Table 1 Clinical efficacy of ixabepilone in locally advanced and metastatic breast cancer
From: Present and future evolution of advanced breast cancer therapy
Author and reference | Trial design | Number of patients | Patient population | Dose schedule | ORR | PFS | Toxicity grade 3/4 |
|---|---|---|---|---|---|---|---|
Roche et al.[22] | Single arm, phase II | 65 | First-line MBC – prior adjuvant A (100%) and T (17%) | Ixa 40 mg/m2 every 3 weeks | 41.5% | TTP 4.8 months (4.2 to 7.6), median OS 22 months (15.6 to 27) | Neutropenia 58%, PN 28% |
Denduliri et al.[23] | Single arm, phase II | 23 | First-line MBC | Ixa 6 mg/m2/day on days 1 to 5 every 3 weeks | 57% | TTP 5.5 months | Neutropenia 22%, fatigue 13%, nausea 9% |
Perez et al.[24] | Single agent, phase II | 126 | Refractory to T, A, and CPC | Ixa 40 mg/m2 every 3 weeks | 11.5% (95% CI: 6.3 to 18.9 months) | 3.1 months (2.7 to 4.2 months) | Neutropenia 54% |
Bunnell et al.[139] | Single arm, phase II | 62 | Refractory to A and T (100%) | Ixa 40 mg/m2 every 3 weeks plus CPC 1,000 mg/m2 twice daily for 14 days | 30% | 3.8 months (2.7 to 5.6 months) | Neutropenia 69%, HFS 34%, PN 19% |
Thomas et al.[140] | Single arm, phase II | 49 | Second-line, third-line, or fourth-line | Ixa 40 mg/m2 every 3 weeks | 12% | TTP 2.2 months, OS 7.9 months (6.1 to 14.5%) | Neutropenia 55%, PN 12.2% |
Low et al.[141] | Single arm, phase II | 37 | First-line | Ixa 6 mg/m2/day on days 1 to 5 every 3 weeks | 22% (9.8 to 38.2%) | TTP 2.6 months | Neutropenia 35%, FN 14% |
Thomas et al.[25] | Randomized, phase III | 752 | >First-line | Ixa 40 mg/m2 every 3 weeks plus CPC 2,500 mg/m2 for 14 days vs. CPC 2,000 mg/m2 for 14 days | 42% vs. 23% | 5.3% vs. 3.8% | PN 23% vs. 0%, myalgias 8% vs. 0.3%, asthenia 7.8% vs. 0.8% |