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Immediate or Deferred Androgen Deprivation for Patients With Prostate Cancer Not Suitable for Local Treatment With Curative Intent: European Organisation for Research and Treatment of Cancer (EORTC) Trial 30891

Urs E. Studer, Peter Whelan, Walter Albrecht, Jacques Casselman, Theo de Reijke, Dieter Hauri, Wolfgang Loidl, Santiago Isorna, Subramanian K. Sundaram, Muriel Debois, Laurence Collette

From the Department of Urology, University Hospital of Bern; Department of Urology, University Hospital of Zurich, Switzerland; Department of Urology, St James' Hospital, Leeds; Department of Urology, Pinderfields Hospital, Wakefield, United Kingdom; Department of Urology, Rudolfstiftung, Vienna; Department of Urology, Krankenhaus Barmherzige Schwestern, Linz, Austria; Department of Urology, Academisch Medisch Centrum, Amsterdam, the Netherlands; Department of Urology, Hospital Nuestra Senora Del Pino, Las Palmas, Spain; Department of Urology, Damiaan Ziekenhuis, Oostende; European Organisation for Research and Treatment of Cancer Data Center, Brussels, Belgium; and the European Organisation for Research and Treatment of Cancer Genitourinary Group

Address reprint requests to Urs E. Studer, Department of Urology, University Hospital of Bern, 3010 Bern, Switzerland; e-mail: urs.studer{at}insel.ch

PURPOSE: This study (EORTC 30891) attempted to demonstrate equivalent overall survival in patients with localized prostate cancer not suitable for local curative treatment treated with immediate or deferred androgen ablation.

PATIENTS AND METHODS: We randomly assigned 985 patients with newly diagnosed prostate cancer T0-4 N0-2 M0 to receive androgen deprivation either immediately (n = 493) or on symptomatic disease progression or occurrence of serious complications (n = 492).

RESULTS: Baseline characteristics were well balanced in the two groups. Median age was 73 years (range, 52 to 81). At a median follow-up of 7.8 years, 541 of 985 patients had died, mostly of prostate cancer (n = 193) or cardiovascular disease (n = 185). The overall survival hazard ratio was 1.25 (95% CI, 1.05 to 1.48; noninferiority P > .1) favoring immediate treatment, seemingly due to fewer deaths of nonprostatic cancer causes (P = .06). The time from randomization to progression of hormone refractory disease did not differ significantly, nor did prostate-cancer specific survival. The median time to the start of deferred treatment after study entry was 7 years. In this group 126 patients (25.6%) died without ever needing treatment (44% of the deaths in this arm).

CONCLUSION: Immediate androgen deprivation resulted in a modest but statistically significant increase in overall survival but no significant difference in prostate cancer mortality or symptom-free survival. This must be weighed on an individual basis against the adverse effects of life-long androgen deprivation, which may be avoided in a substantial number of patients with a deferred treatment policy.

Supported by Grants No. 5U10-CA11488-19 through 5U10 CA11488-35 from the National Cancer Institute, Bethesda, MD. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official view of the National Cancer Institute. Buserelin was in part supplied free by the Hoechst Company (now Sanofi-Aventis).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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