Table 2.
Incidence of Grade 3 and 4 Adverse Events in the Pivotal Phase 3 Trial of Ixabepilone/Capecitabine or Capecitabine Alone In Patients with Metastatic Breast Cancer Previously Treated with Or Resistant to Anthracycline and Resistant to Taxanes
| Ixabepilone plus Capecitabine (n = 369) | Capecitabine (n = 368) | |
|---|---|---|
| Hematological toxicities | % | % |
| Leukopenia | 57 | 6 |
| Anemia | 10 | 4 |
| Neutropenia | 68 | 11 |
| Thrombocytopenia | 8 | 4 |
| Febrile neutropenia | 4 | <1 |
| Nonhematological toxicities | ||
| Peripheral neuropathy | 23 | 0 |
| Hand–foot syndrome | 18 | 17 |
| Fatigue | 9 | 3 |
| Myalgia | 8 | .3 |
| Diarrhea | 6 | 9 |
| Vomiting | 4 | 2 |
| Nausea | 3 | 2 |
| Mucositis | 3 | 2 |
| Arthralgia | 3 | 0 |
Data derived from Thomas ES, Gomez HL, Li RK, et al. J Clin Oncol 2007;25:5210–5217.44