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Clinical Pharmacology
Herceptin
The results for DFS for the integrated analysis of Studies 1 and 2 (Figure 3) and the analysis of DFS results in Studies 1 and 2, and Study 3 are presented in Table 7. Across studies 1 and 2, 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 node negative disease, patients with low tumor grade, and patients within specific ethnic/racial subgroups (Black, Hispanic, Asian/Pacific Islander patients). In Study 3, 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, within specific ethnic/racial subgroups (Black or Hispanic patients), or > 65 years of age.
Table 6: Efficacy Results from Adjuvant Treatment of Breast Cancer (Studies 1 + 2 and Study 3)
| Study 1 + 2 | Study 3 | |||
| AC→ Herceptin + T (n =1872) |
AC→ T (n = 1880) |
Chemo→ Herceptin (n =1693 ) |
Chemo→ Observation (n = 1693) |
|
|
Primary Endpoint |
||||
| DFS events | 133 | 261 | 127 | 219 |
| Hazard ratio (95% CI) | 0.48a (0.39, 0.59) |
0.54 (0.44, 0.67) |
||
| p-value | < 0.0001b | < 0.0001c | ||
| Secondary Endpoints | ||||
| Deaths | 62 | 92 | 31 | 40 |
| Hazard ratio 95% CI | 0.67 | 0.75 | ||
| p-value | NSd | NSd | ||
| CI = confidence interval. a Hazard ratio estimated by Cox regression stratified by clinical trial,intended paclitaxel schedule, number of positive nodes, and hormonereceptor status. b stratified log-rank test. c log-rank test. d NS= non-significant. |
||||
Figure 3: Duration of Disease-Free Survival in Patients with Adjuvant Treatment of Breast Cancer (Studies 1 and 2)
 |
Exploratory analyses of DFS as a function of HER2 overexpression or gene amplification were conducted for patients in Studies 2 and 3, where central laboratory testing data were available. The results are shown in Table 7. The number of events in Study 2 was small with the exception of the IHC 3+/FISH+ subgroup, which constituted 81% of those with data. Definitive conclusions cannot be drawn regarding efficacy within other subgroups due to the small number of events. The number of events in Study 3 was adequate to demonstrate significant effects on DFS in the IHC 3+/FISH unknown and the FISH +/IHC unknown subgroups.
Table 7 : Treatment Outcomes in Studies 2 and 3 as a Function of HER2 Overexpression or Amplification
| 1 | Study 2 | Study 3 | ||
| HER2 Assay Result* | Number of Patients |
Hazard Ratio DFS (95% CI) |
Number of Patients |
Hazard Ratio DFS (95% CI) |
| IHC 3+ | ||||
| FISH (+) | 1170 | 0.42 (0.27, 0.64) | 91 | 0.56 (0.13, 2.50) |
| FISH (-) | 51 | 0.71 (0.04, 11.79) | 8 | ---- |
| FISH Unknown | 51 | 0.69 (0.09, 5.14) | 2258 | 0.53 (0.41, 0.69) |
| IHC < 3+ / FISH (+) | 174 | 1.01 (0.18, 5.65) | 299 ^ | 0.53 (0.20, 1.42) |
| IHC unknown / FISH (+) | ---- | ------ | 724 | 0.59 (0.38, 0.93) |
| * IHC by HercepTest, FISH by PathVysion as performed at a
central laboratory. ^ All cases in this category in study 3 were IHC 2+ . |
||||
Metastatic Breast Cancer
Generic Name: Trastuzumab
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