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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%
  1. A, anthracyclines; CI, confidence interval; CPC, capecitabine; FN, febrile neutropenia; HFS, hand-and-foot syndrome; Ixa, ixabepilone; MBC, metastatic breast cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PN, peripheral neuropathy; TTP, time to tumor progression; T, taxanes.