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document
Epirubicin and cyclophosphamide versus epirubicin and docetaxel as first-line therapy for women with metastatic breast cancer : final results of a randomised phase III trial . BACKGROUND This randomised phase III trial was carried out to compare the efficacy and safety of epirubicin and cyclophosphamide ( EC ) with epirubicin and docetaxel ( Taxotere ) ( ED ) as first-line chemotherapy for metastatic breast cancer . PATIENTS AND METHODS Patients ( n = 240 ) were randomly assigned to receive either ED ( epirubicin 75 mg/m ( 2 ) and docetaxel 75 mg/m ( 2 ) ) or EC ( epirubicin 90 mg/m ( 2 ) and cyclophosphamide 600 mg/m ( 2 ) ) . The primary end point was objective response rate ( ORR ) . Secondary end points were progression-free survival ( PFS ) , overall survival ( OS ) , and safety . RESULTS ORR for patients randomly assigned to receive EC and ED were 42 % and 47 % , respectively ( P = 0.63 ) . Median PFS [ 10.1 versus 10.3 months ; hazard ratio ( HR ) 0.98 ; log-rank P = 0.38 ] and OS ( 19.9 versus 30.0 months ; HR 0.663 ; log-rank P = 0.21 ) were comparable in both arms . Although grade 3/4 leucopenia occurred more frequently with ED ( 81 % versus 73 % ; P = 0.01 ) , there were no significant differences in the incidence of febrile neutropenia and grade 3/4 infections . Grade 3/4 non-haematologic toxicity was infrequent in both arms . Congestive heart failure was observed in one patient in each arm . CONCLUSION In this randomised trial , no differences in the efficacy study end points were observed between the two treatment arms .
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Intervention_Pharmacological
Epirubicin
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
epirubicin
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
epirubicin
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Intervention_Pharmacological
cyclophosphamide ( EC )
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Intervention_Pharmacological
epirubicin
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Intervention_Pharmacological
docetaxel ( Taxotere ) ( ED )
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Intervention_Pharmacological
ED ( epirubicin
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
EC ( epirubicin
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
EC
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Intervention_Pharmacological
ED
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Intervention_Pharmacological
ED
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Outcome_Physical
objective response rate ( ORR )
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Outcome_Mortality
progression-free survival ( PFS )
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Outcome_Mortality
overall survival ( OS )
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Outcome_Mortality
safety .
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Outcome_Physical
ORR
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Outcome_Mortality
Median PFS
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Outcome_Mortality
OS
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Outcome_Adverse-effects
grade 3/4 leucopenia
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Outcome_Adverse-effects
febrile neutropenia
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Outcome_Adverse-effects
grade 3/4 infections
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Outcome_Adverse-effects
Grade 3/4 non-haematologic toxicity
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Outcome_Physical
Congestive heart failure
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Participant_Sex
women
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Participant_Condition
with metastatic breast cancer
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Participant_Condition
metastatic breast cancer
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Participant_Sample-size
Patients ( n = 240