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document
[ Clinical early phase II study of bicalutamide ( Casodex ) in patients with prostatic cancer ] . To investigate the efficacy and safety of bicalutamide ( Casodex ) with its clinically recommended dose , the randomized early phase II study was performed in 124 patients with prostatic cancer ( stage C , D ) . The patients were given 50 , 80 or 100 mg of bicalutamide orally once a day in fixed doses for 12 weeks ; 122 patients were eligible for evaluation . The overall response rate was 50.0 % ( 20/40 ) , 61.0 % ( 25/41 ) and 53.7 % ( 22/41 ) in the 50 mg , 80 mg and 100 mg groups , respectively . The response rate in prostate lesion , bone and lymph node metastases was slightly higher in the 80 mg group than in the 50 mg and 100 mg groups . The proportion of patients showing a response with regard to serum PSA ( CR and PR ) was 84.2 , 92.7 and 97.6 % in the 50 , 80 and 100 mg groups , respectively . The incidence of adverse reactions was 65.0 , 61.0 and 61.0 % in the 50 , 80 and 100 mg groups , respectively , and there was no significant difference in overall safety rating in the three groups . Frequent adverse reactions were gynecomastia and breast pain . Only one patient in the 80 mg group was withdrawn due to shortness of breath . Serum concentrations of LH , testosterone and estradiol increased significantly after treatment . Bicalutamide was concluded to be effective and well tolerated in patients with prostatic cancer , and its recommended dose was 80 mg once daily .
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Intervention_Pharmacological
bicalutamide ( Casodex )
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Intervention_Pharmacological
bicalutamide
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Intervention_Pharmacological
50 , 80 or 100 mg of bicalutamide
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Intervention_Pharmacological
Bicalutamide
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Outcome_Other
efficacy and safety
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Outcome_Other
overall response rate
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Outcome_Physical
response rate in prostate lesion , bone and lymph node metastases
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Outcome_Physical
proportion of patients showing a response with regard to serum PSA ( CR and PR )
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Outcome_Adverse-effects
incidence of adverse reactions
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Outcome_Other
no significant difference
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Outcome_Other
overall safety rating
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Outcome_Adverse-effects
Frequent adverse reactions
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Outcome_Adverse-effects
gynecomastia and breast pain .
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Outcome_Other
withdrawn due to shortness of breath .
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Outcome_Physical
Serum concentrations of LH , testosterone and estradiol increased significantly
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Participant_Condition
prostatic cancer
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Participant_Sample-size
124
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Participant_Condition
cancer
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Participant_Condition
cancer