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Arsenic trioxide in patients with hepatocellular carcinoma: a phase II trial

  • Phase II Studies
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Summary

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.

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Authors and Affiliations

  1. Department of Oncology, National Taiwan University Hospital, 7 Chung-Shan South Road, Taipei, 100, Taiwan

    Chia-Chi Lin, Chiun Hsu, Chih-Hung Hsu, Ann-Lii Cheng & Chih-Hsin Yang

  2. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

    Ann-Lii Cheng

  3. Cancer Research Center, National Taiwan University College of Medicine, Taipei, Taiwan

    Chia-Chi Lin, Chiun Hsu, Chih-Hung Hsu, Wei-Ling Hsu, Ann-Lii Cheng & Chih-Hsin Yang

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  1. Chia-Chi Lin
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  2. Chiun Hsu
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  3. Chih-Hung Hsu
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  4. Wei-Ling Hsu
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Correspondence to Chih-Hsin Yang.

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Lin, CC., Hsu, C., Hsu, CH. et al. Arsenic trioxide in patients with hepatocellular carcinoma: a phase II trial. Invest New Drugs 25, 77–84 (2007). https://doi.org/10.1007/s10637-006-9004-9

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  • DOI: https://doi.org/10.1007/s10637-006-9004-9

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