Trial | Phase | Patient population | nab-Paclitaxel regimen | Patients receiving protocol-specified dose (%) | Efficacy outcomes | Select grade 3/4 adverse events (%) | ||||
---|---|---|---|---|---|---|---|---|---|---|
 |  |  |  |  | ORR (%) | PFS (months) | OS (months) | Neutropenia | Neuropathy | Fatigue |
Ibrahim and colleagues, 2005 [19] | II | CN (n = 15), PT (n = 48) | 300 mg/m2 q3w | 75a | 48 (CN 64; PT 21) | TTP 6.1 | 14.6 | 51 | 11b | 13b |
Gradishar and colleagues, 2005 [20] | III | CN (n = 97), PT (n = 132) | 260 mg/m2 q3w | 96 (received 90 % of protocol-specified dose) | 33 (CN 42; PT 27) | TTP 5.3 | 15.0 | 30c | 10b | <10b,c |
Guan and colleagues, 2009 [27] | II | Chinese; CN (n = 61), PT (n = 43) | 260 mg/m2 q3w | ≥95 | 54 (CN 56; PT 51) | 7.6 | 17.8 | 42 | 7b | NR |
Blum and colleagues, 2007 [28] | II | PT | 100 mg/m2 qw 3/4 (n = 106) | 87 | 14 | 3.0 | 9.2 | 17 | 8b | 5b |
 |  |  | 125 mg/m2 qw 3/4 (n = 75) | 68 | 16 | 3.5 | 9.1 | 32 | 19b | 12b |
II | CN | 300 mg/m2 q3w (n = 76) | 80 | 37 | 11.0 | 27.7 | 43 | 21b | 5b | |
 |  |  | 100 mg/m2 qw 3/4 (n = 76) | 82 | 45 | 12.8 | 22.2 | 25 | 9b | 0 |
 |  |  | 150 mg/m2 qw 3/4 (n = 74) | 53 | 49 | 12.9 | 33.8 | 45 | 22b | 4b |