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 |
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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 | — — |
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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.
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