Combo Beats Monotherapy in Hepatocellular Carcinoma

The addition of sorafenib to doxorubicin may slow progression, increase survival

TUESDAY, Nov. 16 (HealthDay News) -- Combined sorafenib and doxorubicin appears to slow disease progression and increase overall survival and progression-free survival in patients with advanced hepatocellular carcinoma (HCC) more effectively than doxorubicin alone, according to research published in the Nov. 17 issue of the Journal of the American Medical Association.

Ghassan K. Abou-Alfa, M.D., of the Memorial Sloan-Kettering Cancer Center in New York City, and colleagues randomly assigned 96 patients with advanced HCC and Child-Pugh A disease and no prior systemic therapy to intravenous doxorubicin every 21 days plus either 400 mg sorafenib or placebo twice daily. The purpose of the study was to evaluate the safety and efficacy, as determined by time to progression, of the combined therapy compared with the monotherapy in this patient population.

The researchers found that the combination therapy group experienced a median time to progression of 6.4 months, compared to 2.8 months in the monotherapy group. The two groups experienced overall survival of 13.7 months and 6.5 months, and progression-free survival of six months and 2.7 months, respectively.

"Among patients with advanced HCC, treatment with sorafenib plus doxorubicin compared with doxorubicin monotherapy resulted in greater median time to progression, overall survival, and progression-free survival. The degree to which this improvement may represent synergism between sorafenib and doxorubicin remains to be defined. The combination of sorafenib and doxorubicin is not yet indicated for routine clinical use," the authors write.

The research was supported by Bayer; several authors disclosed financial relationships with Bayer.

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