Lenalidomide in International Prognostic Scoring System Low and Intermediate-1 risk myelodysplastic syndromes with del(5q): An Italian phase II trial of health-related quality of life, safety and efficacy

Esther N. Oliva, Roberto Latagliata, Carmelo Laganà, Massimo Breccia, Sara Galimberti, Fortunato Morabito, Antonella Poloni, Enrico Balleari, Agostino Cortelezzi, Giuseppe Palumbo, Grazia Sanpaolo, Antonio Volpe, Giorgina Specchia, Carlo Finelli, Maria Grazia D'Errigo, Filippo Rodà, Caterina Alati, Giuliana Alimena, Francesco Nobile, Maria A. Aloe Spiriti

Research output: Contribution to journalArticle

Abstract

In lower-risk myelodysplastic syndromes (MDS) with del(5q), lenalidomide induces erythroid responses associated with better survival. In a phase II, single-arm trial, 45 patients with anemia and lower-risk del(5q) MDS received lenalidomide 10 mg/day to evaluate quality of life (QoL) changes, measured by QOL-E, safety, responses and survival. Lenalidomide was well tolerated, with 80% completing ≥ 24 weeks of treatment. Earlier study discontinuation was related to disease progression (n = 5), death (n = 1) and withdrawal of consent (n = 3). Within 24 weeks, 82% obtained erythroid responses, durable in 69% at 52 weeks. Cytogenetic responses occurred in 29 patients (64%), with 10 patients achieving a complete cytogenetic response. QoL-E scores correlated with hemoglobin levels and improved in erythroid responders. Erythroid responders had an 86% reduced risk of disease progression and an 80% reduction in mortality risk compared with non-responders. These findings corroborate earlier studies and give further support to the use of lenalidomide in lower-risk MDS and del(5q).

Original languageEnglish
Pages (from-to)2458-2465
Number of pages8
JournalLeukemia and Lymphoma
Volume54
Issue number11
DOIs
Publication statusPublished - 2013

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Keywords

  • Del(5q)
  • Health-related quality of life
  • Lenalidomide
  • Myelodysplastic syndromes
  • Safety

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Oliva, E. N., Latagliata, R., Laganà, C., Breccia, M., Galimberti, S., Morabito, F., Poloni, A., Balleari, E., Cortelezzi, A., Palumbo, G., Sanpaolo, G., Volpe, A., Specchia, G., Finelli, C., D'Errigo, M. G., Rodà, F., Alati, C., Alimena, G., Nobile, F., & Aloe Spiriti, M. A. (2013). Lenalidomide in International Prognostic Scoring System Low and Intermediate-1 risk myelodysplastic syndromes with del(5q): An Italian phase II trial of health-related quality of life, safety and efficacy. Leukemia and Lymphoma, 54(11), 2458-2465. https://doi.org/10.3109/10428194.2013.778406