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. 2017 Jun 26;20(2):119–131. doi: 10.4048/jbc.2017.20.2.119

Table 2. Efficacy data in neoadjuvant trials investigating bevacizumab.

Study Clinical phase No. of cases Standard neoadjuvant regimen pCR definition Treatment arms pCR (breast and axilla) (%) DFS OS Subgroups with prominent therapeutic effect
All HR+ HR–
GeparQuinto [48] Phase III 4 Cycles of epirubicin-cyclophosphamide followed by 4 cycles of docetaxel (early nonresponders excluded) ypT0 N0 8 Cycles of bevacizumab concomitantly with standard NAT 18.4* 7.7 39.3* At 3 yr: 80.8% At 3 yr: 90.7% TN, cT1-3, non-lobular, grade 3
Standard NAT 14.9* 7.8 27.9* At 3 yr: 81.5% At 3 yr: 88.7%
NSABP B-40 [62] Phase III 1,186 4 Cycles of docetaxel (+/– capecitabine or gemcitabine) followed by 4 cycles doxorubicin and cyclophosphamide ypT0 N0 6 Cycles bevacizumab concomitantly with standard NAT 27.6 16.8* NR At 4.7 yr: hazard ratio: 0.8 (p=0.06) At 4.7 yr: hazard ratio: 0.65* (p=0.004) HR+, grade 3, node negatives
10 Cycles of bevacizumab postoperatively
Standard NAT 23 11.1* NR
ARTemis [65] Phase III 781 3 Cycles of docetaxel followed by 3 cycles of 5-FU+epirubicin+cyclophosphamide ypT0/Tis N0 4 Cycles of bevacizumab concomitantly with standard NAT 22* 6 45* NR NR TN, grade 3
Standard NAT 17* 7 31*
CALGB 40601 [45] Phase II 443 12 Cycles of paclitaxel followed by 4 cycles of dose-dense doxorubicin-cyclophosphamide (+/– 4 cycles of carboplatin) ypT0 N0 9 Cycles of bevacizumab concomitantly with standard NAT 52 - - NR NR -
Standard NAT 44 - -
SWOG S0800 [66] Phase II 215 12 Cycles of nab-paclitaxel followed by 6 cycles of doxorubicin- cyclophosphamide ypT0/Tis N0 6 Cycles of bevacizumab concomitantly with standard NAT 36* 24.2 59.4* Hazard ratio: 0.89 (p=0.71) Hazard ratio: 0.84 (p=0.64) TN
Standard NAT 21* 18 28.6*

pCR=pathological complete response; HR+=hormone receptor positive; HR–=hormone receptor negative; DFS=disease-free survival; OS=overall survival; NAT=neoadjuvant therapy; TN=triple-negative; NR=no result; FU=follow-up.

*Significant results.