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document
Outcomes of Japanese breast cancer patients treated with pre-operative and post-operative anastrozole or tamoxifen . The present study examined long-term efficacy outcomes in a subgroup of postmenopausal , estrogen receptor-positive Japanese breast cancer patients from the Pre-Operative " Arimidex " Compared with Tamoxifen trial , following pre-operative ( 3 months ) and post-operative ( 5 years ) adjuvant treatment with either anastrozole or tamoxifen . Patients with large , potentially operable , locally-advanced breast cancer were randomized to receive anastrozole ( 1 mg/day ) plus tamoxifen placebo or tamoxifen ( 20 mg/day ) plus anastrozole placebo pre-operatively . After surgery at 3 months , patients continued on the same study medication as adjuvant therapy for up to 5 years or until recurrence , intolerable toxicity or withdrawal of patient consent . Recurrence-free survival and overall survival were measured from the date of randomization to the date of recurrence or death , whichever occurred first . Patients were monitored for adverse events throughout the study period and up to 30 days following administration of the last study medication . During post-operative adjuvant therapy , 4/48 ( 8 % ) anastrozole and 25/49 ( 51 % ) tamoxifen patients experienced recurrence . There was a significant difference in recurrence-free survival between the two groups ( hazard ratio 0.14 ; 95 % confidence interval 0.05-0.41 ; P = 0.0003 ) . There was a significant increase in overall survival with anastrozole ( 0.21 ; 0.05-0.96 ; P = 0.0436 ) and there were 2/48 ( 4 % ) and 10/49 ( 20 % ) deaths with anastrozole and tamoxifen , respectively . Most patients responding to pre-operative therapy remained recurrence-free . Sequential pre-operative/post-operative treatment with anastrozole resulted in lower recurrence and death rates , compared with tamoxifen .
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Intervention_Pharmacological
pre-operative and post-operative anastrozole or tamoxifen
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Intervention_Pharmacological
Arimidex
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Intervention_Pharmacological
Tamoxifen
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Intervention_Pharmacological
pre-operative ( 3 months ) and post-operative ( 5 years ) adjuvant treatment
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Intervention_Pharmacological
anastrozole
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Intervention_Pharmacological
tamoxifen
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Intervention_Control
tamoxifen placebo
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Intervention_Pharmacological
tamoxifen
53066
Intervention_Control
anastrozole placebo
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Intervention_Pharmacological
adjuvant therapy
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Intervention_Pharmacological
anastrozole
53069
Intervention_Pharmacological
tamoxifen
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Intervention_Pharmacological
anastrozole
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Intervention_Pharmacological
anastrozole
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Intervention_Pharmacological
tamoxifen
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Intervention_Pharmacological
anastrozole
53074
Intervention_Pharmacological
tamoxifen
53075
Outcome_Physical
efficacy outcomes
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Outcome_Physical
Recurrence-free survival
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Outcome_Physical
overall survival
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Outcome_Adverse-effects
adverse events
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Outcome_Physical
recurrence-free survival
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Outcome_Physical
overall survival
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Outcome_Physical
recurrence-free
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Outcome_Physical
recurrence
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Outcome_Adverse-effects
death
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Participant_Condition
breast cancer patients
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Participant_Condition
breast cancer patients
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Participant_Sample-size
locally-advanced breast cancer