Sorafenib (trade name Nexavar, is an inhibitor of protein kinases. It means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors on the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in blood vessels that supply the tumor, where they are involved in the formation of new blood vessels. Nexavar works by slowing the growth of cancer cells and blocking the blood supply that keeps cancer cells from developing . Sorafenib is currently the only molecule capable of combating liver cancer. The two studies, which were also attended by some Italian centre, have shown that treatment with Nexavar (sorafenib) may be extended by more than 40% survival of patients. Sorafenib molecule is not chemotherapy but a part of the targeted therapy. It belongs to these targeted drugs that act by blocking the mechanism of tumor growth in a single cell.
As monotherapy, oral sorafenib (400 mg x 2 times per day) prolongs median overall survival and delayed the median time to progression in patients with advanced hepatocellular carcinoma, as observed in two randomized, double-blind, placebo-controlled, multicenter Phase III (SHARP study and Asia-Pacific), while in the same study no significant differences were seen between sorafenib and placebo in median time to symptomatic progression. Most of the patients included in these trials were Child-Pugh class A. The combination therapy of sorafenib with doxorubicin did not delay the median time to progression significantly compared to doxorubicin alone in this category of patients, as results from a randomized double-blind phase II. But the median duration of overall survival and progression-free survival which was significantly longer in patients who received sorafenib and doxorubicin, compared with doxorubicin alone. The combination of sorafenib with tegafur/uracile or mitomycin looks promising in advanced hepatic tumor, as shown by non-comparative trial.
The oral therapy with sorafenib is generally well tolerated in patients with advanced hepatocellular carcinoma and it showed a good control of adverse effects, diarrhea and hand-foot skin reactions are the most commonly observed in clinical studies.