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Tytuł:
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Arterial chemoembolisation with cisplatin versus epirubicin for hepatocellular carcinoma (ACE 500 study): A multicentre, randomised controlled phase 2/3 trial.
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Autorzy:
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Aramaki O; Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
Takayama T; Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan. Electronic address: .
Moriguchi M; Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
Sakamoto H; Center for Digestive and Liver Diseases, Miyazaki Medical Center Hospital, Miyazaki, Japan.
Yodono H; Department of Radiology, Narumi Hospital, Hirosaki, Japan.
Kokudo N; Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, University of Tokyo, Tokyo, Japan.
Yamanaka N; Department of Surgery, Meiwa Hospital, Hyogo, Japan.
Kawasaki S; Department of Hepato-Biliary-Pancreatic Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Sasaki Y; Department of Surgery, Yao Municipal Hospital, Osaka, Japan.
Kubota K; Second Department of Surgery, Dokkyo Medical University, Tochigi, Japan.
Otsuji E; Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Tanaka S; Department of Hepato-Biliary-Pancreatic Surgery, Tokyo Medical and Dental University, Tokyo, Japan.
Matsuyama Y; Department of Biostatistics, University of Tokyo, Tokyo, Japan.
Fujii M; Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
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Corporate Authors:
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ACE 500 study group
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Źródło:
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European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2021 Nov; Vol. 157, pp. 373-382. Date of Electronic Publication: 2021 Sep 23.
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Typ publikacji:
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Clinical Trial, Phase II; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: Oxford : Elsevier Science Ltd
Original Publication: Oxford ; New York : Pergamon Press, c1990-
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MeSH Terms:
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Carcinoma, Hepatocellular/*therapy
Chemoembolization, Therapeutic/*methods
Cisplatin/*administration & dosage
Epirubicin/*administration & dosage
Liver Neoplasms/*therapy
Aged ; Carcinoma, Hepatocellular/blood supply ; Carcinoma, Hepatocellular/mortality ; Chemoembolization, Therapeutic/adverse effects ; Cisplatin/adverse effects ; Epirubicin/adverse effects ; Female ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Liver/blood supply ; Liver/pathology ; Liver Neoplasms/blood supply ; Male ; Middle Aged ; Survival Rate ; Treatment Outcome
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Contributed Indexing:
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Keywords: Cisplatin; Epirubicin; Hepatocellular carcinoma; Transarterial chemoembolisation; Unresectable hepatocellular carcinoma
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Molecular Sequence:
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UMIN-CTR UMIN000001384
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Substance Nomenclature:
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3Z8479ZZ5X (Epirubicin)
Q20Q21Q62J (Cisplatin)
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Entry Date(s):
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Date Created: 20210926 Date Completed: 20211206 Latest Revision: 20211214
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Update Code:
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20240105
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DOI:
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10.1016/j.ejca.2021.08.027
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PMID:
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34563992
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Background: Transarterial chemoembolisation (TACE) is a treatment option for hepatocellular carcinoma (HCC), but the optimum agent for TACE remains unclear. We compared the efficacy of TACE with cisplatin versus with epirubicin in patients with unresectable HCC.
Methods: This multicentre, randomised, phase 2/3 trial was performed at 21 hospitals in Japan. Patients with liver-confined HCC, performance status 0-2, and Child-Pugh class A/B were randomised to receive TACE with cisplatin or epirubicin. Patients were stratified in accordance with the institution, Child-Pugh class, tumour size, tumour thrombosis, α-fetoprotein and prior treatment. The primary end-point was overall survival in the intention-to-treat population. Tumour response was evaluated in accordance with the Response evaluation criteria in solid tumours criteria.
Findings: Between 2008 and 2012, 455 patients were randomly assigned to undergo TACE with cisplatin (n = 228) or epirubicin (n = 227). Eleven patients were ineligible, and 444 patients were included in the full analysis. Twelve patients not receiving TACE were excluded, and 432 patients were included in the safety analysis set. In phase 2, disease control rates in cisplatin (91·7%) and epirubicin (91·8%) groups exceeded the predefined threshold of 70%, and the study proceeded to phase 3. After a median follow-up of 32·7 months (IQR = 15·3-49·3), median overall survival periods were 2·93 years (95% CI 2·60-3·79) and 2·74 years (95%CI 2·26-3·21), respectively (hazard ratio 0·90 [95% CI 0·71-1·15], p = 0·22). Median times to treatment failure were 1·38 and 1·46 years (hazard ratio 1·09 [95% CI 0·88-1·35], p = 0·88), response rates were 65·3% and 60·6% (p = 0·31), and serious adverse event rates were 49·8% and 48·3% (p = 0·56), respectively. No treatment-related deaths occurred in either group.
Interpretation: In our phase 2/3 randomised trial, cisplatin is not significantly superior to epirubicin in TACE for patients with HCC.
Competing Interests: Conflict of interest statement This study was supported by research grants from the Waksman Foundation of Japan, Inc., with funding from Nippon Kayaku Co. Ltd., Tokyo, Japan. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Eigo Otsuji received funding from Taiho Pharmaceutical Co., Ltd., Japan, Takeda Pharmaceutical Co., Ltd., Japan, and SBI Pharmaceuticals Co., Ltd, Japan.The authors other than E. O received no specific funding for this work.
(Copyright © 2021. Published by Elsevier Ltd.)
