Prospective randomized comparison of chemoembolization with doxorubicin-eluting beads and bland embolization with BeadBlock for hepatocellular carcinoma.
The purpose of this study was to evaluate the added role of a chemotherapeutic in transarterial chemoembolization (TACE) of intermediate-stage hepatocellular carcinoma (HCC). The issue is of major importance since, as suggested by recent evidence, hypoxia or incomplete devascularization of the tumor is a potent stimulator of angiogenesis, and there are not many papers supplying level one evidence confirming the value of a chemotherapeutic. The hypothesis was that since drug-eluting bead (DEB)-TACE is standardized and reproducible, a comparison with bland TACE can readily reveal the potential value of the chemotherapeutic. Two groups were randomized in this prospective study: group A (n = 41) was treated with doxorubicin DEB-TACE, and group B (n = 43) with bland embolization. Patients were randomized for tumor diameter. Patients were embolized at set time intervals (2 months), with a maximum of three embolizations. Tumor response was evaluated using the EASL criteria and alpha-fetoprotein levels. At 6 months a complete response was seen in 11 patients (26.8%) in the DEB-TACE group and in 6 patients (14%) in the bland embolization group; a partial response was achieved in 19 patients (46.3%) and 18 (41.9%) patients in the DEB-TACE and bland embolization groups, respectively. Recurrences at 9 and 12 months were higher for bland embolization (78.3% vs. 45.7%) at 12 months. Time to progression (TTP) was longer for the DEB-TACE group (42.4 +/- 9.5 and 36.2 +/- 9.0 weeks), at a statistically significant level (p = 0.008). In conclusion, DEB-TACE presents a better local response, fewer recurrences, and a longer TTP than bland embolization with BeadBlock. However, survival benefit and bland embolization with smaller particles must be addressed in future papers to better assess the clinical value.
Malagari
Katerina
K
Imaging and Research Unit, Second Department of Radiology, Evgenidion Hospital, University of Athens, Athens, Greece. kmalag@otenet.gr
Pomoni
Mary
M
Kelekis
Alexis
A
Pomoni
Anastasia
A
Dourakis
Spyros
S
Spyridopoulos
Themis
T
Moschouris
Hippokratis
H
Emmanouil
Emmanouil
E
Rizos
Spyros
S
Kelekis
Dimitrios
D
D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D016009:Chi-Square Distribution; D003287:Contrast Media; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007479:Iopamidol; D008113:Liver Neoplasms / Q000473:pathology / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D008297:Male; D008863:Microspheres; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D003287:Contrast Media; D004317:Doxorubicin; D007479:Iopamidol