According to results recently presented at the 2007 European Cancer Organization (ECCO 14), the addition of the targeted agent Nexavar® (sorafenib) to the chemotherapy agent Adriamycin® (doxorubicin) improves survival as initial therapy among patients with advanced hepatocellular carcinoma (HCC), a form of liver cancer.
The liver is the largest organ in the body and is responsible for over 500 functions. These include the secretion of glucose, proteins, vitamins, and fats; the production of bile; the processing of hemoglobin; and the detoxification of numerous substances.
Hepatocellular carcinoma is the most common type of liver cancer; it is named for the type of cell within the liver where the cancer originated. In advanced HCC cancer has spread from the liver to distant sites in the body.
Nexavar is an agent that is targeted against specific biological pathways that are believed to be associated with the growth and spread of cancer cells. Results from several clinical trials have indicated that the addition of Nexavar provides significant anticancer activity in patients with HCC. Trials are ongoing to further evaluate the role of Nexavar.
A multiinstitutional clinical trial was recently conducted to compare Nexavar plus Adriamycin to Adriamycin only in the treatment of HCC. This trial included 96 patients who had not received prior therapy. Patients were treated with either Nexavar/Adriamycin or Adriamycin plus placebo (inactive substitute).
- Time to cancer progression was 8.5 months for patients treated with Nexavar/Adriamycin compared with only 2.8 months for those treated with Adriamycin/placebo.
- Overall survival was 14 months for patients treated with Nexavar/Adriamycin compared with 5.6 months for those treated with Adriamycin/placebo.
- Complete or partial regression of cancer occurred in 4.3% for patients treated with Nexavar/Adriamycin compared with only 2% of patients treated with Adriamycin/placebo.
- In terms of side effects, Nexavar increased the frequency of fatigue from 6.3% to 10.6%. The rate of neutropenia (low levels of immune cells) was similar between the two groups.
The researchers concluded that the addition of Nexavar to Adriamycin improves progression-free and overall survival for patients with HCC. Due to these results, patients initially treated with Adriamycin/placebo are now able to receive the addition of Nexavar. These results provide further evidence that Nexavar significantly improves outcomes for HCC.
Reference: Abou-Alfa G, Johnson P, Knox J, et al. Preliminary results from a Phase II, randomized, double-blind study of sorafenib plus doxorubicin versus placebo plus doxorubicin in patients with advanced hepatocellular carcinoma. Proceedings of the 2007 meeting of the European Cancer Organization. European Journal of Cancer Supplements. 2007; 5:259.
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