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.