PMID- 28766016 OWN - NLM STAT- MEDLINE DCOM- 20190306 LR - 20240318 IS - 1435-5922 (Electronic) IS - 0944-1174 (Print) IS - 0944-1174 (Linking) VI - 53 IP - 2 DP - 2018 Feb TI - Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial. PG - 281-290 LID - 10.1007/s00535-017-1374-6 [doi] AB - BACKGROUND: This prospective study investigated the superiority of transarterial chemoembolization (TACE) with miriplatin over TACE with epirubicin regarding overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC). METHODS: Patients with unresectable HCC were randomized 1:1 to receive TACE with miriplatin or epirubicin in lipiodol. The primary endpoint was OS; secondary endpoints were percentages of patients who achieved treatment effect (TE) 4 (100% necrotizing effect or tumor reduction), duration of time to TACE failure, and adverse events (AEs). OS was compared using a stratified log-rank test adjusted for clinical stage, Child-Pugh class, and institution. RESULTS: Of 257 patients enrolled from August 2008 to August 2010, 247 were analyzed for efficacy and toxicity (miriplatin, n = 124; epirubicin, n = 123). Baseline characteristics were well balanced between the two groups. Median OS times were 1111 days for miriplatin and 1127 days for epirubicin (adjusted hazard ratio 1.01, 95% confidence interval 0.73-1.40, P = 0.946). TE4 rates were 44.4% for miriplatin and 37.4% for epirubicin. Median times to TACE failure were 365.5 days for miriplatin and 414.0 days for epirubicin. AEs of grade 3 or higher, including elevated aspartate aminotransferase (miriplatin, 39.5%; epirubicin, 57.7%) and elevated alanine aminotransferase (miriplatin, 31.5%; epirubicin, 53.7%), were less frequent in the miriplatin than the epirubicin group. CONCLUSIONS: OS after TACE with miriplatin was not superior to that after TACE with epirubicin; however, hepatic AEs were less frequent with miriplatin. CLINICAL TRIAL REGISTRATION: JapicCTI-080632. FAU - Ikeda, Masafumi AU - Ikeda M AD - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. masikeda@east.ncc.go.jp. FAU - Kudo, Masatoshi AU - Kudo M AD - Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan. FAU - Aikata, Hiroshi AU - Aikata H AD - Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan. FAU - Nagamatsu, Hiroaki AU - Nagamatsu H AD - Department of Hepatology, Yame General Hospital, Fukuoka, Japan. FAU - Ishii, Hiroshi AU - Ishii H AD - Hepatobiliary and Pancreatic Section, Gastroenterological Division, The Cancer Institute Hospital of JFCR, Tokyo, Japan. FAU - Yokosuka, Osamu AU - Yokosuka O AD - Department of Gastroenterology and Nephrology, Chiba University, Chiba, Japan. FAU - Torimura, Takuji AU - Torimura T AD - Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan. FAU - Morimoto, Manabu AU - Morimoto M AD - Gastroenterological Center, Yokohama City University Hospital Medical Center, Kanagawa, Japan. FAU - Ikeda, Kenji AU - Ikeda K AD - Department of Hepatology, Toranomon Hospital, Tokyo, Japan. FAU - Kumada, Hiromitsu AU - Kumada H AD - Department of Hepatology, Toranomon Hospital, Tokyo, Japan. FAU - Sato, Tosiya AU - Sato T AD - Department of Biostatistics, Kyoto University School of Public Health, Kyoto, Japan. FAU - Kawai, Ikuko AU - Kawai I AD - Sumitomo Dainippon Pharma Co., Ltd, Osaka, Japan. FAU - Yamashita, Toru AU - Yamashita T AD - Sumitomo Dainippon Pharma Co., Ltd, Osaka, Japan. FAU - Horio, Hiroshi AU - Horio H AD - Sumitomo Dainippon Pharma Co., Ltd, Osaka, Japan. FAU - Okusaka, Takuji AU - Okusaka T AD - Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. CN - Miriplatin TACE Study Group LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170801 PL - Japan TA - J Gastroenterol JT - Journal of gastroenterology JID - 9430794 RN - 0 (Antibiotics, Antineoplastic) RN - 0 (Antineoplastic Agents) RN - 0 (Organoplatinum Compounds) RN - 3Z8479ZZ5X (Epirubicin) RN - 780F0P8N4I (miriplatin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibiotics, Antineoplastic/administration & dosage/adverse effects MH - Antineoplastic Agents/*administration & dosage/adverse effects MH - Carcinoma, Hepatocellular/pathology/*therapy MH - Chemoembolization, Therapeutic/adverse effects/*methods MH - Epirubicin/*administration & dosage/adverse effects MH - Female MH - Humans MH - Liver Neoplasms/pathology/*therapy MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Organoplatinum Compounds/*administration & dosage/adverse effects MH - Survival Analysis MH - Treatment Outcome PMC - PMC5846877 OTO - NOTNLM OT - Carcinoma OT - Chemoembolization OT - Epirubicin OT - Hepatocellular OT - Miriplatin OT - Randomized controlled trial OT - Therapeutic COIS- MI and TO received research Grants from Sumitomo Dainippon Pharma. MK, OY, and TT received speaker's bureau fees and research Grants from Sumitomo Dainippon Pharma. MM received unrestricted Grants from Sumitomo Dainippon Pharma. KI and HK received speaker's bureau fees from Sumitomo Dainippon Pharma. TS received consultant fees from Sumitomo Dainippon Pharma. IK, TY, and HH are employees of Sumitomo Dainippon Pharma. HA, HN, and HI declare that they have no conflict of interest. EDAT- 2017/08/03 06:00 MHDA- 2019/03/07 06:00 PMCR- 2017/08/01 CRDT- 2017/08/03 06:00 PHST- 2017/02/09 00:00 [received] PHST- 2017/07/21 00:00 [accepted] PHST- 2017/08/03 06:00 [pubmed] PHST- 2019/03/07 06:00 [medline] PHST- 2017/08/03 06:00 [entrez] PHST- 2017/08/01 00:00 [pmc-release] AID - 10.1007/s00535-017-1374-6 [pii] AID - 1374 [pii] AID - 10.1007/s00535-017-1374-6 [doi] PST - ppublish SO - J Gastroenterol. 2018 Feb;53(2):281-290. doi: 10.1007/s00535-017-1374-6. Epub 2017 Aug 1.