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- W3011520265 abstract "e14528 Background: Transarterial injection of LEM produces long-lasting embolization of both arteriolar feeders and peribiliary plexus of HCC leading to infarction of tumor. Our group previously reported the efficacy and safety of LEM for HCC in a phase II clinical trial (Yu et al. J Vasc Interv Radiol. 2008). We initiated a randomized study to compare LEM vs. TACE in HCC. (NCT00467974). Methods: Major eligibility criteria: histologically confirmed HCC; unresectable disease without distant metastases; size ≤15cm; absence of portal vein thrombosis. Consented patients (Pts) were randomized into LEM vs. TACE stratified by tumor size and number. Pts were prospectively followed up and assessed with computed tomography (CT) every 8 weeks. The primary endpoint is overall survival (OS) and secondary endpoints include progression free survival (PFS), RECIST response rate (RR) and toxicity. An interim analysis is planned after recruitment of 70 pts. Results: From 07 to 10, total 70 pts were enrolled. 2 pts withdrew consent and were excluded from the analysis. There were no differences in baseline characteristics between LEM and TACE. Male:Female=53:15; Mean Age=64; Tumor size≤7: >7cm=45:23; Child A:B=55:13. The median follow-up was 2.3 years. The OS of LEM was 25.32 months(m) vs. TACE 22.56m (p=0.38). PFS of LEM was 9.00m vs. TACE 7.8m (p=0.50). Partial response of LEM vs. TACE was 30% vs. 18% (p=0.52); disease control rate of LEM vs. TACE was 80% vs. 70% (p=0.39). Commonest G3 or above toxicities include ALT elevation (LEM 22.2% vs. TACE 9.4%); hyperbilirubinemia (LEM 19.4% vs. 9.4%); pain (LEM 0% vs. TACE 4%). Except pain, there were no differences of toxicities between LEM and TACE after procedure (p=0.04). Conclusions: At interim analysis, LEM showed comparable efficacy and toxicity profile to TACE. A trend of better OS, PFS and RR was observed in LEM arm but statistically insignificant. Further accrual and follow-up is ongoing." @default.
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- W3011520265 date "2012-05-20" @default.
- W3011520265 modified "2023-09-27" @default.
- W3011520265 title "A randomized study on lipiodal ethanol mixture (LEM) versus transarterial chemoembolization (TACE) for treatment of hepatocellular carcinoma (HCC): Report of a preplanned interim analysis." @default.
- W3011520265 doi "https://doi.org/10.1200/jco.2012.30.15_suppl.e14528" @default.
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