Table 2.

Efficacy of ixabepilone in combination with capecitabine in patients with MBC in phase III trials

	Ixabepilone + capecitabinea	Capecitabine monotherapyb	HR (95% CI)	P value
Trial 046 (Yardley et al. [4]; Thomas et al. [32]; Hortobagyi et al. [33])
Overall populationc	n = 375	n = 377
ORRd, % (95% CI)	34.7 (30–40)	14.3 (10.9–18.3)	–	<0.0001
Median PFSd, months (95% CI)	5.8 (5.5–7.0)	4.2 (3.8–4.5)	0.75 (0.64–0.88)	0.0003
Median OS, months (95% CI)	12.9 (11.5–14.2)	11.1 (10.0–12.5)	0.90 (0.77–1.05)	0.1936
Subset with primary taxane resistancee	N = 150	N = 137
ORR, % (95% CI)	33 (25.9–41.5)	13 (8.0–20.0)	–	<0.0001
Median PFS, months (95% CI)	5.6 (4.3–7.0)	4.9 (4.0–5.7)	0.83	–
Trial 048 (Hortobagyi et al. [33], Sparano et al. [34])
Overall populationf	n = 609	n = 612
ORR, % (95% CI)	43.3 (38.7–47.9)	28.8 (24.7–33.2)	–	<0.0001
Median PFS, months (95% CI)	6.2 (5.6–6.8)	4.4 (4.1–5.4)	0.79 (0.69–0.90)	0.0005
Median OS, months	16.4 (14.9–17.9)	15.6 (13.9–17.0)	0.90 (0.78–1.03)	0.1162

^aIxabepilone 40 mg/m² i.v. on day 1 plus oral capecitabine 1,000 mg/m² twice daily on days 1–14 of a 3 week cycle

^bCapecitabine 1,250 mg/m² PO twice daily on days 1–14 of a 3 week cycle

^cPatients with locally advanced or MBC previously treated with or resistant to anthracyclines and resistant to taxanes. Resistance was defined by tumor progression during treatment or within 3 months of the last dose for MBC, or recurrence within 6 months of treatment in the adjuvant or neoadjuvant settings

^dAs determined by independent radiology review

^ePrimary resistance defined by progressive disease as best response in previous therapy

^fPatients with locally advanced or MBC treated previously with an anthracycline and a taxane

ORR objective response rate