title: Prospective Study of Transcatheter Arterial Chemoembolization (TACE) with Ginsenoside Rg3 versus TACE Alone for the Treatment of Patients with Advanced Hepatocellular Carcinoma.
abstract: Purpose To conduct a single-center, open-label, randomized, controlled trial to compare the effectiveness and safety of (a) ginsenoside Rg3 combined with transcatheter arterial chemoembolization (TACE) and (b) TACE alone in patients with advanced hepatocellular carcinoma (HCC). Materials and Methods This trial was approved by the Fudan University Zhongshan Hospital ethics committee and was registered with the Chinese Clinical Trial Registry (ChiCTR-TRC-11001643). After informed consent was obtained, 228 patients with advanced HCC (Barcelona Clinic Liver Cancer stage C) were randomly assigned to receive an Rg3 capsule and undergo TACE (n = 152; mean age ± standard deviation, 52.4 years ± 11.8; 84.2% men) or undergo TACE alone (n = 76; mean age, 52.4 years ± 10.4; 82.9% men). TACE was performed by using iodized oil with epirubicin and gelatin sponge after oxaliplatin and 5-fluorouracil were infused. The primary end point was overall survival. Secondary end points included time to progression, time to untreatable progression, disease control rate, and safety. Data were compared with the log-rank test, and survival curves were generated with the Kaplan-Meier method. Results Median overall survival was 13.2 months (95% confidence interval [CI]: 11.15, 15.26) in the TACE with Rg3 group and 10.1 months (95% CI: 9.14, 11.06) in the control group (hazard ratio, 0.63 [95% CI: 0.46, 0.85]; P = .002). Median time to progression (4.3 vs 3.2 months, respectively; P = .151) and median time to untreatable progression (8.3 vs 7.3 months, respectively; P = .063) were similar in the two groups. Disease control rate was 69.7% in the TACE with Rg3 group versus 51.3% in the control group (P = .012). Constipation and epistaxis were more frequent in the Rg3 with TACE group (P < .05). Importantly, Rg3 alleviated some TACE-related adverse syndromes and blood anomalies. Conclusion In patients with advanced HCC and adequate liver function, the combination of TACE and ginsenoside Rg3 may prolong overall survival when compared with TACE alone. (©) RSNA, 2016.
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Bo
authors.initials: B
authors.lastname: Zhou
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Zhiping
authors.initials: Z
authors.lastname: Yan
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Rong
authors.initials: R
authors.lastname: Liu
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Peng
authors.initials: P
authors.lastname: Shi
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Sheng
authors.initials: S
authors.lastname: Qian
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Xudong
authors.initials: X
authors.lastname: Qu
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Liang
authors.initials: L
authors.lastname: Zhu
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: From the Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, People's Republic of China (B.Z., Z.Y., R.L., S.Q., X.Q., L.Z., W.Z., J.W.); Center for Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China (P.S.); and Information Management Department, Children's Hospital of Fudan University, Shanghai, People's Republic of China (P.S.).
authors.forename: Jianhua
authors.initials: J
authors.lastname: Wang
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D036145:Ginsenosides / Q000008:administration & dosage*; D006801:Humans; D008113:Liver Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D036145:Ginsenosides; C097367:ginsenoside Rg3