PMID- 30042075 OWN - NLM STAT- MEDLINE DCOM- 20181114 LR - 20181114 IS - 1535-7732 (Electronic) IS - 1051-0443 (Linking) VI - 29 IP - 8 DP - 2018 Aug TI - Comparison of Stable and Unstable Ethiodized Oil Emulsions for Transarterial Chemoembolization of Hepatocellular Carcinoma: Results of a Single-Center Double-Blind Prospective Randomized Controlled Trial. PG - 1068-1077.e2 LID - S1051-0443(18)31083-2 [pii] LID - 10.1016/j.jvir.2018.03.027 [doi] AB - PURPOSE: To compare the stability of stable and unstable water-in-oil emulsions and the efficacy and safety of these emulsions in a single-center, prospective double-blind trial of transarterial chemoembolization for hepatocellular carcinoma (HCC). MATERIALS AND METHODS: A total of 812 patients with inoperable HCC were randomized (stable emulsion, n = 402; unstable emulsion, n = 410). The 2 emulsions were prepared by using the same protocol except that different solvents were used for chemotherapy agents, including epirubicin, lobaplatin, and mitomycin C. The solvent in the stable emulsion arm was contrast medium and distilled water, and the solvent in the unstable emulsion arm was distilled water. The primary endpoint was overall survival (OS), and secondary endpoints were time to progression (TTP), tumor response, adverse events (AEs), and plasma epirubicin concentrations. RESULTS: In vitro, stable emulsions did not occur until 1 day, and unstable emulsions, with a lower peak plasma concentration (P = .001) in vivo, exhibited rapid separation of the oil and aqueous phases after 10 minutes. Median OS times in the stable and unstable emulsion arms were 17.7 and 19.2 months, respectively (P = .81). No differences were found in TTP, tumor response, and AEs except for myelosuppression (anemia, 3.5% vs 7.6%; thrombocytopenia, 11.5% vs 17.7%), which was significantly more severe and frequent in the unstable emulsion arm (P = .013). CONCLUSIONS: Chemoembolization is equally effective with the use of stable and unstable emulsions, but the use of a stable emulsion has the advantage of less myelosuppression and a favorable pharmacokinetic profile. CI - Copyright (c) 2018 SIR. Published by Elsevier Inc. All rights reserved. FAU - He, Min-Ke AU - He MK AD - Department of Hepatobiliary Oncology, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. FAU - Zou, Ru-Hai AU - Zou RH AD - Department of Ultrasonography, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. FAU - Wei, Wei AU - Wei W AD - Department of Hepatobiliary Oncology, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. FAU - Shen, Jing-Xian AU - Shen JX AD - Department of Radiology, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. FAU - Zhao, Ming AU - Zhao M AD - Minimally Invasive Interventional Division, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. FAU - Zhang, Yong-Fa AU - Zhang YF AD - Department of Liver Surgery, Fudan University Shanghai Cancer Center, Shanghai, P.R. China. FAU - Lin, Xiao-Jun AU - Lin XJ AD - Department of Hepatobiliary Oncology, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. FAU - Zhang, Yao-Jun AU - Zhang YJ AD - Department of Hepatobiliary Oncology, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. FAU - Guo, Rong-Ping AU - Guo RP AD - Department of Hepatobiliary Oncology, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. FAU - Shi, Ming AU - Shi M AD - Department of Hepatobiliary Oncology, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou 510060, P.R. China. Electronic address: shiming@sysu.edu.cn. LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20180702 PL - United States TA - J Vasc Interv Radiol JT - Journal of vascular and interventional radiology : JVIR JID - 9203369 RN - 0 (Antineoplastic Agents) RN - 0 (Emulsions) RN - 8008-53-5 (Ethiodized Oil) SB - IM MH - Antineoplastic Agents/*administration & dosage/adverse effects MH - Carcinoma, Hepatocellular/mortality/pathology/*therapy MH - Chemoembolization, Therapeutic/adverse effects/*methods/mortality MH - China MH - Double-Blind Method MH - Drug Stability MH - Emulsions MH - Ethiodized Oil/*administration & dosage/adverse effects/pharmacokinetics MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Liver Neoplasms/mortality/pathology/*therapy MH - Male MH - Middle Aged MH - Proportional Hazards Models MH - Prospective Studies MH - Risk Factors MH - Time Factors MH - Treatment Outcome EDAT- 2018/07/26 06:00 MHDA- 2018/11/15 06:00 CRDT- 2018/07/26 06:00 PHST- 2017/10/03 00:00 [received] PHST- 2018/03/21 00:00 [revised] PHST- 2018/03/23 00:00 [accepted] PHST- 2018/07/26 06:00 [pubmed] PHST- 2018/11/15 06:00 [medline] PHST- 2018/07/26 06:00 [entrez] AID - S1051-0443(18)31083-2 [pii] AID - 10.1016/j.jvir.2018.03.027 [doi] PST - ppublish SO - J Vasc Interv Radiol. 2018 Aug;29(8):1068-1077.e2. doi: 10.1016/j.jvir.2018.03.027. Epub 2018 Jul 2.