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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.