Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments

Table 5 Summary of most common grade 3 and grade 4 toxicities in the four groups (i.e., reported in ≥5% of patients in any group)

	Arm A		Arm B		Arm C		Arm D
	(N=59)		(N=62)		(N=58)		(N=59)
	G3	G4	G3	G4	G3	G4	G3	G4
Neutropenia	24 (40.7)	22 (37.3)	22 (35.5)	7 (11.3)	15 (25.9)	4 (6.9)	23 (39.0)	11 (18.6)
Leukopenia	15 (25.4)	1 (1.7)	7 (11.3)	3 (4.8)	6 (10.3)	0 (0.0)	6 (10.2)	1 (1.7)
ALT increased	1 (1.7)	0 (0.0)	5 (8.1)	0 (0.0)	8 (13.8)	0 (0.0)	6 (10.2)	0 (0.0)
Diarrhoea	0 (0.0)	2 (3.4)	0 (0.0)	0 (0.0)	4 (6.9)	0 (0.0)	0 (0.0)	0 (0.0)
Myalgia	0 (0.0)	0 (0.0)	4 (6.5)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Alopecia	4 (6.8)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.7)	0 (0.0)	1 (1.7)	0 (0.0)
Hepatotoxicity^a	0 (0.0)	0 (0.0)	1 (1.6)	0 (0.0)	0 (0.0)	0 (0.0)	3 (5.1)	0 (0.0)
Asthenia	4 (6.8)	0 (0.0)	3 (4.8)	0 (0.0)	5 (8.6)	0 (0.0)	6 (10.2)	1 (1.7)
Fatigue	3 (5.1)	0 (0.0)	3 (4.8)	0 (0.0)	3 (5.2)	0 (0.0)	4 (6.8)	0 (0.0)

Data are number (%) of patient; G = CTC Grade.
^aALT are included in hepatotoxicities, but were separately reported by different study investigators.
Arm A: docetaxel and gemcitabine with 3-weekly schedule; Arm B: paclitaxel and gemcitabine with 3-weekly schedule; Arm C: docetaxel and gemcitabine with weekly schedule; Arm D: paclitaxel and gemcitabine with weekly schedule.

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