ORIGINAL ARTICLES  UROLOGY 

Minerva Urologica e Nefrologica 2016 February;68(1):9-13

Copyright © 2016 EDIZIONI MINERVA MEDICA

lingua: Inglese

Impact of Ialuril Soft Gels® in reducing urinary toxicity during radical hypofractionated radiotherapy in prostate cancer: a preliminary experience

Sergio FERSINO ¹, Alba FIORENTINO ¹, Niccolò GIAJ LEVRA ¹, Rosario MAZZOLA ¹, Francesco RICCHETTI ¹, Gioacchino DI PAOLA ², Stefano CAVALLERI ³, Filippo ALONGI ¹ ✉

¹ Radiation Oncology Department, Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy; ² Statistic Science Faculty, University of Palermo, Palermo, Italy; ³ Department of Urology, Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy

BACKGROUND: The aim of this study was to evaluate the impact of Ialuril Soft Gels® in reducing acute genito-urinary (GU) toxicity in patients with prostate cancer treated with volumetric-modulated arc radiotherapy.
METHODS: Forty patients were prospectively recruited. A moderate hypofractionation in 28 fractions (“hypo-moderate”) was prescribed in 20 patients, while an extreme hypofractionation (“hypo-extreme”) in 5 fractions was prescribed in 20 patients. The International Prostate Symptom Score (IPSS) questionnaire was administered in all cases before and after radiotherapy (RT). GU toxicity was evaluated according to CTCAE v4.0. Patients of each group (“hypo-moderate” and “hypo-extreme”) were randomized (1:1) to receive RT alone or RT combined with Ialuril Soft Gels®.
RESULTS: In “hypo-moderate” patients treated with Ialuril Soft Gels® the following GU toxicity was reported: G0 3, G1 6, G2 1, G3 0. In the arm treated without Ialuril Soft Gels®: G0 0, G1 7, G2 2, G3 1. In “hypo-extreme” arm treated with Ialuril Soft Gels® the following GU toxicity was recorded: G0 7, G1 2, G2 1, G3 in 0; while in the arm treated without Ialuril Soft Gels®: G0 5, G1 2, G2 2, G3 1. IPSS was unchanged in “hypo-moderate” and “hypo-extreme” groups and patients treated with Ialuril Soft Gels®, with a median value of 6 and 5 respectively. In patients treated without Ialuril Soft Gels® an increased IPSS was reported in “hypo-moderate” and “hypo-extreme” from 6 to 8 and from 3.5 to 4.5, respectively. At statistical analysis (Fisher’s exact text) Ialuril Soft Gels® was associated with IPSS improvement (P=0.03).
CONCLUSION: Ialuril Soft Gels® seems to have a beneficial role in reducing GU toxicity without worsening the IPSS.