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A Randomized Controlled Trial

Edward C. S. Lai, MS; Chung-Mau Lo, MBBS(HK); Sheung-Tat Fan, MS; Chi-Leung Liu, MBBS(HK); John Wong, PhD, DSc

Arch Surg. 1998;133:183-188.

Objective  To study the effect of adjuvant chemotherapy after curative hepatic resection in patients with hepatocellular carcinoma.

Design  A randomized controlled trial.

Setting  A tertiary referral center.

Patients  During a 54-month period, 142 patients with hepatocellular carcinoma underwent hepatic resection at 1 institution. Sixty-six patients who survived the operation and had no demonstrable evidence of residual disease on ultrasonographic examination and hepatic angiographic testing at 1 month after surgery agreed to participate in the study. The median follow-up time was 28.3 months.

Intervention  Thirty patients received a combination of intravenous epirubicin hydrochloride (8 doses of 40 mg/m² each at 6-week intervals) and transarterial chemotherapy using an emulsion of iodized oil and cisplatin (3 courses with a maximum dose of 20 mL each at 2-month intervals). Thirty-six patients had no adjuvant treatment.

Main Outcome Measures  Recurrence rate and disease-free survival.

Results  A total of 138 courses of intravenous epirubicin was given to the 30 patients. Sixty-one courses of transarterial chemotherapy were given to only 29 of the 30 patients assigned to the treatment group, because the hepatic artery in 1 patient was thrombosed. Six patients (20%) had chemotherapy-related complications with no mortality. Twenty-three of 30 patients in the treatment group and 17 of 36 patients in the control group had recurrences (P=.01). Patients who received adjuvant chemotherapy had a higher incidence of extrahepatic metastases (11 patients vs 5 patients; P=.03). The respective disease-free survival rates at 1, 2, and 3 years were 50%, 36%, and 18% for the treatment group and 69%, 53%, and 48% for the control group (P=.04).

Conclusion  In a group of patients who underwent curative resection of hepatocellular carcinoma, postoperative adjuvant chemotherapy using the present regimen was associated with more frequent extrahepatic recurrences and a worse outcome.

From the Department of Surgery, The University of Hong Kong, Queen Mary Hospital, Hong Kong, People's Republic of China.

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