Details

Autor(en) / Beteiligte

• Santini, Valeria
• Giagounidis, Aristoteles
• Pelligra, Christopher G.
• Franco-Villalobos, Conrado
• Tang, Derek
• Morison, Jessica
• Beach, CL
• Hu, Angela
• Platzbecker, Uwe
• Fenaux, Pierre

Titel

Impact of Lenalidomide Treatment on Overall Survival in Patients With Lower-Risk, Transfusion-Dependent Myelodysplastic Syndromes

Ist Teil von

• Clinical lymphoma, myeloma and leukemia, 2022-09, Vol.22 (9), p.e874-e883

Ort / Verlag

Elsevier Inc

Erscheinungsjahr

2022

Quelle

ScienceDirect Journals (5 years ago - present)

Beschreibungen/Notizen

• •Survival is rarely a primary endpoint in lower-risk-MDS (LR-MDS) trials but should be considered.•Achieving transfusion independence with LEN treatment correlated with longer OS.•Increased serum ferritin was significantly associated with shorter OS.•Therapies significantly reducing transfusion burden can have a positive impact on OS.•OS should be considered as an endpoint in future LR- MDS clinical trials. For patients with lower-risk (LR) myelodysplastic syndromes (MDS), overall survival (OS) is rarely a primary clinical trial endpoint. Treatments such as lenalidomide can reduce red blood cell (RBC) transfusion burden (TB) and serum ferritin, but the long-term impact on OS remains undetermined. Data from 3 trials evaluating lenalidomide in patients with LR-MDS (the phase 2 MDS-003 and phase 3 MDS-004 trials in del[5q]; the phase 3 trial MDS-005 in non-del[5q] patients) were pooled. Predictors of OS were assessed by multivariate analysis using time-dependent models for TB and RBC transfusion independence (RBC-TI), and a landmark analysis of RBC-TI at 17 weeks. Separate analyses using MDS-004 and MDS-005 data determined the relationship between OS and serum ferritin. Median follow-up for MDS-003, MDS-004, and MDS-005 was 3.2, 3.0, and 1.7 years, respectively. In multivariate analyses, transfusion of ≥6 RBC units over 8 weeks was a significant predictor of shorter OS vs. 0 units in the time-dependent TB model (hazard ratio [HR] 4.65; 95% confidence interval [CI] 3.32-6.52; P < .0001). RBC-TI achievement was associated with prolonged OS in the time-dependent (HR 0.48; 95% CI 0.37-0.62; P < .0001) and landmark model (HR 0.57; 95% CI 0.44-0.75; P < .0001). Increased serum ferritin was associated with shorter OS (P < .0001). This analysis of prospective trial data in patients with LR-MDS confirms lenalidomide may improve OS by reducing TB and serum ferritin. OS should be considered as an endpoint in future lower risk MDS clinical trials. Overall survival (OS) is rarely a primary endpoint in lower-risk myelodysplastic syndromes (LR-MDS) clinical trials. Predictors of OS were assessed in 592 patients from 3 trials of lenalidomide in transfusion-dependent LR-MDS. Transfusion independence and increased serum ferritin was associated with longer and shorter OS, respectively. These findings confirm OS should be considered as an endpoint in future trials.