The association between stage migration and overall survival after radiation-based therapies in patients with hepatocellular carcinoma

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Background & Aims Stereotactic body radiation therapy (SBRT) and transarterial radioembolization (TARE) are common locoregional therapies for hepatocellular carcinoma (HCC). However, lack of surrogate endpoints has limited the feasibility of conducting comparative effectiveness clinical trials. Methods We conducted a multi-center retrospective cohort study of adult patients with HCC who received SBRT or TARE as initial treatment between 2008 and 2019. We excluded those with Barcelona Clinic Liver Cancer (BCLC) stage D disease. The primary outcome was overall survival, with transplantation as a competing risk. The independent variable of interest was stage migration to a more advanced BCLC stage (e.g., BCLC stage B → C) within 6 months of treatment. Survival analysis was completed using Kaplan-Meier, and multivariable Cox proportional hazard models was used to identify predictors of survival. Results We included 257 patients with a median age of 65 years; 77% male and 66% White. Most (75%) had Child-Pugh class A cirrhosis. Stage migration within 6 months was observed in 45 18%) patients. Patients who experienced stage migration within 6 months of receiving SBRT or TARE had significantly shorter survival than those without stage migration (median 192 days [IQR 108 – 397 days]) median versus 1259 days [IQR 591 – 2135 days], respectively; p<0.001). In multivariable analysis, stage migration was significantly associated with worse survival (HR 5.1 [95% CI: 4.3– 6.0]), however the correlation between stage migration and survival was not sufficient for surrogacy. The results were consistent in an independent external validation cohort and in relevant subgroup analyses. Conclusions Stage migration at 6 months is associated with overall survival in patients with HCC undergoing SBRT or TARE. Impact and Implications Stage migration in patients with receiving hepatocellular carcinoma (HCC) treatment is a multi-faceted measure of tumor function, functional status, and liver function. In this study we were able to show that worsening Barcelona Clinic Liver Cancer stage within 6 months of receipt of radiation treatment is associated with overall survival. Stage migration could be further explored as an endpoint in future clinical trials in patients with HCC receiving radiation therapies.

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