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

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Abstract
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 wk at which time they also had a white count, Hb 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 wk. 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). Patients (41) were eligible for response evaluation; the majority had evaluable bone disease. No serious toxicity was encountered; 2 patients withdrew from the protocol because of nausea and vomiting, and 1 patient had hot flashes. One complete response was seen in measurable nodal disease which is continuing after 13+ mo., 1 minor response was seen in evaluable bone disease and 4 patients had long (> 10 mo.) stability of bone disease with subjective improvement. Although the response rate was low, patient acceptability was excellent. Tamoxifen may warrant further trial in a less heavily pretreated patient population.

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