A Prospective, Randomized, Controlled Trial of Preoperative Transarterial Chemoembolization for Resectable Large Hepatocellular Carcinoma

Objective: To evaluate the effect of preoperative transarterial chemoembolization (TACE) for resectable large hepatocellular carcinoma (HCC). Summary Background Data: Resection of HCC is potentially curative, but local recurrence is very common. There is currently no effective neoadjuvant or adjuvant therapy. Methods: From July 2001 to December 2003, 108 patients (hepatitis B carrier = 98.1%) with resectable HCC (>= 5 cm) was randomly assigned to preoperative TACE treatment (n = 52) or no preoperative treatment (control group) (n = 56). Results: Five patients (9.6%) in the preoperative TACE group did not receive surgical therapy because of extrahepatic metastasis or liver failure. The preoperative TACE group had a lower resection rate (n = 47, 90.4% vs. n = 56, 100%; P = 0.017), and longer operative time (mean, 176.5 minutes vs. 149.3 minutes; P = 0.042). No significant difference was found between the 2 groups in operative blood loss, surgical morbidity, and hospital mortality. At a median follow-up of 57 months, 41 (78.8%) of 52 patients of the preoperative TACE group and 51 (91.1%) of 56 patients in the control group had recurrent disease (P = 0.087). The 1-, 3-, and 5-year disease-free survival rates were 48.9%, 25.5%, and 12.8%, respectively, for the preoperative TACE group and 39.2%, 21.4%, and 8.9%, respectively, for the control group (P = 0372), The 1-, 3-, and 5-year overall survival rates were 73.1%, 40.4%, and 30.7%, respectively, for the preoperative TACE group and 69.6%, 32.1%, and 21.1%, respectively, for the control group (P 0.679). Conclusions: Preoperative TACE did not improve surgical Outcome. It resulted in drop-out front definitive surgery because of progression of disease and liver failure.