A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study
Lam, Marnix; Garin, Etienne; Maccauro, Marco; Kappadath, S. Cheenu; Sze, Daniel Y.; Turkmen, Cuneyt; Cantasdemir, Murat; Haste, Paul; Herrmann, Ken; Alsuhaibani, Hamad Saleh; Dreher, Matthew; Fowers, Kirk D.; Salem, Riad
(2022) European Journal of Nuclear Medicine and Molecular Imaging, volume 49, issue 10, pp. 3340 - 3352
(Article)
Abstract
Purpose: To investigate the relationships between tumor absorbed dose (TAD) or normal tissue absorbed dose (NTAD) and clinical outcomes in hepatocellular carcinoma (HCC) treated with yttrium-90 glass microspheres. Methods: TARGET was a retrospective investigation in 13 centers across eight countries. Key inclusion criteria: liver-dominant HCC with or without portal vein
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thrombosis, < 10 tumors per lobe (at least one ≥ 3 cm), Child–Pugh stage A/B7, BCLC stages A–C, and no prior intra-arterial treatment. Multi-compartment pre-treatment dosimetry was performed retrospectively. Primary endpoint was the relationship between ≥ grade 3 hyperbilirubinemia (such that > 15% of patients experienced an event) without disease progression and NTAD. Secondary endpoints included relationships between (1) objective response (OR) and TAD, (2) overall survival (OS) and TAD, and (3) alpha fetoprotein (AFP) and TAD. Results: No relationship was found between NTAD and ≥ grade 3 hyperbilirubinemia, which occurred in 4.8% of the 209 patients. The mRECIST OR rate over all lesions was 61.7%; for the target (largest) lesion, 70.8%. Responders and non-responders had geometric mean total perfused TADs of 225.5 Gy and 188.3 Gy (p = 0.048). Probability of OR was higher with increasing TAD (p = 0.044). Higher TAD was associated with longer OS (HR per 100 Gy increase = 0.83, 95% CI: 0.71–0.95; p = 0.009). Increased TAD was associated with higher probability of AFP response (p = 0.046 for baseline AFP ≥ 200 ng/mL). Conclusion: Real-world data confirmed a significant association between TAD and OR, TAD and OS, and TAD and AFP response. No association was found between ≥ grade 3 hyperbilirubinemia and NTAD. Trial registration number: NCT03295006.
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Keywords: Dosimetry, Hepatocellular carcinoma, Radioembolization, Yttrium-90, alpha-Fetoproteins, Carcinoma, Hepatocellular/pathology, Humans, Treatment Outcome, Embolization, Therapeutic/adverse effects, Microspheres, Liver Neoplasms/pathology, Hyperbilirubinemia/drug therapy, Retrospective Studies, Yttrium Radioisotopes/therapeutic use, Radiology Nuclear Medicine and imaging, Research Support, Non-U.S. Gov't, Journal Article
ISSN: 1619-7070
Publisher: Springer-Verlag
Note: Funding Information: This study was funded by BTG International/Boston Scientific Corporation. Funding Information: We thank Joe Thornton (Boston Scientific Corporation) for study oversight, Nikhil Chauhan, PhD and Samantha Ryan, MSc (Boston Scientific Corporation) for statistical support, Eveline Boucher for medical guidance, and Alexandra J. Greenberg-Worisek, PhD, MPH (Boston Scientific Corporation) for medical writing assistance. Funding Information: Ken Herrmann, MD: Reports personal fees from Bayer, personal fees and other from Sofie Biosciences, personal fees from SIRTEX, non-financial support from ABX, personal fees from Adacap, personal fees from Curium, personal fees from Endocyte, grants and personal fees from BTG, personal fees from IPSEN, personal fees from Siemens Healthineers, personal fees from GE Healthcare, personal fees from Amgen, personal fees from Novartis, personal fees from ymabs, personal fees from Aktis Oncology, personal fees from Theragnostics, personal fees from Pharma15, outside the submitted work. Publisher Copyright: © 2022, The Author(s).
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