S1109
Clinical – Upper GI
ESTRO 2026
15 fractions: 67.5 Gy (RBE 1.1) (n=20) for peripheral tumours and 58.0 Gy (RBE 1.1) (n=28) for central tumours. The primary endpoint was safety, measured as the proportion with all-cause death or RILD defined as change in CP score ≥ 2 in cirrhotic patients or ALAT ≥ 5 × ULN in non-cirrhotic patients within 4 months from radiotherapy start. The primary analysis set comprised patients receiving ≥ 5 fractions. Adverse events (AEs) were graded per CTCAE v5.0. Results: Among 48 evaluable patients (Group 1 n=22; Group 2 n=26), no deaths were observed within 4 months. RILD (CP score rise ≥ 2) occurred in 3/48 patients (6.3%), all in Group 2 (11.5%). Treatment was generally well tolerated, and all but one patient completed the planned course. A total of 19 grade 3–4 AEs were recorded: 1 in Group 1 and 18 in Group 2, corresponding to 4.5 and 69.2 events per 100 patients, respectively. The most frequent grade 3–4 AEs were nausea (4/48; 8.3%), RILD (3/48; 6.3%), ascites (3/48; 6.3%), and fatigue (2/48; 4.2%); all in Group 2. The remaining 7 events (36.8%) comprised other diagnoses. All grade 3–4 events were confined to 8 patients, of whom 4 experienced multiple related events. Table 2 summarises AEs, including RILD. Follow-up is ongoing; discontinuations to date were predominantly due to progression/recurrence. Conclusion: Preliminary findings indicate a favourable short-term safety profile of proton therapy for HCC, also for patients with large tumours and impaired liver function. Protocol-defined RILD occurred in 3/48 patients (6.3%); all in the higher-risk Group 2. No deaths occurred within 4 months from the start of radiotherapy; long-term follow-up is ongoing.
Fayers, P.M., Aaronson, Bjordal N.K., Groenvold K., Curran M., D., and A. Bottomley. Eortc Qlq-C30 Scoring Manual (3rd Edition). Brussels: European Organisation for Research and Treatment of Cancer, 2021.U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (Ctcae) Version 5.0, 2017.van Hagen, P., M. C. Hulshof, J. J. van Lanschot, E. W. Steyerberg, M. I. van Berge Henegouwen, B. P. Wijnhoven, D. J. Richel, et al. "Preoperative Chemoradiotherapy for Esophageal or Junctional Cancer." [In eng]. N Engl J Med 366, no. 22 (May 31 2012): 2074-84. https://doi.org/10.1056/NEJMoa1112088. Keywords: MR-Linac, online adaptive radiotherapy A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma: Short-Term Safety Data (NCT05203120) Amalie B. Bjørn 1,2 , Gerda E. Villadsen 3 , Elizaveta M. Tabaksblat 4 , Emilie Glavind 3 , Esben S. Worm 4 , Jakob B. Thomsen 1 , Lars P. Larsen 5 , Line B. Stick 1 , Marianne F. Rønjom 6 , Merete Krogh 7 , Mette V. Felter 6 , Per R. Poulsen 1 , Peter Jepsen 3 , Hanna R. Mortensen 1,2 , Britta Weber 1 1 Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark. 2 Department of Clinical Medicin, Faculty of Health Sciences, Aarhus University, Aarhus, Denmark. 3 Department of Gastroenterology and Hepatology, Aarhus University Hospital, Aarhus, Denmark. 4 Department of Oncology, Aarhus University Hospital, Aarhus, Denmark. 5 Department of Radiology, Aarhus University Hospital, Aarhus, Denmark. 6 Department of Oncology, Herlev Gentofte Hospital, Copenhagen, Denmark. 7 Department of Oncology, Odense University Hospital, Odense, Denmark Purpose/Objective: Hepatocellular carcinoma (HCC) often arises in cirrhotic livers, where the risk of radiation-induced liver disease (RILD) limits photon radiotherapy. Proton therapy enables precise dose delivery and reduces hepatic radiotherapy exposure. This study aimed to evaluate the short-term safety of proton therapy in Proffered Paper 3981
patients with HCC. Material/Methods:
A Danish, national, prospective, single-arm phase II study (NCT05203120) enrolled patients with HCC, not suitable for resection or ablation. Patients had a maximum of 3 tumours and a maximum total tumour size of 12 cm. A maximum Child–Pugh (CP) score of 8 was allowed in the study.Patients were allocated to two predefined cohorts: Group 1 (tumour ≤ 5 cm and CP class A), or Group 2 (tumour 5–12 cm and/or CP class B with score ≤ 8). Proton therapy was delivered in
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