Konrad Mohnike1,2,3, Ingo G Steffen4, Max Seidensticker5,6, Peter Hass7, Robert Damm8, Nils Peters9, Ricarda Seidensticker5,6, Kerstin Schütte10, Jörg Arend11, Jan Bornschein12, Tina Streitparth5, Christian Wybranski13, Gero Wieners5, Patrick Stübs14, Peter Malfertheiner15, Maciej Pech8,6, Jens Ricke5,6. 1. Department of Radiology and Nuclear Medicine, University of Magdeburg, Leipziger Str.44, 39120, Magdeburg, Germany. konrad.mohnike@berlin-dtz.de. 2. Diagnostisch Therapeutisches Zentrum am Frankfurter Tor, Berlin, Germany. konrad.mohnike@berlin-dtz.de. 3. Deutsche Akademie für Mikrotherapie e.V., Magdeburg, Germany. konrad.mohnike@berlin-dtz.de. 4. Department of Radiology, Charité, Berlin, Germany. 5. Department of Radiology, Luwig-Maximilians-University Munich, Munich, Germany. 6. Deutsche Akademie für Mikrotherapie e.V., Magdeburg, Germany. 7. Department of Radiotherapy, University of Magdeburg, Magdeburg, Germany. 8. Department of Radiology and Nuclear Medicine, University of Magdeburg, Leipziger Str.44, 39120, Magdeburg, Germany. 9. Diagnostisch Therapeutisches Zentrum am Frankfurter Tor, Berlin, Germany. 10. Nils-Stensen-Hospital, Osnabrueck, Germany. 11. Department of Surgery, University of Magdeburg, Magdeburg, Germany. 12. Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK. 13. Department of Radiology, University Hospital of Cologne, Cologne, Germany. 14. DRK-Hospital Berlin-Koepenick, Berlin, Germany. 15. Department of Gastroenterology, Hepatology and Infectiology, University of Magdeburg, Magdeburg, Germany.
Abstract
BACKGROUND AND AIMS: The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma. METHODS:Seventy-seven patients were treated after randomization to iBT or cTACE, as single or repeated interventions. Crossover was allowed if clinically indicated. The primary endpoint was time to untreatable progression (TTUP). Eligibility criteria included a Child-Pugh score of ≤ 8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and ≤ 4 lesions. Survival was analyzed by using the Cox proportional hazard model with stratification for Barcelona Clinic Liver Cancer (BCLC) stages. RESULTS:Twenty patients were classified as BCLC-A (iBT/cTACE 8/12), 35 as BCLC-B (16/19), and 22 as BCLC-C (13/9). The 1-, 2-, and 3-year TTUP probabilities for iBT compared with cTACE were 67.5% versus 55.2%, 56.0% versus 27.4%, and 29.5% versus 11.0%, respectively, with an adjusted hazard ratio (HR) of 0.49 (95% confidence interval 0.27-0.89; p = 0.019). The 1-, 2-, and 3-year TTPs for iBT versus cTACE were 56.0% versus 28.2%, 23.9% versus 6.3%, and 15.9% versus 6.3%, respectively, with an adjusted HR of 0.49 (0.29-0.85; p = 0.011). The 1-, 2-, and 3-year OS rates were 78.4% versus 67.7%, 62.0% versus 47.3%, and 36.7% versus 27.0%, respectively, with an adjusted HR of 0.62 (0.33-1.16; p = 0.136). CONCLUSIONS: This explorative phase II trial showed a superior outcome of iBT compared with cTACE in hepatocellular carcinoma and supports proceeding to a phase III trial.
RCT Entities:
BACKGROUND AND AIMS: The aim of this single-center, open-label phase II study was to assess the efficacy of image-guided high-dose-rate (HDR) brachytherapy (iBT) compared with conventional transarterial embolization (cTACE) in unresectable hepatocellular carcinoma. METHODS: Seventy-seven patients were treated after randomization to iBT or cTACE, as single or repeated interventions. Crossover was allowed if clinically indicated. The primary endpoint was time to untreatable progression (TTUP). Eligibility criteria included a Child-Pugh score of ≤ 8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and ≤ 4 lesions. Survival was analyzed by using the Cox proportional hazard model with stratification for Barcelona Clinic Liver Cancer (BCLC) stages. RESULTS: Twenty patients were classified as BCLC-A (iBT/cTACE 8/12), 35 as BCLC-B (16/19), and 22 as BCLC-C (13/9). The 1-, 2-, and 3-year TTUP probabilities for iBT compared with cTACE were 67.5% versus 55.2%, 56.0% versus 27.4%, and 29.5% versus 11.0%, respectively, with an adjusted hazard ratio (HR) of 0.49 (95% confidence interval 0.27-0.89; p = 0.019). The 1-, 2-, and 3-year TTPs for iBT versus cTACE were 56.0% versus 28.2%, 23.9% versus 6.3%, and 15.9% versus 6.3%, respectively, with an adjusted HR of 0.49 (0.29-0.85; p = 0.011). The 1-, 2-, and 3-year OS rates were 78.4% versus 67.7%, 62.0% versus 47.3%, and 36.7% versus 27.0%, respectively, with an adjusted HR of 0.62 (0.33-1.16; p = 0.136). CONCLUSIONS: This explorative phase II trial showed a superior outcome of iBT compared with cTACE in hepatocellular carcinoma and supports proceeding to a phase III trial.
Authors: Max Seidensticker; Matthias Philipp Fabritius; Jannik Beller; Ricarda Seidensticker; Andrei Todica; Harun Ilhan; Maciej Pech; Constanze Heinze; Maciej Powerski; Robert Damm; Alexander Weiss; Johannes Rueckel; Jazan Omari; Holger Amthauer; Jens Ricke Journal: Cancers (Basel) Date: 2021-04-21 Impact factor: 6.639