RENOIR phase 3 rituximab-lenalidomide vs rituximab as maintenance treatment in relapsed/refractory follicular lymphoma
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT: Maintenance treatment in older patients with relapsed or refractory (R/R) follicular lymphoma (FL) remains an area of investigation. RENOIR was a multicenter, phase 3, open-label randomized trial conducted by the Fondazione Italiana Linfomi (FIL) in older patients with R/R FL after 1 or 2 previous therapies. Patients achieving partial response or complete response (CR) after 4 to 6 cycles of standard rituximab (R)-based chemotherapy were randomized 1:1 to maintenance with R alone (standard arm) or R plus lenalidomide (R2; experimental arm). The primary end point was 2-year progression-free survival (PFS) from randomization, with an expected hazard ratio (HR) of 0.5. A total of 152 patients (median age, 71 years) were enrolled. After induction, 129 (85%) achieved an overall response (CR, 58%) and were randomized to R (n = 65) or R2 (n = 64). At a median follow-up of 68 months, the 2-year PFS was 73% in the R2 arm and 64% in the R arm. An unplanned hypothesis-generating subgroup analysis showed a greater 2-year PFS benefit with R2 in patients aged <70 years: R2, 96% vs R, 69%. Two-year overall survival rates were similar (R2, 80% vs R, 89%). Grade 3/4 adverse events were more frequent in R2, mainly neutropenia and gastrointestinal disorders. In conclusion, the primary end point of the study was not met, and R2 maintenance did not significantly improve 2-year PFS in older patients with R/R FL, although a numerical benefit was observed. R2 showed a more favorable benefit-risk profile in patients aged <70 years, whereas in older patients careful consideration of individual tolerability is warranted. This trial was registered at www.clinicaltrials.gov as NCT02390869.
Source: Blood Advances
Authors: Barbara Botto, Carola Boccomini, Andrea Evangelista, Vittorio Ruggero Zilioli, Antonella Anastasia, Federica Cavallo, Francesco Merli, Manuela Zanni, Monica Tani, Annalisa Chiarenza, Anna Marina Liberati, Annarita Conconi, Chiara Rusconi, Alessia Bari, Ilaria Del Giudice, Gianluca Gaidano, Michele Spina, Nilla Maschio, Claudia Castellino, Delia Rota-Scalabrini, Benedetta Puccini, Annalisa Arcari, Sara Bigliardi, Giorgia Matta, Benedetta Bianchi, Donato Mannina, Dario Marino, Piero Galieni, Fabrizio Ciambelli, Gerardo Musuraca, Cristina Muzi, Chiara Bottelli, Elisa Genuardi, Erika Meli, Simone Ferrero, Stefano Luminari, Marco Ladetto, Giovannino Ciccone, Umberto Vitolo
Institutions: Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, Piedmont Reference Center for Epidemiology and Cancer Prevention, Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, University of Turin, Azienda Sanitaria Unità Locale di Reggio Emilia, Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo, Ospedale "Santa Maria delle Croci" di Ravenna, Policlinico Universitario di Catania, Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", Azienda Ospedaliera S.Maria, Ospedale degli Infermi, Fondazione IRCCS Istituto Nazionale dei Tumori, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria di Modena, Policlinico Umberto I, Sapienza University of Rome, Università degli Studi del Piemonte Orientale “Amedeo Avogadro”, Azienda Ospedaliero Universitaria Maggiore della Carita, Centro di Riferimento Oncologico, Istituto Oncologico Veneto, Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo, Candiolo Cancer Institute, Azienda Ospedaliero-Universitaria Careggi, Guglielmo da Saliceto Hospital, Ospedale di Circolo e Fondazione Macchi, Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte, Ospedale di Circolo di Busto Arsizio, Azienda Socio Sanitaria Territoriale della Valle Olona, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,800
Awards: G387172998, G4727469100, G7768979985
OpenAlex ID: W7165882093