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PROACTIF is a French post-approval registry study investigating transarterial radioembolization (TARE) with yttrium-90 (Y-90) glass microspheres in the treatment of primary and metastatic liver tumors. The purpose of the study is to evaluate effectiveness, quality of life (QoL), safety and dosimetry data in real-world clinical settings. This prospective, open-label, non-interventional study includes patients treated with Y-90 in France, who were not opposed to data collection. Primary endpoints are overall survival (OS) and progression of QoL after treatment. All Grade ≥3 treatment-emergent adverse events (TEAEs), defined as occurring within 90 days after administration, and all serious adverse events (SAEs) within 12 months (M) were recorded. HCC patients (N=670) with a baseline assessment as of Jan 2023 were enrolled from 31 sites. Of those, 88.7% were male; median age was 70 years; 39.7% had solitary disease; mean index lesion size was 68.7 mm; 40.6% had portal vein thrombosis; 2.1%, 33.3%, 60.0% were BCLC A, B, C, respectively. The majority of patients were Child-Pugh A (80.3%) and ECOG 0 (55.5%). Selective (≤2 segments) and lobar administration was performed in 49.5% and 48.9%, respectively (first vial) with multicompartment dosimetry used in 73% of cases. Median OS was 20.8 M 95% CI: 18.3, 23.3; OS rates were 87.2% 84.2, 89.6 at 6 M, 69.9% 65.8, 73.6 at 12 M, 55.4% 50.8, 59.8 at 18 M, and 44.7% 39.8, 49.5 at 24M. Median OS by subgroup was 21.7 M 19.3, 25.2 and 16.0 M 13.7, 20.7 for unilobar and bilobar disease; 22.8 M 20.8, 29.2 and 18.5 M 15.9, 21.8 for selective and non-selective administration; 29.6 M 24.8,- and 16.4 M 13.8, 20.6 for ALBI 1/2 and 3; 29.6 M 20.8,- and 17.7 M 15.4, 21.3 for BCLC B and BCLC C. 42 patients experienced 60 TEAE (39 device/procedure related), 37 patients experienced 42 SAEs (22 device/procedure related). This interim analysis of HCC patients from the PROACTIF liver malignancy registry demonstrates that patients were appropriately selected and received personalized treatment, resulting in long survival, low adverse event rates, and a favorable risk-benefit profile. Future analyses will include intrahepatic cholangiocarcinoma and metastatic colorectal cancer. Final results are expected in 2025.
Garin et al. (Wed,) studied this question.
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