passages: 446
passages: document
passages: 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 doxorubicin ( PLD ) and topotecan in patients with epithelial ovarian carcinoma that recurred after or did n'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 weeks or topotecan 1.5 mg/m ( 2 ) /d for 5 consecutive days every 3 weeks . Patients were stratified prospectively for platinum sensitivity and for the presence 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 response 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 subgroup demonstrated a nonstatistically significant survival trend in favor of topotecan ( P =.455 ) . Severe hematologic toxicity was more common with topotecan and was more likely to be associated with dosage modification , or growth factor or blood product utilization . CONCLUSION The comparable efficacy , favorable safety profile , and convenient dosing support the role of PLD as a valuable treatment option in this patient population .
entities: 447
entities: Intervention_Pharmacological
entities: pegylated liposomal doxorubicin
entities: 448
entities: Intervention_Pharmacological
entities: topotecan .
entities: 449
entities: Intervention_Pharmacological
entities: pegylated liposomal doxorubicin ( PLD )
entities: 450
entities: Intervention_Pharmacological
entities: topotecan
entities: 451
entities: Intervention_Pharmacological
entities: PLD
entities: 452
entities: Intervention_Pharmacological
entities: topotecan
entities: 453
entities: Intervention_Pharmacological
entities: PLD
entities: 454
entities: Intervention_Pharmacological
entities: topotecan
entities: 455
entities: Intervention_Pharmacological
entities: PLD
entities: 456
entities: Intervention_Pharmacological
entities: topotecan
entities: 457
entities: Intervention_Pharmacological
entities: PLD
entities: 458
entities: Intervention_Pharmacological
entities: topotecan
entities: 459
entities: Intervention_Pharmacological
entities: PLD
entities: 460
entities: Intervention_Pharmacological
entities: PLD
entities: 461
entities: Intervention_Pharmacological
entities: topotecan .
entities: 462
entities: Intervention_Pharmacological
entities: PLD
entities: 463
entities: Intervention_Pharmacological
entities: topotecan
entities: 464
entities: Intervention_Pharmacological
entities: topotecan
entities: 465
entities: Intervention_Pharmacological
entities: topotecan
entities: 466
entities: Intervention_Pharmacological
entities: PLD
entities: 467
entities: Outcome_Other
entities: efficacy
entities: 468
entities: Outcome_Other
entities: safety
entities: 469
entities: Outcome_Mortality
entities: overall progression-free survival rates
entities: 470
entities: Outcome_Other
entities: overall response rates
entities: 471
entities: Outcome_Mortality
entities: Median overall survival times
entities: 472
entities: Outcome_Mortality
entities: overall survival
entities: 473
entities: Outcome_Adverse-effects
entities: Severe hematologic toxicity
entities: 474
entities: Outcome_Other
entities: efficacy
entities: 475
entities: Outcome_Other
entities: safety
entities: 476
entities: Participant_Condition
entities: patients with epithelial ovarian carcinoma that recurred after or did n't respond to first-line , platinum-based chemotherapy .
entities: 477
entities: Participant_Condition
entities: Patients with measurable and assessable disease
entities: 478
entities: Participant_Sample-size
entities: 474