Review Article
Clinical Trials with Pegylated Liposomal Doxorubicin in the Treatment of Ovarian Cancer
Table 2
Phase-III studies with pegylated liposomal doxorubicin (PLD) as a single agent or in combination regimens.
| | Author | Dose/schedule | Clinical setting
PFI (mts) | No. pts | RR (%) | PFS (median)
(mts) | OS |
| |
O’Byrne et al. [47] |
PLD (50 mg/m2) q28 versus
PTX (175 mg/m2) q21 | | 214 | | | | | REC | 107 | 17.8 | 5.4 | 11.4 | | | 107 | 22.4 | 6.0 | 14.0 | | Gordon et al. [48, 49] | PLD (50 mg/m2) d1, q28 versus
TPT (1.5 mg/m2) d1–5 q21 | RES | 255
130
125 | 12.3
6.5
| 2.3
3.4
| 8.9
10.3
| | Mutch et al. [50] | PLD (50 mg/m2) d1, q28 versus
GEM (1,000 mg/m2) d1, 8, q21 | RES | 195
96
99 | 8.3
6.1
| 3.6
3.1
| 12.7
13.5
| | Ferrandina et al. [51] | PLD (40 mg/m2) q28 versus
GEM (1,000 mg/m2) d1, 8, 15 q28 | RES | 153
76
77 | 16
29
| 4.0
5.0
| 14
12.7*
|
Monk et al. [52]
OVA-301 | TRAB (1.1 mg/m2) d1, q21 versus
PLD (50 mg/m2) q28 | ALL | 672 | 28.0*
19.0 | 7.3*
5.9 | 20.5
19.4 | PLD (30 mg/m2) d1
TRAB (1.1 mg/m2) d1, q21 versus PLD (50 mg/m2) q28 |
SEN | 430 | | | | 335
337 | 35*
23 | 9.2*
7.5 | —
— | Markman et al. [53]
SWOG SO200 | PLD (30 mg/m2) d1/CBDCA (AUC 5) d1, q28 versus
CBDCA (AUC 5) d1, q28 | SEN
6–24 mts | 31
30 | 59*
28 | 12*
8 | 31
18 |
Pujade-Lauraine et al. [54]
CALYPSO | PLD (30 mg/m2) d1
JM8 (AUC 5) d1, q28 versus
PTX (175 mg/m2) d1
JM8 (AUC 5) d1, q21 | SEN
>6 mts | 467
509 | —
— | 11.3*
9.4 | —
— |
|
|
GEM: gemcitabine; OS: overall survival; PFS: progression-free survival; PTX: paclitaxel; REC: not otherwise specified recurrent disease; RES: platinum-resistant recurrent disease; RR: response rate; SEN: platinum-sensitive recurrent disease; TRAB: trabectedin; q: every; d: day. *Statistically significant.
|
