Table 1.
Phase III trials with pegylated liposomal doxorubicin (PLD) for recurrent/refractory ovarian cancer (OC)
| Author | Trial details | Arms | Eligibility | Outcomes | ||
|---|---|---|---|---|---|---|
| Gordon et al 20011 | Randomized
Multi-center Open-label Second line |
Topo 1.5 mg/m2/day × 5 days | Recurrence after platinum based therapy
No prior exposure to either agent |
N = 474 | ||
| Topo (235) | PLD (239) | |||||
| Median PFS (weeks) | 17 | 16.1 | ||||
| Median OS (weeks) | 56.7 | 60 | ||||
| PLD 50 mg/m2 day 1 every 28 days | Platinum-sensitive Median PFSa (weeks) | 23.3 | 28.9 | |||
| Platinum-sensitive Median OSb (weeks) | 71.1 | 108 | ||||
| Mutch et al 200741 | Randomized
Multi-center Second line Allowed cross over at progression |
PLD 50 mg/m2 day 1 every 28 days | Recurrence after first-line
Platinum based therapy No prior exposure to either agent |
N = 195 | ||
| Gem (99) | PLD (96) | |||||
| Median PFS (months) | 3.6 | 3.1 | ||||
| Gem 1000 mg/m2, days 1 and 8 | Median OS (months) | 12.7 | 13.5 | |||
| Ferrandina et al 200842 | Randomized
Multi-center Second line |
Gem 1000 mg/m2 days 1, 8, and 15
PLD 40 mg/m2 every 28 days |
Recurrence within 12 months after CT
No prior exposure to either agent |
N = 153 | ||
| Gem (77) | PLD (76) | |||||
| Median PFS (weeks) | 20 | 16 | ||||
| Median OS (weeks)c | 51 | 56 |
a
P = 0.037,
b
P = 0.008,
c
P = 0.048, all other results not significant.
Abbreviations: Gem, gemcitabine; Topo, topotecan; OS, overall survival; PFS, progression-free survival.