• Keigo Osuga, Yasuaki Arai, Hiroshi Anai, Yoshito Takeuchi, Takeshi Aramaki, Eiji Sugihara, Takanobu Yamamoto, Yoshitaka Inaba, Fumikiyo Ganaha, Hiroshi Seki, Shunichi Sadaoka, Mikio Sato, Takeshi Kobayashi, Yoshihisa Kodama, Shinichi Inoh, and Koichiro Yamakado.
• Department of Diagnostic and Interventional Radiology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan. osuga@radiol.med.osaka-u.ac.jp
• J Vasc Interv Radiol. 2012 Oct 1; 23 (10): 1278-85.

PurposeA multicenter phase I/II study of transarterial chemoembolization with a fine cisplatin powder and gelatin particles (GPs) for multifocal hepatocellular carcinoma (HCC) was conducted. Primary endpoints were dose-limiting toxicity (DLT) and recommended dose (RD). Secondary endpoints were the incidence and severity of adverse events and tumor response.Materials And MethodsNonselective transarterial chemoembolization was performed until all tumor enhancement disappeared. Lipiodol was not used. In the phase I study, the cisplatin dose was escalated from 35 mg/m(2) to 65 mg/m(2) in 15-mg/m(2) increments to determine DLT and RD. In the phase II study, 40 patients were treated with the RD. Toxicity was assessed by Common Toxicity Criteria for Adverse Effects (version 3.0), and tumor response was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0) and European Association for the Study of the Liver (EASL) criteria.ResultsA total of 46 patients were enrolled. As no DLT occurred at any dose level in the phase I study, RD was determined as 65 mg/m(2). In the phase II study, the treatment was discontinued in one patient as a result of vasovagal response. Toxicities of grade 3 or higher included nausea (2.2%), pancreatitis (2.2%), cholecystitis (2.2%), thrombocytopenia (8.7%), hyperbilirubinemia (2.2%), and increased aspartate aminotransferase (28.3%) and alanine aminotransferase (21.7%) levels. Tumor response rates under RD were 25.6% and 64.1% by RECIST and EASL criteria, respectively.ConclusionsNonselective transarterial chemoembolization with fine cisplatin powder and GPs was well tolerated and effective in patients with multifocal HCC at the RD of 65 mg/m(2).Copyright © 2012 SIR. Published by Elsevier Inc. All rights reserved.

31 keywords...

hide…