To evaluate the clinical efficacy of -inferferon(IFN-) plus cis-platinum in hepatocellular carcinoma (HCC), 56 inoperable patients with HCC were divided into IFN- plus cis-platinum treated group (n=30) and no antitumor therapy group (n=26). cis-platinum. By the univariate analysis, the absence of portal vein thrombus (p<0.05). alkaline phosphatase smaller than 280 U/L (p=0.001), total bilirubin less than 2.0 mg% (p<0.05). serum triglyceride less than 155 mg/dl (p<0.05) were shown to be the factors most significantly favoring a better survival. By the multivariate analysis, using Cox proportional hazards model, IFN- plus cis-platinum treated group (p=0.0001). alkaline phosphatase less than 280 mg/dl (p=0.005, the absence of portal vein thrombus (p=0.020) were indie favorable prognostic factors. We conclude that IFN- plus cis-platinum is useful in patients with inoperable HCC and the above favorable prognostic factors may also be useful in the design and analysis of future clinical trials of systemic chemotherapy for HCC Keywords: Hepatocellular carcinoma, Combined Cis-platinum, Alpha Interferon Therapy INTRODUCTION Hepatocellular carcinoma (HCC) is usually a major cause of cancer death in many Asian countries1,2). Since almost all patients Rabbit Polyclonal to MRPL12 have considerable intrahepatic spread of the tumor and/or metastatic disease at the time of diagnosis, the disease is usually unresctable. Although some of these patients were treatable surgically, the disease is actually too extensive to perform surgical attempt or which will recur after resection. Therefore, they might be considered candidates for systemic or regional therapy. Until now, several reports for systemic chemotherapy of HCC experienced shown an unsatisfactory response of less than 10%3,4). Therefore, the development of new active anticancer brokers is essential, Cis-platinum has a broad spectrum of antineoplastic action and there has been many reports demonstrating favorable effects for the treatment of 742112-33-0 various malignant diseases5,6). Interferon has been shown to have a powerful antiproliferative effect on the human hepatoma cell collection7, 8). In this study, we statement our experience of IFN- plus cis-platinum treatment in 30 patients with HCC. The current study was also undertaken to evaluate the survival time of patients with HCC and find prognostic factors which allow the selection of patients with a life expectancy long enough to undergo therapy. MATERIALS AND METHODS 1. Patients Between April 1992 and July 1994, at the Department of Internal Medicine. Kosin Medical College, Pusan, Korea, 56 patients with HCC were joined on this study. Their tumor was inoperable because of underlying severe cirrhosis or extrahepatic metastasis or poor general condition. The diagnosis of HCC was made histologically in 32 patients and in the remaining 24 patients diagnosis was based on markedly elevated alphafetoprotein (AFP) values (>500ng/ml, range 1271C32,000 ng/ml) with space occupying lesions demonstrable by ultrasonography or computer tomographic scan. Twenty-nine were cirrhotics. The diagnosis of underlying cirrhosis was based on clinical and laboratory features plus endoscopic evidence of esophageal varices and positive liver scan. The 56 patients were divided into no antitumor therapy group (26 cases, 42%) and treatment group (30 cases, 58%) and are summarized in Table 1. Karnovsky score was greater than 70% (i.e., the patient was ambulant and able to take care of most daily needs). Forty-five patients (80.4%) were men (mean age, 63 years, range 37C65 years) and eleven (19.6%) patients were women (mean age, 64 years, range, 46C61 years). Table 1. Clinical and Laboratory Data of the 56 Patients Studied Markers of previous or present HBV infection were tested by radioimmunoassay (RIA) (Abott laboratories Kit), and 42 of the 56 patients (75%) were HBsAg positive. Although the control group had more patients with bilirubin level greater than 2.0mg%, no statistical difference was seen between the 742112-33-0 two groups with respect to any of the other parameters. Patients were not enrolled if they had received any prior chemotherapy or immunotherapy. 2. Trial Protocol We performed a retrospective study of IFN- plus cis-platinum treated group (n=30) and no antitumor therapy group (n=26). Cis-platinum was given by slow intravenous infusion in a dose of 60 742112-33-0 mg/m2 diluted with 5% dextrose at 4 weekly interval9). Anti-emetic agents were given prophylatically and a daily fluid intake of at least 3L was ensured. Interferon was administered on alternative day and doses of 3106 units intramuscularly for 3 months consecutively10). In all.