Hormonal treatment of advanced breast cancer. A randomized trial of tamoxifenVersus nandrolone decanoate

Abstract

The response to tamoxifen (TAM) (10 mg to 20 mg twice orally) was compared with the response to nandrolone decanoate (NAN) (50 mg every second week or 100 mg every third week intramuscularly) in this randomized study in previously untreated women with advanced breast cancer. Patients were postmenopausal or postmenopause was induced with irradiation therapy. The two treatment groups were highly similar in different patient characteristics. Of 67 evaluable patients treated with TAM, ten (15%) had a complete or partial remission, 28 (42%) had stabilized disease and 29 (43%) had progressive disease. In the 60 patients treated with NAN, the figures were ten (17%), 22 (37%) and 28 (47%) respectively. The response rates did not differ significantly. Tam was as good as NAN in osseous metastases. Four of 34 patients responded to TAM and three of 38 patients responded to NAN. NAN had a tendency for better response in the treatment of visceral metastases. Six (43%) of 14 patients responded to NAN while only three (14%) of 21 responded to TAM (P = 0.1 1). The median duration of remission was 24 months in the TAM arm and 17 months in NAN (insignificant). As second line treatment, NAN after TAM gave one complete remission and three partial remissions, but none responded to TAM after NAN. The side-effects of both drugs were rare and mild. These data indicate that TAM and NAN are comparable in the treatment of advanced breast cancer. Cancer 60:2376-2381.1987. OR OVER 90 YEARS hormonal manipulation has F been an effective treatment of metastatic breast cancer. Beatson reported in 1896 a case of a patient with breast cancer whose metastases had regressed after ovariectomy. This regression was later correlated to the reduction of estrogen level. After that time, estrogens, progestins, androgens, adrenalectomy, and hypophysec-tomy have been used as treatment of advanced breast cancer, but these treatments have many side effects.'-' A great advance in hormonal therapy was the antiestrogen, TAM, with less than 3% of patients having side-effects or withdrawing from the treatment.6-8 However, hormonal manipulation with a single drug gives only a 15% to 40% response rate. Sequential therapy with TAM and me-droxyprogesterone acetate seems slightly better today with a response rate of 50% to 60% but more patients should be treated before a conclusion can be Androgens and anabolic steroids cause tumor regression and they have been said to be better in bone metas-tases," but as far as we know no randomized clinical trials have been done to compare TAM and NAN, This study was intended to compare these two compounds in the treatment of metastatic breast cancer. Patients and Methods Putient Selection The study commenced at the beginning of 1979 and ceased at the end of 1983. The trial was carried out at the Department of Radiotherapy of Turku University Central Hospital. Eligible patients were previously untreated postmenopausal women (more than 5 years from menopause or ovarian irradiation) with metastatic or locally advanced breast cancer, i...