Phase I study of miriplatin combined with transarterial chemotherapy using CDDP powder in patients with hepatocellular carcinoma

BMC Gastroenterology

Research Article

Hirokazu Kawai¹  Kenya Kamimura¹  Yasushi Tamura¹  Masato Igarashi¹  Satoshi Yamagiwa¹  Minoru Nomoto¹  Yutaka Aoyagi¹  Takeshi Suda¹  Takeshi Yokoo¹  Masaaki Takamura¹ 

[1] Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan;

关键词: Miriplatin;    Hepatocellular carcinoma;    Cisplatin powder;    Phase I clinical trial;   

DOI  :  10.1186/1471-230X-12-127

 received in 2012-05-14, accepted in 2012-09-17,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundThere is no standard therapeutic procedure for the hepatocellular carcinoma (HCC) in patients with poor hepatic reserve function. With the approval of newly developed chemotherapeutic agent of miriplatin, we have firstly conducted the phase I study of CDDP powder (DDP-H) and miriplatin combination therapy and reported its safety and efficacy for treating unresectable HCC in such cases. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for the combination of transarterial oily chemoembolization (TOCE) and transarterial chemotherapy (TAC) using miriplatin and DDP-H for treating unresectable hepatocellular carcinoma (HCC).MethodsTransarterial chemotherapy using DDP-H was performed through the proper hepatic artery targeting the HCC nodules by increasing the dose of DDP-H (35–65 mg/m2) followed by targeting the HCC nodules by transarterial oily chemoembolization with miriplatin.ResultsA total of nine patients were enrolled in this study and no DLT was observed with any dose of DDP-H in all cases in whom 80 mg (median, 18–120) miriplatin was administered. An anti-tumour efficacy rating for partial response was obtained in one patient, while a total of four patients (among eight evaluated) showed stable disease response, leading to 62.5% of disease control rate. The pharmacokinetic results showed no further increase in plasma platinum concentration following miriplatin administration.ConclusionOur results suggest that a combination of DDP-H and miriplatin can be safely administered up to their respective MTD for treating HCC.Trial registrationThis study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR000003541).

【 授权许可】

Unknown   
© Kamimura et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.