Table 2. Safety Analysisa.
| Adverse effect | Study group | |||||
|---|---|---|---|---|---|---|
| EP (n = 407) | EC-P (n = 406) | |||||
| Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | |
| Leukopenia | 301 (74.0) | 153 (37.6) | 62 (15.2) | 281 (69.2) | 134 (33.0) | 38 (9.4) |
| Neutropenia | 295 (72.5) | 59 (14.5) | 196 (48.2) | 268 (66.0) | 92 (22.7) | 131 (32.3) |
| Anemia | 194 (47.7) | 13 (3.2) | 0 | 132 (32.5) | 7 (1.7) | 0 |
| Thrombocytopenia | 51 (12.5) | 4 (1.0) | 0 | 45 (11.1) | 7 (1.7) | 2 (0.5) |
| Gastrointestinal tract toxic effects | 337 (82.8) | 20 (4.9) | 0 | 281 (69.2) | 23 (5.7) | 0 |
| Neurotoxic effects | 159 (39.1) | 6 (1.5) | 0 | 146 (36.0) | 14 (3.4) | 0 |
| Hepatotoxic effects | 129 (31.7) | 5 (1.2) | 1 (0.2) | 111 (27.3) | 7 (1.7) | 0 |
| Cardiotoxic effects | 107 (26.3) | 0 | 0 | 98 (24.1) | 1 (0.2) | 0 |
| Alopecia | 246 (60.4) | 67 (16.5) | 1 (0.2) | 186 (45.8) | 47 (11.6) | 0 |
| Fatigue | 65 (16.0) | 0 | 0 | 60 (14.8) | 1 (0.2) | 0 |
| Hyperpigmentation | 7 (1.7) | 0 | 0 | 11 (2.7) | 0 | 0 |
Abbreviations: EC-P, epirubicin and cyclophosphamide followed by paclitaxel; EP, epirubicin plus paclitaxel.
a
Data are presented as No. (%) of patients.