Transarterial chemoembolization of unresectable hepatocellular carcinoma with drug eluting beads: results of an open-label study of 62 patients.
The purpose of this study was to assess the safety and efficacy of doxorubicin-loaded beads (DC Beads) delivered by transarterial embolization for the treatment of unresectable hepatocellular carcinoma (HCC). This open-label, single-center, single-arm study included 62 cirrhotic patients with documented single unresectable HCC. Mean tumor diameter was 5.6 cm (range, 3-9 cm) classified as Okuda stages 1 (n = 53) and 2 (n = 9). Patients received repeat embolizations with doxorubicin-loaded beads every 3 months (maximum of three). The maximum doxorubicin dose was 150 mg per embolization, loaded in DC Beads of 100-300 or 300-500 microm. Regarding efficacy, overall, an objective response according to the European Association for the Study of the Liver criteria was observed in 59.6%, 81.8%, and 70.8% across three treatments. A complete response was observed in 4.8% after the first procedure and 3.6% and 8.3% after the second and third procedures, respectively. At 9 months a complete response was seen in 12.2%, an objective response in 80.7%, progressive disease in 6.8%, and 12.2% showed stable disease. Mean tumor necrosis ranged from 77.4% to 83.9% (range, 28.6%-100%) across three treatments. alpha-Fetoprotein levels showed a mean decrease of 1123 ng/ml (95% CI = 846-1399; p = 3 x 10(-11)) after the first session and remained stable after the second and third embolizations (42 and 70 ng/ml decrease, respectively). Regarding safety, bilirubin, gamma-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase showed only transient increases during the study period. Severe procedure-related complications were seen in 3.2% (cholecystitis, n = 1; liver abscess, n = 1). Postembolization syndrome was observed in all patients. We conclude that hemoembolization using doxorubicin-loaded DC Beads is a safe and effective treatment of HCC as demonstrated by the low complication rate, increased tumor response, and sustained reduction of alpha-fetoprotein levels.
Malagari
Katerina
K
Second Department of Radiology, University of Athens, 1 Rimini Str., Haidari, 12462, Athens, Greece. kmalag@acn.gr
Chatzimichael
Katerina
K
Alexopoulou
Efthymia
E
Kelekis
Alexios
A
Hall
Brenda
B
Dourakis
Spyridon
S
Delis
Spyridon
S
Gouliamos
Athanasios
A
Kelekis
Dimitrios
D
D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D003287:Contrast Media; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007479:Iopamidol; D008113:Liver Neoplasms / Q000628:therapy*; D053783:Magnetic Resonance Imaging, Interventional; D008297:Male; D008863:Microspheres; D010743:Phospholipids; D015641:Radiography, Interventional; D013459:Sulfur Hexafluoride; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D003287:Contrast Media; D010743:Phospholipids; C420843:contrast agent BR1; D004317:Doxorubicin; D007479:Iopamidol; D013459:Sulfur Hexafluoride