PROGNOSTIC FACTORS IN PATIENTS AFFECTED BY HEPATOCELLULAR-CARCINOMA TREATED WITH SYSTEMIC CHEMOTHERAPY - THE EXPERIENCE OF THE NATIONAL-CANCER-INSTITUTE-OF-MILAN

Background. Survival times and overall response rates are generally po or in patients with unresectable hepatocellular carcinoma submitted to systemic chemotherapy. Limited data are reported in the literature co ncerning the factors influencing survival among this subset of patient s but the distribution of these variables may affect the results of cl inical trials. Patients and methods: The data on 103 patients undergoi ng systemic chemotherapy at the Istituto Nazionale Tumori from January 1988 through July 1991 have been analyzed using univariate and Cox mu ltivariate analysis. Forty-eight patients were treated with mitoxantro ne alone, 40 with mitoxantrone plus beta-interferon, 11 with fluoroura cil plus folinic acid and the remaining four with adriamycin. Results: Median survival time, and 6-month and 12-month survival rates, were 7 .1, 55% and 29%, respectively. Lactate dehydrogenase value (P = 0.0009 ), TNM stage (P = 0.001), vascular invasion (P = 0.001), bilirubin (P = 0.008), Child status (P = 0.01), aspartate amino-transferase (P = 0. 02), extent of liver involvement (P = 0.02) and performance status (P = 0.03) were the most significant factors influencing survival in univ ariate analysis. In the multivariate analysis, aspartate amino-transfe rase (P = 0.02) and, particularly, TNM stage (p = 0.0009) were confirm ed as independent variables correlating with survival. A prognostic in dex was calculated on the basis of these factors and high- and low-ris k groups were identified. Median survival time and 12-month survival w ere 11.1 months and 43% for the low-risk group, and 4.9 months and 9% for the high-risk group (p = 0.0005). Conclusion: The results of this analysis may provide guidance for the design of future therapeutic tri als in unresectable hepatocellular carcinoma. In particular, patient s tratification should be considered for further clinical trials.