Intensified adjuvant treatment of prostate carcinoma: feasibility analysis of a phase I/II trial

Mario Balducci, Gian Carlo Mattiucci, Antonio De Belvis, Vincenzo Valentini, Giovanna Mantini, Sergio Fersino, Anna Rita Alitto, Vincenzo Frascino, Mariangela Massaccesi, Bruno Fionda, Stefano Luzi, Francesco Di Nardo, Alessio Giuseppe Morganti, Vincenzo Iorio

Risultato della ricerca: Contributo in rivistaArticolo in rivista

2 Citazioni (Scopus)

Abstract

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.
Lingua originaleEnglish
pagine (da-a)N/A-N/A
Numero di pagine8
RivistaBioMed Research International
Volume2014
DOI
Stato di pubblicazionePubblicato - 2014

Keywords

  • PROSTATE CARCINOMA

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