EORTC protocol 30853: orchidectomy versus zoladex plus flutamide in the management of metastatic carcinoma of the prostate

Article Abstract:

Currently, the preferred method of treatment for advanced prostate cancer is the reduction of male hormones, which may be accomplished with drugs, castration, or both. Castration is known to cause side effects, most notable among these are a loss of potency and libido, and the psychological effects of the operation. Hot flashes and ankle edema may also occur. These side effects do not represent serious health hazards. It is important, therefore, that any drug therapy proposed as an alternative to castration be shown to have a level of side effects that is in keeping with the benefit provided the patient. For this reason, the side effects experienced by 148 castrated patients with prostate cancer were compared with the side effects experienced by 149 prostate cancer patients treated with a combination of zoladex plus flutamide. On follow-up, gynecomastia, or breast development, was noted in 20 patients receiving the drug combination; in three cases, gynecomastia was painful. Eleven castrated patients experienced gynecomastia, one painfully. Similarly, hot flashes and severe pain were roughly comparable between the two groups. Compared with only one castrated patient, a total of eight patients receiving the drug regimen had their treatment modified due to adverse reactions, which included liver toxicity and gastrointestinal side effects. However, comparison of these numbers is not appropriate, since after castration considerably less treatment modification is possible. The results of the study indicate that the side effects of treatment with zoladex and flutamide are not significantly worse than the side effects of orchidectomy in patients with advanced prostate cancer. (Consumer Summary produced by Reliance Medical Information, Inc.)

Complications and side effects, Surgery, Drug therapy

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Comparability of EORTC and DAPROCA studies in advanced prostate cancer

Article Abstract:

The authors provide a detailed discussion of the problems facing the comparison of two distinct clinical trials and then apply these principles to the comparison of the studies on prostate cancer treatment carried out by the European Organization for Research and Treatment of Cancer (EORTC) and the Danish Prostatic Cancer Group (DAPROCA). Although randomization is an important first step in the design of a clinical trial, randomization does not guarantee that the experimental groups are directly comparable for any particular prognostic factor. For comparisons between studies, it is advantageous to stratify patients according to prognostic factors, and then randomly assign patients to treatment groups from within each strata. A further complication of clinical trials is the use of different end-point measures. For example, it is not possible to directly compare time to disease progression with overall survival time. The authors recommend death as a useful endpoint and emphasize that death from all causes should be included, not only death from cancer progression. In the comparison of the EORTC and DAPROCA trials, one finds that the EORTC trial found no differences between orchidectomy and zoladex/flutamide treatment in overall survival. The DAPROCA study found a longer period to disease progression for the zoladex/flutamide treatment when compared with orchidectomy. However, the duration of survival after disease progression was shorter, so that when the two were added together, the difference between the groups vanished and the results were comparable to the EORTC study. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Zoladex and flutamide versus orchiectomy in the treatment of advanced prostatic cancer: a combined analysis of two European studies, EORTC 30853 and DAPROCA 86

Article Abstract:

Two major European studies, EORTC 30853 and DAPROCA 86, have compared the effectiveness of pharmacologic and surgical methods for depriving advanced prostate cancers of male sex hormones. A total of 591 patients were included in the two studies, which compared the combination of zoladex and flutamide with castration. The pharmacologically treated group enjoyed a longer period between treatment and disease progression, while in the castrated group the time from progression to death was longer. Overall, there were no significant differences between the groups in the period of time from treatment to death. The median survival time was between 24 and 30 months for the both the pharmacologic and the surgically treated group. The studies were unable to demonstrate any superiority of the drug treatment to castration. (Consumer Summary produced by Reliance Medical Information, Inc.)

Patient outcomes, Mortality

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