A Comparison of the Effect of Diethylstilbestrol with Low Dose Estramustine Phosphate in the Treatment of Advanced Prostatic Cancer: Final Analysis of a Phase III Trial of the European Organization for Research on Treatment of Cancer

Abstract

In a randomized phase III trial performed by the Urological Group of the European Organization for Research on Treatment of Cancer low dose estramustine phosphate (280 mg. twice daily for 8 weeks and 140 mg. twice daily thereafter) was compared to diethylstilbestrol (1 mg. 3 times daily) in patients with stages T3 to T4, M0 or M1 prostatic cancer. Of 248 patients entered 227 were evaluable for analysis: 115 received estramustine phosphate and 112 received diethylstilbestrol. The best response of the local tumor as assessed by palpation was seen in patients receiving diethylstilbestrol. There was no significant difference between treatments for response rate of metastases, interval to local progression, distant progression, over-all survival and death of carcinoma of the prostate. Duration of survival was correlated with the assessment of local response as determined by palpation. The response of distant lesions also was correlated closely with survival. Diethylstilbestrol (1 mg. 3 times daily) was associated with a significantly worse degree of cardiovascular toxicity than estramustine phosphate. This finding was especially obvious in patients who had no history of cardiovascular disease. Gastrointestinal toxicity occurred in 25 patients treated with estramustine phosphate, including 6 in whom cessation of treatment was necessary. Further studies are required to determine the optimum dose of diethylstilbestrol and estramustine phosphate, and to establish the best form of hormonal treatment for prostatic carcinoma.

The Final Analysis of the EORTC Genito-Urinary T ract Cancer Co-Operative Group Phase III Clinical Trial (Protocol 30805) Comparing Orchidectomy, Orchidectomy plus Cyproterone Acetate and Low Dose Stilboestrol in the Management of Metastatic Carcinoma of the Prostate

“…Treatment with medroxyprogesterone acetate gave inferior results [1]. The second study (protocol 30762) compared DES 1 mg 3 times a day with Estracyt and no difference was demonstrated between these two treatments using the same endpoints [2]. De Voogt et al [3] comparing data from both studies demonstrated that there is a definite increased risk in cardiovascular complications including death with the dose of DES that was given.…”

Estramustine Phosphate for Preventing Flare-Up in Luteinizing Hormone-Releasing Hormone Analogue Depot Therapy

“…However, a marked testoster one surge cannot be prevented [3], Estramustine phos phate (ECT) is known to cause significant decrease in serum testosterone [4], as do other estrogens such as diethylstilbestrol (DES), and yet its cardiovascular compli cations are reported to be milder than those of DES [5]. We herein report our evaluation of the usefulness of ECT for preventing flare-up during LHRH analogue depot therapy.…”

Analogues of LHRH versus orchidectomy: comparison of economic costs for castration in advanced prostate cancer

“…Most (Smith et al, 1986;Pavone-Macaluso et al, 1986;Benson & Gill, 1986 [1981][1982][1983][1984][1985][1986] Type ofpatient and department 1981-82 1983-86 Average stay (days) (Table II). Table III shows the average cost per patient of a policy of initial LHRH analogue treatment followed by orchidectomy after 3, 6, 12, 24 or 36 months.…”