Long term follow up of the response adapted FOLL12 trial for patients with advanced stage follicular lymphoma: A study by the fondazione italiana linfomi (FIL).
作者:Maria Elena Nizzoli, Antonella Anastasia, Carola Boccomini, Jacopo Olivieri, Ilaria Del Giudice, Simone Ferrero, Paolo Corradini, Gianluca Gaïdano, Antonello Pinto, Benedetta Puccini, Marta Coscia, Marco Ladetto, Caterina Stelitano, Francesca Ricci, Silvia Bolis, Alessia Bari, Annarita Conconi, Annalisa Arcari, Gerardo Musuraca, Annalisa Chiarenza, Dondi Alessandra, Vittoria Tarantino, Guido Gini, Filippo Ballerini, Sabrina Zoli, Sara Galimberti, Luigi Marcheselli, Luca Arcaini, Stefano Luminari · 发表于:Blood · 年份:2025 · DOI:10.1182/blood-2025-1004 · 被引用次数:1 · 研究领域:Lymphoma Diagnosis and Treatment、Chronic Lymphocytic Leukemia Research、Cutaneous lymphoproliferative disorders research
Abstract Background. The FOLL12 study demonstrated that in High tumor burden patients with Follicular lymphoma (FL) treated with immunochemotherapy (ICT), standard rituximab maintenance (RM) was associated with improved Progression Free Survival (PFS) compared with a response-adapted post-induction approachbased on metabolic response and molecular assessment of minimal residual disease (MRD). We here present updated results of study endpoints after a median follow up of 7.9 years. Methods. The FOLL12 study enrolled adult patients with gr1-3a FL, advanced stage and high tumor burden. Eligible patients were randomly assigned to receive ICT with either R-CHOP or R-Bendamustine followed by standard RM or a response-adapted post-induction approachbased on metabolic response and molecular assessment of minimal residual disease (MRD).End of Induction (EOI) metabolic response was centrally defined applying the 5-point Deauville scale (DS) that defined Complete metabolic response (CMR) in case of DS 1-3. MRD was defined according to nested PCR assessment of IGH::BCL2 rearrangement on bone marrow and peripheral blood and was evaluated only for patients with a molecular marker (MM) at baseline assessment. Post induction therapy in the experimental arm consisted of: CMR and MRD- patients, observation; CMR and MRD+ (EOI or Follow up) 4 weekly rituximab until MRD- for up to 3 courses; no CMR, one dose of ibritumomab tiuxetan followed by standard RM. The primary study endpoint was Progressi...