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document
Sequential alternate administration of tamoxifen and medroxyprogesterone acetate in advanced breast cancer : clinical-biological randomized study . From January 1985 to September 1988 , 60 women with advanced breast cancer were randomized in two arms to receive : A ) tamoxifen ( TAM ) ( 20 mg/die ) until progression or B ) TAM ( 20 mg/die for 14 days ) then medroxyprogesterone acetate ( MPA ) ( 1500 mg/die p.o . for 14 days ) followed by 7 days of wash-out before repeating the TAM/MPA treatment . All patients were post-menopausal , previously untreated with hormone therapy , and with tumor receptor status determined immediately before randomization ; all had objectively evaluable lesions . In order to verify hormone receptor variations due to the antiestrogen , when possible a second biopsy was performed after the initial 14 day cycle of TAM . Thirty-one and 29 patients were included respectively in arms A and B . Objective regression ( CR + PR ) was observed in 58 % of group A and 75 % of group B , with CR in 11 % and 23 % , respectively . Differences were not statistically significant . Median time to progression was 12 months for group A and 9 for group B . Overall survival has not yet been reached in group A while it was 34 months for patients of group B. Metrorrhagia was observed in two cases of group A and in 6 of group B , and thrombophlebitis in 1 and 3 cases , respectively . The second biopsy confirmed a clear increase of PgR content in 8/11 cases ( 75 % ) . Plasma level variations of TAM , N-desmethyl TAM and MPA were checked at various intervals on 3 patients of group B , and confirmed that our schedule is able to produce a drug wash-out period for tumor cells . In conclusion , our study demonstrated that while the manipulation of hormone receptors seems possible , results indicating better overall survival and time to progression were not obtained with alternate sequential TAM-MPA therapy .
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Intervention_Pharmacological
tamoxifen
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Intervention_Pharmacological
medroxyprogesterone acetate
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Intervention_Pharmacological
two arms to receive : A ) tamoxifen ( TAM ) ( 20 mg/die ) until progression or B ) TAM ( 20 mg/die for 14 days ) then medroxyprogesterone acetate ( MPA ) ( 1500 mg/die p.o .
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Intervention_Control
for 14 days ) followed by 7 days of wash-out before repeating the TAM/MPA treatment .
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Intervention_Educational
when possible a second biopsy was performed after the initial 14 day cycle of TAM .
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Outcome_Physical
hormone receptor variations
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Outcome_Physical
biopsy
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Outcome_Physical
Objective regression
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Outcome_Physical
Median time to progression
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Outcome_Mortality
Overall survival
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Outcome_Physical
Metrorrhagia
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Outcome_Physical
PgR content
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Outcome_Physical
Plasma level variations of TAM , N-desmethyl TAM and MPA
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Participant_Condition
advanced breast cancer
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Participant_Sample-size
60
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Participant_Sex
women
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Participant_Condition
advanced breast cancer
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Participant_Condition
post-menopausal
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Participant_Condition
evaluable lesions
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Participant_Sample-size
Thirty-one
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Participant_Sample-size
29