Value of estrogenic recruitment before chemotherapy: first randomized trial in primary XXXX .

@entity172 @entity1 @entity632 @entity0 @entity5 @entity2082 @entity786 @entity134 @entity1487
PURPOSE: Several preclinical studies showed that short-term pretreatment of @entity0 cells with @entity172 can increase the antitumor efficacy of different cytotoxic drugs. Some early clinical studies in @entity1 with @entity0 did seem to support these findings. Therefore, the efficacy of estrogenic recruitment followed by chemotherapy was compared with that of chemotherapy alone in a randomized phase III study in @entity1 with lymph node-positive primary @entity0 . @entity1 AND METHODS: Three hundred twenty-eight @entity1 with @entity0 who were younger than 66 years of age were randomly allocated to chemotherapy with @entity1487 , @entity632 , and @entity786 (FAC) or FAC plus pretreatment with @entity2082 (EE(2)). FAC (500, 50, and 500 mg/m(2), respectively) was administered intravenously once every 4 weeks for four cycles. EE(2) (0.5 mg) was administered orally, both 24 hours and immediately preceding FAC chemotherapy. RESULTS: @entity1 and @entity5 characteristics and chemotherapy dosages were comparable in both treatment groups. Of 318 assessable @entity1 , with a median follow-up of 6.8 years, 177 @entity1 had a relapse and 127 died. No significant differences were observed between the two treatment groups with respect to relapse-free, local recurrence-free, and overall survival according to univariate and multivariate analyses adjusted for age, menopausal status, @entity5 size, grade, number of positive nodes, and @entity134 -receptor status. The power for the detection of an increase of 50% in the median relapse-free survival was 80%. CONCLUSION: Estrogenic recruitment of @entity0 cells before FAC chemotherapy did not influence the efficacy of adjuvant chemotherapy in @entity0 @entity1 after a follow-up of 6.8 years.
