Phase II trial of tamoxifen in metastatic carcinoma of the prostate

✍ Scribed by John H. Glick; Alan Wein; Kristin Padavic; William Negendank; David Harris; Harvey Brodovsky

• Publisher: John Wiley and Sons
• Year: 1982
• Tongue: English
• Weight: 551 KB
• Volume: 49
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/1097-0142(19820401)49:7<1367::aid-cncr2820490711>3.0.co;2-8

✦ Synopsis

Fifty-one patients with advanced metastatic carcinoma of the prostate were treated with the antiestrogen tamoxifen. Thirty-eight of these patients were refractory to prior hormonal manipulation with estrogens and/or orchiectomy, and five (13%) achieved an objective response (partial regression or stable disease using the National Prostate Cancer Project criteria). Median survival of the responders was significantly longer than that of the nonresponders (P < 0.05). An additional 13 patients who had not previously received hormonal manipulation were treated with tamoxifen; one partial response and three disease stabilizations were noted. Response was separately evaluated for 15 patients with objectively measurable lesions using standard Phase I1 response criteria. Only 1/15 (7%) partial response and 3/15 (20%) disease stabilizations were documented. Subjective benefit in terms of significant pain relief was noted in 17/50 (34%) of patients. Toxicity was mild, but two possible "tumor flares" were noted. These results do not support the continued investigation of tamoxifen in advanced carcinoma of the prostate.