Study of tamoxifen in metastatic renal cell carcinoma and the influence of certain prognostic factors: a Southwest Oncology Group Study.

A prospective study of tamoxifen therapy in doses of 10 mg twice daily was carried out in 79 patients with advanced renal cell cancer. The objective response rate (complete response plus partial response) was 6.3% (five of 79 patients), while 34.1% (27 of 79 patients) had stable disease. Survival of this group of patients (complete response plus partial response plus stable disease) was significantly longer than that of patients with progressive disease (P less than 0.04). Also, among patients with a good performance status at the beginning of the study, survival was longer than among those with a poor performance status (P less than 0.001). No statistical significance was found in the survival of these patients according to sex (P = 0.55) or whether or not they had received previous systemic therapy (P = 0.97). Toxicity was low and acceptable. We concluded that stratification according to performance status may be used in future randomized systemic therapy protocols for patients with metastatic renal cell cancer. Also, in spite of the low response rate to hormonal therapy including tamoxifen, the use of these agents with combination chemotherapy may enhance the overall response rate without increasing side effects.