Gastroenterology

Gastroenterology

Volume 131, Issue 2, August 2006, Pages 461-469
Gastroenterology

Clinical–liver, pancreas, and biliary tract
Prospective Cohort Study of Transarterial Chemoembolization for Unresectable Hepatocellular Carcinoma in 8510 Patients

https://doi.org/10.1053/j.gastro.2006.05.021Get rights and content

Background & Aims: To elucidate the survival of the patients with unresectable hepatocellular carcinoma (HCC) who underwent transcatheter arterial lipiodol chemoembolization (TACE) and to analyze the factors affecting the survivals. Methods: During the last 8 years, a nationwide prospective cohort study was performed in 8510 patients with unresectable HCC who underwent TACE using emulsion of lipiodol and anticancer agents followed by gelatin sponge particles as an initial treatment. Exclusion criteria were extrahepatic metastases and/or any previous treatment prior to the present TACE. The primary end point was survival. The survival rates were calculated by the Kaplan–Meier method. The multivariate analyses for the factors affecting survival were evaluated by the Cox proportional hazard model. The mean follow-up period was 1.77 years. Results: For overall survival rates by TACE, median and 1-, 3-, 5-, and 7-year survivals were 34 months, 82%, 47%, 26%, and 16%, respectively. Both the degree of liver damage and the tumor-node-metastasis (TNM) system proposed by the Liver Cancer Study Group of Japan demonstrated good stratification of survivals (P = .0001). The multivariate analyses showed significant difference in degree of liver damage (P = .0001), α-fetoprotein value (P = .0001), maximum tumor size (P = .0001), number of lesions (P = .0001), and portal vein invasion (P = .0001). The last 3 factors could be replaced by TNM stage. The TACE-related mortality rate after the initial therapy was .5%. Conclusions: TACE showed safe therapeutic modality with a 5-year survival of 26% for unresectable HCC patients. The degrees of liver damage, TNM stage, and α-fetoprotein values were independent risk factors for patient survival.

Section snippets

Patients

During the last 8 years from January 1994 to December 2001, a total of 72,866 patients with primary liver cancer were newly registered biannually by the Liver Cancer Study Group of Japan throughout some 800 medical institutions using a registration/questionnaire sheet with more than 180 questions. HCC patients occupied 95% (69,182/72,866) of primary liver cancer. Of these, 8542 patients were assigned in the current prospective cohort study, who underwent TACE as an initial treatment for

Results

During an 8-year follow-up period, the total numbers of patient deaths and censored cases were 3605 and 4905, respectively. The number of patients who died and were censored annually was as follows: 1316 and 1939 during year 1, 1067 and 1258 from 1 to 2 years, 630 and 764 from 2 to 3 years, 341 and 454 from 3 to 4 years, 148 and 216 from 4 to 5 years, 72 and 145 from 5 to 6 years, 23 and 81 from 6 to 7 years, and 8 and 48 from 7 to 8 years, respectively.

Discussion

As the background of causal factor of HCC in the current study, hepatitis C virus infection was more prevalent than hepatitis B virus (74% to 11%, respectively). The ratio of hepatitis C virus to hepatitis B virus was almost similar to that reported by a Spanish paper11 and was different from that from Hong Kong where hepatitis B virus was predominant12 and from France where alcohol abuse was the main cause of HCC.8 In relation to the tumor size, small HCC no larger than 2 cm in diameter was

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