Table 4.

Activity and efficacy by treatment arm and clinical setting

	Whole set		Locally advanced		Metastatic not pre-treated with anthracyclines		Metastatic pre-treated with anthracyclines
	3-weekly N = 69	Weekly N = 66	3-weekly N = 22	Weekly N = 20	3-weekly N = 26	Weekly N = 26	3-weekly N = 21	Weekly N = 20
Objective response
Complete response, n	7	2	2	1	2	-	3	1
Partial response, n	20	20	9	9	7	7	4	4
Stable disease, n	19	16	10	8	8	7	1	1
Progressive disease, n	5	9	-	1	2	4	3	4
Not evaluable (non responding), n	18	19	1	1	7	8	10	10
Response rate, % (95% exact CI)	39.1 (27.6-51.6)	33.3 (22.2-46.0)	50.0 (28.2-71.8)	50.0 (27.2-72.8)	34.6 (17.2-55.7)	26.9 (11.6-47.8)	33.3 (14.6-57.0)	25.0 (8.7-49.1)
Progression free survival
Progressed patients, n (%)	42 (60.9)	44 (66.7)	6 (27.3)	6 (30.0)	18 (69.2)	20 (76.9)	18 (85.7)	18 (90.0)
Median, months (95% CI)	15.2 (11.8-36.6)	13.1 (7.7-22.4)	n.r.	n.r.	11.9 (10.2-36.6)	10.4 (6.2-22.4)	9.1 (5.9-29.7)	6.2 (4.2-14.4)
HR weekly vs 3 weekly (95% CI)	1.29 (0.84-1.97)		1.10 (0.35-3.45)		1.29 (0.67-2.47)		1.52 (0.78-2.97)
Overall survival
Dead patients, n (%)	27 (39.1)	32 (48.5)	3 (13.6)	2 (10.0)	13 (50.0)	15 (57.7)	11 (52.4)	15 (75.0)
Median, months (95% CI)	42.9 (27.7-na)	33.0 (25.2-na)	n.r.	n.r.	26.7 (21.2-na)	28.5 (11.4-na)	33.2 (16.3-na)	28.8 (19.8-na)
HR weekly vs 3 weekly (95% CI)	1.38 (0.82-2.30)		0.78 (0.13-4.69)		1.41 (0.67-2.99)		1.54 (0.70-3.36)

n.r. = not reached