|
r those who had received prior anthracycline therapy in the adjuvant setting, chemotherapy consisted of paclitaxel (175mg/m2 over 3hours every 21days for at least six cycles); for all other patients, chemotherapy consisted of anthracycline plus cyclophosphamide (AC: doxorubicin 60mg/m2 or epirubicin 75mg/m2 plus 600mg/m2 cyclophosphamide every 21days for six cycles). Sixty‑five percent of patients randomized to receive chemotherapy alone in this study received Herceptin at the time of disease progression as part of a separate extension study.
Based upon the determination by an independent response eva luation committee the patients randomized to Herceptin and chemotherapy experienced a significantly longer median time to disease progression, a higher overall response rate (ORR), and a longer median duration of response, as compared with patients randomized to chemotherapy alone. Patients randomized to Herceptin and chemotherapy also had a longer median survival (see Table 9). These treatment effects were observed both in patients who received Herceptin plus paclitaxel and in those who received Herceptin plus AC; however the magnitude of the effects was greater in the paclitaxel subgroup.
Table 9: Study5: Efficacy Results in First‑Line Treatment for Metastatic Breast Cancer
|
|
Combined Results |
Paclitaxel Subgroup |
AC Subgroup |
|
|
Herceptin + All Chemotherapy
(n=235) |
All Chemotherapy
(n=234) |
Herceptin + Paclitaxel
(n=92) |
Paclitaxel
(n=96) |
Herceptin + AC*
(n=143) |
AC
(n=138) |
|
|
|
Primary Endpoint |
|
Median TTP (mos)†, ‡ |
7.2 |
4.5 |
6.7 |
2.5 |
7.6 |
5.7 |
|
95% CI |
7, 8 |
4, 5 |
5, 10 |
2, 4 |
7, 9 |
5, 7 |
|
p‑value§ |
<0.0001 |
<0.0001 |
0.002 |
|
Secondary Endpoints |
|
Overall Response Rate† |
45 |
29 |
38 |
15 |
50 |
38 |
|
95% CI |
39, 51 |
23, 35 |
28, 48 |
8, 22 |
42, 58 |
30, 46 |
|
p‑value¶ |
<0.001 |
<0.001 |
0.10 |
|
Median Resp Duration (mos)†,‡ |
8.3 |
5.8 |
8.3 |
4.3 |
8.4 |
6.4 |
|
25%, 75% Quartile |
6, 15 |
4, 8 |
5 ,11 |
4, 7 |
6, 15 |
4, 8 |
|
Med Survival (mos)‡ |
25.1 |
20.3 |
22.1 |
|
|
