Author:
Ikeda Masafumi,Kudo Masatoshi,Aikata Hiroshi,Nagamatsu Hiroaki,Ishii Hiroshi,Yokosuka Osamu,Torimura Takuji,Morimoto Manabu,Ikeda Kenji,Kumada Hiromitsu,Sato Tosiya,Kawai Ikuko,Yamashita Toru,Horio Hiroshi,Okusaka Takuji,
Abstract
Abstract
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.
Publisher
Springer Science and Business Media LLC
Cited by
49 articles.
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