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. 2022 May 27;14(5):885–895. doi: 10.4254/wjh.v14.i5.885

Table 2.

Comparing key features of the LEGACY study and DOSISPHERE trial


LEGACY
DOSISPHERE
Study design Multi-center single-arm retrospective study Multicenter randomized control phase ii trial
Objective To assess clinical outcomes of Y-90 glass microsphere treatment in patients with unresectable solitary HCC lesions To compare clinical outcomes of lobar TARE using 120 Gy (SDA) versus > 205 Gy (PDA) in patients with intermediate/advanced HCC
Inclusion criteria Unresectable solitary lesions (≤ 8 cm); BCLC A or C (ECOG 0-1); Child-Pugh score A ≥ 1 unresectable lesion ≥ 7 cm; BCLC A, B, or C
Exclusion criteria Patients with vascular or extrahepatic disease, significant ascites, encephalopathy, or prior LRT, LT, resection, or systemic therapy Patients with micro-aggregate albumin (MAA) studies demonstrating poor tumor targeting
Overall survival At 3 yr, 86.6% for patients treated with TARE alone (median dose 410 Gy) and 92.8% for patients who down-staged via TARE Overall survival was improved in the personalized dosimetry group (26.6 mo vs 10.7 mo)
Downstaging 21% successfully down-staged to LT; 6.8% to resection. 36% patients in the PDA group and 3.5% (1/28) in the SDA group down-staged to resection1
1

Including patients with portal vein tumor thrombus.

HCC: Hepatocellular carcinoma; BCLC: Barcelona clinic liver criteria; LRT: Locoregional therapy; LT: Liver transplant; PDA: Personalized dosimetry group; SDA: Standardized dosimetry group; TARE: Transarterial radio-embolization.