Table 2.
Phase II trials that evaluated single-agent ixabepilone in patients with locally advanced or metastatic breast cancer23–27
| Reference | Patient population | Patients, n | Treatment | ORR, % | Median duration of response, months | Median TTP/PFS, months | Median OS, months | Main grade 3 or 4 toxic effects |
|---|---|---|---|---|---|---|---|---|
| Denduluri et al23 | Metastatic breast cancer with no previous exposure to taxanes in the adjuvant or metastatic setting | 23 | Ixabepilone (6 mg/m2) as a 1-hour IV infusion on days 1−5 of a 21-day cycle | 57 | 5.6 | 5.5 | Not reported | Fatigue (13%) Nausea (9%) Motor neuropathy (4%) Neutropenia (22%) |
| Low et al24 | Advanced breast cancer previously treated with taxanes in the neoadjuvant, adjuvant, or metastatic setting | 37 | Ixabepilone (6 mg/m2) as a 1-hour IV infusion on days 1−5 of a 21-day cycle | 22 | 3.7 | 2.5 | Not reported | Fatigue (13%) Diarrhea (11%) Neutropenia (35%) Febrile neutropenia (14%) Thrombocytopenia (8%) |
| Perez et al25 | Advanced breast cancer resistant to anthracyclines, taxanes, and capecitabine | 126 | Ixabepilone (40 mg/m2) as a 3-hour IV infusion on day 1 of a 21-day cycle | 11.5a 18.3b | 5.7 | 3.1 | 8.6 | Neuropathy (14%) Fatigue/asthenia (14%) Myalgia/arthralgia (8%) Stomatitis/mucositis (7%) Neutropenia (54%) Leukopenia (49%) |
| Roché et al26 | Metastatic breast cancer previously treated with adjuvant anthracyclines (17% had received taxanes as part of an adjuvant regimen) | 65 | Ixabepilone (40 mg/m2) as a 3-hour IV infusion on day 1 of a 21-day cycle | 41.5 | 8.2 | 4.8 | 22.0 | Sensory neuropathy (20%) Myalgia (8%) Vomiting (7%) Infection with grade 3 or 4 Neutrogena (6%) Neutropenia (58%) Leukopenia (50%) |
| Thomas et al27 | Metastatic breast cancer resistant to taxanes | 49 | Ixabepilone (40 mg/m2) as a 3-hour IV infusion on day 1 of a 21-day cycle | 12 | 10.4 | 2.2 | 7.9 | Fatigue (27%) Sensory neuropathy (12%) Myalgia (10%) Pain (10%) Infection/febrile Neutrogena (10%) Nausea (6%) Vomiting (6%) Neutropenia (53%) |
a
Evaluated by an IRR for 113 evaluable patients.
b
Evaluated by investigators for all 126 treated patients.
Abbreviations: ORR, objective response rate; TTP, time-to-progression; PFS, progression-free survival; OS, overall survival.