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

Robinson, Mark; Smith, Philip; Richards, B.; Newling, D. W. W.; Pauw, M. De; Sylvester, R.

doi:10.1159/000475067

Cited by 98 publications

(46 citation statements)

References 6 publications

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“…The results were similar in EORTC protocol 30762, which included a thromboembolic event incidence of 17%, 16% of which were lethal. In the present study, the risk increased with age, a weight > 75 kg and a history of cardiovascular disease [ 26 ] . More recent studies using 3 mg of DES have reported similar results.…”

Section: Adverse Events From Low Doses Of Dessupporting

confidence: 50%

“…The fi nal analysis of EORTC protocol 30805, which compared orchiectomy plus cyproterone acetate and low-dose DES (1 mg daily) in patients with metastatic disease, evaluated the clinical effi cacy and toxicity of low-dose DES in a multicentre, prospective, randomized trial [ 26 ] . In the DES arm, 14.8% (16/108) of patients reported thromboembolic events vs 8.3% (9/108) in the orchiectomy-only arm.…”

Section: Adverse Events From Low Doses Of Desmentioning

confidence: 99%

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Current role of diethylstilbestrol in the management of advanced prostate cancer

et al. 2012

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What ' s known on the subject? and What does the study add? Diethylstilbestrol (DES) has been found to have anti-tumour properties and clinical effectiveness in prostate cancer that is resistant to the fi rst-line hormonal therapy.This review found that low-dose DES has anti-tumour effi cacy with limited cardiovascular side effects and should be considered for secondary hormone manoeuvres.The aim of this review was to describe the most recent data from contemporary clinical trials of diethylstilbestrol ( DES) to better determine its current role in advanced prostate cancer treatment as new hormonal therapies emerge. Relevant clinical studies using 1 mg of DES in castrate-resistant prostate cancer (CRPC) were identifi ed from the literature, clinical trial databases, websites and conference abstracts. The effi cacy and safety outcomes were summarized. DES in CRPC produced a biological response (change in PSA level) and improved the median survival of patients when used as a second-line hormone therapy after standard androgen deprivation with bicalutamide and LHRH analogues. These fi ndings were for low doses of DES. The 1-mg dose is associated with a reduced toxicity, including fewer thromboembolic and cardiovascular events. Low-dose DES appears to be safe and effective for CRPC before initiating chemotherapy. The cost/effi ciency ratio may encourage physicians to consider DES as a therapy option before chemotherapy in non-symptomatic CRPC.

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Section: Adverse Events From Low Doses Of Dessupporting

confidence: 50%

Section: Adverse Events From Low Doses Of Desmentioning

confidence: 99%

Current role of diethylstilbestrol in the management of advanced prostate cancer

et al. 2012

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“…Other suggested mechanisms include inhibition of the secretion of gonadotropins and a sharp reduction in free testosterone levels (14). DES also increases the production of sex hormonebinding globulin (SHBG) and prolactin, thus, decreasing the amount of bio-available testosterone (6,15). There is also evidence that estrogens may inhibit synthesis of androgens by tumor tissue, such as reports of estrogens suppressing the levels of tumor testosterone and dihydrotestosterone in an estrogen receptor-independent manner (16).…”

Section: Introductionmentioning

confidence: 99%

Diethylstilbestrol for the treatment of patients with castration-resistant prostate cancer: Retrospective analysis of a single institution experience

et al. 2013

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Abstract. The aim of the present retrospective study was to evaluate the efficacy and safety of diethylstilbestrol (DES) as treatment for patients with castration-resistant prostate cancer (CRPC) and to identify predicting factors of response to DES. Patients treated with DES during the castration-resistant phase following the failure of prior treatment with LH-RH analogs during the castration-sensitive phase were retrieved from a prostate cancer database of our institution. Patients were treated with a daily dose of DES of 1-4 mg (mean, 2.6 mg) and anticoagulants for thromboembolic prophylaxis until disease progression. We analyzed their medical records, biochemical prostate-specific antigen (PSA) response and time to disease progression (TDP). Disease response and progression were identified according to the PCWG2 criteria. Patient data were examined using Kaplan-Meier survival analysis and statistical correlation tests with intra-patient comparison of the LH-RH and DES treatment phases. Fortythree DES-treated CRPC patients were found in our database through July 2011. The median age was 66 years. Sixty-three percent of the patients achieved a ≥50% decline in their serum PSA levels during DES therapy. Median TDP was 20.4 months for LH-RH analog treatment in the castration-sensitive phase, and 7.1 months for DES treatment in the castration-resistant phase. Durable responses (>1 year) were observed in 31% of the patients. Median overall survival was 57 months from the start of the DES therapy. There was no significant correlation between the TDP under LH-RH analogs and under DES therapy among the 38 patients eligible for correlation analysis. However, the magnitudes of serum PSA responses under DES and LH-RH analogs were significantly correlated with each other, and with the TDP under DES therapy. There were no treatment-related deaths. Four patients (9%) developed thromboembolic complications while under treatment, some of which appeared to be related to a discontinuation of thromboprophylaxis. In conclusion, DES confers substantial clinical benefit in the treatment of CRPC, with a relatively good safety profile when administered with thromboprophylaxis. The use of DES may be effective in CRPC, irrespective of the length of the hormone-sensitive period with LH-RH treatment. The magnitude of PSA response to previous treatment with LH-RH analogs, as well as to DES, was predictive of the duration of response to DES.

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“…The European Organisation for the Research and Treatment of Cancer (EORTC) trial 30805 demonstrated the equivalent efficacy of 1mg DES daily to orchiectomy. 12 Another trial also showed superior results over anti-androgen monotherapy. 13 Interest in oestrogen therapy has also been rekindled by recent trials, suggesting that the parenteral administration of oestrogens may avoid a majority of cardiovascular (CV) toxicity.…”

Section: E F F E C T O F N O N -S T E R O I D a L A N T I -A N D R O mentioning

confidence: 99%

Androgen Deprivation Therapy and Neuroendocrine Differentiation in Prostate Carcinoma – A Possible Inductive Role

Sciarra¹,

Albanesi²,

Fattore³

et al. 2006

European Endocrinology

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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

Cited by 98 publications

References 6 publications

Current role of diethylstilbestrol in the management of advanced prostate cancer

Current role of diethylstilbestrol in the management of advanced prostate cancer

Diethylstilbestrol for the treatment of patients with castration-resistant prostate cancer: Retrospective analysis of a single institution experience

Androgen Deprivation Therapy and Neuroendocrine Differentiation in Prostate Carcinoma – A Possible Inductive Role

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