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

Purpose: To compare the efficacy and safety of pegylated liposomal doxorubi cin (PLD) and topotecan in patients with epithelial ovarian carcinoma that recurred after or didn't respond to first-line, platinum-based chemotherapy . Patients and Methods: patients with measurable and assessable disease were randomized to receive either PLD 50 mg/m(2) as a 1-hour infusion every 4 we eks or topotecan 1.5 mg/m(2)/d for 5 consecutive days every 3 weeks. Patien ts were stratified prospectively for platinum sensitivity and for the prese nce or absence of bulky disease. Results: A total of 474 patients were treated (239 PLD and 235 topotecan). They comprised the intent-to-treat population. The overall progression-free survival rates were similar between the two arms (P = .095). The overall r esponse rates for PLD and topotecan were 19.7% and 17.0%, respectively (P = .390). Median overall survival times were 60 weeks for PLD and 56.7 weeks for topotecan. Data analyzed in platinum-sensitive patients demonstrated a statistically significant benefit from PLD for progression-free survival (P = .037), with medians of 28.9 for PLD versus 23.3 weeks for topotecan. For overall survival, PLD was significantly superior to topotecan (P = .008), with a median of 108 weeks versus 71.1 weeks. The platinum-refractory subgr oup demonstrated a nonstatistically significant survival trend in favor of topotecan (P = .455). Severe hematologic toxicity was more common with topo tecan and was more likely to be associated with dosage modification, or gro wth factor or blood product utilization. Conclusion: The comparable efficacy, favorable safety profile, and convenie nt dosing support the role of PLD as ct valuable treatment option in this p atient population. (C) 2001 by American Society of Clinical Oncology.