Background. The role of orthotopic liver transplantation in the treatment of patients with cirrhosis and hepatocellular carcinoma is controversial, and determining which patients are likely to have a good outcome after liver transplantation is difficult. Methods. We studied 48 patients with cirrhosis who had small, unresectable hepatocellular carcinomas and who underwent liver transplantation. In 94 percent of the patients, the cirrhosis was related to infection with hepatitis B virus, hepatitis C virus, or both. The presence of tumor was confirmed by biopsy or serum alpha-fetoprotein assay. The criteria for eligibility for transplantation were the presence of a tumor 5 cm or less in diameter in patients with single hepatocellular carcinomas and no more than three tumor nodules, each 3 cm or less in diameter, in patients with multiple tumors. Twenty-eight patients with sufficient hepatic function underwent treatment for the tumor, mainly chemoembolization, before transplantation. After liver transplantation, the patients were followed prospectively for a median of 26 months (range, 9 to 54). No anticancer treatment was given after transplantation. Results. The overall mortality rate was 17 percent. After four years, the actuarial survival rate was 75 percent and the rate of recurrence-free survival was 83 percent. Hepatocellular carcinoma recurred in four patients (8 percent). The overall and recurrence-free survival rates at four years among the 35 patients (73 percent of the total) who met the predetermined criteria for the selection of small hepatocellular carcinomas at pathological review of the explanted liver were 85 percent and 92 percent, respectively, whereas the rates in the 13 patients (27 percent) whose tumors exceeded these limits were 50 percent and 59 percent, respectively (P 0.01 for overall survival; P 0.002 for recurrence-free survival). In this group of 48 patients with early-stage tumors, tumor–node– metastasis status, the number of tumors, the serum alphafetoprotein concentration, treatment received before transplantation, and 10 other variables were not significantly correlated with survival. Conclusions. Liver transplantation is an effective treatment for small, unresectable hepatocellular carcinomas in patients with cirrhosis. (N Engl J Med 1996;334: 693-9.) 1996, Massachusetts Medical Society. From the Liver Transplantation Unit, Department of Surgery (V.M., E.R., R.D., A.P., F.B., F.M., L.G.), and the Departments of Pathology (S.A.) and Anesthesia (M.A.), National Cancer Institute, and the Institute of Medical Statistics and Biometry, University of Milan (A.M.) — all in Milan, Italy. Address reprint requests to Dr. Gennari at the Liver Transplantation Unit, Istituto Nazionale Tumori, Via Venezian 1, 20133 Milan, Italy. Supported by the Italian Association for Cancer Research. T HE value of orthotopic liver transplantation in the treatment of hepatocellular carcinoma has often been debated. Although liver replacement could be curative for patients with tumors confined to the liver, the long-term results of liver transplantation in patients with hepatocellular carcinoma have been disappointing, with an overall five-year survival rate ranging from 30 to 40 percent. 1-9 In recent years, revisions of the tumor–node–metastasis (TNM) classification system 9 and other systems for determining the stage of hepatocellular carcinoma 10 have made possible a more detailed, retrospective analysis of treatment in these patients. In several studies, tumor stage before transplantation was directly related to the rate of recurrence of cancer after liver transplantation. Moreover, in patients with early-stage hepatocellular carcinoma, liver transplantation was more effective than resection of the liver. 11-15 To examine further the efficacy of transplantation, we undertook a prospective cohort study of patients with cirrhosis who had unresectable hepatocellular carcinomas and who received liver transplants; in this study we also assessed the influence of characteristics used to select patients for transplantation on the recurrence of cancer and on survival.
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