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Table 1 Study outcomes of TNBC patients treated with NCCN-recommended (v1.2016) monotherapy and combination therapy

From: Current treatment landscape for patients with locally recurrent inoperable or metastatic triple-negative breast cancer: a systematic literature review

Author

Study description

Treatment

Patient population

% 1L

% 2L

% 3L+

N‡

ORR‡ %

DOR, months

PFS, months

OS, months

% TNBC patients

NCCN-recommended (v1.2016) monotherapies

 Aftimos et al. [23]

Retrospective phase III sub-group analysis

Eri

2L+ MBC w/mTNBC

0

100

22

18

N/R

N/R

N/R

17

 Awada et al. [24]

Phase II

Pac

1L mTNBC

100

0

0

28

28.6

N/R

3.5

13.1

100

 Baselga et al. [25]

Phase II

Cis

1L–2L mTNBC

72

28

0

60

10

N/R

1.5

9.4

100

Phase II

Cis

1L mTNBC

   

42

12

N/R

N/R

N/R

100

Phase II

Cis

2L mTNBC

   

16

6

N/R

N/R

N/R

100

 Brufsky et al. [26]

RIBBON-2

Physician’s choice chemo

2L MBC w/mTNBC

0

100

0

47

18

N/R

2.7

12.6

21

 Isakoff et al. [27]

Phase II

Car/cis

1L–2L mTNBC

80

20

0

86

25.6

N/R

2.9

11

100

Phase II

Car/cis

1L mTNBC

   

69

29

N/R

N/R

N/R

100

Phase II

Car/cis

2L mTNBC

   

17

11.8

N/R

N/R

N/R

100

 Miles et al. [28]

RIBBON-1 + AVADO + E2100 pooled subgroup

Cap/doc/pac

1L MBC w/mTNBC

100

0

0

255

23.3

N/R

5.4

17.5

26

 Perez et al. [29]

BEACON

Physician’s choice chemo

3L+ MBC w/mTNBC

0

0

100

117

N/R

N/R

N/R

8.8

28

 Pivot et al. [30]

Prespecified phase III subgroup

Cap

1L–3L+ MBC w/mTNBC

9

49

43

96

9

N/R

2.1

N/R

25

 Sparano et al. [31]

Phase III

Cap

1L–3L+ MBC w/mTNBC

19

63

18

134

N/R

N/R

1.81

N/R

22

 Study 301†

Phase III subgroup

Cap

1L MBC w/mTNBC

   

40

12

4.4

N/R

9.9

24.5

Eri

1L MBC w/mTNBC

   

40

10.4

6.6

N/R

13.1

27.1

Phase III subgroup

Cap

2L+ MBC w/mTNBC

   

96

~ 10

5.9

2.8

9.2

24.5

Eri

2L+ MBC w/mTNBC

   

110

~ 10

4.2

3.4

15.2

27.1

 Tredan et al. [32]

Phase II

Ixa

1L mTNBC

100

0

0

40

30

4.5

4.1

N/R

100

 Twelves et al. [9] and Pivot et al. [13]

EMBRACE + 301 pooled subgroup

Eri

1L–3L+ MBC w/mTNBC

11

27

62

243

12

N/R

2.8

12.9

22.9

EMBRACE + 301 pooled subgroup

Eri

2L+ MBC w/mTNBC

   

199

11

N/R

2.8

12.4

22.9

 Twelves et al. [9] and Pivot et al. [13]

EMBRACE + 301 pooled subgroup

Physician’s choice chemo

1L–3L+ MBC w/mTNBC

13

37

50

185

10.3

N/R

2.6

8.2

23.1

EMBRACE + 301 pooled subgroup

Physician’s choice chemo

2L+ MBC w/mTNBC

   

153

9

N/R

2.5

8.1

23.1

 von Minckwitz et al. [33]

TANIA

Physician’s choice chemo

2L MBC w/mTNBC

0

100

0

57

N/R

N/R

2.1

N/R

23

NCCN-v1.2016-recommended combination therapies

 Brodowicz et al. [34]§

TURANDOT

Bev+pac

1L MBC w/mTNBC

100

0

0

63

49

N/R

9

24.2

22

 Dieras et al. [35]

