TY - JOUR
T1 - Intensified adjuvant treatment of prostate carcinoma: feasibility analysis of a phase I/II trial
AU - Mantini, Giovanna
AU - Fersino, Sergio
AU - Alitto, Anna Rita
AU - Frascino, Vincenzo
AU - Massaccesi, Mariangela
AU - Fionda, Bruno
AU - Iorio, Vincenzo
AU - Luzi, Stefano
AU - Balducci, Mario
AU - Mattiucci, Gian Carlo
AU - Di Nardo, Francesco
AU - De Belvis, Antonio
AU - Morganti, Alessio Giuseppe
AU - Valentini, Vincenzo
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - PROSTATE CARCINOMA
KW - PROSTATE CARCINOMA
UR - http://hdl.handle.net/10807/62655
U2 - 10.1155/2014/480725
DO - 10.1155/2014/480725
M3 - Article
SN - 2314-6133
VL - 2014
SP - N/A-N/A
JO - BioMed Research International
JF - BioMed Research International
ER -