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 poor in patients with unresectable hepatocellular carcinoma submitted to systemic chemotherapy. Limited data are reported in the literature concerning the factors influencing survival among this subset of patients but the distribution of these variables may affect the results of clinical trials.


METHODS
The data on 103 patients undergoing systemic chemotherapy at the Istituto Nazionale Tumori from January 1988 through July 1991 have been analyzed using univariate and Cox multivariate analysis. Forty-eight patients were treated with mitoxantrone alone, 40 with mitoxantrone plus beta-interferon, 11 with fluorouracil 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 univariate analysis. In the multivariate analysis, aspartate amino-transferase (P = 0.02) and, particularly, TNM stage (p = 0.0009) were confirmed as independent variables correlating with survival. A prognostic index was calculated on the basis of these factors and high- and low-risk groups were identified. Median survival time and 12-month survival were 11.1 months and 43% for the low-risk group, and 4.0 months and 9% for the high-risk group (p = 0.0005).


CONCLUSIONS
The results of this analysis may provide guidance for the design of future therapeutic trials in unresectable hepatocellular carcinoma. In particular, patient stratification should be considered for further clinical trials.
Division of Medical Oncology B, Istituto Nazionale Tumori, Milan, Italy.
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M
Colleoni
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Bajetta
P
P
Nelli
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Boni
A M
AM
Bochicchio
F
F
Nolè
R
R
Buzzoni
L
L
Celio
V
V
Mazzaferro
G
G
Bonfanti
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D006077:Government Agencies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D011379:Prognosis; D016016:Proportional Hazards Models; D012307:Risk Factors; D015996:Survival Rate
D001219:Aspartate Aminotransferases