Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial

Autor: Manabu Morimoto, Toru Yamashita, Hiroshi Aikata, Hiroshi Horio, Masafumi Ikeda, Takuji Okusaka, Tosiya Sato, Hiromitsu Kumada, Kenji Ikeda, Ikuko Kawai, Hiroaki Nagamatsu, Masatoshi Kudo, Hiroshi Ishii, Takuji Torimura, Osamu Yokosuka
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Oncology
Adult
Male
medicine.medical_specialty
Carcinoma
Hepatocellular
Organoplatinum Compounds
Miriplatin
Antineoplastic Agents
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Internal medicine
medicine
Carcinoma
Clinical endpoint
Humans
Chemoembolization
Therapeutic
Prospective cohort study
Adverse effect
skin and connective tissue diseases
Epirubicin
Aged
Neoplasm Staging
Aged
80 and over
Original Article—Liver
Pancreas
and Biliary Tract
Antibiotics
Antineoplastic
business.industry
Hazard ratio
Liver Neoplasms
Hepatocellular
Middle Aged
medicine.disease
Survival Analysis
Treatment Outcome
Randomized controlled trial
030220 oncology & carcinogenesis
Hepatocellular carcinoma
Lipiodol
030211 gastroenterology & hepatology
Chemoembolization
Female
Therapeutic
business
medicine.drug
Zdroj: Journal of Gastroenterology
ISSN: 1435-5922
0944-1174
Popis: 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.
Databáze: OpenAIRE
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