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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1789-1797
Number of pages9
JournalCancer Medicine
Volume4
Issue number12
DOIs
Publication statusPublished - 2015

Fingerprint

Myelodysplastic Syndromes
Hemoglobins
Quality of Life
Therapeutics
Survival
lenalidomide
Fatigue
Anemia
Mortality
Chromosome 5q Deletion Syndrome
Population

Keywords

  • 5q deletion syndrome
  • anemia
  • lenalidomide
  • myelodysplastic syndromes
  • quality of life

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Early lenalidomide treatment for low and intermediate-1 International Prognostic Scoring System risk myelodysplastic syndromes with del(5q) before transfusion dependence. / Oliva, Esther N.; Lauseker, Michael; Aloe Spiriti, Maria Antonietta; Poloni, Antonella; Cortelezzi, Agostino; Palumbo, Giuseppe A.; Balleari, Enrico; Sanpaolo, Grazia; Volpe, Antonio; Ricco, Alessandra; Ronco, Francesca; Alati, Caterina; D'Errigo, Maria Grazia; Santacaterina, Irene; Kündgen, Andrea; Germing, Ulrich; Latagliata, Roberto.

In: Cancer Medicine, Vol. 4, No. 12, 2015, p. 1789-1797.

Research output: Contribution to journalArticle

Oliva, EN, Lauseker, M, Aloe Spiriti, MA, Poloni, A, Cortelezzi, A, Palumbo, GA, Balleari, E, Sanpaolo, G, Volpe, A, Ricco, A, Ronco, F, Alati, C, D'Errigo, MG, Santacaterina, I, Kündgen, A, Germing, U & Latagliata, R 2015, 'Early lenalidomide treatment for low and intermediate-1 International Prognostic Scoring System risk myelodysplastic syndromes with del(5q) before transfusion dependence', Cancer Medicine, vol. 4, no. 12, pp. 1789-1797. https://doi.org/10.1002/cam4.523
Oliva, Esther N. ; Lauseker, Michael ; Aloe Spiriti, Maria Antonietta ; Poloni, Antonella ; Cortelezzi, Agostino ; Palumbo, Giuseppe A. ; Balleari, Enrico ; Sanpaolo, Grazia ; Volpe, Antonio ; Ricco, Alessandra ; Ronco, Francesca ; Alati, Caterina ; D'Errigo, Maria Grazia ; Santacaterina, Irene ; Kündgen, Andrea ; Germing, Ulrich ; Latagliata, Roberto. / Early lenalidomide treatment for low and intermediate-1 International Prognostic Scoring System risk myelodysplastic syndromes with del(5q) before transfusion dependence. In: Cancer Medicine. 2015 ; Vol. 4, No. 12. pp. 1789-1797.
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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.",
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