nab-Paclitaxel dose and schedule in breast cancer

Breast Cancer Research

Table 2 nab -Paclitaxel in combination with select targeted therapies 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
Bevacizumab combinations
Seidman and colleagues, 2013 [31]	II	CN	130 mg/m² qw + bev 10 mg/kg q2w (n = 79)	33^a	46	8.8	23.7	33	46	19
			260 mg/m² q2w + bev 10 mg/kg q2w (n = 54)^b	39^a	41	5.8	19.0	6	56	35
			260 mg/m² q3w + bev 15 mg/kg q3w (n = 75)	53	45	7.7	21.3	16	33	17
Danso and colleagues, 2008 [32]	II	CN	125 mg/m² qw 3/4 + bev 10 mg/kg q2w (n = 50)	NR	33	7.4	NR	50	13^c	13^c
Rugo and colleagues, 2012 [33]	III	CN	150 mg/m² qw 3/4 + bev 10 mg/kg q2w (n = 271)	NR^d	NR	9.2	27	47	25	16
HER2-targeted therapy combinations
Mirtsching and colleagues, 2011 [34]	II	CN	125 mg/m² qw 3/4 (HER2-/unknown; n = 50), 125 mg/m² qw 3/4 + trastuz (HER2+; n = 22)	100^e	42 (HER2-negative 38.1; HER2-positive 52.4)	14.5 (HER2-negative 12.8; HER2-positive 18.7)	29 (HER2-negative 27.3; HER2-positive 36.8)	8^f	6^f	5^f
Yardley and colleagues, 2013 [35]	II	CN and PT (second line)	100 mg/m² qw 3/4 + lapatinib (n = 60)^g	78^a	53	9.1	Not reached	22^f	3^f	10

^aPercentage of patients without nab-paclitaxel dose reductions. ^bArm closed early due to toxicity. ^cEstimated from a bar graph in the publication. ^dForty-five percent of patients had a dose reduction by cycle 3. ^eMedian dose intensity was 100 % of planned dose. Dose modifications due to toxicity were required in 19 % of patients; the type of modification was not specified. ^fNo grade 4 event. ^gOriginal dose was modified after toxicity in first few patients. bev, bevacizumab; CN, chemotherapy-naïve; HER2, human epidermal growth factor receptor 2; NR, not reported; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PT, previously treated; q2w, every 2 weeks; q3w, every 3 weeks; qw, weekly; qw 3/4, during the first 3 of 4 weeks; trastuz, trastuzumab

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