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.
A 52-year-old male was admitted with autoimmune pancreatitis (AIP), showing mononuclear cell infiltration in both the pancreas and salivary glands with both normal sialography and anti-SS-A/SS-B antibodies. Although the AIP improved with glucocorticoid treatment, subsequent abdominal computed tomography (CT) revealed a nodular shadow in the bilateral kidneys, which was confirmed as interstitial nephritis by renal biopsy. The patient's serum immunoglobulin G4 (IgG4) level was 10 times higher than the upper limit of the normal range. IgG4-positive mononuclear cell infiltration was detected in the salivary gland, pancreas, and kidney. A new entity proposed as 'IgG4-related autoimmune disease' was considered.
The development of hepatocellular carcinoma (HCC) is very closely associated with chronic liver disease. In the present study, the prevalence of the hepatitis B virus (HBV) and hepatitis C virus (HCV) infection as a causative role in the development of HCC was analysed in 253 patients with HCC, who were admitted to our hospital during 1976-90. Among these patients, 68 (27%) were positive for HBsAg but negative for anti-HCV antibody (group I); in contrast, 147 (58%) were negative for HBsAg but positive for anti-HCV antibody (group II), 19 (7.5%) were both positive (group III), and 19 (7.5%) were both negative (group IV). To evaluate the serial changes in the prevalence of HBsAg and anti-HCV antibody, changes in the number of patients were compared between group I and group II. The number of group I patients reached a peak during 1982-84 and was thereafter followed by a decreasing trend, whereas the number of group II patients steadily increased and reached a plateau over 6 recent years. These results suggest that HCV infection recently seems to play a more important role in the development of HCC than chronic HBV infection, even in the Nagasaki Prefecture, where the HBV carrier rate is higher than elsewhere in Japan.
Hepatitis B virus with a G-to-A point mutation at nucleotide 83 in the precore region (mutant hepatitis B virus 83), which cannot produce HBeAg, is commonly found in HBe antibody-positive hepatitis B virus carriers. We analyzed the consecutive changes in the prevalence of mutant hepatitis B virus 83 during the course of chronic hepatitis B virus infection. Forty-five patients with chronic hepatitis B who were followed up for more than 2 yr in our hospital were studied by polymerase chain reaction in combination with a restriction fragment length polymorphism assay.
Mutant hepatitis B virus83 was found in 14 of 18 (78%) HBe antibody-positive patients and in 8 of 27 (30%) HBeAg-positive patients at baseline. Eighteen of the 22 patients who had mutant hepatitis B virus 83 (82%) showed mixed viral populations of wild-type hepatitis
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