Effectiveness and safety of selective internal radiation therapy using yttrium-90 glass microspheres for hepatocellular carcinoma: real-world results from the multi-center prospective PROACTIF cohort of 989 patients

作者：Boris Guiu, Clément Bailly, Eric Vibert, Ghoufrane Tlili, Denis Mariano-Goulart, Julien Edeline, Yann Touchefeu, Emmanuel Durand, Jean Frédéric Blanc, Julia Chalaye, Hélène Regnault, Antoine Bouvier, Géraldine Sergent, Christian Sengel, Stéphane Renaud, Agnès Rode, Claude Somma, P. Chevallier, Vincent Habouzit, I. Brenot-Rossi, Anthony Dohan, Lambros Tselikas, Thierry Debaere, Sylvain Manfredi, Arnaud Dieudonné, Kirk Fowers, Éveline Boucher, Binal Patel, Eric Vicaut, Étienne Garin, Etienne Garin, Emmanuel Durand, Olivier Meyrignac, Clara Prud’homme, Gilles Grimon, Anthony Dohan, Maxime Barat, Raphaël Dautry, Julia Chalaye, Hélène Regnault, Hicham Kobeiter, Haytham Derbel, Eric Vicaut, Eric Vibert, Olivier Rosmorduc, Anton Pachev, Thomas Aparicio, Laëtitia Vercellino, Etienne Garin, Etienne Garin, Julien Edeline, Y. Rolland, J. Farce, Samuel Lesourd, Xavier Palard-Novello, Inna Dygai‐Cochet, François Godard, Romain Popoff, Julie Pellegrinelli, Arnaud Dieudonné, Stéphanie Becker, Stéphane Renaud, Aymeric Guibal, Mohamed Abdel-Rehim, F. Khemissa Akouz, Sibel Isal, Charles Mastier, Arnaud Muller, Guillaume Guthier, Paul Calame, Hatem Boulahdour, Vincent Di Martino, Elodie Chevalier, Valérie Laurent, Xavier Orry, Thierry Yzet, Eric Nguyen-Khac, Vandici Ovidiu-Florian, Chalabia Fergani, Antoine Bouvier, Pacôme Fosse, Frédéric Oberti, Ghoufrane Tlili, Jean Frédéric Blanc, Panteleimon Papadopoulos, Ronan Abral, Antoine Boizet, Jean Romain Risson, Sylvain Manfredi, François Ghiringhelli, Romaric Loffroy, Michel Greget, F. Hubelé, Claude Somma, Olivier Durieux, Géraldine Sergent, C. Baillet, Massih Ningarhari, Christian Sengel, Julie Roux, Julien Ghelfi, Thomas Decaens, Clément Bailly, Yann Touchefeu, Fréderic Douane, Matthieu Barbaud, P. Chevallier, Mohamed El Zibawi, Philippe Viaud, M. Razzouk, Jean Goupil, M. Sainmont, Jean-Marie Peron, Philippe Otal, Fatima-Zohra Mokrane, David Sefrioui, Frederic Di Fiore, Vincent Habouzit, Rémi Grange, Jean Marc Phelip, Jean-Pierre Tasu, David Tougeron, R. Perdrisot, I. Brenot-Rossi, Gilles Piana, Brice Chanez, Daniel Ouk, Clément Mennetrey, Franck Grillet, Amine Bouhamama, Sandrine Parisse-Di Martino, Marco Dioguardi Burgio, Maxime Ronot, Rachida Lebtahi, Mohammed Bouattour, Laurent Milot, Jérôme Dumortier, Boris Guiu, Denis Mariano-Goulart, Eric Assénat, Carole Allimant, C. Kühn, Marjolaine Fourcade, Agnès Rode, Philippe Merle, Jean Palussière, Vincent Prega-Renaud, Thierry De Baere, Lambros Tselikas, Iulian Enescu · 发表于：EClinicalMedicine · 年份：2026 · DOI：10.1016/j.eclinm.2026.103884 · 被引用次数：4 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Effects of Radiation Exposure、Advanced Radiotherapy Techniques

Background: Selective Internal Radiation Therapy with yttrium-90 (Y90) has been used for decades, yet guideline recommendations remain inconsistent. High-quality real-world data is needed to guide practice. The objectives of this study were to evaluate effectiveness, safety, and patient quality of life (QoL) with TheraSphere™ treatment in real-world clinical practice, and to identify clinical and dosimetric factors associated with survival. Methods: PROACTIF was a prospective, open label, non-interventional, all-comers cohort study that recruited patients who received Y90 glass microspheres (TheraSphere™) per local standard of care across 34 French sites (January 2019-January 2024). Co-primary endpoints were overall survival (OS) and QoL. Secondary endpoints included safety, conversion to surgery, and factors associated with OS. OS and time-to-deterioration in QoL (Functional Assessment of Cancer Therapy-Hepatobiliary) were assessed by Kaplan-Meier analysis. Adverse events were descriptively summarized using Common Terminology Criteria for Adverse Events, version 5. Trial registration: ClinicalTrials.gov Identifier, NCT04069468. Findings: Amongst 989 HCC patients, 13·3%/18·9%/57·9%/5·8% were Barcelona Clinic Liver Cancer (BCLC) A/B/C/D, respectively; 35·3% had portal-vein tumor thrombosis (PVT); 74·4% were treated using multicompartment dosimetry, and 53·6% with selective Y90 administration. Mean index lesion dose was 435·4 Gy. For all patients, median OS (mOS) [95% CI] was 2...