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Prognostic Value of Serum Biological Markers in Patients with Hepatocellular Carcinoma¹

Divisions of Clinical Immunology [R. P., E. L., G. C.], Surgical Oncology C [F. I.], and Medical Oncology B [S. P., B. D.], and Clinical Trials Office [F. P.] and Immunometric Laboratory [M. G. G., G. E.], National Cancer Institute; Divisions of Gastroenterology [F. C.] and Infectious Diseases [R. O.], Federico II University; and Chair of Statistics, Second University of Napoli [C. G.], 80131 Napoli, Italy

Purpose: Prognosis of patients with hepatocellular carcinoma (HCC) is assessed by using indexes based on clinical and instrumental parameters. The Cancer of the Liver Italian Program (CLIP) staging system combines the Child-Pugh classification with tumor size, portal invasion, and -fetoprotein and predicts the outcome of HCC patients more precisely than the Okuda staging system. Serum levels of a number of biological variables have been found to be increased in patients with HCC and are associated with different outcomes. Our aims in this study were to test the prognostic role of the serum levels of soluble intercellular adhesion molecule-1 (sICAM-1), soluble interleukin-2 receptor (sIL-2R), interleukin 6 (IL-6), and anti-p53 and to assess whether the addition of any of the above serum markers could further improve the predictive ability of the CLIP score.

Experimental Design: Serum levels of sICAM-1, sIL-2R, IL-6, and anti-p53 were assayed in 80 patients with HCC and correlated with their outcomes. Nonparametric procedures were applied to test correlations between serum sICAM-1, sIL-2R, IL-6, anti-p53, and other prognostic factors. For survival analyses, the product-limit method, log-rank test, and Cox proportional hazards model were applied.

Results: Only serum levels of sIL-2R correlated with survival, which was longer for patients with lower values (950 units/ml). However, with multivariate analysis sIL-2R did not confirm its predictive role when tested with the CLIP score as a covariate, with a hazard of death of 1.51 (95% confidence interval, 0.76–3.01).

Conclusions: Serum levels of sICAM-1, sIL-2R, IL-6, and anti-p53 are not useful as prognostic factors for HCC in clinical practice. They do not improve the predictive ability of the CLIP score.

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