Table 3.
Adverse events that occurred in ≥10% of clinical trials of ixabepilone for locally advanced or metastatic breast cancer23–28
| Study | Thomas et al28 | Denduluri et al23 | Roché et al26 | Low et al24 | Thomas et al27 | Perez et al25 | |
|---|---|---|---|---|---|---|---|
| Dose/schedule | Ixabepilone 40 mg/m2 every 3 weeks + capecitabine 2000 mg/m2 on days 1–14 | Capecitabine 2500 mg/m2 on days 1–14 | Ixabepilone 6 mg/m2 daily on days 1–5 every 3 weeks | Ixabepilone 40 mg/m2 every 3 weeks | Ixabepilone 40 mg/m2 every 3 weeks | Ixabepilone 40 mg/m2 every 3 weeks | Ixabepilone 40 mg/m2 every 3 weeks |
| Number of patients treated | 369 | 368 | 23 | 65 | 37 | 49 | 126 |
| Patient population | Pretreated; resistant to anthracyclines and resistant to taxanes | No previous exposure to taxanes in adjuvant or metastatic setting | Previously treated with adjuvant anthracyclines | Previously treated with taxanes in neoadjuvant, adjuvant, or metastatic setting | Resistant to taxanes | Resistant to anthracyclines, taxanes, and capecitabine | |
| Nonhematologic adverse events, % all grades (% grade 3/4) | |||||||
| Peripheral sensory neuropathy | 64 (21) | 16 (0) | 52 (0) | 71 (20) | 54 (3) | 63 (12) | 60 (14) |
| Fatigue/asthenia | 64 (16) | 30 (4) | 78 (13) | 68 (6) | 65 (14) | 76 (27) | 50 (14) |
| Myalgia/arthralgia | 53 | 6 | 30 | 97 | 51 | 84 | 49 |
| Alopecia | 31 | 3 | 87 | 92 | 54 | 43 | 48 |
| Nausea | 53 | 40 | 61 | 54 | 54 | 57 | 42 |
| Stomatitis/mucositis/pharyngitis | 33 | 21 | – | 32 | – | 28 | 29 |
| Vomiting | 39 | 24 | 39 | 26 | 22 | 41 | 29 |
| Diarrhea | 44 | 39 | 48 | 29 | 35 | 31 | 22 |
| Rash | – | – | – | 22 | – | 12 | – |
| Musculoskeletal pain | – | – | – | – | – | – | 20 |
| Anorexia | 31 | 14 | – | 18 | – | 18 | 19 |
| Constipation | 22 | 6 | 56 | 20 | 27 | 20 | 16 |
| Nail changes | 20 | 8 | 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 | 16 | 0.3 | 9 | 6 | – | – | 10 |
| Taste disturbance/dysgeusia | = | = | 65 | 11 | 32 | – | 6 |
| Hand-foot syndrome | 64 | 62 | – | – | – | – | – |
| Hematologic adverse events, % all grades (% grade 3/4) | |||||||
| Neutropenia | 89 (67) | 43 (11) | 87 (22) | 89 (58) | 68 (35) | N/A (53) | 79 (54) |
| Leukopenia | 90 (57) | 54 (6) | – | 92 (50) | – | 6 (2) | 90 (49) |
| Anemia | 90 (9) | 70 (4) | 83 (0) | 92 (3) | 73 (0) | 6 (4) | 84 (8) |
| Thrombocytopenia | 54 (8) | 31 (4) | 52 (4) | 40 (0) | 41 (8) | – | 44 (8) |