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passages: document
passages: Long-term survival in a phase III , randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma . BACKGROUND We have continued to monitor the survival of patients randomised in a previously reported multicentre phase III study of topotecan versus paclitaxel in patients with advanced epithelial ovarian cancer who had failed one prior platinum-based regimen . PATIENTS AND METHODS Patients with bidimensionally measurable disease were randomised to topotecan ( 1.5 mg/m ( 2 ) /day for 5 days ) or paclitaxel ( 175 mg/m ( 2 ) /day as a 3-h infusion ) every 21 days . Patients were eligible for treatment with the alternate therapy at third line . The European Organisation for Research and Treatment of Cancer Quality of Life ( EORTC QOL ) -C30 questionnaire was also used to measure eight symptoms at baseline and during each course ( pain , anorexia , diarrhoea , fatigue , nausea and vomiting , dyspnea , constipation and insomnia ) . RESULTS A total of 226 patients were evaluable for response . Demographic characteristics were similar in both treatment groups , as were results of the EORTC QOL-30 questionnaire . For the topotecan group , median time to progression was 18.9 weeks ( range < 1 to 92.6+ weeks ; 25 % censored ) , and , for paclitaxel , 14.7 weeks ( range < 1 to 137.3+ weeks ; 12.3 % censored ) ; P = 0.076 . At 4 years post-randomisation , median survival in the topotecan group was 63.0 weeks ( range < 1 to 238.4+ weeks ; 20.5 % censored ) and , for paclitaxel , 53.0 weeks ( range < 1 to 226.3+ weeks ; 12.3 % censored ) ; P = 0.44 . CONCLUSION Topotecan continues to demonstrate comparable efficacy and survival to paclitaxel with manageable and non-cumulative haematological toxicity . Non-haematological toxicity was generally mild for both groups . The long-term survival rate indicates substantial therapeutic benefit for this group of patients receiving topotecan at relapse of ovarian cancer .
entities: 800
entities: Intervention_Pharmacological
entities: topotecan
entities: 801
entities: Intervention_Pharmacological
entities: paclitaxel
entities: 802
entities: Intervention_Pharmacological
entities: topotecan
entities: 803
entities: Intervention_Pharmacological
entities: paclitaxel
entities: 804
entities: Intervention_Pharmacological
entities: topotecan
entities: 805
entities: Intervention_Pharmacological
entities: paclitaxel
entities: 806
entities: Intervention_Pharmacological
entities: topotecan
entities: 807
entities: Intervention_Pharmacological
entities: paclitaxel
entities: 808
entities: Intervention_Pharmacological
entities: topotecan
entities: 809
entities: Intervention_Pharmacological
entities: paclitaxel
entities: 810
entities: Intervention_Pharmacological
entities: Topotecan
entities: 811
entities: Intervention_Pharmacological
entities: paclitaxel
entities: 812
entities: Intervention_Pharmacological
entities: topotecan
entities: 813
entities: Outcome_Other
entities: European Organisation for Research and Treatment of Cancer Quality of Life ( EORTC QOL ) -C30 questionnaire
entities: 814
entities: Outcome_Pain
entities: pain
entities: 815
entities: Outcome_Physical
entities: anorexia
entities: 816
entities: Outcome_Physical
entities: diarrhoea
entities: 817
entities: Outcome_Physical
entities: fatigue
entities: 818
entities: Outcome_Physical
entities: nausea
entities: 819
entities: Outcome_Physical
entities: vomiting
entities: 820
entities: Outcome_Physical
entities: dyspnea
entities: 821
entities: Outcome_Physical
entities: constipation
entities: 822
entities: Outcome_Physical
entities: insomnia
entities: 823
entities: Outcome_Physical
entities: progression
entities: 824
entities: Outcome_Mortality
entities: median survival
entities: 825
entities: Outcome_Other
entities: efficacy
entities: 826
entities: Outcome_Mortality
entities: survival
entities: 827
entities: Outcome_Physical
entities: haematological toxicity . Non-haematological toxicity
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entities: Participant_Condition
entities: advanced epithelial ovarian carcinoma .
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entities: Participant_Condition
entities: patients with advanced epithelial ovarian cancer who had failed one prior platinum-based regimen .
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entities: Participant_Condition
entities: Patients with bidimensionally measurable disease
entities: 831
entities: Participant_Sample-size
entities: 226
entities: 832
entities: Participant_Condition
entities: ovarian cancer .