Nanoparticle Albumin Bound Paclitaxel in the Treatment of Human Cancer: Nanodelivery Reaches Prime-Time?

Table 1

Randomized phase II and III trials with nab-paclitaxel in mBC.

(a) Phase II

	Arms		Pts	RR (%); INV. RAD.; 𝑃=.047	RR (%); IND. RAD.; 𝑃=.047	PFS (%); INV. RAD.; 𝑃=.047	PFS (%); IND. RAD. 𝑃=.047	OS; (months); 𝑃=.47
Gradishar et al., 2009 [26]; Gradishar et al., 2012 [27]; Update OS; (first line)	Nab-paclitaxel	300 mg/m^2 q3w; 150 mg/m^2 qw; 100 mg/m^2 qw	76; 74; 76	46; 74; 63	37; 49; 45	10.9; 14.6; 7.5	11; 12.9; 12.8	27.7; 33.8; 22.2
	Docetaxel; 100 mg/m^2 q3w		74	39	35	7.8	7.5	26.6
	Arms		Pts	ORR (%)		Median PFS (months)		OS (months)
				𝑃=.73		𝑃=ND		𝑃=.71
Blum et al., 2007 [28]; (following lines)	Nab-paclitaxel; 125 mg/m^2 qw		75	16		3.5		9.1
	Nab-paclitaxel; 100 mg/m^2 qw		106	14		3.0		9.2
	Arm		Pts	RR I line; (%); 𝑃=ND	RR > I line; (%); 𝑃=ND	ORR; (%); 𝑃=ND	Median TTP; (weeks) 𝑃=ND	Median survival (weeks); 𝑃=ND
Ibrahim et al., 2002 [19]; (first and; following lines)	Nab-paclitaxel; 300 mg/m^2 q3w		63	64	21	48	26.6	63.6
	Arms		Pts	Median PFS; (months); 𝑃=ND	PFS at 6 months (%); 𝑃=ND	MDR; (months); 𝑃=ND	Median OS (months); 𝑃=ND	OS at 6 months (%); 𝑃=ND
Roy et al., 2009 [29]; (first line)	Nab-paclitaxel; 125 mg/sqm; Gemcitabine; 1000 mg/sqm; days 1 and 8		50	7.9	60	6.9	Not; reached	92

(b) Phase III

					AEs (%) 𝑃=.001
	Arms	Pts	RR (%); 𝑃=.001	TTP weeks; 𝑃=.006	Grade IV neutropenia	Grade III sensory neuropathy
Gradishar et al., 2005 [30]; (first line)	Nab-paclitaxel 260 mg/sqm	229	33	23.0	9	10
	Paclitaxel; 175 mg/sqm	225	19	16.9	22	2

P: P value; nd: not done; AEs: adverse events; inv. rad.: investigator radiologist; ind. rad.: independent radiologist; ORR: overall response rate; RR: response rate; TTP: time to progression; PFS: progression-free survival; OS: overall survival; MDR: median duration of response.