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 (> or =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 in 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= 0.372). 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 from definitive surgery because of progression of disease and liver failure.