Prospective case-controlled trial of adjuvant chemotherapy after resection of hepatocellular carcinoma.

Recurrence of hepatocellular carcinoma (HCC) after curative hepatic resection is frequent and is an important factor adversely influencing long-term survival. The role of postoperative chemotherapy in the reduction of tumor recurrence rate is still controversial. During the period of 1992-1995 a series of 49 patients who underwent curative resection of HCC and had at least one risk factor of tumor recurrence were followed in this prospective study. Patients were allocated to adjuvant chemotherapy and control groups. Twenty-four patients received a combination of low dose intravenous epirubicin (20 mg/m2) and mitomycin (5 mg) monthly for seven courses starting 5 to 6 weeks after surgery. Twenty-five patients had no adjuvant treatment. The disease-free and overall survivals were compared for the two groups. A total of 154 courses of chemotherapy were given to the 24 patients. The chemotherapy-related side effects were mild and tolerable with no mortality. At a median follow-up of 39 months (range 9-71 months), 9 patients in the adjuvant chemotherapy group and 16 patients in the control group developed tumor recurrence. The respective 1-, 2-, 3-, and 5-year disease-free survival rates were 75%, 67%, 63%, and 63% for patients in the adjuvant chemotherapy group and 68%, 42%, 37%, and 32% for patients in the control group (p = 0.0575). The 1-, 2-, 3-, and 5-year overall survival rates were 100%, 96%, 77%, and 72% in the adjuvant chemotherapy group and 92%, 67%, 63%, and 51% in the control group (p = 0.0746). In conclusion, postoperative adjuvant chemotherapy using the present regimen has a tendency to reduce tumor recurrence rate and may improve long-term survival for high risk patients.

RCT Entities:   Population Interventions Outcomes