Arsenic trioxide in patients with hepatocellular carcinoma: A phase II trial
Journal
Investigational New Drugs
Journal Volume
25
Journal Issue
1
Pages
77-84
Date Issued
2007
Author(s)
Abstract
Background: Arsenic trioxide induces growth inhibition and apoptosis in human hepatocellular carcinoma (HCC) cell lines. A phase II trial was conducted to evaluate the efficacy and toxicity of single-agent arsenic trioxide in patients with HCC. Methods: Inclusion criteria included advanced HCC patients to whom no standard palliative treatment can be offered, good organ function and liver function reserve. Patients received arsenic trioxide 0.16-0.24 mg/kg per day for 5-6 days per week for 3-4 weeks, followed by one-week rest. Tumor response was assessed every 2 cycles. Primary endpoint was the percentage of patients with 6-month disease stabilization. Results: Twenty-nine patients (median age, 59) with locally advanced or metastatic HCC received a total of 61 cycles (median, 2; range, 1-6). One patient had partial response. Three patients had disease stabilization for at least six months. The 6-month tumor stabilization rate was 14% (95% CI, 1-27). The median overall survival was 4.8 months (95% CI, 1.4-8.2) and one-year survival was 30%. Conclusion: Single-agent arsenic trioxide using this dose schedule is not active against advanced HCC. ? 2006 Springer Science+Business Media, LLC.
SDGs
Other Subjects
arsenic trioxide; asadin; aspartate aminotransferase; bilirubin; chlorotrianisene; creatinine; doxorubicin; gemcitabine; thalidomide; adult; aged; allergic reaction; alopecia; aminotransferase blood level; anemia; anorexia; article; bilirubin blood level; cancer survival; clinical article; clinical trial; constipation; controlled clinical trial; controlled study; creatinine blood level; diarrhea; drug dose regimen; drug efficacy; fatigue; female; fever; human; hypomagnesemia; hyponatremia; infection; leukopenia; liver cell carcinoma; liver toxicity; male; nephrotoxicity; neutropenia; phase 2 clinical trial; pigment disorder; priority journal; pruritus; QT prolongation; side effect; sinus tachycardia; thrombocytopenia; unspecified side effect; vomiting; weight reduction; Adult; Aged; Antineoplastic Agents; Arsenicals; Carcinoma, Hepatocellular; Drug Administration Schedule; Fatigue; Female; Humans; Injections, Intravenous; Leukopenia; Liver Neoplasms; Male; Middle Aged; Neoplasm Staging; Neutropenia; Oxides; Survival Analysis; Treatment Outcome
Type
journal article