87052
document
Fadrozole HCL ( CGS-16949A ) versus megestrol acetate treatment of postmenopausal patients with metastatic breast carcinoma : results of two randomized double blind controlled multiinstitutional trials . BACKGROUND Breast cancer patients with prior response to endocrine therapy achieve subsequent benefit from additional endocrine therapies . The efficacy and safety of an aromatase inhibitor , fadrozole HCL , were compared with megestrol acetate in post menopausal patients who had disease progression after receiving antiestrogen therapy either for metastatic disease or as adjuvant therapy . METHODS In 2 multiinstitutional prospective trials , 683 postmenopausal patients were randomized to receive either fadrozole HCL , 1 mg twice daily , or megestrol acetate , 40 mg 4 times daily , in a double blind fashion after progression on first-line hormonal therapy . Objective response rates , time to progression , survival and safety of the two regimens were compared . RESULTS Results of intent-to-treat analyses are presented in this study . No significant differences were detected between the two treatment groups in time to progression , objective response rates , duration of response , and survival in either trial . There were no clinically meaningful differences between the treatment groups in the incidence and severity of adverse experiences , except that weight gain , fluid retention , and dyspnea were observed in more patients in the megestrol acetate group compared with those receiving fadrozole HCL , whereas nausea and vomiting were observed in more patients in the fadrozole HCL group compared with those receiving megestrol acetate . CONCLUSIONS Fadrozole HCL was as efficacious as megestrol acetate in postmenopausal patients with metastatic breast carcinoma after one hormonal therapy . Adverse experiences were mild with both therapies , but megestrol acetate was associated wiht a higher frequency of weight gain , fluid retention and dyspnea , whereas fadrozole HCL was associated with a higher frequency of nausea and vomiting .
87053
Intervention_Pharmacological
Fadrozole HCL ( CGS-16949A )
87054
Intervention_Pharmacological
megestrol acetate
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Intervention_Pharmacological
fadrozole HCL
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Intervention_Pharmacological
fadrozole HCL , 1 mg twice daily
87057
Intervention_Pharmacological
megestrol acetate , 40 mg 4 times daily
87058
Intervention_Pharmacological
first-line hormonal therapy
87059
Intervention_Pharmacological
Fadrozole HCL
87060
Intervention_Pharmacological
fadrozole HCL
87061
Outcome_Physical
Objective response rates
87062
Outcome_Physical
time to progression
87063
Outcome_Mortality
survival
87064
Outcome_Other
safety
87065
Outcome_Physical
time to progression
87066
Outcome_Physical
objective response rates
87067
Outcome_Physical
duration of response
87068
Outcome_Mortality
survival
87069
Outcome_Adverse-effects
adverse experiences
87070
Outcome_Adverse-effects
weight gain
87071
Outcome_Adverse-effects
fluid retention
87072
Outcome_Adverse-effects
dyspnea
87073
Outcome_Adverse-effects
nausea and vomiting
87074
Outcome_Physical
efficacious
87075
Outcome_Adverse-effects
weight gain , fluid retention and dyspnea
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Outcome_Adverse-effects
nausea and vomiting
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Participant_Condition
postmenopausal
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Participant_Condition
metastatic breast carcinoma
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Participant_Condition
Breast cancer
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Participant_Condition
with prior response to endocrine therapy
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Participant_Sample-size
683
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Participant_Condition
postmenopausal
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Participant_Condition
metastatic breast carcinoma