mg powder for concentrate for solution for infu(十六)
|
|
Combination Therapy
|
|
|
Herceptin1
N=172
|
Herceptin plus paclitaxel2
N=68
|
Paclitaxel2
N=77
|
Herceptin plus docetaxel3
N=92
|
Docetaxel3
N=94
|
|
Response rate
(95 %CI)
|
18 %
(13 - 25)
|
49 %
(36 - 61)
|
17 %
(9 - 27)
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61 %
(50-71)
|
34 %
(25-45)
|
|
Median duration of response (months)
(95%CI)
|
9.1
(5.6-10.3)
|
8.3
(7.3-8.8)
|
4.6
(3.7-7.4)
|
11.7
(9.3 – 15.0)
|
5.7
(4.6-7.6)
|
|
Median TTP (months)
(95 %CI)
|
3.2
(2.6-3.5)
|
7.1
(6.2-12.0)
|
3.0
(2.0-4.4)
|
11.7
(9.2-13.5)
|
6.1
(5.4-7.2)
|
|
Median Survival (months)
(95 %CI)
|
16.4
(12.3-ne)
|
24.8
(18.6-33.7)
|
17.9
(11.2-23.8)
|
31.2
(27.3-40.8)
|
22.74
(19.1-30.8)
|
TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
1. Study H0649g: IHC3+ patient subset
2. Study H0648g: IHC3+ patient subset
3. Study M77001: Full analysis set (intent-to-treat), 24 months results
Combination treatment with Herceptin and anastrozole
Herceptin has been studied in combination with anastrozole for first line treatment of metastatic breast cancer in HER2 overexpressing, hormone-receptor (i.e. estrogen-receptor (ER) and/or progesterone-receptor (PR)) positive postmenopausal patients. Progression free survival was doubled in the Herceptin plus anastrozole arm compared to anastrozole (4.8 months versus 2.4 months). For the other parameters the improvements seen for the combination were for overall response (16.5 % versus 6.7 %); clinical benefit rate (42.7 % versus 27.9 %); time to progression (4.8 months versus 2.4 months). For time to response and duration of response no difference could be recorded between the arms. The median overall survival was extended by 4.6 months for patients in the combination arm. The difference was not statistically significant, however more than half of the patients in the anastrozole alo |
