Dr. Rassiwala on Results of "All-comers" Downstaging Protocol

Jasmine Rassiwala, MD, resident physician, University of California, San Francisco (UCSF), discusses the analysis of the “all-comers” downstaging protocol, which investigated whether there were upper limits in tumor burden for successful downstaging of patients with hepatocellular carcinoma (HCC) to liver transplant.

This study looked at patients with any tumor burden in the liver, except in the metastatic stage, to see whether they could be brought down within the criteria for liver transplant.

In an earlier study, tumor burden was negatively predictive for successful downstaging (HR, 0.87; P <.05). Patients with a sum of number of tumors plus largest tumor diameter of 8 had a 68% probability of being downstaged to within Milan criteria at 1 year, compared with those with a tumor burden of 14 who had a 38% probability at 1 year.

The population of 74 patients, named the “all-comers,” had an overall greater tumor burden than those in the UCSF Downstaging (UCSF-DS) group (12 cm compared with 6.3 cm median tumor diameter). All-comer patients underwent downstaging via loco regional therapy, (LRT) and if they remained within Milan criteria for 6 months, they were placed on the liver transplant list.

Sixty-two percent of all-comers were successfully downstaged at 12 months, which was still lower than the UCSF-SD group at 89%.

Nine (12%) patients in this study underwent orthotopic liver transplantation, and 7 patients who were downstaged are still awaiting liver transplant.

Although downstaging or transplanting the entire population of “all-comers” is unrealistic, Rassiwala hopes to see if there is a subset of patients within this group that could be more suited to downstaging or transplant.