nab-Paclitaxel dose and schedule in breast cancer

Breast Cancer Research

Table 1 nab-Paclitaxel monotherapy in metastatic breast cancer

Trial	Phase	Patient population	nab-Paclitaxel regimen	Patients receiving protocol-specified dose (%)	Efficacy outcomes			Select grade 3/4 adverse events (%)
					ORR (%)	PFS (months)	OS (months)	Neutropenia	Neuropathy	Fatigue
Ibrahim and colleagues, 2005 [19]	II	CN (n = 15), PT (n = 48)	300 mg/m² q3w	75^a	48 (CN 64; PT 21)	TTP 6.1	14.6	51	11^b	13^b
Gradishar and colleagues, 2005 [20]	III	CN (n = 97), PT (n = 132)	260 mg/m² q3w	96 (received 90 % of protocol-specified dose)	33 (CN 42; PT 27)	TTP 5.3	15.0	30^c	10^b	<10^b,c
Guan and colleagues, 2009 [27]	II	Chinese; CN (n = 61), PT (n = 43)	260 mg/m² q3w	≥95	54 (CN 56; PT 51)	7.6	17.8	42	7^b	NR
Blum and colleagues, 2007 [28]	II	PT	100 mg/m² qw 3/4 (n = 106)	87	14	3.0	9.2	17	8^b	5^b
			125 mg/m² qw 3/4 (n = 75)	68	16	3.5	9.1	32	19^b	12^b
Gradishar and colleagues, 2009 and 2012 [29, 30]	II	CN	300 mg/m² q3w (n = 76)	80	37	11.0	27.7	43	21^b	5^b
			100 mg/m² qw 3/4 (n = 76)	82	45	12.8	22.2	25	9^b	0
			150 mg/m² qw 3/4 (n = 74)	53	49	12.9	33.8	45	22^b	4^b

^aPercentage of patients without nab-paclitaxel dose reductions. ^bNo grade 4 event. ^cEstimated from a bar graph in the publication. CN, chemotherapy-naïve; NR, not reported; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PT, previously treated; q3w, every 3 weeks; qw 3/4, during the first 3 of 4 weeks; TTP, time to progression

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