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.