Early lenalidomide treatment for low and intermediate-1 International Prognostic Scoring System risk myelodysplastic syndromes with del(5q) before transfusion dependence.

Abstract

Lenalidomide is approved for the treatment of transfusion-dependent (TD) del(5q) myelodysplastic syndromes (MDS). However, few data are available in patients with transfusion-independent (TI) del(5q) MDS. In the first, observational, part of this 2-part study, we assessed the impact of transfusion dependence on overall survival (OS) and non-leukemic death in untreated del(5q) MDS patients who were TD (n = 136), TI with hemoglobin (Hb) ≥10 mg/dL (n = 88), or TI with Hb <10 mg/dL (n = 96). In the second, interventional, part we assessed the quality-of-life (QoL) benefits and clinical efficacy of lenalidomide (10 mg/day) in 12 patients with TI del(5q) MDS and Hb <10 mg/dL. In the untreated population, OS was significantly longer in TI than in TD patients (TI [Hb ≥10 g/dL], 108 months; TI [Hb <10 g/dL], 77 months; TD, 44 months). Transfusion dependence also negatively impacted non-leukemic death rates. In the interventional part of the study, baseline Hb levels were found to correlate significantly with physical (R = 0.666, P = 0.035) and fatigue (R = 0.604, P = 0.049) QoL scores. Median physical QoL scores improved significantly after 12 weeks' treatment with lenalidomide (+12.5; P = 0.020). Evaluable TI patients experienced early increases in Hb levels, and all attained an erythroid response. Our findings suggest that TI patients with moderate anemia may benefit from early treatment with lenalidomide.

• Authors: Esther N Oliva, Michael Lauseker, Maria Antonietta Aloe Spiriti, Antonella Poloni, Agostino Cortelezzi, Giuseppe A Palumbo, Enrico Balleari, Grazia Sanpaolo, Antonio Volpe, Alessandra Ricco, Francesca Ronco, Caterina Alati, Maria Grazia D'Errigo, Irene Santacaterina, Andrea Kündgen, Ulrich Germing, Roberto Latagliata
• Journal: Cancer medicine (Cancer Med) Vol. 4 Issue 12 Pg. 1789-97 (Dec 2015) ISSN: 2045-7634 [Electronic] United States
• PMID: 26376955 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Chemical References

• Biomarkers
• Immunologic Factors
• Thalidomide
• Lenalidomide

Topics

• Adult
• Aged
• Aged, 80 and over
• Biomarkers
• Chromosome Deletion
• Chromosomes, Human, Pair 5
• Female
• Follow-Up Studies
• Humans
• Immunologic Factors (administration & dosage, therapeutic use)
• Lenalidomide
• Male
• Middle Aged
• Myelodysplastic Syndromes (drug therapy, genetics, mortality)
• Prognosis
• Quality of Life
• Thalidomide (administration & dosage, analogs & derivatives, therapeutic use)
• Treatment Outcome