End-of-life considerations
In the early- and intermediate-HCC populations, life expectancy reported in the most recent European Society For Medical Oncology guidelines155 is > 24 months, with reported expected survival of > 5 years in the early population and > 2.5 years in the intermediate population. There is insufficient reliable evidence to indicate whether or not SIRT provides an extension to life of > 3 months.
The NICE end-of-life supplementary advice142 outlines that end-of-life criteria should be applied when both of the criteria below are satisfied:
The treatment is indicated for patients with a short life expectancy, normally < 24 months.
There is sufficient evidence to indicate that the treatment offers an extension to life, normally of at least an additional 3 months, compared with current NHS treatment.
Undiscounted LYG predicted in the AG’s base-case analysis are presented in . These indicate that normal life expectancy for patients ineligible for CTT is < 24 months, with expected mean survival of 14.72 months on lenvatinib and 15.49 months on sorafenib. This conclusion remains consistent irrespective of the subgroup considered or the choice of parametric model used to represent OS.
Undiscounted survival estimates used in the AG model
Regarding the criterion relating to > 3 months’ life extension, the AG’s base-case analysis suggests that SIRT is marginally inferior to both systemic therapies (sorafenib and lenvatinib), indicating that this criterion is not met. The results for the subgroup with no MVI similarly suggest that sorafenib produces marginally greater LYG than SIRT. In the low tumour burden/ALBI 1 subgroup, SIRTs are predicted to provide an extension to life of 2.11 months compared with sorafenib and 2.80 months compared with lenvatinib. These predicted survival gains, however, exclude potential gains from downstaging. In scenarios conducted in the low tumour burden/ALBI 1 subgroup that allow for downstaging, predicted survival gains increase to 4.61 months compared with sorafenib and 5.30 months compared with lenvatinib. These predicted gains are, however, subject to significant uncertainty owing to the small sample sizes and the fact that this is a post hoc subgroup analysis. There are also very significant uncertainties regarding the plausibility of downstaging patients in this population.
