Abstract 934P
Background
TARGET aimed to collect clinical data to evaluate relationships between absorbed dose (AD), adverse events (AEs), and objective response (OR) in hepatocellular carcinoma (HCC) patients treated with yttrium-90 (90Y) glass microspheres.
Methods
TARGET was a global, retrospective, single-arm study of 209 patients from 13 centers across 8 countries. Inclusion criteria: liver-dominant disease with or without portal vein thrombosis (PVT); ≤10 HCC tumors per lobe (at least one ≥3 cm); Child-Pugh stage A or B7; BCLC stage A, B, or C; and no prior intra-arterial treatment. Data collection included patient, disease, and treatment-specific variables; treatment-related AEs; and tumor response. Multicompartment pre-/post-treatment dosimetry was retrospectively determined with Simplicit90Y™ software (Mirada). Logistic regression was used to evaluate relationships between 1) OR by mRECIST and total perfused tumor AD (TAD) and 2) AEs of ≥ Grade 3 hyperbilirubinemia without disease progression and normal tissue AD (NTAD). Multivariate Cox regression was used to evaluate associations between predictive/clinical variables and overall survival (OS).
Results
No relationship was found between ≥ Grade 3 hyperbilirubinemia (4.8% of patients) and NTAD. OR rate by mRECIST for target lesions was 70.8%, and 61.7% over all lesions. Responders had a significantly higher mean TAD (225.5 Gy, 95% CI: 201.0, 253.0) compared to non-responders (188.3 Gy, 95% CI: 64.6, 215.3; p<0.05). In patients with a TAD < 200 Gy, 52.7% responded; in those with 200 to 300 Gy TAD, 64.9% responded; and in those with a TAD of > 300 Gy, 72.1% responded. Higher TAD was associated with longer OS (p =0.016). Median OS in patients with < 200 Gy TAD was 16.1 months (95% CI: 11.3, 19.4); in those with 200-300 Gy TAD, 25.1 months (95% CI: 14.5, 32.9); and in those with TAD > 300 Gy, 36.7 months (95% CI: 20.2, 43.9).
Conclusions
Global real-world data confirmed a significant association between TAD and OR and between TAD and OS in HCC patients treated with 90Y glass microspheres. With a low incidence, a relationship between ≥ Grade 3 hyperbilirubinemia and NTAD was not found.
Clinical trial identification
NCT03295006.
Editorial acknowledgement
Medical writing support was provided by Alexandra Greenberg-Worisek, PhD, MPH (Boston Scientific Corporation).
Legal entity responsible for the study
Boston Scientific Corporation.
Funding
Boston Scientific Corporation.
Disclosure
M. Lam: Financial Interests, Personal, Other, Consultant; Received Research Support: Boston Scientific; Financial Interests, Personal, Research Grant, Receives Research Sujpport: Terumo; Financial Interests, Personal and Institutional, Other, Personal - Research Support; Institutional - Royalties: Quirem Medical. R. Salem: Financial Interests, Personal, Other, Consultant; receives research grant support; serves on scientific advisory boards: Boston Scientific/BTG; Financial Interests, Personal, Other, Consultant; receives research grant support; serves on scientific advisory boards: Merit Medical; Financial Interests, Personal, Other, Consultant; receives research grant support; serves on scientific advisory boards: Terumo Medical; Financial Interests, Personal, Other, Receives research grant support; serves on scientific advisory board: Bayer/Onyx; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Elixis. E. Garin: Financial Interests, Personal, Other, Receives research grant funding; payment or honoraria; support for attending meetings/travel: Boston Scientific.