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Table 1 Select clinical trials of nab-P in metastatic breast cancer

From: The treatment patterns, efficacy, and safety of nab®-paclitaxel for the treatment of metastatic breast cancer in the United States: results from health insurance claims analysis

Trial

Phase

Patient population

Regimen

Efficacy

Selecta Grade ≥ 3 AEs, %

PFS, mo

OS, mo

Neutropenia

Neuropathy

Monotherapy

Ibrahim et al. 2005 [11]

2

First line (n = 15)

nab-P 300 mg/m2 q3w

TTP 6.1

14.6

51

11b

Second line or later (n = 48)

Gradishar et al. 2009 [12] & 2012 [13]

2

First line

nab-P 300 mg/m2 q3w (n = 76)

11.0

27.7

43

21b

nab-P 100 mg/m2 qw 3/4 (n = 76)

12.8

22.2

25

9b

nab-P 150 mg/m2 qw 3/4 (n = 74)

12.9

33.8

45

22b

Gradishar et al. 2005 [10]

3

First line(n = 97)

nab-P 260 mg/m2 q3w

TTP 5.3

15.0

30

10b

Second line or later (n = 132)

Combination therapy with cytotoxic agents

Roy et al. 2009 [14]

2

First line (N = 50)

nab-P 125 mg/m2 + gemcitabine 1000 mg/m2 qw 2/3

7.9

Median not reached; 6-mo OS 92 %

54

8b

Schwartzberg et al. 2012 [15]

2

First line (N = 50)

nab-P 125 mg/m2 qw 2/3 + oral capecitabine 825 mg/m2 twice daily on days 1 and 15 of a 21-day cycle

10.6

19.9

10

2b

HER2 negative

Combination therapy with targeted agents

Seidman et al. 2013 [16]

2

First line, HER2 negative

nab-P 130 mg/m2 qw + bev 10 mg/kg q2w (n = 79)

8.8

23.7

33

46

nab-P 260 mg/m2 q2w + bev 10 mg/kg q2w (n = 54)

5.8

19.0

6

56

nab-P 260 mg/m2 q3w + bev 15 mg/kg q3w (n = 75)

7.7

21.3

16

33

Rugo et al. 2015 [17]

3

First line, predominantly HER2 negative

nab-P 150 mg/m2 qw 3/4 + bev 10 mg/kg q2w (n = 271)

9.3

23.5

51

27

Mirtsching et al. 2011 [18]

2

First line (N = 72)

nab-P 125 mg/m2 qw 3/4 + trastuzumab 4 mg/kg bolus then 2 mg/kg qw (HER2 positive only)

14.5

29.0

11b

8b

HER2 positive (n = 22)

Yardley et al. 2013 [19]

2

First/second line (N = 60)

nab-P 125 mg/m2 qw 3/4 + oral lapatinib 1250 mg daily

9.1

Median not reached

22b

3b

  1. AE adverse event, bev bevacizumab, HER2 human epidermal growth factor receptor, nab-P nab-paclitaxel, OS overall survival, PFS progression-free survival, TTP time to tumor progression, qw every week, q2w every 2 weeks, q3w every 3 weeks, qw 2/3 weekly for the first 2 of 3 weeks; qw 3/4 weekly for the first 3 of 4 weeks
  2. aNeutropenia and neuropathy are common grade ≥ 3 toxicities associated with nab-P treatment
  3. bNo grade 4 events