Review Article

Clinical Trials with Pegylated Liposomal Doxorubicin in the Treatment of Ovarian Cancer

Table 1

Phase-II studies with pegylated liposomal doxorubicin (PLD) as a single agent or in combination regimens.

AuthorDose/scheduleClinical setting PFI (mts)No. ptsRR (%)PFS (median) (mts)

Muggia et al. [25] 50 mg/m2, q21≤63525.75.7
Gordon et al. [18]50 mg/m2, q21ALL8916.84.8
Rose et al. [26]50 mg/m2, q28≤63713.54.0
40 mg/m2, q287.74.0
Katsumata et al. [28]50 mg/m2, q28≤66320.95.6
Markman et al. [31]40 mg/m2, q28≤6449.1
ALL13.57.2
Lorusso et al. [35]35 mg/m2, q21≤61718.9
≥62010.0
Sehouli et al. [36]20 mg/m2, q15ALL6410.94.3
Du Bois et al. [37]PLD (40 mg/m2) d1
CBDCA (AUC 6) d1, q28
≥6676811.6
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≤122728.07.5
Campos et al. [44]PLD (30 mg/m2), d1, q21 PTX (70 mg/m2), weeklyALL
≤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
ALL3037.05.5
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.