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.
Similar content being viewed by others
References
Kawai S, Okamura J, Ogawa M, Ohashi Y, Tani M, Inoue J, Kawarada Y, Kusano M, Kubo Y, Kuroda C, Sakata Y, Shimamura Y, Jinno K, Takahashi A, Takayasu K, Tamura K, Nagasue N, Nakanishi Y, Makino M, Masuzawa M, Mikuriya S, Monden M, Yumoto Y, Mori T, Oda T, the Cooperative Study Group for Liver Cancer Treatment of Japan (1992) Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma—a comparison of Lipiodol-transcatheter arterial embolization with and without Adriamycin (first cooperative study). Cancer Chemother Pharmacol 31 [Suppl I]: S1
Lahtinen R, Kuikka J, Nousiainen T, Uusitupa M, Lansimies E (1992) Cardiotoxicity of epirubicin and doxorubicin: a double-blind randomized study. Eur J Haematol 46: 301
Liver Cancer Study Group of Japan (1987) The general rules for the clinical and pathological study of primary liver cancer (in Japanese). Kanehara & Co., Tokyo, p 18
Liver Cancer Study Group of Japan (1989) The general rules for the clinical and pathological study of primary liver cancer. Jpn J Surg 19: 98
Okamura J, Kawai S, Ogawa M, Ohashi Y, Tani M, Inoue J, Kawarada Y, Kusano M, Kubo Y, Kuroda C, Sakata Y, Shimamura Y, Jinno K, Takahashi A, Takayasu K, Tamura K, Nagasue N, Nakanishi Y, Makino M, Masuzawa M, Mikuriya S, Monden M, Yumoto Y, Mori T, Oda T, the Cooperative Study Group for Liver Cancer Treatment of Japan (1992) Prospective and randomized clinical trial for the treatment of hepatocellular carcinoma—a comparison of L-TAE with Farmorubicin and L-TAE with Adriamycin (second cooperative study). Cancer Chemother Pharmacol 31 [Suppl I]: S20
Raoul JL, Heresbach D, Bretagne JF, Bentue Ferrer D, Duvauferrier R, Bourquet P, Messner M, Gosselin M (1992) Chemoembolization of hepatocellular carcinomas. A study of the biodistribution and pharmacokinetics of doxorubicin. Cancer 70: 585
Author information
Authors and Affiliations
Consortia
Rights and permissions
About this article
Cite this article
Kawai, S., Tani, M., Okamura, J. et al. 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). Cancer Chemother. Pharmacol. 33 (Suppl 1), S97–S102 (1994). https://doi.org/10.1007/BF00686677
Issue Date:
DOI: https://doi.org/10.1007/BF00686677