Universität zu Köln

Mohnike, Konrad, Steffen, Ingo G., Seidensticker, Max, Hass, Peter ORCID: 0000-0003-0164-5284, Damm, Robert, Peters, Nils, Seidensticker, Ricarda, Schuette, Kerstin, Arend, Joerg, Bornschein, Jan ORCID: 0000-0001-8673-3122, Streitparth, Tina, Wybranski, Christian, Wieners, Gero, Stuebs, Patrick, Malfertheiner, Peter, Pech, Maciej and Ricke, Jens (2019). Radioablation by Image-Guided (HDR) Brachytherapy and Transarterial Chemoembolization in Hepatocellular Carcinoma: A Randomized Phase II Trial. Cardiovasc. Interv. Radiol., 42 (2). S. 239 - 250. NEW YORK: SPRINGER. ISSN 1432-086X

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Abstract

Background and AimsThe 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.MethodsSeventy-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 of8 points, absence of portal vein thrombosis (PVT) at the affected liver lobe, and4 lesions. Survival was analyzed by using the Cox proportional hazard model with stratification for Barcelona Clinic Liver Cancer (BCLC) stages.ResultsTwenty 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).ConclusionsThis explorative phase II trial showed a superior outcome of iBT compared with cTACE in hepatocellular carcinoma and supports proceeding to a phase III trial.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mohnike, Konrad UNSPECIFIED UNSPECIFIED UNSPECIFIED Steffen, Ingo G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Seidensticker, Max UNSPECIFIED UNSPECIFIED UNSPECIFIED Hass, Peter UNSPECIFIED orcid.org/0000-0003-0164-5284 UNSPECIFIED Damm, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Peters, Nils UNSPECIFIED UNSPECIFIED UNSPECIFIED Seidensticker, Ricarda UNSPECIFIED UNSPECIFIED UNSPECIFIED Schuette, Kerstin UNSPECIFIED UNSPECIFIED UNSPECIFIED Arend, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Bornschein, Jan UNSPECIFIED orcid.org/0000-0001-8673-3122 UNSPECIFIED Streitparth, Tina UNSPECIFIED UNSPECIFIED UNSPECIFIED Wybranski, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Wieners, Gero UNSPECIFIED UNSPECIFIED UNSPECIFIED Stuebs, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED Malfertheiner, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Pech, Maciej UNSPECIFIED UNSPECIFIED UNSPECIFIED Ricke, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-158329
DOI:	10.1007/s00270-018-2127-5
Journal or Publication Title:	Cardiovasc. Interv. Radiol.
Volume:	42
Number:	2
Page Range:	S. 239 - 250
Date:	2019
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1432-086X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DOSE-RATE BRACHYTHERAPY; PROTON-BEAM THERAPY; RADIOFREQUENCY ABLATION; LIVER MALIGNANCIES; INTERSTITIAL BRACHYTHERAPY; RESECTION; COMPLICATIONS; EMBOLIZATION; MANAGEMENT; SURVIVAL Multiple languages Cardiac & Cardiovascular Systems; Radiology, Nuclear Medicine & Medical Imaging Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/15832