Randomized comparison of selective internal radiotherapy (SIRT) versus drug-eluting bead transarterial chemoembolization (DEB-TACE) for the treatment of hepatocellular carcinoma.
OBJECTIVE
To prospectively compare SIRT and DEB-TACE for treating hepatocellular carcinoma (HCC).


METHODS
From 04/2010-07/2012, 24 patients with histologically proven unresectable N0, M0 HCCs were randomized 1:1 to receive SIRT or DEB-TACE. SIRT could be repeated once in case of recurrence; while, TACE was repeated every 6 weeks until no viable tumor tissue was detected by MRI or contraindications prohibited further treatment. Patients were followed-up by MRI every 3 months; the final evaluation was 05/2013.


RESULTS
Both groups were comparable in demographics (SIRT: 8males/4females, mean age 72 ± 7 years; TACE: 10males/2females, mean age 71 ± 9 years), initial tumor load (1 patient ≥25 % in each group), and BCLC (Barcelona Clinic Liver Cancer) stage (SIRT: 12×B; TACE 1×A, 11×B). Median progression-free survival (PFS) was 180 days for SIRT versus 216 days for TACE patients (p = 0.6193) with a median TTP of 371 days versus 336 days, respectively (p = 0.5764). Median OS was 592 days for SIRT versus 788 days for TACE patients (p = 0.9271). Seven patients died in each group. Causes of death were liver failure (n = 4 SIRT group), tumor progression (n = 4 TACE group), cardiovascular events, and inconclusive (n = 1 in each group).


CONCLUSIONS
No significant differences were found in median PFS, OS, and TTP. The lower rate of tumor progression in the SIRT group was nullified by a greater incidence of liver failure. This pilot study is the first prospective randomized trial comparing SIRT and TACE for treating HCC, and results can be used for sample size calculations of future studies.
Department of Diagnostic and Interventional Radiology, Johannes Gutenberg University Medical Center, Langenbeckstr. 1, 55131, Mainz, Germany, michael.pitton@unimedizin-mainz.de.
Michael B
MB
Pitton
Roman
R
Kloeckner
Christian
C
Ruckes
Gesine M
GM
Wirth
Waltraud
W
Eichhorn
Marcus A
MA
Wörns
Arndt
A
Weinmann
Mathias
M
Schreckenberger
Peter R
PR
Galle
Gerd
G
Otto
Christoph
C
Dueber
D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000379:methods*; D006528:Carcinoma, Hepatocellular / Q000532:radiotherapy / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D004337:Drug Carriers / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome
D004337:Drug Carriers