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Prostatic cancer and SCH-13521: II. Histological alterations and the pituitary gonadal axis
Abstract:
We herein report on the results of treatment of 13 men with stage D prostatic carcinoma with a non-steroidal compound, SCH-13521 (flutamide). The dosage of the drug was 750 mg. in 3 divided doses daily and treatment extended for 2 to 20 months. Two patients failed to respond in any fashion, 7 had objective evidence of response and the others had varying degrees of subjective response. Plasma testosterone was never suppressed and sexual potency was not altered by the drug. Gynecomastia occurred in several patients, 1 patient had intractable vomiting and 2 had thromboembolic disease. In tissue biopsies after therapy, cytotoxic changes in some acinar cells were noted but healthy-appearing neoplastic cells were always abundant. These observations suggest the pre-treatment existence of autonomous cells that no conventional hormonal manipulation will succeed in destorying. However, the palliation that flutamide seems to afford makes it important to conduct an appropriately designed study that will compare it in a suitable fashion to the effectiveness of diethylstilbestrol.
Insights
Flutamide (SCH-13521) showed palliative effects in stage D prostate cancer patients, with some experiencing objective responses. The drug did not suppress testosterone or alter sexual potency but caused side effects like gynecomastia.
Area of Science:
- Oncology
- Pharmacology
Background:
- Stage D prostate carcinoma is an advanced form of prostate cancer.
- Hormonal therapies are a cornerstone in managing advanced prostate cancer.
Purpose of the Study:
- To evaluate the efficacy and safety of flutamide (SCH-13521) in treating men with stage D prostatic carcinoma.
- To assess the impact of flutamide on testosterone levels and sexual potency.
Main Methods:
- A cohort of 13 men with stage D prostate carcinoma received flutamide at 750 mg daily in divided doses.
- Treatment duration ranged from 2 to 20 months.
- Objective and subjective responses, hormonal levels, sexual function, and adverse events were monitored.
Main Results:
- Seven out of 13 patients showed objective evidence of response to flutamide.
- Other patients experienced subjective improvements, while two showed no response.
- Flutamide did not suppress plasma testosterone or affect sexual potency.
- Observed side effects included gynecomastia, vomiting, and thromboembolic disease.
Conclusions:
- Flutamide demonstrates palliative benefits in stage D prostate cancer, suggesting the presence of hormone-independent cancer cells.
- Further studies comparing flutamide with established treatments like diethylstilbestrol are warranted.