• Numa Cellini, Stefano Luzi, Alessio Giuseppe Morganti, Giovanna Mantini, Vincenzo Valentini, Marco Racioppi, Mariavittoria Leone, Gian Carlo Mattiucci, Cinzia Di Gesù, Mario Giustacchini, Antonio Destito, Daniela Smaniotto, and Eugenio Alcini.
• Istituto di Radiologia, Cattedra di Radioterapia, Universitá Cattolica del Sacro Cuore, Policlinico a Gemelli, Rome, Italy.
• Tumori. 2002 Nov 1; 88 (6): 495-9.

AbstractThe aim of this study was to evaluate the prognostic role of several clinical variables in a patient population undergoing neoadjuvant hormonotherapy (NHT) with external beam radiotherapy (ERT) to identify subsets of patients with an unfavorable prognosis who require intensified therapy. Eighty-four patients (mean age, 68.2 +/- 6.1 years; range, 52-81 years) underwent ERT (45 Gy to pelvic volume; 65 Gy mean dose to prostate volume) and NHT (oral flutamide: 250 mg three times daily for 30 days; LH-RH analogue: one vial every 28 days starting two months before radiotherapy and for its entire duration). The distribution according to clinical stage was T2: 46.4%, T3: 50.0%, T4: 3.6%. The distribution according to the Gleason score was grade 2-4: 17.9%; grade 5-7: 53.6%; grade 8-10: 28.5%. The distribution according to pretreatment PSA levels (in ng/mL) was 0-4: 5.9%; 4-10: 26.2%; 10-20:16.7%; > or = 20: 51.2%. With a median follow-up of 36 months, 3.6% of patients died; hematogenous metastases and local disease progression were found in 16.7% and 6% of patients, respectively. Overall, the incidence of disease progression was 17.9%. 32.9% of patients showed biochemical failure during followup. Overall, metastasis-free, local progression-free and biochemical failure-free actuarial survival at five years was 89.2%, 66.5%, 85.0% and 41.9%, respectively. At univariate analysis (log-rank) clinical stage (cT) was shown to be significantly correlated with the incidence of metastasis (P = 0.0004), local progression (P < 0.0001) and disease-free survival (P = 0.0005). At multivariate analysis (Cox) the correlations between clinical stage and metastasis (P = 0.0175), local progression (P = 0.0200) and disease-free survival (P = 0.0175) were confirmed. Gleason score and pretreatment PSA levels did not show any significant correlation with these endpoints. These results confirm the indications of the recent literature, which, in prostate carcinoma at higher clinical stages, suggest the use of prolonged hormonal therapy after radiotherapy.

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