S472
Clinical - Gynaecological
ESTRO 2026
supporting the value of PRO data for RT optimization and patient-centered dose guidance. References: 1. Charnalia S, Spampinato S, Pötter R, et al. Risk factors for acute gastrointestinal (GI) toxicity during EBRT and concurrent chemotherapy in LACC. Radiot and Oncol. Vol 206 Suppl 1 (2025). p. 864 -8652. Available online: https://healthcaredelivery.cancer.gov/pro- ctcae/instruments/pro-ctcae/pro- ctcae_spanish.pdf Keywords: Patient Reported Outcomes, Cervix Cancer Digital Poster Highlight 3438 Five-Year Results of a Prospective Clinical Trial of Adjuvant Vaginal Cuff SBRT in Endometrial Cancer: an Effective Brachytherapy proxy (NCT06394258) Maria Inês Antunes 1 , Filipa Ferreira 2 , Sandra Vieira 1 , Ana Soares 1 , Carlo Greco 1 1 Radiotherapy Department, Champalimaud Foundation, Lisbon, Portugal. 2 Clinical Trials Unit, Champalimaud Foundation, Lisbon, Portugal Purpose/Objective: To evaluate the feasibility, reproducibility, safety, local control, toxicity profile and quality of life (QoL) of stereotactic body radiotherapy (SBRT) to the vaginal cuff (VC- SBRT) as adjuvant treatment for endometrial carcinoma (EC), with the aim to reproduce high-dose-rate brachytherapy (HDR-VBT) dose distributions. Material/Methods: A cohort of 40 surgically staged EC patients (FIGO 2009 stage I–III; ECOG 0–2) were treated between February 2018 and November 2020 in an IRB-approved phase I-II study (NCT 06394258).Group 1 (n = 25): VC- SBRT alone (15 Gy/3 fractions).Group 2 (n = 15): pelvic EBRT (46 Gy/23 fractions) plus VC- SBRT boost (10 Gy/2 fractions).Target
delineation complied with GEC-ESTRO/ICRU 89 guidelines. The PTV was obtained with a 3 mm isotropic margin expansion from the CTV. Daily CBCT and intra-fraction monitoring with vaginal cylinder, rectal balloon, and bladder catheter ensured sub-millimetric anatomical reproducibility.
Primary endpoints: feasibility of HDR-VBT- like dose distributions, online intra/inter- fraction motion management, and treatment- related adverse events (TRAEs, CTCAE v3.0).Secondary endpoints: local control (LC), disease-free survival (DFS), overall survival (OS), and patient-reported outcomes (EORTC QLQ-C30/EN24, HADS). Median follow-up: 67.4 months. Results: Local control: No vaginal/pelvic relapses were observed in both groups; no VC relapses.Survival: 5-year OS 82.5% overall (100% and 73.3% in group 1 and 2, respectively); Group 2 had3 deaths due to disease progression and 1 from unrelated causes.Distant progression: 7 patients (17.5%) developed distant metastases (mostly pulmonary) predominantly in higher-risk Group 2.Toxicity profile: 72.5% experienced grade 1–2 acute TRAEs (mainly dysuria, urinary urgency); no grade ≥ 3 events; all AE resolved within 6–24 months. QoL: analysis of the EORTC QLQ-C30 questionnaire responses showed patient satisfaction across most quality-of-life domains. However, the results from the EORTC QLQ-C24 indicated modifications of the sexual function domain. HADS scores for anxiety/depression consistently decreased over time. Dosimetry: all OAR constraints (EQD2: bladder ≤ 90 Gy; rectum/sigmoid ≤ 75 Gy)
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