The GIDEON trial “can provide us with important information on safety and single-arm efficacy in the Child-Pugh B population,” said Bert H. O’Neil, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill.

“The results suggest that safety is similar between Child-Pugh A and Child-Pugh B patients; however, the duration of therapy for the Child-Pugh B population was exceedingly short, 8.5 weeks. This suggests that equivalent numbers of adverse events occur in a shorter period of time,” Dr. O’Neill said. “The low number of dose reductions in the Child-Pugh B population is also interesting, but is also affected by the short treatment duration.” Taken together, these findings suggest that sorafenib can be started at full doses in future studies of the Child-Pugh B population, he said.

Dr. O’Neil cautioned against extrapolating these results to current clinical practice at this time, concluding that sorafenib should remain investigational in Child-Pugh B patients, for whom the “the standard of care remains best supportive care.” Sorafenib should probably not be used at all in the Child-Pugh C cirrhotic population, he added. ■

Disclosure: Dr. O’Neil reported having a consultant or advisory role for Amgen and Bayer-Onyx and receiving honoraria from Amgen.