Table 4. Univariate analysis of outcomes according to clinical parameters.

Variable	CBR, n (%) a	P-value	RR, n (%) a	P-value	Median PFS (months)	P-value	Median OS (months)	P-value
Age
18–65 years	83/220 (37.7)		26/172 (15.1)		3.2		10.7
>65 years	19/52 (36.5)	1	8/38 (21.1)	0.638	2.8	0.439	11.9	0.632
ECOG performance status
0	40/75 (53.3)		17/59 (28.8)		4.1		15.5
1	54/152 (35.5)		14/122 (11.5)		3.4		11.4
2	8/44 (18.2)	<0.001	3/28 (10.7)	0.001	1.7	<0.001	4.1	0.001
No. previous chemotherapies b
1	10/18 (55.6)		4/16 (25.0)		4.55		18.3
2	15/61 (24.6)		8/55 (14.5)		2.9		9.3
>2	77/193 (39.9)	0.024	22/139 (15.8)	0.415	3.1	0.405	10.9	0.041
Previous taxane
Yes	59/196 (30.1)		17/146 (11.6)		2.8		9.9
No	35/66 (53.0)	0.001	14/56 (25.0)	0.048	4.3	0.191	14.5	0.023
Setting of prior anthracycline
Adjuvant	13/36 (36.1)		2/30 (6.7)		2.9		8.5
Metastatic	53/126 (42.1)		24/102 (23.5)		3.7		11.9
Both	36/110 (32.7)	0.332	8/78 (10.3)	0.050	2.6	0.949	11.2	0.439
Cumulative dose prior anthracycline
<180 mg m−2	26/77 (33.8)		10/59 (16.9)		2.8		9.3
180–250 mg m−2	27/73 (37.0)		8/55 (14.6)		2.8		11.9
>250 mg m−2	31/88 (35.2)	0.913	8/73 (11.0)	0.697	3.1	0.616	12.3	0.333
Anthracycline-free interval
0–12 months	28/96 (29.2)		9/74 (12.2)		2.6		10.7
>12 months	61/150 (40.7)	0.078	20/120 (16.7)	0.429	3.2	0.253	11.9	0.892
Anthracycline resistance
Yes	47/138 (40.5)		18/91 (19.8)		3.3		11.3
No	47/116 (34.1)	0.300	14/104 (13.5)	0.237	3.0	0.604	11.1	0.611

Abbreviations: CBR=clinical benefit rate; RR=response rate (partial+complete response); PFS=progression-free survival time; OS=overall survival time.

^an=number of patients who were evaluable for predefined parameter and end point.

^bIncluding chemotherapy and hormonal therapy in the adjuvant and metastatic setting.