To evaluate the impact of Ialuril soft Gel® in reducing acute genito-urinary (GU) toxicity in patients with prostate cancer treated with Volumetric Modulated Arc Radiotherapy.
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Forty patients were prospectively recruited.
A moderate hypofractionation in 28 fractions ("Hypo-moderate") was prescribed in 20 patients, while an extreme hypofractionated ("Hypo-extreme") in 5 fractions was prescribed in 20 patients. 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 Gel®.
In "Hypo-moderate" patients treated with Ialuril soft Gel® the following GU toxicity was reported: G0 3, G1 6, G2 1, G3 0. In the arm without Ialuril soft Gel®: G0 0, G1 7, G2 2, G3 1. In "Hypo-extreme" arm with Ialuril soft Gel® it was recorded the following GU toxicity: G0 7, G1 2, G2 1, G3 in 0; while in the arm without Ialuril soft Gel®: G0 5, G1 2, G2 2, G3 1. IPSS was unchanged in "Hypo-moderate" and "Hypo-extreme" and patients undergoing Ialuril soft Gel®, with a median value of 6 and 5 respectively. In patients without Ialuril soft Gel® an increased IPSS was reported in "Hypo-moderate" and "Hypo-extreme" from 6 to 8 and 3. 5 to 4. 5 respectively. At statistical analysis (Fisher's exact text) Ialuril soft Gel® was associated with IPSS improvement (p 0. 03).
Ialuril soft Gel® seems to have an encouraging role to reduce GU toxicity without a worsening on IPSS score.
Minerva urologica e nefrologica = The Italian journal of urology and nephrology. 2015 Oct 22 [Epub ahead of print]
S Fersino, A Fiorentino, N Giaj Levra, R Mazzola, F Ricchetti, G Di Paola, S Cavalleri, F Alongi
Radiation Oncology Department, Sacro Cuore Don Calabria Hospital, Negrar Verona, Italy