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Table 6 Trials of tyrosine kinase inhibitors targeting the angiogenic pathway in metastatic breast cancer

From: Antiangiogenic therapy for breast cancer

Reference

Phase

Number of patients

Treatment

Response (%)

PFS (months)

Burstein et al. [49]

II

64

Sunitinib

PR 2; SD ≥6 months 8

2.5 (TTP)

Lyandres et al. [50]

I

15

Sunitinib + cyclophosphamide + methotrexate

PR 7; SD >6 months 7

NR

Gianni et al. [51]

II

13

Sunitinib + docetaxel

PR 61; SD 23

NR

Kozloff et al. [52]

I

20

Sunitinib + paclitaxel

CR 10; PR 15

NR

Wildiers et al. [53]

II (randomised)

36

Taxane→ sunitinib

NR

3.4

  

19

Taxane → no treatment

NR

3.1

NCT00373256

III

NR

Paclitaxel + sunitinib Paclitaxel + bevacizumab

Did not meet primary end point (increased PFS)

Bergh et al. [54]

III

296

Docetaxel + sunitinib

51

8.6; OS 24.8

  

297

Docetaxel + placebo

39

8.3; OS 25.5

Crown et al. [55]

III

221

Capecitabine + sunitinib

19

5.5; OS 16.4

  

221

Capecitabine

16

5.9; OS 16.5

Barrios et al. [56]

III

244

Sunitinib

11

2.8; OS 15.3

  

238

Capecitabine

16

4.2; OS 24.6

Bianchi et al. [59]

II

54

Sorafenib

PR 1; SD ≥6 months 37

NR

Baselga et al. [60]

II (randomised)

114

Capecitabine + sorafenib

NR

PFS increased (P = 0.0006 versus Capecitabine + placebo)

  

115

Capecitabine + placebo

  

Gradishar et al. [61]

II (randomised)

119

Paclitaxel + sorafenib

67

6.9; TTP 8.1

  

118

Paclitaxel + placebo

54

5.6 (P = 0.0857); TTP 5.6 (P = 0.0171)

Isaacs et al. [113]

I/II

35

Anastrozole + sorafenib

CBR 20 (PR + SD ≥6 months)

NR

Taylor et al. [63]

I

21

Pazopanib

PR 5; SD ≥6 months 21

3.7 (TTP)

Miller et al. [66]

II

46

Vandetanib

SD ≥6 months 2

NR

Boér et al. [67]

II (randomised)

35

Docetaxel + vandetanib

NR

9

  

29

Docetaxel + placebo

NR

6

de Boer et al. [69]

I

13 (9 evaluable)

Motesanib diphosphate + taxane

PR 22; SD ≥6 months 11

NR

Rugo et al. [71]

II (randomised)

168

Docetaxel + axitinib

40

8.2 (TTP)

   

Docetaxel

23

7.0 (P = 0.052)

  1. CBR, clinical benefit rate; CR, complete response; NR, not reported; ORR, overall response; OS, overall survival; PFS, progression free survival; PR, partial response; pts, patients; SD, stable disease; TTP, time to progression.