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document
Epirubicin-based chemotherapy in metastatic breast cancer patients : role of dose-intensity and duration of treatment . PURPOSE To determine whether the duration and the dose of epirubicin modify the long-term outcome of patients with metastatic breast cancer ( MBC ) . PATIENTS AND METHODS Four hundred seventeen anthracycline-naive MBC patients were randomized to receive one of the following regimens : arm A : 11 cycles of fluorouracil 500 mg/m ( 2 ) , epirubicin 75 mg/m ( 2 ) , and cyclophosphamide 500 mg/m ( 2 ) ( FEC 75 ) every 21 days ; arm B : four cycles of FEC 100 ( same regimen but with epirubicin 100 mg/m ( 2 ) ) then eight cycles of FEC 50 ( epirubicin 50 mg/m ( 2 ) ) ; and arm C : four cycles of FEC 100 then restart the same regimen at disease progression in case of prior response or stabilization . RESULTS Hematologic toxicity was similar . Nausea/vomiting and stomatitis were significantly less frequent in arm A as was left ventricular ejection fraction decrease in arm C ( A = six patients , B = five patients , and C = one patient ) . Six patients died of infections ( A = four patients and C = two patients ) . After four cycles , the objective response rate ( ORR ) was better with FEC 100 than with FEC 75 ( 49.2 % v 40 % , respectively ; P : =.07 ) . The ORR was better with the longer regimens ( arm A , 56.9 % ; B , 64 % ; and C , 47.6 % ; P : =.06 ) and was 41 % after second-line FEC 100 . After a median follow-up of 41 months , the response duration and time to progression ( TTP ) were significantly better with arm B , the longer regimen ( P : =.012 and P : < 10 ( -3 ) , respectively ) . The median survival times for arms A , B , and C were similar ( 17.9 , 18.9 , and 16 . 3 months , respectively ; P : =.49 ) . CONCLUSION In MBC , longer epirubicin-based regimens are better in terms of response duration and TTP . FEC 100 regimens improve the ORR . However , four initial cycles of FEC 100 and identical retreatment at disease progression yielded equivalent overall survival to longer regimens .
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Intervention_Pharmacological
Epirubicin-based chemotherapy
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Intervention_Pharmacological
epirubicin
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Intervention_Pharmacological
fluorouracil
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Intervention_Pharmacological
epirubicin
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
FEC
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Intervention_Pharmacological
FEC 100
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Intervention_Pharmacological
epirubicin
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Intervention_Pharmacological
FEC 50 ( epirubicin
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Intervention_Pharmacological
FEC 100
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Intervention_Pharmacological
FEC
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Intervention_Pharmacological
FEC
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Intervention_Pharmacological
FEC
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Intervention_Pharmacological
FEC
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Intervention_Pharmacological
FEC
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Outcome_Adverse-effects
Hematologic toxicity
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Outcome_Adverse-effects
Nausea/vomiting and stomatitis
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Outcome_Physical
left ventricular ejection fraction
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Outcome_Mortality
died of infections
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Outcome_Physical
objective response rate ( ORR )
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Outcome_Physical
ORR
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Outcome_Physical
response duration and time to progression ( TTP )
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Outcome_Physical
median survival times
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Outcome_Physical
response duration and TTP
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Outcome_Physical
ORR
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Outcome_Physical
overall survival
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Participant_Condition
metastatic breast cancer
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Participant_Condition
metastatic breast cancer ( MBC )
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Participant_Sample-size
Four hundred seventeen
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Participant_Condition
anthracycline-naive MBC