Table 4.
Treatment-Related Adverse Events (%) Occurring in 10% of More of Patients in Clinical Trials Of Ixabepilone Monotherapy in Metastatic Breast Cancer: Key Phase 2 Trials
| Adverse Event | Denduluri et al.40 (n = 23) | Roché et al.39 (n = 65) | Low et al.38 (n = 37) | Thomas et al.37 (n = 49) | Perez et al.36 (n = 126) |
|---|---|---|---|---|---|
| Nonhematological toxicity | |||||
| Peripheral sensory neuropathy | 52 (Grade 3/4: 0) | 71 (Grade 3/4: 20) | 54 (Grade 3/4: 3) | 63 (Grade 3/4: 12) | 60 (Grade 3/4: 14) |
| Fatigue/asthenia | 78 (Grade 3/4: 13) | 68 (Grade 3/4: 6) | 64 (Grade 3/4: 13) | 76 (Grade 3/4: 27) | 50 (Grade 3/4: 14) |
| Myalgia, arthralgia | 30 | 97 | 52 | 84 | 49 |
| Alopecia | 87 | 92 | 54 | 43 | 48 |
| Nausea | 61 | 54 | 54 | 57 | 42 |
| Stomatitis, mucositis, pharyngitis | – | 32 | – | 28 | 29 |
| Vomiting | 39 | 26 | 21 | 41 | 29 |
| Diarrhea | 48 | 29 | 35 | 31 | 22 |
| Rash | – | 22 | – | 12 | – |
| Musculoskeletal pain | – | – | – | – | 20 |
| Anorexia | – | 18 | – | 18 | 19 |
| Constipation | 56 | 20 | 27 | 20 | 16 |
| Nail changes | 56 | 17 | 30 | 8 | 9 |
| Fever | – | 14 | – | 16 | – |
| Abdominal pain, cramping | – | 8 | – | 10 | 13 |
| Headache | – | 14 | – | – | 11 |
| Neuropathic pain | – | 12 | – | 8 | – |
| Pain, other | – | 14 | – | 65 | 8 |
| Infection without neutropenia | – | 14 | – | 12 | – |
| Infection, febrile neutropenia | 0 | 6 | 14 | 6 | – |
| Motor neuropathy | 9 | 6 | – | – | 10 |
| Taste disturbance, dysgeusia | 65 | 11 | 33 | – | 6 |
| Hematological toxicity | |||||
| Neutropenia | 87 (Grade 3/4: 22) | 89 (Grade 3/4: 58) | 67 (Grade 3/4: 35) | – (Grade 3/4: 53) | 79 (Grade 3/4: 54) |
| Leukopenia | – | 92 (Grade 3/4: 50) | – | 6 (Grade 3/4: 2) | 90 (Grade 3/4: 49) |
| Anemia | 83 (Grade 3/4: 0) | 92 (Grade 3/4: 3) | 73 (Grade 3/4:) | 6 (Grade 3/4: 4) | 84 (Grade 3/4: 8) |
| Thrombocytopenia | 52 (Grade 3/4: 4) | 40 (Grade 3/4: 0) | 40 (Grade 3/4: 8) | – | 44 (Grade 3/4: 8) |