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
Division of Radiotherapy, Istituto Europeo di Oncologia (IEO), European Institute of Oncology Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Milan, Italy.
Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Front Oncol. 2021 Nov 17;11:778729. doi: 10.3389/fonc.2021.778729. eCollection 2021.
This 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.
Primary 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.
Twenty-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.
The 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.
本研究对一项II期试验的初步结果进行描述性分析，该试验采用一种新型混合束放射治疗（RT）方法，即先进行碳离子放疗（CIRT），然后进行调强光子放疗，并联合激素治疗，用于高危前列腺癌（HR PCa），特别关注急性毒性。
主要终点是评估急性毒性方面的安全性。次要终点是治疗的早期和长期耐受性、生活质量（QoL）和疗效。根据RTOG/EORTC收集急性和晚期毒性数据。通过国际前列腺症状评分（IPSS）、欧洲癌症研究与治疗组织生活质量核心问卷（EORTC QLQ-C30）、欧洲癌症研究与治疗组织前列腺癌特异性问卷（EORTC QLQ-PR25）评估入组患者的生活质量，通过国际勃起功能指数-5（IIEF-5）评估性功能。
26名患者入组本研究，但目前只有15名患者完成了放疗疗程并被纳入分析。在CIRT后即刻，没有患者出现胃肠道/泌尿系统毒性。在整个放疗疗程完成后1个月和3个月时，未观察到大于2级的胃肠道/泌尿系统毒性。生活质量评分总体令人满意。
评估了所提议的混合治疗方案的可行性，并记录了良好的急性毒性特征。这些发现为继续采用这种混合方法、评估长期耐受性和疗效注入了信心。
