Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan

Trial ID # Study 30-49; Trial 4
Phase III
Drug Class Chemotherapy, Chemotherapy
Drug Name Liposomal doxorubicin, Topotecan
Alternate Drug Names Pegylated Liposomal Doxorubicin Hydrochloride, liposomal doxorubicin, LipoDox, Evacet, Dox-SL, Doxil, Hycamptamine, Hycamtin, TOPO
Drugs in Trial Liposomal doxorubicin, Topotecan
Eligible Participant

Platinum sensitive, resistant or refractory disease after first-line platinum-based chemotherapy

Patients Enrolled

474; 46% Pt-S, 54% Pt-R/Pt-Rf

Therapy Setting


Study Design

Open-Label, Randomized


ORR, DCR, PFS, OS, evaluated per RECIST or CA125


Platinum-resistant or refractory patients:
PLD (n=130) vs Top (124):

ORR: 12.3% (1CR, 15PR, n=130) vs 6.5% (1CR, 7PR, n=124)
DCR: 30.0% (1CR, 15PR, 36SD, n=130) vs 49.2% (1CR, 7PR, 53SD, n=124)
PFS : 2.3 vs 3.4 months
OS: 8.9 vs 10.3 months

Clinically Significant Adverse Events

PLD vs Top:
Serious AE: 9 patients with sepsis in topotecan arm (3 deaths)
Grade 3-4 AE: neutropenia (12 vs 77%), anemia (5 vs 28%), thrombocytopenia (1 vs 34%), leukopenia (10 vs 50%), hand-foot syndrome (PPE) (23 vs 0%)


Liposomal doxorubicin and topotecan have similar efficacy, but very different toxicity profiles


Gordon AN et al. Recurrent Epithelial Ovarian Carcinoma: A Randomized Phase III Study of Pegylated Liposomal Doxorubicin Versus Topotecan. J Clin Oncol (2001) 19(14):3312-22

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