Abstract | PURPOSE: To compare effectiveness of transarterial ethanol ablation ( TEA) and transcatheter arterial chemoembolization (TACE) for unresectable hepatocellular carcinoma and determine whether TEA leads to better overall survival and tumor response than TACE. MATERIALS AND METHODS: In this institutional review board-approved preregistered randomized controlled trial (n = 200), informed consent was obtained. Primary outcome was overall survival; secondary outcomes were time to progression ( TTP), progression-free survival (PFS), tumor response at computed tomography, and treatment-related toxicity. Eligible patients were randomized at a 1:1 ratio. Treatment included transcatheter delivery of ethiodized oil- ethanol mixture (2:1 ratio by volume up to 60 mL) for TEA and cisplatin- ethiodized oil emulsion (0.5 mg cisplatin per milliliter up to 30 mg), followed by 1-mm gelatin-sponge pellets, for TACE. Study was terminated after interim analysis (n = 98); 90 patients were available for analysis. Overall survival, TTP, and PFS were analyzed with Kaplan-Meier method; differences were compared with log-rank test. RESULTS: Study was terminated prematurely after interim analysis, which showed no difference in overall survival; this was unlikely to change with further patient accrual. Median overall survival in TEA and TACE was 24.3 months (95% confidence interval [CI]: 12.8, 32.7) and 20.1 months (95% CI: 9.3, 31.2), respectively (P = .358). Median TTP and PFS for intralesional progression were longer with TEA than TACE ( TTP, 34.6 months [95% CI: 28.2, 41] vs 26.05 months [95% CI: 18.7, 33.3]; PFS, 14.8 months [95% CI: 10.2, 19.5] vs 9.3 months [95% CI: 7.1, 11.5]) (P = .028 and 0.029, respectively). Complete response rate on a tumor basis was persistently and significantly higher with TEA at 3 months (62 of 88 [70%] vs 39 of 76 [51%], P = .012), 6 months (64 of 88 [73%] vs 41 of 76 [54%], P = .012), and 12 months (66 of 88 [75%] vs 45 of 76 [59%], P = .031). CONCLUSION: Although there was no significant difference in overall survival, TEA demonstrated better complete tumor response, longer time to intralesional progression, and longer PFS.
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Authors | Simon Chun Ho Yu, Joyce Wai Yi Hui, Edwin Pun Hui, Stephen Lam Chan, Kit Fai Lee, Frankie Mo, John Wong, Brigette Ma, Paul Lai, Tony Mok, Winnie Yeo |
Journal | Radiology
(Radiology)
Vol. 270
Issue 2
Pg. 607-20
(Feb 2014)
ISSN: 1527-1315 [Electronic] United States |
PMID | 24126369
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
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Copyright | © RSNA, 2013 |
Chemical References |
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Carcinoma, Hepatocellular
(therapy)
- Chemoembolization, Therapeutic
(methods)
- Ethanol
(administration & dosage)
- Ethiodized Oil
(administration & dosage)
- Female
- Humans
- Liver Neoplasms
(therapy)
- Male
- Middle Aged
- Survival Rate
- Treatment Outcome
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