The addition of chemotherapy to hormonal therapy for treatment of patients with metastatic carcinoma of the prostate.
Patients with advanced prostate carcinoma that had been stabilized by orchiectomy (ORCH) or hormone therapy for at least 3 months, were randomized to either diethylstilbestrol (DES) alone or DES plus Cytoxan or DES plus Emcyt. A total of 188 patients were randomized between July, 1976 and February, 1982 of which 161 were evaluable for objective response to treatment. Objective response rates, response duration, or survival experiences were not demonstrably different between treatment arms, either for all patients or within good or poor prognosis groups determined by initial pain or acid phosphatase level. Subjective improvements in performance status were small for each treatment. Pain relief was somewhat greater in the chemotherapy-hormone combinations than in the DES/ORCH, but the advantage was not statistically significant. Side effects were primarily nausea and vomiting and leukopenia, mostly in the DES + Cytoxan arm. The duration of stabilization prior to entry did not influence response overall, although there were opposing trends within each of the two chemotherapy arms. The premise for combining antitumor agents with hormones before hormone failure is still felt to be a more logical approach than waiting for the ultimate hormone failure, and a combination of hormones plus two antitumor agents is being evaluated in a subsequent ongoing trial where a more rigid design limits the duration of the preentry period of hormone stabilization.
D000368:Aged; D002369:Castration; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D004054:Diethylstilbestrol / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D004961:Estramustine / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D011897:Random Allocation
D009588:Nitrogen Mustard Compounds; D004961:Estramustine; D004054:Diethylstilbestrol; D003520:Cyclophosphamide