A phase Ii study of Nolvadex® tamoxifen citrate in the treatment of advanced prostatic adenocarcinoma

: Prostatic Carcinoma is known to be a hormonally responsive neoplasm which contains both estrogen and androgen receptors. Sixty-three heavily pretreated patients with Stage D prostatic adenocarcinoma received tamoxifen (Nolvadex) at a dose of 20 mg twice a day. Patients were examined every 4 weeks at which time they also had a white count, hemoglobin and platelet count, acid phosphatase, SMA-12, and recording of the status of their measurable or evaluable disease. If the evaluable disease was metastatic to bone, the relevant x-rays were repeated every 8 weeks. The median age of the patients was 66. The Karnofsky status of the patients for whom this information was known was 40% (6), 45% (1), 50% (1), 60% (8), 70% (11), 80% (6), 90% (5), and 100% (2). Forty-one patients were eligible for response evaluation; the majority had evaluable bone disease. No serious toxicity was encountered; two patients withdrew from the protocol because of nausea and vomiting and one patient had hot flashes. One complete response was seen in measurable nodal disease which is continuing after 13+ months, 1 minor response was seen in evaluable bone disease, and 4 patients had long (more than 10 months) stability of bone disease with subjective improvement. We conclude that although the response rate was low, patient acceptability was excellent and that tamoxifen may warrant further trial in a less heavily pretreated patient population.