Review Article
Nanoparticle Albumin Bound Paclitaxel in the Treatment of Human Cancer: Nanodelivery Reaches Prime-Time?
Table 3
Randomized phase II and III trials with nab-paclitaxel in melanoma.
| (a) Phase II |
| | | Arms | | Pts | RR (%) | PFS | OS | | | | | | Median (MO)
| At 6 (%) | Median
(MO) | 1 year
(%) |
| | Hersh et al., 2010 [46] (first* and following** line) |
Nab-paclitaxel |
*150 mg/m2 q3w
**100 mg/m2 q3w | 37
37 | 21.6
2.7 | 4.5
3.5 | 34
27 | 9.6
12.1 | 41
49 |
| | | Arms | | Pts | RR
(%) | Median PFS
(MO) | Median OS (MO) |
| | Kottschade et al., 2011 [47] (first* and following** line) |
Nab-paclitaxel |
*100 mg/m2 q3w
Carboplatin AUC2 | 41 | 25.6 | 4.3
| 11.1 |
**100 mg/m2 q3w
Carboplatin AUC2 | 35 | 8.8 | 4.2 | 10.9 |
|
|
| (b) Phase III |
| | | Arms | Pts | ORR (%) | PFS | OS | AEs grade ≥ III (%) | | | | | | Median (MO) | BRAF status | Median
(MO) | BRAF status |
Neutropenia |
Leukopenia |
Fatigue |
Neuropathy | | | | | | WT
(MO) | V600Em (MO) | Uk
(MO) | WT
(MO) | V600Em
(MO) | Uk
(MO) | | | | | | | | | | <.001 | | | |
| Hersh et al.,
2010 [48]
(first line) | Nab-paclitaxel
150 mg/m2 qw | 264 | 15 | 4.8 | 5.4 | 5.3 | 3.7 | 12.8 | 12.7 | 16.9 | 11.1 |
20 |
12 |
8 |
25 | Dacarbazine
1000 mg/sqm q3w | 265 | 11 | 2.5 | 2.5 | 3.5 | 2.2 | 10.7 | 11.1 | 11.2 | 9.9 |
10 |
7 |
2 |
0 |
|
|
P: P value; nd: not done; AEs: adverse events; WT: wild type; V600Em: with mutation of V600E; Uk: unknown BRAF mutation; ORR: overall responce rate; RR: response rate; PFS: progression-free survival; OS: overall survival.
|
