NCCN updates hepatobiliary cancer guidelines, adding Nexavar

The US National Comprehensive Cancer Network has announced important updates to the NCCN Hepatobiliary Cancer Guidelines. The NCCN Clinical Practice Guidelines in Oncology are widely recognized and applied as the standard of care in oncology in the USA in both the community and the academic practice settings, says the not-for-profit alliance of 21 of the nation's leading cancer centers.

The guidelines now include sorafenib (Bayer and Onyx' Nexavar), an oral multikinase inhibitor, as a treatment option for patients with hepatocellular carcinoma who have unresectable disease or decline surgery. This change was precipitated by a presentation of results from the Phase III Sorafenib HCC SHARP trial at the 2007 American Society of Clinical Oncology meeting. In that study, overall survival was reported to be extended 44% (46 weeks versus 34 weeks) in patients with advanced HCC who received sorafenib compared with placebo.

Currently, the guidelines specify that sorafenib is recommended only for patients with liver function status characterized by a Child-Pugh "class A" score. Furthermore, the recommendations regarding sorafenib therapy do not include patients potentially eligible for liver transplant, since the impact of sorafenib on this population of patients is unknown.