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Value of Estrogenic Recruitment Before Chemotherapy: First Randomized Trial in Primary Breast Cancer

By M. Bontenbal, W. L. J. van Putten, J. Th. M. Burghouts, M. G. A. Baggen, G. J. Ras, W. F. Stiegelis, M. Beudeker, J. Th. P. Janssen, J. J. Braun, G. H. M. van der Linden, P. C. van der Velden, A. N. van Geel, P. Helle, M. Leisink, J. A. Foekens, J. G. M. Klijn

From the Departments of Medical Oncology, Statistics, Surgery, and Radiotherapy, Rotterdam Cancer Institute (Daniel den Hoed Kliniek), University Hospital Rotterdam; Ikazia Hospital; and Sint Clara Hospital, Rotterdam; Bosch Medicenter, ’s-Hertogenbosch; Ignatius Hospital, Breda; Hospital Walcheren, Vlissingen; Sint Franciscus Hospital, Roosendaal; Schieland Hospital, Schiedam; Drechtsteden Hospital, Refaja Location, Dordrecht; and St Het van Weel-Bethesda Hospital, Dirksland, the Netherlands.
Deceased.

Address reprint requests to M. Bontenbal, MD, PhD, Rotterdam Cancer Institute (Daniel den Hoed Kliniek), University Hospital Rotterdam, PO Box 5201, 3008 AE Rotterdam, the Netherlands; email bom{at}onch.azr.nl

PURPOSE: Several preclinical studies showed that short-term pretreatment of breast cancer cells with estrogens can increase the antitumor efficacy of different cytotoxic drugs. Some early clinical studies in patients with advanced breast cancer 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 women with lymph node–positive primary breast cancer.

PATIENTS AND METHODS: Three hundred twenty-eight patients with stage II/IIIA breast cancer who were younger than 66 years of age were randomly allocated to chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide (FAC) or FAC plus pretreatment with ethinyl estradiol (EE₂). FAC (500, 50, and 500 mg/m², respectively) was administered intravenously once every 4 weeks for four cycles. EE₂ (0.5 mg) was administered orally, both 24 hours and immediately preceding FAC chemotherapy.

RESULTS: Patient and tumor characteristics and chemotherapy dosages were comparable in both treatment groups. Of 318 assessable patients, with a median follow-up of 6.8 years, 177 patients 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, tumor size, grade, number of positive nodes, and steroid-receptor status. The power for the detection of an increase of 50% in the median relapse-free survival was 80%.

CONCLUSION: Estrogenic recruitment of breast cancer cells before FAC chemotherapy did not influence the efficacy of adjuvant chemotherapy in stage II/IIIA breast cancer patients after a follow-up of 6.8 years.

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