Phase II

Bev+pac

1L–2L mTNBC

81

19

0

61

47.53

7.5

7.2

17.4

100

Phase II

Bev+pac

1L mTNBC

   

46

N/R

N/R

7.2

N/R

100

Phase II

Bev+pac

2L mTNBC

   

16

N/R

N/R

7

N/R

100

 Fan et al. [36]

Phase II

Doc+cap

1L mTNBC

100

0

0

26

15.4

N/R

4.8

21.5

100

 Halim et al. [37]

Phase II

Car+pac

2L+ mTNBC

0

100

50

60

N/R

N/R

N/R

100

 Li et al. [38]

Phase II

Cap+cis

1L–3L mTNBC

84.9

12.1

3

33

63.6

N/R

8.2

17.8

100

Phase II

Cap+cis

1L mTNBC

   

28

64.3

N/R

8.2

19.6

100

Phase II

Cap+cis

2L–3L mTNBC

   

5

60

N/R

5.1

16.5

100

 Liao et al. [39]

Phase II

Doc+cap

1L mTNBC

100

0

0

27

14.8

N/R

4.9

21.5

100

 Liao et al. [39]

Phase II

Vin+cap

1L mTNBC

100

0

0

18

27.8

N/R

5.2

18.2

100

 Miles et al. [28]* (many combinations with high ORR—OS is still not much higher)

Pooled phase III (E2100, AVADO, RIBBON-1)

Bev+(cap/doc/pac/nab-pac/(dox/epi/CP/ FU))

1L MBC w/mTNBC

100

0

0

360

42.3

N/R

8.1

18.9

25

 O’Shaughnessy et al. [40]

Phase III

Gem+car

1L–3L mTNBC

58

42

244

32

N/R

4.1

11.1

100

Phase III

Gem+car

1L mTNBC

   

149

N/R

N/R

4.6

13.9

100

Phase III

Gem+car

2L–3L mTNBC

   

109

N/R

N/R

2.9

8.1

100

 Pivot et al. [30]

Prespecified phase III subgroup

Ixa+cap

1L–3L+ MBC w/mTNBC

7

48

45

91

27

N/R

4.1

N/R

24.3

 Rugo et al. [41]

Phase III

Bev+nab-pac

1L MBC w/mTNBC

100

0

0

65

N/R

N/R

7.4

N/R

24

 Rugo et al. [41]

Phase III

Bev+ixa

1L MBC w/mTNBC

100

0

0

63

N/R

N/R

5.6

N/R

26

 Rugo et al. [41]

Phase III

Bev+pac

1L MBC w/mTNBC

100

0

0

73

N/R

N/R

6.5

N/R

26

 Sparano et al. [31]

Phase III

Ixa+cap

1L–3L+ MBC w/mTNBC

20

61

19

122

N/R

N/R

4.2

N/R

20

  1. 1L first-line, 2L second-line, 3L third-line, APaT all patients as treated, Bev bevacizumab, Cap capecitabine, Car carboplatin, chemo chemotherapy, Cis cisplatin, CP cyclophosphamide, Doc docetaxel, Dox doxorubicin, Epi epirubicin, Eri eribulin, FU fluorouracil, Gem gemcitabine, Ixa ixabepilone, MBC metastatic breast cancer, mTNBC metastatic triple-negative breast cancer, N/R not reported, ORR objective response rate, Pac paclitaxel, TNBC triple-negative breast cancer, Vin vinorelbine
  2. *Paclitaxel in E2100, docetaxel in AVADO, capecitabine in one cohort of RIBBON-1, and either a single-agent taxane or an anthracycline-based combination in the second cohort of RIBBON-1. Of the total n = 255 in the meta-analysis, n = 46 belong to the taxane/anthracycline cohort of RIBBON-1; the number (< 46) of this subset of patients receiving anthracycline combination is unknown
  3. †Based on internal communication with trial sponsor (Eisai); not published results
  4. ‡n and ORR based on APaT population
  5. §2L+ MBC with mTNBC outcomes are available in a separate study from Pivot et al. [13]