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February 23, 2011

Doxorubicin Plus Sorafenib in Treatment of Advanced Hepatocellular Carcinoma

JAMA. 2011;305(8):781. doi:10.1001/jama.2011.159

To the Editor: In the recently published phase 2 randomized trial of advanced hepatocellular carcinoma treatment, Dr Abou-Alfa and colleagues stated that at the time the trial was designed, doxorubicin-based chemotherapy was the accepted standard treatment, justifying the selection of doxorubicin-placebo as the control group vs doxorubicin-sorafenib as the experimental group.1 Even though doxorubicin was the most common treatment for advanced hepatocellular carcinoma at the time, its efficacy had only been assessed in limited nonrandomized phase 2 trials, with no phase 3 randomized trials comparing doxorubicin and placebo.2 We think that placebo or best supportive care, with or without a doxorubicin-plus-placebo group, would have been a more appropriate control group in the trial.