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Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma--a comparison between L-TAE with farmorubicin and L-TAE with adriamycin: preliminary results (second cooperative study). Cooperative Study Group for Liver Cancer Treat

Abstract：

:A randomized controlled clinical trial was conducted to compare the use of farmorubicin (FARM) and adriamycin (ADR) in Lipiodol transcatheter arterial chemoembolization (L-TAE) as a treatment of hepatocellular carcinoma. In all, 192 hospitals participated, and 415 patients were enrolled in the study during the period from October 1989 through December 1990, and their data were collected. The patients were randomly allocated to group A (FARM) or group B (ADR) by a central telephone registration. Several clinical characteristics were slightly worse in group A than in group B, but there was no statistically significant difference. The actual doses of FARM and ADR were 72 mg/body and 48 mg/body, respectively. Additional treatments, including repeated TAE or surgery, were given to 248 patients. The 1- and 2-year survival rates were 69% and 44% for group A and 74% and 57% for group B, respectively. The difference was marginally significant (P value in the log-rank test, 0.038). When each group of patients was classified into two subgroups, i.e., high-risk and low-risk categories, based on the severity index calculated by the Cox regression model from significant prognostic factors, the ADR subgroup was significantly superior to the FARM subgroup in the low-risk category, but there was no significant difference between the subgroups in the high-risk category. The change in the serum alpha-fetoprotein level, the extent of Lipiodol accumulation in the tumor, and the extent of tumor reduction did not show any significant difference between the groups. At the above-mentioned doses, ADR seemed to have efficacy almost the same as or slightly superior to that of FARM in L-TAE for the treatment of hepatocellular carcinoma.

journal_name

Cancer Chemother Pharmacol

journal_title

Cancer chemotherapy and pharmacology

authors

Kawai S,Tani M,Okamura J,Ogawa M,Ohashi Y,Monden M,Hayashi S,Inoue J,Kawarada Y,Kusano M

doi

10.1007/BF00686677

subject

Has Abstract,Author List Incomplete

pub_date

1994-01-01 00:00:00

pages

S97-102

eissn

0344-5704

issn

1432-0843

journal_volume

33 Suppl

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma--a comparison between L-TAE with farmorubicin and L-TAE with adriamycin: preliminary results (second cooperative study). Cooperative Study Group for Liver Cancer Treat