Background We conducted a randomized, prospective trial comparingexternal irradiation with external irradiation plus goserelin(an agonist analogue of gonadotropin-releasing hormone thatreduces testosterone secretion) in patients with locally advancedprostate cancer.
Methods From 1987 to 1995, 415 patients with locally advancedprostate cancer were randomly assigned to receive radiotherapyalone or radiotherapy plus immediate treatment with goserelin.The patients had a median age of 71 years (range, 51 to 80).Patients in both groups received 50 Gy of radiation to the pelvisover a period of five weeks and an additional 20 Gy over anadditional two weeks as a prostatic boost. Patients in the combined-treatmentgroup received 3.6 mg of goserelin (Zoladex) subcutaneouslyevery four weeks starting on the first day of irradiation andcontinuing for three years; those patients also received cyproteroneacetate (150 mg orally per day) during the first month of treatmentto inhibit the transient rise in testosterone associated withthe administration of goserelin.
Results Data were available for analysis on 401 patients. Themedian follow-up was 45 months. Kaplan–Meier estimatesof overall survival at five years were 79 percent (95 percentconfidence interval, 72 to 86 percent) in the combined-treatmentgroup and 62 percent (95 percent confidence interval, 52 to72 percent) in the radiotherapy group (P = 0.001). The proportionof surviving patients who were free of disease at five yearswas 85 percent (95 percent confidence interval, 78 to 92 percent)in the combined-treatment group and 48 percent (95 percent confidenceinterval, 38 to 58 percent) in the radiotherapy group (P<0.001).
Conclusions Adjuvant treatment with goserelin, when startedsimultaneously with external irradiation, improves local controland survival in patients with locally advanced prostate cancer.
Source Information
From University Hospital, Grenoble, France (M.B.); Akademisch Medisch Centrum, Amsterdam, the Netherlands (D.G.); Princess Margaret Hospital, Toronto (P.W.); Centre Régional de Lutte contre le Cancer Val d'Aurelle, Montpellier, France (J.B.D.); Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (R.-O.M.); Oncologisch Centrum, Brussels (G.S.); Ospedale San Giovanni, Bellinzona, Switzerland (J.B.); Rambam Medical Center, Haifa, Israel (A.K.); Ufficio Sternberg & Pansadoro, Rome (C.S.); and the European Organization for Research and Treatment of Cancer Data Center, Brussels (T.G., L.C., M.P.).
Address reprint requests to Dr. Bolla at the Radiotherapy Department, University Hospital, B.P. 217 38043 Grenoble CEDEX 9, France.
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