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Concurrent doxorubicin plus docetaxel is not more effective than concurrent doxorubicin plus cyclophosphamide in operable breast cancer with 0 to 3 positive axillary nodes : North American Breast Cancer Intergroup Trial E 2197 . PURPOSE The combination of doxorubicin and cyclophosphamide ( AC ) is a standard adjuvant regimen . Doxorubicin and docetaxel ( AT ) is one of the most active cytotoxic regimens for metastatic breast cancer . The purpose of this trial was to determine whether adjuvant AT improved disease-free survival compared with AC in operable breast cancer . PATIENTS AND METHODS Women with invasive breast cancer were eligible if there were one to three positive lymph nodes or if the node-negative tumor was greater than 1 cm . Patients were randomly assigned after surgery to receive doxorubicin ( 60 mg/m ( 2 ) ) plus either cyclophosphamide ( 600 mg/m ( 2 ) ; AC ) or docetaxel ( 60 mg/m ( 2 ) ; AT ) given every 3 weeks for four cycles , followed by hormone therapy for patients with estrogen receptor ( ER ) and/or progesterone receptor ( PR ) -positive tumors . RESULTS There were 2,882 eligible patients enrolled . After a median follow-up of 79.5 months , there was no significant difference in disease-free survival ( DFS ; 85 % in both arms ) or overall survival ( 91 % v 92 % ) at 5 years . The hazard ratio for AC versus AT was 1.02 ( 95 % CI for DFS , 0.86 to 1.22 ; P = .78 ) . In an exploratory analysis of prespecified stratification factors by ER and PR expression there were trends toward improved DFS for AT in ER/PR-negative disease . Grade 3 neutropenia associated with fever or infection occurred more often with AT ( 26 % v 10 % ; P < .05 ) . CONCLUSION AT did not improve DFS or overall survival in this population , and was associated with more toxicity .
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Intervention_Pharmacological
Concurrent doxorubicin plus docetaxel
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Intervention_Pharmacological
concurrent doxorubicin plus cyclophosphamide
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Intervention_Pharmacological
doxorubicin and cyclophosphamide ( AC )
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Intervention_Pharmacological
Doxorubicin and docetaxel ( AT )
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Intervention_Pharmacological
doxorubicin
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Intervention_Pharmacological
plus either cyclophosphamide
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Intervention_Pharmacological
or docetaxel
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Intervention_Pharmacological
AC
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Intervention_Pharmacological
AT
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Outcome_Physical
metastatic breast cancer .
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Outcome_Physical
disease-free survival
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Participant_Condition
breast cancer
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Participant_Condition
operable breast cancer
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Participant_Sex
Women
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Participant_Condition
invasive breast cancer
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Participant_Sample-size
2,882