Table 3. Summary of events in patients entered in the efficacy analysis.
| Events n (%) | FEC100 (n=235) | Epi-Vnr (n=236) |
|---|---|---|
| First event | 105 (44.7) | 110 (46.6) |
| Relapse | 87 (37.0) | 95 (40.2) |
| Local only | 13 (5.5) | 17 (7.2) |
| Distant (with or without local) | 74 (31.5) | 78 (33.0) |
| Contralateral breast cancer | 10 (4.2) | 5 (2.1) |
| Second cancer | 5 (2.1) | 5 (2.1) |
| Death | 3 (1.3) | 5 (2.1) |
| Any event | ||
| Relapse | 89 (37.9) | 96 (40.7) |
| Local only | 10 (4.2) | 9 (3.8) |
| Local then distant | 4 (1.7) | 8 (3.4) |
| Local and distant simultaneously | 5 (2.1) | 8 (3.4) |
| Distant only | 70 (29.8) | 71 (30.1) |
| Contralateral breast cancer | 10 (4.2) | 10 (4.2) |
| Second cancer | 8 (3.4) | 5 (2.1) |
| Any death | 62 (26.4) | 71 (30.1) |
| Of breast cancer | 54 (23.0) | 63 (26.7) |
| Of second cancer | 3 (1.3) | 0 |
| Due to toxic effects | 1 (0.4) | 0 |
| Due to cardiac events | 2 (0.8) | 1 (0.4) |
| Other causes | 2 (0.8)a | 7 (3.0)b |
Epi-Vnr=epirubicin–vinorelbine.
a
Necrotic enteritis (n=1), unknown (n=1).
b
Cirrhosis (n=1), unknown (n=6).