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Multicenter Study
. 2021 Jan;44(1):36-49.
doi: 10.1007/s00270-020-02643-x. Epub 2020 Sep 25.

Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France

Romaric Loffroy  1 , Maxime Ronot  2 , Michel Greget  3 , Antoine Bouvier  4 , Charles Mastier  5 , Christian Sengel  6 , Lambros Tselikas  7 , Dirk Arnold  8 , Geert Maleux  9 , Jean-Pierre Pelage  10 , Olivier Pellerin  11 , Bora Peynircioglu  12 , Bruno Sangro  13 , Niklaus Schaefer  14 , María Urdániz  15 , Nathalie Kaufmann  16 , José Ignacio Bilbao  17 , Thomas Helmberger  18 , Valérie Vilgrain  2 ; CIRT-FR Principal Investigators
Collaborators, Affiliations
Multicenter Study

Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France

Romaric Loffroy et al. Cardiovasc Intervent Radiol. 2021 Jan.

Abstract

Purpose: Radioembolization has emerged as a treatment modality for patients with primary and secondary liver tumours. This observational study CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France) aims to evaluate real-life clinical practice on all patients treated with transarterial radioembolization (TARE) using SIR-Spheres yttrium-90 resin microspheres in France. In this interim analysis, safety and quality of life data are presented. Final results of the study, including secondary effectiveness outcomes, will be published later. Overall, CIRT-FR is aiming to support French authorities in the decision making on reimbursement considerations for this treatment.

Methods: Data on patients enrolled in CIRT-FR from August 2017 to October 2019 were analysed. The interim analysis describes clinical practice, baseline characteristics, safety (adverse events according to CTCTAE 4.03) and quality of life (according to EORTC QLQ C30 and HCC module) aspects after TARE.

Results: This cohort included 200 patients with hepatocellular carcinoma (114), metastatic colorectal cancer (mCRC; 38) and intrahepatic cholangiocarcinoma (33) amongst others (15). TARE was predominantly assigned as a palliative treatment (79%). 12% of patients experienced at least one adverse event in the 30 days following treatment; 30-day mortality was 1%. Overall, global health score remained stable between baseline (66.7%), treatment (62.5%) and the first follow-up (66.7%).

Conclusion: This interim analysis demonstrates that data regarding safety and quality of life generated by randomised-controlled trials is reflected when assessing the real-world application of TARE.

Trial registration: Clinical Trials.gov NCT03256994.

Keywords: Interim analysis; Radioembolization; SIR-spheres; SIRT; Transarterial radioembolization; Yttrium-90.

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Conflict of interest statement

RL, MG reported consultancy to SIRTEX Medical; LT received speaker fees from SIRTEX Medical and fees from Boston Scientific, Amgen, Ipsen and GE healthcare as well as grants from BMS and Terumo Medical; DA received consulting fees and speaker honoraria from Terumo, Boston Scientific, SIRTEX Medical and Biocompatibles; GM and JIB reported to act as proctor and speaker for SIRTEX; J-PP was speaker at the SIRTEX symposium and investigator of SIRFLOX and SARAH studies, consultant for Merit Medical, Terumo and Guerbet and received research grants from Guerbet and Merit Medical; BP reported occasional proctor activities for SIRTEX Medical; BS received lecture and/or consulting fees from Adaptimmune, Bayer, BMS, BTG, Eisai, Ipsen, Lilly, Roche and Sirtex, research fees from BMS and SIRTEX Medical. VV received speaker fees from SIRTEX Medical, Supersonic Imagine, Canon, as well as grants from Guerbet. MR, AB, CM, CS, OP, NS, MU, NK, TH declared no conflict of interest. All authors report no conflict of interest directly related to the submitted work.

Figures

Fig. 1
Fig. 1
Health-related quality of life over time (EORTC-QLQ 30). Shows HRQOL score of 46 patients (A-F) and 25 patients (G, H) collected at baseline (before the first treatment), right after treatment (within 1 week later) and at the first follow-up (13 weeks after treatment on average) by analysing global health (A, B), functionality (C, D), symptoms (E, F) and HCC18 module (G, H) score according to EORTC-QLQ30 version 3.0 and the EORTC QLQ-HCC18 version 2.0. For the global health and the functional score, a high score indicates high health and for the symptoms and HCC18 scale a low score indicates few symptoms and better HRQOL, respectively. For general comparisons between baseline to right after treatment and baseline to the first follow-up, boxplots were used (A, C, E, G). The difference between baseline to right after treatment (black) and baseline to first follow-up (light colour) was plotted for individual patients using a waterfall diagram (B, D, F, H). Cut-offs (dashed line) for clinically significant improvement were set at + 10 for global health, functional score, − 10 for symptoms score, HCC18 module and at -10 for global health, functional score and + 10 for symptoms score, HCC18 module for deterioration
See this image and copyright information in PMC

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