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Preliminary results for EORTC trial 22911: radical prostatectomy followed by postoperative radiotherapy in prostate cancers with a high risk of progression]
Authors:M Bolla  H Van Poppel  L Collette
Institution:1. Département de cancérologie–radiothérapie, CHU de Grenoble, hôpital Albert-Michallon, BP 217, 38043 Grenoble cedex 09, France;2. Département d''urologie universitaire Ziekenhuis, Gasthuisberg, Louvain, Belgique;3. European Organization for Treatment and Research on Cancer, Bruxelles, Belgique;2. Department of Radiation Oncology, Mercy UC Davis Cancer Center, Merced, CA;1. Department of Radiation Oncology, Catalan Institute of Oncology, University of Barcelona, l’Hospitalet de Llobregat, Spain;2. Department of Radiation Oncology, Policlinico di Bari, Universitá degli Studi di Bari, Italy;3. Department of Urology, Hospital de Bellvitge, Barcelona, Spain;4. Department of Radiation Oncology, Grupo Quirón, Madrid, Spain;5. Department of Radiation Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain;1. Harvard Radiation Oncology Program, Boston, MA;2. Department of Statistics, University of Connecticut, Storrs, CT;3. 21st Century Oncology, Fort Myers, FL;4. UF Health Cancer Center, Orlando, FL;5. Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women''s Hospital, Boston, MA;1. Radiation Oncology, San Camillo and Forlanini Hospital, Rome, Italy;2. Radiation Oncology, Campus Biomedico University, Rome, Italy;3. Radiation Oncology Department, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland;4. Department of Oncology, Radiation Oncology, University of Turin School of Medicine, Turin, Italy;5. Radiation Oncology Department, Sacro Cuore – Don Calabria Hospital, Negrar, Verona, Italy
Abstract:PURPOSE: Local failure after radiotherapy can arise with cancer extending beyond the capsule and/or involvement of seminal vesicles or positive surgical margins. METHODOLOGY: After undergoing radical prostatectomy 1005 patients were randomly assigned (1999-2001) to a wait and see policy or an immediate postoperative irradiation (60 Gy delivered over 6 weeks); eligible patients had pN0 M0 tumors and one or more pathological risk factors mentioned above. The main end-point was 5-year biochemical progression free survival. RESULTS: After a median follow-up of 5-year biochemical progression free survival was significantly improved in the irradiated group (74%, 98% CI: 68.7-79.3 vs 52.6%, 98% CI: 46.6-58.5; P<0.0001) Clinical progression free survival was also significantly improved (P<0.0009). The cumulative rate of loco-regional failure was also significantly improved (P<0.0009). Grade 2 or 3 late effects were significantly more frequent in the postoperative irradiation group (P=0.0005), but severe toxicity (grade 3 or higher) were rare with a 5-year rate of 2.6% in the wait-and-see group and 4.2% in the postoperative irradiation group (P=0.07). CONCLUSION: Immediate external irradiation after radical prostatectomy improves biochemical progression free survival and local control in patients with positive surgical margin or pT3 prostate cancer who are at high risk of progression. Further follow-up is needed to assess the impact on overall survival.
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