Table 4.
Phase II combination regimens with pegylated liposomal doxorubicin (PLD) in ovarian cancer (OC)
Combination | Study population | Results | Grade 3–4 toxicities | Reference |
---|---|---|---|---|
PLD (30 mg/m2) day 1
Topotecan (1 mg/m2) days 1–5 Every 3 weeks |
N = 27 platinum refractory | RR = 28%
SD = 44% TTP = 30 weeks |
Hematologic: 70% | verhaar-Langereis et al 200676 |
PLD (30–35 mg/m2) day 1
Oxaliplatin (70 mg/m2) day 2 Every 4 weeks |
N = 43 platinum sensitive (29) and refractory (14) | RR = 54%
SD = 29% TTP = 10.2 mos |
Neutropenia 12% | Nicoletto et al 200678 |
PLD (20 mg/m2) days 1 and 2
Oxaliplatin (60 mg/m2) day 1 and 2; every 3 weeks |
N = 40 recurrent OC | RR = 67%
SD = 25% |
Neutropenia 37% | Recchia et al 200779 |
PLD (30 mg/m2) day 1
Carboplatin (AUC 5) day 1 Every 4 weeks |
N = 104 recurrent OC | RR = 62.5%
SD = 19% TTP = 9.4 mos |
Hematologic 51% | Ferrero et al 200780 |
PLD (30 mg/m2) day 1
Carboplatin (AUC 5) day 1 Every 4 weeks |
N = 31 platinum-sensitive | RR = 52%
TTP = 12 mos |
Hematologic 81% | Alberts et al 200881 |
PLD (40 mg/m2) day 1
Carboplatin (AUC 6) day 1 Every 4 weeks |
N = 67 recurrent OC | RR = 68%
TTP = 11.6 mos |
Neutropenia 24%
Fatigue 12% Pain 10% |
du Bois et al 200782 |
PLD (30 mg/m2) day 1
vinorelbine (30 mg/m2) day 1 Every 3 weeks |
N = 30 recurrent OC | RR = 37%
SD = 10% TTP 5.5 mos |
Neutropenia 12%
PPE 7% Stomatitis 7% |
Katsaros et al 200477 |
PLD (30 mg/m2) day 1
Gemcitabine (1000 mg/m2) Days 1 and 8 every 3 weeks |
N = 67 recurrent OC | RR = 34.3%
SD = 38.8% TTP = 28 weeks |
Neutropenia 7%
PPE 10% Stomatitis 10% |
D’Agostine et al 200383 |
PLD (20 mg/m2) days 1 and 15
Gemcitabine (2000 mg/m2) Days 1 and 15 every 4 weeks |
N = 18 platinum refractory | RR = 28%
TTP = 17 mos |
Anemia 17% | Tas et al 200874 |
Notes: SD, stable disease; TTP, time to progression.
Abbreviation: RR, response rate.