Transarterial Radioembolisation with Y90 Resin Microspheres and the Effect of Reimbursement Criteria in France: Final Results of the CIRT-FR Prospective Observational Study.

IF 2.8 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS CardioVascular and Interventional Radiology Pub Date : 2025-02-01 Epub Date: 2025-01-14 DOI:10.1007/s00270-024-03955-y
M Ronot, R Loffroy, D Arnold, M Greget, C Sengel, J B Pinaquy, O Pellerin, G Maleux, B Peynircioglu, J P Pelage, N Schaefer, B Sangro, N de Jong, B Zeka, M Urdaniz, T Helmberger, V Vilgrain
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Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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Y90树脂微球经动脉放射栓塞和法国报销标准的影响:CIRT-FR前瞻性观察研究的最终结果。
目的:本研究分析了法国CIRSE sir微球治疗注册表(CIRT-FR),报告了法国肝细胞癌(HCC)和结直肠癌肝转移(CRLM)患者使用Y90树脂微球经动脉放射栓塞(TARE)治疗的实际结果,重点关注安全性、有效性和健康相关生活质量(HRQoL)。本文讨论了根据国家报销标准治疗的患者的结果。方法:对2017年8月至2020年7月期间接受TARE Y90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个月收集一次患者资料。结果:共纳入252例(HCC 193例,CRLM 59例)CIRT-FR患者。根据报销建议,分析组之间在有效性、安全性和HRQoL方面没有发现差异。HCC和CRLM的中位总生存期分别为19.0 (95% CI, 16.1-22.4)和10.8 (95% CI, 8.0-13.5)个月。13%的患者发生了严重的手术相关不良事件。HRQoL总体保持稳定,功能评分和症状有一些波动。结论:在我们的队列中,基于报销建议,无论分析组如何,患者在临床结果方面表现相似。我们的研究结果表明,在选择合适的患者群体时,可以给予多学科肿瘤委员会更多的决策权,而不是限制性的报销标准。结果证实,TARE联合Y90树脂微球治疗肝癌是一种有效、安全的治疗方法,大多数患者的HRQoL维持正常。
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来源期刊
CiteScore
5.50
自引率
13.80%
发文量
306
审稿时长
3-8 weeks
期刊介绍: CardioVascular and Interventional Radiology (CVIR) is the official journal of the Cardiovascular and Interventional Radiological Society of Europe, and is also the official organ of a number of additional distinguished national and international interventional radiological societies. CVIR publishes double blinded peer-reviewed original research work including clinical and laboratory investigations, technical notes, case reports, works in progress, and letters to the editor, as well as review articles, pictorial essays, editorials, and special invited submissions in the field of vascular and interventional radiology. Beside the communication of the latest research results in this field, it is also the aim of CVIR to support continuous medical education. Articles that are accepted for publication are done so with the understanding that they, or their substantive contents, have not been and will not be submitted to any other publication.
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