TABLE 3.
Summary of adverse events (AEs) among 219 women with HER2‐positive advanced breast cancer treated with pertuzumab + trastuzumab + chemotherapy (PTC) or trastuzumab + chemotherapy (TC)
| AEs, n (%) | PTC (N = 105) | TC (N = 108) | p value |
|---|---|---|---|
| Grade ≥3 AE | 65 (61.9) | 75 (69.4) | 0.253 |
| Serious AE | 19 (18.1) | 23 (21.3) | 0.608 |
| Death due to AE | 1 (1.0) | 1 (0.9) | 1.000 |
| Treatment discontinuation due to AE | 19 (18.1) | 11 (10.2) | 0.115 |
| Dose reduction of chemotherapeutic agents due to grade ≥3 AE | 26 (24.8) | 27 (25.0) | 1.000 |
| LVEF (<50% or ≥ 15% reduction from baseline) | 3 (2.9) | 0 (0.0) | 0.118 |
| AEs of special interests, n (%) | All grade | Grade ≥3 | All grade | Grade ≥3 |
|---|---|---|---|---|
| Stomatitis | 24 (22.9) | 2 (1.9) | 17 (15.7) | 2 (1.9) |
| Diarrhea | 22 (21.0) | 3 (2.9) | 7 (6.5) | 1 (0.9) |
| Neutropaenia | 82 (78.1) | 48 (45.7) | 79 (73.1) | 52 (48.1) |
| Febrile neutropaenia | 16 (15.2) | 16 (15.2) | 18 (16.7) | 18 (16.7) |
| Infusion reaction | 2 (1.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Cardiac dysfunction | 1 (1.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Skin and subcutaneous disorder | 24 (22.9) | 0 (0.0) | 18 (16.7) | 2 (1.9) |
Abbreviations: LVEF, left ventricular ejection fraction.