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- Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study
Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study
Auteurs
Emmanuel Bachy, John F. Seymour, Pierre Feugier, Fritz Offner, Armando López-Guillermo, David Belada, Luc Xerri, John V. Catalano, Pauline Brice, François Lemonnier, Alejandro Martin, Olivier Casasnovas, Lars M. Pedersen, Véronique Dorvaux, David Simpson, Sirpa Leppa, Jean Gabarre, Maria G. da Silva, Sylvie Glaisner, Loic Ysebaert, Anne Vekhoff, Tanin Intragumtornchai, Steven Le Gouill, Andrew Lister, Jane A. Estell, Gustavo Milone, Anne Sonet, Jonathan Farhi, Harald Zeuner, Hervé Tilly, Gilles Salles
Résumé
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/m
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.