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Observational Study
. 2025 Feb;48(2):205-220.
doi: 10.1007/s00270-024-03955-y. Epub 2025 Jan 14.

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

M Ronot #  1 , R Loffroy #  2 , D Arnold  3 , M Greget  4 , C Sengel  5 , J B Pinaquy  6 , O Pellerin  7 , G Maleux  8 , B Peynircioglu  9 , J P Pelage  10 , N Schaefer  11 , B Sangro  12 , N de Jong  13 , B Zeka  14 , M Urdaniz  15 , T Helmberger  16 , V Vilgrain  1
Affiliations
Observational Study

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

M Ronot et al. Cardiovasc Intervent Radiol. 2025 Feb.

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.

Keywords: Colorectal liver metastases; Hepatocellular carcinoma; Liver; Reimbursement; Resin microspheres; Transarterial radioembolisation; Yttrium-90.

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Conflict of interest statement

Declarations. Conflict of interest: Valérie Vilgrain received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, and payment for expert testimony from Sirtex. Dirk Arnold received consulting fees and honoraria for presentations and lectures and travel support from Boston Scientific and Terumo, MSD, BMS, AstraZeneca, Roche, Servier, Sanofi and Merck Serono. He is on the guidelines committee of the European Society for Medical Oncology and supported oncopolicy manuscripts for the European Cancer Organisation. Maxime Ronot received honoraria for lectures from GE Healthcare, Ipsen, Canon-Toshiba, Alexion Pharmaceuticals, Guerbet, and Sirtex. Geert Maleux received honoraria for speaker’s bureau from Sirtex Medical and operated as a proctor for Sirtex. Bruno Sangro received grants or contracts from Sirtex and BMS, consulting fees from Adaptimmune, Astra Zeneca, Bayer, BMS, Boston Scientific, Eisai, Eli Lilly, Incyte, Ipsen, Roche, Sirtex Medical, Terumo; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astra Zeneca, Bayer, BMS, Eisai, Incyte, Ipsen, Roche, Sirtex Medical; Participation on a Data Safety Monitoring Board or Advisory Board from Adaptimmune, Astra Zeneca, Bayer, BMS, Boston Scientific, Eisai, Eli Lilly, Incyte, Ipsen, Roche, Sirtex Medical, Terumo, and has a leadership or fiduciary role in the International Liver Cancer Association. Michel Greget recieved honoraria from Sirtex as a lecturer in educationnal events and operated as a proctor for Sirtex. Romaric Loffroy received honoraria for lectures from Sirtex. Olivier Pellerin received honoraria for lectures from Merit Medical and he is co-founder of PERSEA. Thomas Helmberger, Christian Sengel, Niklaus Schaefer, Bora Peynircioglu, Maria Urdaniz, Bleranda Zeka and Niels de Jong had nothing to declare. Ethical Approval: All procedures performed in CIRT-FR were in accordance with the ethical standards of the national ethics committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study has been approved by the applicable ethics committee. Informed Consent: All participants signed an informed consent form.

Figures

Fig. 1
Fig. 1
Patient allocation by indication and by analysis group based on HAS reimbursement recommendations. *Reasons for patient exclusion were: treatment cancelled due to lack of tumour uptake of MAA during workup (n = 1), due to coil migration during workup (n = 1) and contraindication to perform hepatic radioembolisation due to a defect of arterialisation of secondary lesions (n = 1). For one patient no reason was provided. Three HCC and two CRLM patients could not be classified into analysis groups due to missing data. Abbreviations. (m)ITT: (modified) intention-to-treat; HAS: Haute Autorité de Santé; MAA: macroaggregated albumin; HCC: hepatocellular carcinoma; CRLM: colorectal liver metastases
Fig. 2
Fig. 2
Health-related quality of life (HRQoL) changes over time. The figure illustrates the change in HRQoL measured using the EORTC QLQ-C30 for HCC at 3 (n = 91), 6 (n = 48), 9 (n = 41) and 12 months (n = 29), and CRLM at 3 months (n = 25). Proportions of patients with changes larger than 10 points worse than baseline, larger than 10 points better or within this range are depicted in red, green and grey, respectively. Two-sided one-sample paired t-test p-values (or Wilcoxon signed-rank test p-values) were reported for the statistical significance of changes from baseline. Shapiro–Wilk test was used to test the normality assumptions on changes from baseline. A red star indicates a statistically significant (p < 0.05) worsening compared to baseline. A General scores encompassing functional, symptom and global health assessments. B A detailed breakdown of the functional scores, including physical, cognitive, role and social functioning. C A detailed breakdown of the symptom scores nausea/vomiting, fatigue, dyspnoea, pain, appetite loss, insomnia, diarrhoea and constipation. Abbreviations. HCC: hepatocellular carcinoma; CRLM: colorectal liver metastases; EORTC QLQ: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Fig. 3
Fig. 3
Overall survival (OS) for patients based on analysis groups. The figure shows OS plots using the Kaplan Meier method. Statistically significant differences between groups were assessed using the log-rank test. A OS of Group 1 (n = 144) and Group 2 (n = 46) HCC patients. B OS of Group 1 (n = 144), Group 2a (n = 21) and Group 2b (n = 25) HCC patients. P-values are as follows: Group 2b vs Group 1 p = 0.034, Group 2b vs Group 2a p = 0.001, Group 1 vs Group 2a p = 0.19. C OS of Group 3 (n = 10) and Group 4 (n = 47) CRLM patients. D OS of Group 3 (n = 10), Group 4a (n = 15) and Group 4b (n = 32) CRLM patients. P-values are as follows: Group 4b vs Group 3 p = 0.097, Group 4b vs Group 4a p = 0.008, Group 3 vs Group 4a p = 0.6. Abbreviations. HCC: hepatocellular carcinoma; CRLM: colorectal liver metastases
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