Ronot M, Loffroy R, Arnold D, Greget M, Sengel C, Pinaquy J B, Pellerin O, Maleux G, Peynircioglu B, Pelage J P, Schaefer N, Sangro B, de Jong N, Zeka B, Urdaniz M, Helmberger T, Vilgrain V
Department of Radiology, Hôpital Beaujon APHP Nord, Université Paris Cité, Paris, CRI, INSERM, 1149, Clichy, France.
Department of Vascular and Interventional Radiology, Image-Guided Therapy Center, CHU Dijon Bourgogne, François-Mitterrand University Hospital, 14 Rue Gaffarel, 21000, Dijon, France.
Cardiovasc Intervent Radiol. 2025 Feb;48(2):205-220. doi: 10.1007/s00270-024-03955-y. Epub 2025 Jan 14.
This analysis of the CIRSE Registry for SIR-Spheres Therapy in France, CIRT-FR, reports on real-world outcomes of transarterial radioembolisation (TARE) with Y90 resin microspheres for hepatocellular carcinoma (HCC) and colorectal cancer liver metastases (CRLM) patients in France, focusing on safety, effectiveness and health-related quality of life (HRQoL). Results on patients treated based on national reimbursement criteria are discussed here.
Prospective, multicentre, observational study of HCC and CRLM patients treated between August 2017 and July 2020 with TARE Y90 resin microspheres. Patients were assigned to different analysis groups based on reimbursement recommendations. Follow-up period was at least 24 months with patient data collected every 3 months.
In total, 252 (193 HCC, 59 CRLM) patients of CIRT-FR were included in the analysis. No differences in effectiveness, safety and HRQoL were found between analysis groups based on reimbursement recommendations. Median overall survival for HCC and CRLM was 19.0 (95% CI, 16.1-22.4) and 10.8 (95% CI, 8.0-13.5) months, respectively. Serious procedure-related adverse events occurred in 13% of the patients. HRQoL generally remained stable, with some fluctuations in function scores and symptoms.
In our cohorts, patients performed similarly regarding clinical outcomes irrespective of their analysis group based on reimbursement recommendations. Our results suggest that instead of restrictive reimbursement criteria, more decision-making power in selecting suitable patient groups could be given to multidisciplinary tumour boards. Results confirm that TARE with Y90 resin microspheres is an effective and safe treatment for liver cancer, with maintained HRQoL in most patients.
本项针对法国SIR-Spheres治疗CIRSE注册研究(CIRT-FR)的分析报告了法国肝细胞癌(HCC)和结直肠癌肝转移(CRLM)患者使用钇-90树脂微球进行经动脉放射性栓塞(TARE)的真实世界结局,重点关注安全性、有效性和健康相关生活质量(HRQoL)。本文讨论了基于国家报销标准治疗的患者的结果。
对2017年8月至2020年7月期间接受TARE钇-90树脂微球治疗的HCC和CRLM患者进行前瞻性、多中心、观察性研究。根据报销建议将患者分配到不同的分析组。随访期至少24个月,每3个月收集患者数据。
CIRT-FR分析共纳入252例患者(193例HCC,59例CRLM)。基于报销建议的分析组之间在有效性、安全性和HRQoL方面未发现差异。HCC和CRLM的中位总生存期分别为19.0个月(95%CI,16.1 - 22.4)和10.8个月(95%CI,8.0 - 13.5)。13%的患者发生了严重的与手术相关的不良事件。HRQoL总体保持稳定,功能评分和症状有一些波动。
在我们的队列中,无论基于报销建议的分析组如何,患者在临床结局方面表现相似。我们的结果表明,与其采用限制性报销标准,不如赋予多学科肿瘤委员会更多选择合适患者群体的决策权。结果证实,钇-90树脂微球TARE是一种有效且安全的肝癌治疗方法,大多数患者的HRQoL得以维持。