Journal Article

DKFZ-2024-00972

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Carbon ion radiotherapy of hepatocellular carcinoma provides excellent local control: The prospective phase I PROMETHEUS trial

Hoegen-Saßmannshausen, P. (First author)DKFZ* ; Naumann, P. ; Hoffmeister-Wittmann, P. ; Ben Harrabi, S. ; Seidensaal, K. ; Weykamp, F.DKFZ* ; Mielke, T. ; Ellerbrock, M. ; Habermehl, D. ; Springfeld, C. ; Dill, M.DKFZ* ; Longerich, T. ; Schirmacher, P. ; Mehrabi, A. ; Chang, D.-H. ; Hörner-Rieber, J.DKFZ* ; Jäkel, O.DKFZ* ; Haberer, T. ; Combs, S. E.DKFZ* ; Debus, J.DKFZ* ; Herfarth, K. ; Liermann, J.

2024
Elsevier Amsterdam

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Please use a persistent id in citations: doi:10.1016/j.jhepr.2024.101063

Abstract: Background & Aims:Inoperable hepatocellular carcinoma (HCC) can be treated by stereotactic body radiotherapy. However, carbon ion radiotherapy (CIRT) is more effective for sparing non-tumorous liver. High linear energy transfer could promote therapy efficacy. Japanese and Chinese studies on hypofractionated CIRT have yielded excellent results. Because of different radiobiological models and the different etiological spectrum of HCC, applicability of these results to European cohorts and centers remains questionable. The aim of this prospective study was to assess safety and efficacy and to determine the optimal dose of CIRT with active raster scanning based on the local effect model (LEM) I.Methods:CIRT was performed every other day in four fractions with relative biological effectiveness (RBE)-weighted fraction doses of 8.1–10.5 Gy (total doses 32.4–42.0 Gy [RBE]). Dose escalation was performed in five dose levels with at least three patients each. The primary endpoint was acute toxicity after 4 weeks.Results:Twenty patients received CIRT (median age 74.7 years, n = 16 with liver cirrhosis, Child-Pugh scores [CP] A5 [n = 10], A6 [n = 4], B8 [n = 1], and B9 [n = 1]). Median follow up was 23 months. No dose-limiting toxicities and no toxicities exceeding grade II occurred, except one grade III gamma-glutamyltransferase elevation 12 months after CIRT, synchronous to out-of-field hepatic progression. During 12 months after CIRT, no CP elevation occurred. The highest dose level could be applied safely. No local recurrence developed during follow up. The objective response rate was 80%. Median overall survival was 30.8 months (1/2/3 years: 75%/64%/22%). Median progression-free survival was 20.9 months (1/2/3 years: 59%/43%/43%). Intrahepatic progression outside of the CIRT target volume was the most frequent pattern of progression.Conclusions:CIRT of HCC yields excellent local control without dose-limiting toxicity.

Note: #EA:E050#

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Contributing Institute(s):

1. E050 KKE Strahlentherapie (E050)
2. NWG Experimentelle Hepatologie, Entzündung und Krebs (D500)
3. NWG Experimentelle Hepatologie, Entzündung und Krebs (F240)
4. E040 Med. Physik in der Strahlentherapie (E040)
5. DKTK HD zentral (HD01)
6. DKTK Koordinierungsstelle München (MU01)

Research Program(s):

1. 315 - Bildgebung und Radioonkologie (POF4-315) (POF4-315)

Appears in the scientific report 2024

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