an age was 49 (range 22 to 74years; 6% ≥ 65years). Disease characteristics included 54% ER+ and/or PR+ and 71% node positive. Prior to randomization, all patients underwent primary surgery for breast cancer.
Table 7: Efficacy Results from Adjuvant Treatment of Breast Cancer (Studies1+2, Study3, and Study4)
|
|
DFS events |
Hazard ratio
(95% CI)
p value |
Deaths |
Hazard ratio
p value |
|
CI=confidence interval. |
|
|
|
Studies 1 + 2* |
AC→TH
(n=1872) |
133 |
0.48†
(0.39, 0.59)
p=<0.0001‡ |
62 |
0.67
p=NS§ |
AC→T
(n=1880) |
261 |
|
92 |
|
Study 3 |
Chemo→Herceptin
(n=1693) |
127 |
0.54
(0.44, 0.67)
p=<0.0001¶ |
31 |
0.75
p=NS§ |
Chemo→Observation
(n=1693) |
219 |
|
40 |
|
Study 4 # |
TCH
(n=1075) |
134 |
0.67
(0.54–0.84)
p=0.0006‡,Þ |
56 |
|
AC→TH
(n=1074) |
121 |
0.60
(0.48–0.76)
p=<0.0001‡,Þ |
49 |
|
AC→T
(n=1073) |
180 |
|
80 |
|
The results for DFS for the integrated analysis of Studies1 and 2, Study3, and Study4 are presented in Table7. The duration of DFS for Studies1 and 2 is presented in Figure4, and the duration of DFS for Study4 is presented in Figure5. Across all four studies, there were insufficient numbers of patients within each of the following subgroups to determine if the treatment effect was different from that of the overall patient population: patients with low tumor grade, patients within specific ethnic/racial subgroups (Black, Hispanic, Asian/Pacific Islander patients), and patients > 65years of age.
Figure 4
Duration of Disease‑Free Survival in Patients with Adju
