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	Recurrence
Study Design	Open-Label, Randomized
Endpoints	ORR, DCR, PFS, OS, evaluated per RECIST or CA125
Efficacy	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%)
Conclusion	Liposomal doxorubicin and topotecan have similar efficacy, but very different toxicity profiles
Reference	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 https://www.ncbi.nlm.nih.gov/pubmed/11454878