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document
Randomized phase II trial of high-dose 4'-epi-doxorubicin + cyclophosphamide versus high-dose 4'-epi-doxorubicin + cisplatin in previously untreated patients with extensive small cell lung cancer . One hundred and eleven previously untreated patients with extensive small cell lung cancer were included in a prospective randomized study with the aim to assess the efficacy and tolerance of high-dose epirubicin ( 120 mg/m2 ) in combination with either cyclophosphamide ( 800 mg/m2 ; arm 1 ) or cisplatin ( 60 mg/m2 ; arm 2 ) . Ninety-six patients were evaluable for response and toxicity and additional 12 patients for toxicity only . The overall response rate ( CR+PR ) in arm 1 and 2 were 61.4 ( 27/44 ) and 67.3 % ( 35/52 ) , respectively . The mean duration of remission was 4.4 months ( arm 1 ) and 4.9 months ( arm 2 ) . The mean survival time was 6.6 months in arm 1 and 7.7 months in arm 2. WHO grade 4 toxicity was encountered in 25.5 and 15.8 % of patients in arm 1 and 2 , respectively . One case of cardiotoxicity resulting in the patient 's death was observed in arm 1 . Both combinations showed considerable antitumor activity . Toxicity was acceptable .
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Intervention_Pharmacological
4'-epi-doxorubicin
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
4'-epi-doxorubicin
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
high-dose epirubicin
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
cisplatin
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Outcome_Other
efficacy
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Outcome_Other
tolerance
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Outcome_Other
response
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Outcome_Other
toxicity
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Outcome_Adverse-effects
toxicity
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Outcome_Physical
overall response rate ( CR+PR )
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Outcome_Physical
mean duration of remission
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Outcome_Mortality
mean survival time
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Outcome_Adverse-effects
WHO grade 4 toxicity
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Outcome_Adverse-effects
cardiotoxicity
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Outcome_Mortality
death
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Outcome_Physical
antitumor activity
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Outcome_Adverse-effects
Toxicity
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Participant_Condition
extensive small cell lung cancer
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Participant_Sample-size
One hundred and eleven
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Participant_Condition
extensive small cell lung cancer
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Participant_Sample-size
Ninety-six patients
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Participant_Sample-size
12 patients