Introduction
Patients and Methods
Study Design
Patients
Inclusion criteria |
≥18 years |
HCC, proven by histology or according to EASL criteria |
Intermediate stage HCC (stage B according to BCLC) |
At least one measurable lesion in magnetic resonance imaging (MRI) |
Tumor load ≤50 % |
Preserved liver function (Child Pugh A – B7) |
Exclusion criteria |
Patients feasible for curative treatment (e.g., resection or local ablation) |
Previous TACE or SIRT |
Chemotherapy during the last 4 weeks |
Child Pugh stage C |
BCLC stage C |
ECOG Performance Status >0 |
Tumor involvement >50 % of the liver |
Extrahepatic tumor |
Serum bilirubin >2.0 mg/dl; serum albumin 2.8 g/dl, serum creatinine >2 mg/dl; leukocytes <3,000/ml; thrombocytes <50,000/ml |
Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria) |
Esophageal bleeding during the last 3 months |
Hepatic encephalopathy |
Transjugular intrahepatic portosystemic shunt (TIPS) |
Infiltration or occlusion of the portal vein |
Hepatopulmonary shunt ≥20 % in the macroaggregated albumin (MAA) scan |
Contraindications against angiography |
Gravidity |
Liver MRI
CT Scan
SIRT Procedure
TACE Procedure
Outcome Measures
Statistical Analysis
Results
Patient Characteristics
Patient demographics | SIRT | TACE |
---|---|---|
Patients treated (n) | 12 | 12 |
Male/Female | 8/4 | 10/2 |
Age (years) | 71.8 ± 7.2 (58–82) | 70.5 ± 9.0 (59–87) |
Etiology of liver cirrhosis | ||
(alcohol/HCV/HBV/cryptogen) | 5/5/0/2 | 5/4/1/3* |
Prior curative treatment | ||
Resection/local ablation | 3/4 | 5/1 |
Tumor burden | ||
SLD** (mm) | 61.3 ± 36.4 mm (10–134) | 60.8 ± 37.6 mm (30–163) |
Tumor volume < 25 %/≥ 25 % | 11/1 | 11/1 |
Tumor grading | ||
G1/G2/G3 | 6/6/0 | 6/5/1 |
AFP (ng/ml) | 3308 ± 10204 (6.2–32346***) Median 14.0 | 164 ± 529 (2.7–1847***) Median 7.8 |
Liver function | ||
Child A/B/C | 10/2/0 | 9/3/0 |
BCLC A/B | 0/12 | 1/11 |
Laboratory | ||
Bilirubin (mg/dl) | 1.17 ± 0.54 (0.38–2.10) | 1.26 ± 0.55 (0.59–2.04) |
Albumin (g/l) | 34.08 ± 5.57 (28–43) | 31.92 ± 4.25 (24–39) |
INR | 1.11 ± 0.12 (1–1.4) | 1.13 ± 0.09 (1–1.3) |
Thrombocytes (/nl) | 159.83 ± 53.59 (111–265) | 156.25 ± .85.03 (59–402) |
Leucocytes (/nl) | 5.23 ± 1.60 (2.27–8.28) | 5.49 ± 1.52 (3.96–8.20) |
Treatment strategy | ||
Randomization to treatment (days) | 28.8 ± 13.8 (13–56) | 15.7 ± 5.9 (4–24) |
Treatment session per patient (n) | 1.5 ± 0.5 (1–2) | 3.8 ± 2.6 (1–10 |
Interval between treatment sessions (days) | 33.5 ± 6.8 (27–42) | 48.2 ± 14.0 (19–89) |
Uni-/bilobar approach | 4/8 | 5/7 |
Dose | ||
Total liver dose | 1847 ± 504 MBq (1160–2940) | 259.4 ± 158.4 mg (87.5–648.5) |
Right liver lobe dose | 1216 ± 288 MBq (830–1630) | 205.4 ± 76.5 mg (144.5–359.5) |
Left liver lobe dose | 946 ± 250 MBq (590–1460) | 126.4 ± 68.4 mg (60–289) |
Follow-up (days) | 435 ± 320 (77–1024) | 404 ± 304 (52–950) |
SIRT/TACE procedures and follow-up
Outcome
Outcome measures | SIRT | TACE |
p
|
---|---|---|---|
PFS | 180 (120/414); 266 ± 55 | 216 (88/355); 237 ± 49 |
p = 0.6193 |
OS | 592 (192/–); 437 ± 72 | 788 (178/950); 583 ± 119 |
p = 0.9271 |
TTP | 371 (132/561); 353 ± 69 | 336 (91/609); 315 ± 69 |
p = 0.5764 |
nTTP | 488 (148/925); 490 ± 114 | 647 (182/–); 416 ± 83 |
p = 0.9322 |
Causes of death | SIRT | TACE |
---|---|---|
Tumor progression | 1 | 4 |
Liver failure | 4 | 1 |
Cardiovascular event | 1 | 1 |
Non-conclusive | 1 | 1 |
Suspension from randomized treatment strategy | ||
Access vessel vanishing | 3 (5*) | |
Dissection of access vessel | 1 | |
Arteriovenous fistula due to local tumor progression | 1 | 2 |
Thrombosis of the main portal vein | 1 | |
Local tumor progression | 2 | |
Local tumor progression and ascites | 3 | |
Complications of access vessels | ||
Damage to arterial feeding vessel | 8 | |
Vanishing after 1–5 treatment sessions (median 3.5) | 7 | |
Dissection of access vessel | 1 | |
Tumor treatment beyond randomized treatment | ||
Liver transplantation | 1 | |
Microwave-ablation | 1 | 1 |
DC-Bead-TACE | 3 | |
Radiation of spine metastases/radiation and spondylodesis | 1/1 | 1/0 |
Systemic treatment with Sorafenib | 3 | 5 |
Significant clinical findings | ||
Arterioportal and arteriovenous fistulas by tumor progression | 1 | 2 |
Bone metastases | 2 | 2 |
Lung metastases | 1 | |
Portal vein thrombosis | 2 | 2 |
Liver vein thrombosis | 1 | |
Liver insufficiency | 5 | 2 |
Encephalopathy | 1 | |
Variceal bleeding/bleeding and ligation of esophageal varices | 1/0 | 2/1 |
Angina pectoris and aortocoronary-bypass-graft | 1 | |
False aneurysm of the femoral artery (access site), surgical revision with subsequent renal failure and hemodialysis | 1 |