Long term update on toxicity and survival of a phase II trial of linac‐based stereotactic body radiation therapy for low‐intermediate risk prostate cancer

Author:

D'Agostino Giuseppe R.1ORCID,Badalamenti Marco1,Stefanini Sara1,Baldaccini Davide1,Franzese Ciro12,Faro Lorenzo Lo1,Di Cristina Luciana1,Vernier Veronica1,Reggiori Giacomo1,Scorsetti Marta12

Affiliation:

1. Department of Radiotherapy and Radiosurgery IRCCS Humanitas Research Hospital Rozzano Milan Italy

2. Department of Biomedical Sciences Humanitas University Pieve Emanuele Milan Italy

Abstract

AbstractBackgroundIn 2016 we published a phase II study exploring safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) delivered with Volumetric Modulated Arc Therapy (VMAT) and Flattening Filter Free (FFF) beams techniques in prostate cancer (PC) patients. We present herein the updated results on late toxicity and long‐term survival.MethodsPatients enrolled in the study had a biopsy‐confirmed localized PC and the features of a low‐ or intermediate‐risk disease (National Comprehensive Network Criteria). The radiotherapy (RT) schedule consisted of 35 Gy delivered in five fractions every other day. Toxicities were registered according to the common toxicity adverse events v4.0. Biochemical recurrence was defined as an increase of prostate specific antigen after nadir, confirmed at least once. Local recurrence (LR) and distant metastases were detected either with Choline‐ or PSMA‐PET/CT scans.Kaplan‐Meier curves for Biochemical Recurrence‐Free Survival (BFS), Local Control (LC), Distant Metastasis Free Survival (DMFS) and Cancer Specific Survival, were calculated by using MedCalc.ResultsNinety patients were submitted to SBRT between February 2012 and March 2015. Fifty‐eight patients (64.5%) had a Gleason Score of 6, while 32 (35.5%) had a Gleason Score of 7. A late grade 1 Genito‐Urinary toxicity was observed in 54.5% of patients while a grade 2 in 3.3%. A late Gastro‐intestinal grade 1 toxicity was reported in 18.9% of patients, while a grade 2 in 2.2%. Erectile dysfunction was reported by 13% of patients No heavier toxicities were observed. At a median follow‐up of 102 months, 5‐ and 8‐year BFS were 93.0% and 84.4% respectively, 5‐ and 8‐year LC were 95.2% and 87.0% respectively, 5‐ and 8‐year DMFS were 95.3% and 88.4%, respectively.ConclusionsThis long‐term update confirms that SBRT is a valid therapeutic strategy for low‐intermediate risk PC. RT with VMAT and FFF warrants optimal results in terms of toxicity and disease control.

Publisher

Wiley

Subject

Urology,Oncology

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