Table 3.
Treatment-related adverse events
| System organ class preferred term, n (%) | Everolimus plus letrozole (n = 20) | FEC (n = 20) | P value (all grades) | ||
|---|---|---|---|---|---|
| All grades (%) | Grade 3–4 (%) | All grades (%) | Grade 3–4 (%) | ||
| Mucositis oral | 15 (75.0) | 1 (5.0) | 1 (5.0) | 0 (0.0) | < 0.001 |
| Anemia | 10 (50.0) | 0 (0.0) | 10 (50.0) | 0 (0.0) | 1 |
| Insomnia | 6 (30.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0.092 |
| Fatigue | 4 (20.0) | 0 (0.0) | 11 (55.0) | 0 (0.0) | 0.048 |
| Cough | 4 (20.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 1 |
| Aspartate/Alanine aminotransferase increased | 4 (20.0) | 0 (0.0) | 6 (30.0) | 0 (0.0) | 0.716 |
| Bullous dermatitis/Rash maculo-papular | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.23 |
| Oropharyngeal pain | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.231 |
| Flu like symptoms | 2 (10.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 1 |
| Nausea | 1 (5.0) | 0 (0.0) | 13 (65.0) | 0 (0.0) | < 0.001 |
| Diarrhea | 1 (5.0) | 0 (0.0) | 2 (10.0) | 0 (0.0) | 1 |
| Constipation | 1 (5.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 0.605 |
| Weight loss | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
| Tumor pain | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
| Hyperlipidemia | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
| Pruritus | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
| Toxic epidermal necrolysis | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
| Bone pain | 1 (5.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
| Non-cardiac chest pain | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
| Paresthesia | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
| Laryngeal inflammation | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
| White blood cell decreased | 1 (5.0) | 0 (0.0) | 9 (45.0) | 4 (20.0) | 0.008 |
| Vomiting | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
| Stomach pain | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
| Anorexia | 0 (0.0) | 0 (0.0) | 6 (30.0) | 0 (0.0) | 0.02 |
| Fever | 0 (0.0) | 0 (0.0) | 2 (10.0) | 0 (0.0) | 0.487 |
| Alopecia | 0 (0.0) | 0 (0.0) | 9 (45.0) | 0 (0.0) | 0.001 |
| Generalized edema | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
| Bone marrow hypocellular | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
| Palpitations | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
| Hot flashes | 0 (0.0) | 0 (0.0) | 2 (10.0) | 0 (0.0) | 0.487 |
| Headache | 0 (0.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 0.231 |
| Neutrophil count decreased | 0 (0.0) | 0 (0.0) | 6 (30.0) | 4 (20.0) | 0.02 |
Adverse events occurring in all enrolled patients were reported according to National Cancer Institute Common Toxicity Criteria (Version 4.0). Data were presented as number of patients (%). FEC Fluorouracil, epirubicin plus cyclophosphamide