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 |
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.