TY  - JOUR
A1  - Vogl, Thomas J.
A1  - Langenbach, Marcel Christian
A1  - Hammerstingl, Renate Maria
A1  - Albrecht, Moritz Hans Ernst
A1  - Chatterjee, Arindam R
A1  - Gruber-Rouh, Tatjana
T1  - Evaluation of two different transarterial chemoembolization protocols using Lipiodol and degradable starch microspheres in therapy of hepatocellular carcinoma: a prospective trial
T2  - Hepatology international
N2  - Background: This prospective randomized trial is designed to compare the performance of conventional transarterial chemoembolization (cTACE) using Lipiodol-only with additional use of degradable starch microspheres (DSM) for hepatocellular carcinoma (HCC) in BCLC-stage-B based on metric tumor response. Methods: Sixty-one patients (44 men; 17 women; range 44–85) with HCC were evaluated in this IRB-approved HIPPA compliant study. The treatment protocol included three TACE-sessions in 4-week intervals, in all cases with Mitomycin C as a chemotherapeutic agent. Multiparametric magnetic resonance imaging (MRI) was performed prior to the first and 4 weeks after the last TACE. Two treatment groups were determined using a randomization sheet: In 30 patients, TACE was performed using Lipiodol only (group 1). In 31 cases Lipiodol was combined with DSMs (group 2). Response according to tumor volume, diameter, mRECIST criteria, and the development of necrotic areas were analyzed and compared using the Mann–Whitney-U, Kruskal–Wallis-H-test, and Spearman-Rho. Survival data were analyzed using the Kaplan–Meier estimator. Results: A mean overall tumor volume reduction of 21.45% (± 62.34%) was observed with an average tumor volume reduction of 19.95% in group 1 vs. 22.95% in group 2 (p = 0.653). Mean diameter reduction was measured with 6.26% (± 34.75%), for group 1 with 11.86% vs. 4.06% in group 2 (p = 0.678). Regarding mRECIST criteria, group 1 versus group 2 showed complete response in 0 versus 3 cases, partial response in 2 versus 7 cases, stable disease in 21 versus 17 cases, and progressive disease in 3 versus 1 cases (p = 0.010). Estimated overall survival was in mean 33.4 months (95% CI 25.5–41.4) for cTACE with Lipiosol plus DSM, and 32.5 months (95% CI 26.6–38.4), for cTACE with Lipiodol-only (p = 0.844), respectively. Conclusions: The additional application of DSM during cTACE showed a significant benefit in tumor response according to mRECIST compared to cTACE with Lipiodol-only. No benefit in survival time was observed.
KW  - Hepatocellular carcinoma
KW  - TACE
KW  - Lipiodol
KW  - DSM
KW  - Mitomycin C
KW  - Magnetic resonance imaging
KW  - Response
KW  - Survival
KW  - Tumor volume
KW  - Necrotic area
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/63638
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-636381
SN  - 1936-0541
N1  - Open Access funding enabled and organized by Projekt DEAL. The study was supported by PharmaCept GmbH, Berlin, Germany.
VL  - 15.2021
IS  - 3
SP  - 685
EP  - 694
PB  - Springer
CY  - New York, NY ; Berlin ; Heidelberg
ER  -