Randomized clinical control study of locoregional therapy combined with arsenic trioxide for the treatment of hepatocellular carcinoma.

Abstract

The objective of this study was to determine the efficacy and safety of locoregional therapy (LRT) combined with arsenic trioxide (As2 O3 ) treatment in primary hepatocellular carcinoma (HCC) patients. One hundred twenty-five primary HCC patients were recruited for a randomized controlled study. Patients were randomly divided into group A (n = 61) and group B (n = 64). All patients received transarterial chemoembolization. Group A patients were given As2 O3 at 10 mg/d for 4 courses (21 days per course) with a 2-week interval between courses. Survival times, therapeutic responses, extrahepatic metastases, and adverse events were recorded. A better therapeutic response was found in group A patients, as shown by higher objective response rate (ORR) and clinical benefit rate (CBR) values in group A versus group B (ORR, 81.96% [95% confidence interval (CI), 72.32%-91.62%] vs 59.37% [95% CI, 47.34%-71.41%], χ(2) = 7.650, P < .05; CBR, 95.08% [95% CI, 89.66%-100.00%] vs 81.25% [95% CI, 71.69%-90.81%], χ(2) = 5.659, P < .05). There were fewer patients with extrahepatic metastases in group A versus group B (group A, 6 cases or 9.84% [95% CI, 2.36%-17.31%]; group B, 12 cases or 18.75% [95% CI, 9.19%-28.31%]). The survival rate for group A patients was significantly higher than that for group B patients (P < .05). No significant differences were found between the 2 groups in terms of hematology or digestive system, liver, or kidney dysfunction except for facial and limb edema. LRT combined with As2 O3 treatment prevents extrahepatic metastasis and prolongs the survival time for primary HCC patients.