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Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study

E. Bachy, JF. Seymour, P. Feugier, F. Offner, A. López-Guillermo, D. Belada, L. Xerri, JV. Catalano, P. Brice, F. Lemonnier, A. Martin, O. Casasnovas, LM. Pedersen, V. Dorvaux, D. Simpson, S. Leppa, J. Gabarre, MG. da Silva, S. Glaisner, L....

. 2019 ; 37 (31) : 2815-2824. [pub] 20190724

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc20023534

PURPOSE: The PRIMA study (ClinicalTrials.gov identifier: NCT00140582) established that 2 years of rituximab maintenance after first-line immunochemotherapy significantly improved progression-free survival (PFS) in patients with follicular lymphoma compared with observation. Here, we report the final PFS and overall survival (OS) results from the PRIMA study after 9 years of follow-up and provide a final overview of safety. METHODS: Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma were nonrandomly assigned to receive one of three immunochemotherapy induction regimens. Responding patients were randomly assigned (stratified by induction regimen, response to induction treatment, treatment center, and geographic region) 1:1 to receive 2 years of rituximab maintenance (375 mg/m2, once every 8 weeks), starting 8 weeks after the last induction treatment, or observation (no additional treatment). All patients in the extended follow-up provided their written informed consent (data cutoff: December 31, 2016). RESULTS: In total, 1,018 patients completed induction treatment and were randomly assigned to rituximab maintenance (n = 505) or observation (n = 513). Consent for the extended follow-up was provided by 607 patients (59.6%) of 1,018 (rituximab maintenance, n = 309; observation, n = 298). After data cutoff, median PFS was 10.5 years in the rituximab maintenance arm compared with 4.1 years in the observation arm (hazard ratio, 0.61; 95% CI, 0.52 to 0.73; P < .001). No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40; P = .7948); 10-year OS estimates were approximately 80% in both study arms. No new safety signals were observed. CONCLUSION: Rituximab maintenance after induction immunochemotherapy provides a significant long-term PFS, but not OS, benefit over observation.

Centre Henri Becquerel Rouen France

Centre Hospitalier Régional Universitaire de Nancy Université de Lorraine INSERM 1256 Nancy France

Centre Hospitalier Universitaire d'Angers Angers France

Centre Hospitalier Universitaire de Nantes Centre de Recherche en Cancérologie et Immunologie Nantes Angers INSERM Université de Nantes Nantes France

Charles University Hradec Králové Czech Republic

Chulalongkorn University Bangkok Thailand

Concord Hospital Concord University of Sydney New South Wales Australia

Department of Haematology and INSERM 1231 University Hospital F Mitterrand Dijon France

F Hoffman La Roche Basel Switzerland

Frankston Hospital and Monash University Frankston Victoria Australia

Fundaleu Buenos Aires Argentina

Ghent University Ghent Belgium

Helsinki University Hospital University of Helsinki Helsinki Finland

Herlev University Hospital Copenhagen Denmark

Hôpital de Mercy Centre Hospitalier Régional Metz Thionville Metz France

Hôpital Pitié Salpêtrière Paris France

Hôpital Saint Louis Assistance Publique Hôpitaux de Paris Paris France

Hôpitaux Universitaires Henri Mondor Université Paris Est Créteil INSERM U955 Créteil France

Hospices Civils de Lyon Université Claude Bernard Lyon 1 Institut National de la Santé et de la Recherche Médicale 1052 Pierre Bénite France

Hospital Clinic Barcelona Spain

Hospital Universitario de Salamanca Institute for Biomedical Research of Salamanca Centro de Investigación Biomédica en Red de Cáncer Salamanca Spain

Institut Curie Hôpital Rene Huguenin Saint Cloud France

Institut Paoli Calmettes Aix Marseille Université Marseille France

Institut Universitaire du Cancer de Toulouse Oncopole Toulouse France

North Shore Hospital Auckland New Zealand

Portuguese Institute of Oncology Lisbon Portugal

Queen Mary University of London London United Kingdom

Royal Melbourne Hospital and University of Melbourne Melbourne Victoria Australia

Saint Antoine Hospital Assistance Publique Hôpitaux de Paris Paris France

UCL Mont Godinne Yvoir Belgium

Citace poskytuje Crossref.org

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