Table 3 nab -Paclitaxel in patients with early-stage breast cancer
Trial | Phase | Patient population | nab-Paclitaxel regimen | Patients receiving protocol-specified dose (%) | Efficacy outcomes | Select grade 3/4 adverse events (%) | |||
|---|---|---|---|---|---|---|---|---|---|
| Â | Â | Â | Â | Â | pCR in breast and LNs (%) | Other parameters | Neutropenia | Neuropathy | Fatigue |
Neoadjuvant | |||||||||
Untch and colleagues (GeparSepto), 2014 [36] | III | Unselected (n = 1,204) | nab-P 125 mg/m2 qw × twelve cycles → EC q3w × four cycles (+ trastuz and pertuz throughout for HER2+) | NR | 38 | NR | 61 | 10 | 6 |
Nahleh and colleagues (S0800), 2014 [37] | II | HER2– IBC or LABC (n = 200) | Bev + nab-P 100 mg/m2 qw × 12 → AC + peg q2w × six cycles | NR | 36 | NR | NR | NR | NR |
|  |  |  | nab-P 100 mg/m2 qw × twelve cycles followed or preceded by AC + peg q2w × six cycles |  | 21 |  |  |  |  |
II | HR+, HER2− (n = 81) | nab-P 150 mg/m2 qw 3/4 (monotherapy) | 70 | 7.4 | RCB 0 + 1 = 25 %; ORR = 77 % | 16 | 3a | 4a | |
Robidoux and colleagues, 2010 [41] | II | Unselected (n = 66) | nab-P 100 mg/m2 qw × twelve cycles → FEC q3w × four cycles (+ trastuz for HER2+) | 98 | 26 | cCR = 12 %; estimated 2-year PFS = 81 % | 3a | 5a | 6a |
Zelnak and colleagues, 2012 [43] | II | HER2+ (n = 27) | nab-P 260 mg/m2 q2w × four cycles → vin + trastuz | NR | 48 | ORR = 100 %; cCR = 74 % | 6a,b | 3a,b | 1a,b |
Adjuvant | |||||||||
McArthur and colleagues, 2011 [44] | II | HER2− (n = 80) | AC + peg + bev → nab-P 260 mg/m2 q2w + bev × four cycles → bev | NR | NR | 4a | 14a | 10a |  |
Pippen and colleagues, 2011 [45] | II | HER2− (n = 197) | AC + peg + bev → nab-P 260 mg/m2 q2w + bev × four cycles → bev | 91 | NR | 8 | 5 | 13 |  |