Morgane Cheminant, Patrick Fogarty, Sylvain Carras, Clémentine Sarkozy, Cédric Rossi, Luc Fornecker, Bijou Fontanet, Adrien Chauchet, Sandra Leguyader-Peyrou, Laure Lebras, Lucie Oberic, Loïc Ysebaert, Ghandi Damaj, Gaelle Labouré, Ludovic Fouillet, Stéphanie Guidez, François Lemonnier, Krimo Bouabdallah, Thomas Gastinne, Nadine Morineau, Sandy Amorim, Fabrice Jardin, Julie Abraham, Roch Houot, Catherine Thieblemont, Franck Morschhauser, Rémy Gressin, Steven Le Gouill, Olivier Hermine, Fanny Cherblanc, Alain Monnereau, Aurélien Belot, Hervé Ghesquieres, Benoit Tessoulin
Although clinical trials showed outcomes improvement in MCL, their applicability to real-world practice remains limited. Using the prospective REALYSA registry (NCT03869619), we evaluated contemporary management, highlighting evolving practices and differences by age. Among 295 patients, 63% were ≥ 65 years, 48% had a high-risk MIPI score with Ki-67 ≥ 30% in 53% and aggressive morphology in 11%. Younger patients received high-dose cytarabine (93%) and ASCT (78%). Older patients were treated with bendamustine-rituximab (28%), R-CHOP (18%), and low-dose cytarabine (20%). Two-year event-free (EFS-2y) and overall (OS-2y) survivals were 80% and 89% in < 65y; 60% and 77% in ≥ 65y. Among 238 patients responders after induction, rituximab maintenance (RM) use was frequent but lower in older patients (88% vs. 76%). In time-dependent Cox models adjusted for age (< 65 vs. ≥ 65) and MIPI, RM was associated with a lower hazard of EFS events (HR 0.48; 95% CI: 0.25-0.92), although residual confounding related to treatment selection may remain. In the second-line setting (n = 72), most patients were POD24 (89%) and 56% received ibrutinib, yet outcomes remained poor (CR 24%, ORR 35%, median EFS and OS of 6.3 and 25.6 months, respectively). These findings underscore the need for improved strategies for older and high-risk patients. Retrospective landmark analyses suggest a potential association between RM and improved EFS but are limited by baseline differences between groups.