Author:
Marvaso Giulia,Vischioni Barbara,Pepa Matteo,Zaffaroni Mattia,Volpe Stefania,Patti Filippo,Bellerba Federica,Gandini Sara,Comi Stefania,Corrao Giulia,Zerini Dario,Augugliaro Matteo,Fodor Cristiana,Russo Stefania,Molinelli Silvia,Ciocca Mario,Ricotti Rosalinda,Valvo Francesca,Giandini Tommaso,Avuzzi Barbara,Valdagni Riccardo,De Cobelli Ottavio,Cattani Federica,Orlandi Ester,Jereczek-Fossa Barbara Alicja,Orecchia Roberto
Abstract
PurposeThis study represents a descriptive analysis of preliminary results of a Phase II trial on a novel mixed beam radiotherapy (RT) approach, consisting of carbon ions RT (CIRT) followed by intensity-modulated photon RT, in combination with hormonal therapy, for high-risk prostate cancer (HR PCa) with a special focus on acute toxicity.MethodsPrimary endpoint was the evaluation of safety in terms of acute toxicity. Secondary endpoints were early and long-term tolerability of treatment, quality of life (QoL), and efficacy. Data on acute and late toxicities were collected according to RTOG/EORTC. QoL of enrolled patients was assessed by IPSS, EORTC QLQ-C30, EORTC QLQ-PR25, and sexual activity by IIEF-5.ResultsTwenty-six patients were enrolled in the study, but only 15 completed so far the RT course and were included. Immediately after CIRT, no patients experienced GI/GU toxicity. At 1 and 3 months from the whole course RT completion, no GI/GU toxicities greater than grade 2 were observed. QoL scores were overall satisfactory.ConclusionsThe feasibility of the proposed mixed treatment schedule was assessed, and an excellent acute toxicity profile was recorded. Such findings instil confidence in the continuation of this mixed approach, with evaluation of long-term tolerability and efficacy.
Funder
Università degli Studi di Milano