Table 2.

Progression-free and overall survival in recent clinical studies of nab-paclitaxel in metastatic breast cancer

Study, author, year	Type of study	N (ITT)	Patient population or stage of disease	Line of therapy	Regimen	PFS, months, median	OS, months, median
Unselected (all subtypes; n = 5)
CALGB 40502, Rugo, 2015 [30]	Phase III	799	Stage IIIC or IV locally recurrent or MBC	First	Beva + paclitaxel 90 mg/m2 qw 3/4	11	27.4b
					Bev + nab-P 150 mg/m2 qw 3/4	9.3	23.5
					Bev + ixabepilone 16 mg/m2 qw 3/4	7.4	23.6
Jain, 2016 [32]	Phase II/III	180	MBC	Multiple (all lines)	nab-P 260 mg/m2 q3w	7.8	NR
					PICN 260 mg/m2 q3w	5.3	NR
					PICN 295 mg/m2 q3w	8.1	NR
Sun, 2014 [31]	Phase II	73	MBC	Multiple (all lines)	nab-P 125 mg/m2 qw 3/4 → cisplatin 75 mg/m2 q4w	9.8	26.9
Dent, 2013 [63]	Retrospective	43	MBC	Multiple (all lines)	nab-P 260 mg/m2 q3w	NR	10.8
					nab-P 100 mg/m2 qw 3/4		13.6
Aigner, 2013 [64]	Retrospective	36	MBC	Multiple (all lines)	nab-P 100-150 mg/m2 qw	7.5	14.2
HER2− or TNBC (n = 4)
TBCRC 019, Forero-Torres, 2015 [37]	Phase II	64	Metastatic TNBC	Multiple (all lines)	nab-P 100 mg/m2 qw 3/4 + tigatuzumab (10 mg/kg, then 5 mg/kg q2w)	2.8	NR
					nab-P 100 mg/m2 qw 3/4	3.7
Palumbo, 2015 [38]	Phase II	52	HER2− MBC	Second	nab-P 260 mg/m2 q3w	8.9	Not yet reached
Hamilton, 2013 [65]	Phase II	34	Metastatic TNBC	First	nab-P 100 mg/m2 qw 3/4 + carbo AUC 2 qw 3/4 + bev 10 mg/kg q2w	9.2	NR

No HER2+ studies reported OS or PFS

AUC area under the curve, bev bevacizumab, carbo carboplatin, HER2 human epidermal growth factor receptor 2, ITT intention to treat, MBC metastatic breast cancer, nab-P nab-paclitaxel, NR not reported, OS overall survival, PFS progression-free survival, PICN paclitaxel injection concentrate for nanodispersion, qw weekly, qw 3/4 first 3 of 4 weeks, q2w every 2 weeks, q3w every 3 weeks, q4w every 4 weeks, TNBC triple-negative breast cancer

^aBev was optional per protocol amendment; 97% of patients received bev

^bMedian OS was 26.5 months for comparison vs nab-P