A randomized phase II trial of intra-arterial chemotherapy using SM-11355 Miriplatin for hepatocellular carcinomaReport as inadecuate




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Investigational New Drugs

, Volume 30, Issue 5, pp 2015–2025

First Online: 21 December 2011Received: 10 October 2011Accepted: 27 November 2011

Abstract

Background SM-11355 is a platinum complex developed to treat hepatocellular carcinoma HCC via administration into the hepatic artery as a sustained-release suspension in iodized oil. We conducted a multicenter phase II trial in patients with HCC to evaluate the efficacy and safety of SM-11355, using a Zinostatin stimalamer suspension in iodized oil as a reference. Methods Patients with unresectable HCC were randomized 2:1 to receive administration of the SM-11355 or Zinostatin stimalamer suspension into the hepatic artery. A second injection was given 4–12 weeks later. Efficacy was evaluated by CT 3 months after treatment and categorized as therapeutic effect TE V to I, where TE V was defined as disappearance or 100% necrosis of all treated tumors. Results A total of 122 patients were evaluated for efficacy and toxicity SM-11355, n = 83; Zinostatin stimalamer, n = 39. Baseline characteristics were similar in the two groups. The TE V rates were 26.5% 22-83 and 17.9% 7-39 in the SM-11355 and Zinostatin stimalamer groups, respectively. In the SM-11355 group,the most frequent drug-related adverse events AEs of ≥ grade 3 were elevated AST, elevated ALT, thrombocytopenia, and hyperbilirubinemia. The AEs with the largest difference between the two groups SM-11355 vs. Zinostatin stimalamer were hepatic vascular injury 0 vs. 48.4% and eosinophilia 84.3 vs. 41.0%. The 2-year and 3-year survival rates were 75.9% vs. 70.3% and 58.4% vs. 48.7%, respectively. Conclusions The results suggest that SM-11355 in iodized oil has similar efficacy to Zinostatin stimalamer and that repeated dosing of SM-11355 is possible without hepatic vascular injury in cases of relapse.

KeywordsIodized oil MIRIPLA Liver cancer Suspension Parallel study  Download fulltext PDF



Author: Takuji Okusaka - Hiroshi Kasugai - Hiroshi Ishii - Masatoshi Kudo - Michio Sata - Katsuaki Tanaka - Yasukazu Shioyama - Kaz

Source: https://link.springer.com/







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