Document Detail


Intensified Adjuvant Treatment of Prostate Carcinoma: Feasibility Analysis of a Phase I/II Trial.
MedLine Citation:
PMID:  25093169     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Purpose. To perform a preliminary feasibility acute and late toxicity evaluation of an intensified and modulated adjuvant treatment in prostate cancer (PCa) patients after radical prostatectomy. Material and Methods. A phase I/II has been designed. Eligible patients were 79 years old or younger, with an ECOG of 0-2, previously untreated, histologically proven prostate adenocarcinoma with no distant metastases, pT2-4 N0-1, and with at least one of the following risk factors: capsular perforation, positive surgical margins, and seminal vesicle invasion. All patients received a minimum dose on tumor bed of 64.8 Gy, or higher dose (70.2 Gy; 85.4%), according to the pathological stage, pelvic lymph nodes irradiation (57.7%), and/or hormonal therapy (69.1%). Results. 123 patients were enrolled and completed the planned treatment, with good tolerance. Median follow-up was 50.6 months. Grade 3 acute toxicity was only 2.4% and 3.3% for genitourinary (GU) and gastrointestinal (GI) tract, respectively. No patient had late grade 3 GI toxicity, and the GU grade 3 toxicity incidence was 5.8% at 5 years. 5-year BDSF was 90.2%. Conclusions. A modulated and intensified adjuvant treatment in PCa was feasible in this trial. A further period of observation can provide a complete assessment of late toxicity and confirm the BDSF positive results.
Authors:
Giovanna Mantini; Sergio Fersino; Anna Rita Alitto; Vincenzo Frascino; Mariangela Massaccesi; Bruno Fionda; Vincenzo Iorio; Stefano Luzi; Mario Balducci; Gian Carlo Mattiucci; Francesco Di Nardo; Antonio De Belvis; Alessio Giuseppe Morganti; Vincenzo Valentini
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Publication Detail:
Type:  Journal Article     Date:  2014-06-30
Journal Detail:
Title:  BioMed research international     Volume:  2014     ISSN:  2314-6141     ISO Abbreviation:  Biomed Res Int     Publication Date:  2014  
Date Detail:
Created Date:  2014-08-05     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101600173     Medline TA:  Biomed Res Int     Country:  United States    
Other Details:
Languages:  eng     Pagination:  480725     Citation Subset:  IM    
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