Table 1.
Phase-II 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) |
|---|---|---|---|---|---|
| Muggia et al. [25] | 50 mg/m2, q21 | ≤6 | 35 | 25.7 | 5.7 |
| Gordon et al. [18] | 50 mg/m2, q21 | ALL | 89 | 16.8 | 4.8 |
| Rose et al. [26] | 50 mg/m2, q28 | ≤6 | 37 | 13.5 | 4.0 |
| 40 mg/m2, q28 | 7.7 | 4.0 | |||
| Katsumata et al. [28] | 50 mg/m2, q28 | ≤6 | 63 | 20.9 | 5.6 |
| Markman et al. [31] | 40 mg/m2, q28 | ≤6 | 44 | 9.1 | — |
| ALL | 13.5 | 7.2 | |||
| Lorusso et al. [35] | 35 mg/m2, q21 | ≤6 | 17 | 18.9 | — |
| ≥6 | 20 | 10.0 | — | ||
| Sehouli et al. [36] | 20 mg/m2, q15 | ALL | 64 | 10.9 | 4.3 |
| Du Bois et al. [37] | PLD (40 mg/m2) d1 CBDCA (AUC 6) d1, q28 |
≥6 | 67 | 68 | 11.6 |
| Rapoport et al. [38] | PLD (50 mg/m2) d1 CBDCA (AUC 5) d1, q28 |
ALL 7–12 |
40 19 |
67.5 52.6 |
11.9 9.7 |
| Ferrero et al. [39] | PLD (30 mg/m2) d1 CBDCA (AUC 5) d1, q28 |
ALL 7–12 ≥12 |
96 43 53 |
62.5 — — |
9.4 7.9 11.4 |
| Nicoletto et al. [40] | PLD (30 mg/m2) d1 OXA (70 mg/m2) d1, q28 |
≤6 ≥6 |
14 29 |
28.6 66.7 |
5.9 9.9 |
| D'Agostino et al. [41] | PLD (30 mg/m2), d1 GEM (1000 mg/m2), d1, 8 q21 |
≤12 ≥12 |
36 31 |
25.0 45.2 |
— — |
| Ferrandina et al. [42] | PLD (30 mg/m2), d1 GEM (1000 mg/m2), d1, 8 q21 |
RES ≥12 |
66 45 |
21.6 53.7 |
5 8.7 |
| Verhaar- Langereis et al. [43] |
PLD (30 mg/m2) d1/TPT (1.0 mg/m2) d1–5 q21 and PLD (40 mg/m2), d1 TPT (0.75 mg/m2), d1–5 q21 | ≤12 | 27 | 28.0 | 7.5 |
| Campos et al. [44] | PLD (30 mg/m2), d1, q21 PTX (70 mg/m2), weekly | ALL ≤12 ≥12 |
37 24 13 |
29.0 17.0 54.0 |
— |
| Katsaros et al. [45] | PLD (30 mg/m2), d1 vinorelbine (30 mg/m2), d1, q21 |
ALL | 30 | 37.0 | 5.5 |
| Joly et al. [46] | PLD (40 mg/m2), d1 ifosfamide (1700 mg/m2), d1–3 q28 |
ALL RES SEN |
98 57 41 |
28.0 19.0 41.0 |
— |
PFS: progression-free survival; RR: response rate; RES: platinum-resistant recurrent disease (platinum sensitivity according to the cutoff of 12-month platinum-free interval); SEN: platinum-sensitive recurrent disease; q: every; d: day; CDDP: cisplatin; CBDCA: carboplatin; PFI: platinum-free interval; GEM: gemcitabine; PTX: paclitaxel; TPT: topotecan; OS: overall survival.