Contemporary Treatment and Survival Outcomes in Mantle Cell Lymphoma: A National Real-World Analysis From REALYSA, a...

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.