Safety and Efficacy of 166 Ho Radioembolization in Hepatocellular Carcinoma: The HEPAR Primary Study

The Journal of Nuclear Medicine

article

Margot T.M. Reinders¹  Karel J. van Erpecum²  Maarten L.J. Smits¹  Arthur J.A.T. Braat¹  Joep de Bruijne²  Rutger Bruijnen¹  Dave Sprengers³  Robert A. de Man³  Erik Vegt⁴  Jan N.M. IJzermans⁵  Adriaan Moelker⁴  Marnix G.E.H. Lam¹ 

[1] Department of Radiology and Nuclear Medicine, University Medical Centre, Utrecht University;Department of Gastroenterology and Hepatology University Medical Centre, Utrecht University;Department of Gastroenterology and Hepatology, Erasmus MC–University Medical Centre;Department of Radiology and Nuclear Medicine, Erasmus MC–University Medical Centre;Department of Surgery, Erasmus MC–University Medical Centre

关键词: hepatocellular carcinoma;    radioembolization;    holmium;    oncology;    locoregional treatment;   

DOI  :  10.2967/jnumed.122.263823

学科分类：医学（综合）

来源: Society of Nuclear Medicine

【 摘 要 】

The safety and efficacy of 166Ho radioembolization was first determined in the HEPAR and HEPAR II studies, which, however, excluded patients with hepatocellular carcinoma (HCC). The aim of this prospective clinical early phase II study was to establish the toxicity profile of 166Ho radioembolization in patients with measurable, liver-dominant HCC; Barcelona clinic liver cancer stage B or C; a Child–Pugh score of no more than B7; and an Eastern Cooperative Oncology Group performance status of 0–1 without curative treatment options. Methods: The primary endpoint was a rate of unacceptable toxicity defined as grade 3 hyperbilirubinemia (Common Terminology Cancer Adverse Events, version 4.03) in combination with a low albumin or ascites level in the absence of disease progression or treatment-related serious adverse events. Secondary endpoints included overall toxicity, response, survival, change in α-fetoprotein, and quality of life. Thirty-one patients with Barcelona clinic liver cancer stage B (71%) or C (29%) HCC were included, mostly multifocal (87%) or bilobar (55%) disease. Results:10%) included an aspartate transaminase and γ-glutamyltransferase increase (16%), hyperglycemia (19%), and lymphopenia (29%). Treatment-related unacceptable toxicity occurred in 3 of 31 patients. At 3 mo, 54% of target lesions showed a complete or partial response according to modified RECIST. Median overall survival was 14.9 mo (95% CI, 10.4–24.9 mo). No significant changes in quality of life or pain were observed. Conclusion: The safety of 166Ho radioembolization was confirmed in HCC, with less than 10% unacceptable toxicity. Efficacy data support further evaluation.

【 授权许可】

CC BY