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ThermoDox (Liposomal Doxorubicin) Ineffective in Liver Cancer

Drug plus ablation fails to improve survival versus ablation alone (Jan. 31)

According to a recent announcement, ThermoDox (heat-activated liposomal doxorubicin; Celsion Corporation), in combination with radiofrequency ablation (RFA), did not meet the primary endpoint of a phase III trial in patients with hepatocellular carcinoma (HCC).

Specifically, the HEpatocellular Carcinoma Study of RFA and ThermoDox (HEAT) study failed to meet the goal of demonstrating persuasive evidence of clinical effectiveness (i.e., improved progression-free survival [PFS]). The trial was designed to show a 33% improvement in PFS, with 80% power and a P value equal to 0.05.

The HEAT trial was a randomized, placebo-controlled study conducted at clinical sites around the world, including the U.S. and Canada. A total of 701 patients with intermediate (tumor size: 3 to 7 cm), unresectable HCC were randomly assigned to treatment with ThermoDox 50 mg/m2 plus RFA or RFA alone.

ThermoDox is an investigational, heat-activated formulation of liposomal doxorubicin — an oncology drug used for the treatment of a wide range of cancers. According to the product’s developer, ThermoDox was designed to enhance the efficacy of doxorubicin by encapsulating it with lysolipid thermally sensitive liposomes. These heat-sensitive liposomes change structure when heated to a specific temperature (via a heat source, such as RFA), thereby creating openings in the liposome that release doxorubicin directly into the targeted tumor and surrounding tissue.

HCC — also known as primary liver cancer — is one of the most common and deadly forms of cancer worldwide. With few approved treatment options, it is estimated that up to 90% of patients with unresectable (inoperable) liver cancer will die within 5 years of diagnosis. Currently, HCC is the fourth leading cause of death from cancer and the third most common cancer in men. Approximately 26,000 new cases occur in the U.S. each year. The World Health Organization (WHO) estimates that HCC may become the number one cancer worldwide by 2020, surpassing lung cancer.

Source: Celsion Corporation; January 31, 2013.

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