Session Time: 6:00pm-7:00pm
Presentation Time: 6:00pm-6:05pm
*Purpose: Patients with HCC meeting UNOS-downstaging (DS) criteria (1 lesion 5.1-8 cm, 2-3 lesions at least one 3.1-5 cm and total tumor diameter (TTD) ≤8 cm, or 4-5 tumors ≤3 cm with TTD ≤8 cm) have excellent LT outcomes after successful DS. However, the likelihood of successful DS and LT-related outcomes for “all-comers” (AC) patients with tumor burden initially exceeding UNOS-DS criteria is poorly understood.
*Methods: Consecutive patients with HCC meeting AC (n=82) or UNOS-DS criteria (n=230) at 7 LT centers in 4 UNOS regions were enrolled from 2015-2020 and prospectively followed to evaluate downstaging and LT outcomes.
*Results: Median pre-treatment characteristics between the AC and UNOS-DS groups did not significantly differ in terms of MELD (9 vs 9), Child-Pugh (CP) score (6 vs 6), and AFP (20 vs 12 ng/mL). TTD prior to first local-regional therapy (LRT) was 10.0 cm for AC (IQR 8.3-12.9) vs 6.2 cm for UNOS-DS (IQR 5.5-7.1) (p<0.001). AC patients required more LRT to be downstaged (2 vs 1; p=0.001) and had a lower probability of successful downstaging (69% vs 85% within 12 months; p<0.001). In multivariable (MV) analysis of the AC cohort, increasing sum of largest tumor diameter plus number of lesions prior to first LRT was negatively associated with successful downstaging (HR 0.82; p=0.026). Dropout probability due to tumor progression or death was similar at 3 years (AC 52% vs UNOS-DS 45%, p=0.27) with pre-treatment CP class B/C the only factor associated with dropout in the AC cohort (HR 2.58 vs CP A; p=0.009). Intention-to-treat (ITT) survival at 3 years was 69% for UNOS-DS vs. 58% for AC (p=0.07) and reduced to 23% in AC with CP B/C cirrhosis. Probability of LT at 3 years was 42% for AC vs. 58% in UNOS-DS (p=0.11) with no differences in explant tumor stage, grade, or vascular invasion. In the combined cohort, 39% were under-staged on explant. Factors associated with under-staging in MV logistic regression included increasing sum of largest tumor diameter plus number of lesions on last imaging prior to LT (OR 1.4; p=0.006) and AFP >20 (OR 6.4; p=0.004). Post-LT 2-year survival was 91% for AC vs 90% for UNOS-DS (p=0.67) with HCC recurrence observed in only 5% of AC after median post-LT follow-up of 19 mo.
*Conclusions: In this first prospective multi-regional comparative study on HCC downstaging, we observed an overall 70% probability of successful downstaging in AC with increasing pre-treatment tumor burden associated with unsuccessful downstaging. 3-year ITT survival in AC was nearly 60% though AC with CP B/C had poor survival. Explant pathology and 2-year post-LT outcome was similar between cohorts suggesting that LT is a reasonable goal in selected AC patients though efforts to improve under-staging are needed.
To cite this abstract in AMA style:Natarajan B, Tabrizian P, Hoteit M, Frenette C, Ghaziani T, Dhanasekaran R, Parikh N, Guy J, Shui A, Florman S, Yao F, Mehta N. Outcomes of Downstaging Hepatocellular Carcinoma (HCC) to within Milan Criteria Before Liver Transplantation (LT): A Multicenter Analysis of the “All-comers” Protocol [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/outcomes-of-downstaging-hepatocellular-carcinoma-hcc-to-within-milan-criteria-before-liver-transplantation-lt-a-multicenter-analysis-of-the-all-comers-protocol/. Accessed June 18, 2021.
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