Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma

Abstract

This randomized, controlled trial assessed the efficacy of transarterial Lipiodol (Lipiodol Ultrafluide, Laboratoire Guerbet, Aulnay-Sous-Bois, France) chemoembolization in patients with unresectable hepatocellular carcinoma. From March 1996 to October 1997, 80 out of 279 Asian patients with newly diagnosed unresectable hepatocellular carcinoma fulfilled the entry criteria and randomly were assigned to treatment with chemoembolization using a variable dose of an emulsion of cisplatin in Lipiodol and gelatin-sponge particles injected through the hepatic artery (chemoembolization group, 40 patients) or symptomatic treatment (control group, 40 patients). One patient assigned to the control group secondarily was excluded because of unrecognized systemic metastasis. Chemoembolization was repeated every 2 to 3 months unless there was evidence of contraindications or progressive disease. Survival was the main end point. The chemoembolization group received a total of 192 courses of chemoembolization with a median of 4.5 (range, 1-15) courses per patient. Chemoembolization resulted in a marked tumor response, and the actuarial survival was significantly better in the chemoembolization group (1 year, 57%; 2 years, 31%; 3 years, 26%) than in the control group (1 year, 32%; 2 years, 11%; 3 years, 3%; P ‫؍‬ .002). When adjustments for baseline variables that were prognostic on univariate analysis were made with a multivariate Cox model, the survival benefit of chemoembolization remained significant (relative risk of death, 0.49; 95% CI, 0.29-0.81; P ‫؍‬ .006). Although death from liver failure was more frequent in patients who received chemoembolization, the liver functions of the survivors were not significantly different. In conclusion, in Asian patients with unresectable hepatocellular carcinoma, transarterial Lipiodol chemoembolization significantly improves survival and is an effective form of treatment.

Asian Pacific Association for the Study of the Liver consensus recommendations on hepatocellular carcinoma

“…In 2002, two prospectively RCTs have demonstrated a significant survival benefit from TACE in selected HCC patients with preserved liver function and adequate performance status [331,332]. A subsequent meta-analysis confirmed these findings [333].…”

“…In two RCTs and one systematic review with meta-analysis, TACE was found to improve survival compared with supportive care in patients with unresectable HCC [331][332][333]. Untreated patients at an intermediate stage present a median survival of 16 months.…”

“…Chemoembolization increases the median survival of these patients to 19-20 months according to RCTs and metaanalysis of pooled data, and is considered the standard of care [333,343]. In the two RCTs, 1-, 2-, and 3-year survival rates both for Asian patients and for European patients were 57 versus 96%, 31 versus 77%, and 26 versus 47%, respectively [331,332,339].…”

Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data

“…(7)(8)(9)(10)(11)(12)(13) These metaanalyses identified a distinct survival benefit for lipiodol TACE with cisplatin or doxorubicin compared to best supportive care. (14,15) As a result, Lipiodol TACE has been recommended as the standard of care for the treatment of unresectable, large, or multinodular noninvasive tumors isolated to the liver in patients who have neither evidence of hepatic decompensation nor cancer-related symptoms, that is, those cases classified as intermediate stage according to the Barcelona Clinic for Liver Cancer (BCLC) staging system.…”

Treatment of inoperable hepatocellular carcinoma with pegylated liposomal doxorubicin (PLD): results of a phase II study

“…In selected patients with unresectable, liver-only, disease hepatic embolisation or chemoembolisation confers a survival advantage compared with conservative management (Llovet et al, 2002;Lo et al, 2002). However, in the recent meta-analysis, this effect may be limited to chemoembolisation but not embolisation .…”