A phase II study of lenalidomide alone in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes with chromosome 5 abnormalities.

Abstract

UNLABELLED:

This phase II study assessed the efficacy and safety of lenalidomide in patients with relapsed/refractory acute myeloid leukemia (N = 18) and high-risk myelodysplastic syndrome (N = 9) with chromosome 5 abnormalities. The overall complete remission rate with or without platelet recovery was 7% (2/27). Activity of lenalidomide was limited to patients with noncomplex cytogenetics.

BACKGROUND:

Lenalidomide is effective in low-risk myelodysplastic syndromes (MDS) with deletion 5q. We conducted a phase II study to evaluate the safety and efficacy of lenalidomide in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk MDS with any chromosome 5 abnormality.

PATIENTS AND METHODS:

Eighteen adults with AML and 9 with high-risk MDS were enrolled. Lenalidomide was given orally at doses 5 to 25 mg daily for 21 days of a 28-day cycle until disease progression or unacceptable adverse event.

RESULTS:

Median age for all 27 patients was 64 years (range, 39-88 years) with a median of 2 previous therapies (range, 1-6 lines). Two patients (7%) with AML and 5q deletion and +8 cytogenetic abnormality in 2 separate clones achieved complete remission (CR) or CR without platelet recovery (CRp). Response durations were 4 and 6 months, respectively. No responses were seen in patients with chromosome 5 abnormality in a complex cytogenetic background. Twenty patients (74%) developed neutropenic fever or infection requiring hospitalization.

CONCLUSIONS:

Clinical activity of lenalidomide as single agent in AML and high-risk MDS with chromosome 5 abnormalities appears to be limited to patients with noncomplex cytogenetics.

• Authors: Yiming Chen, Hagop Kantarjian, Zeev Estrov, Stefan Faderl, Farhad Ravandi, Kristy Rey, Jorge Cortes, Gautam Borthakur
• Journal: Clinical lymphoma, myeloma & leukemia (Clin Lymphoma Myeloma Leuk) Vol. 12 Issue 5 Pg. 341-4 (Oct 2012) ISSN: 2152-2669 [Electronic] United States
• PMID: 22579233 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Inc. All rights reserved.

Chemical References

• Thalidomide
• Lenalidomide

Topics

• Adult
• Aged
• Aged, 80 and over
• Chromosome Aberrations
• Chromosome Deletion
• Chromosomes, Human, Pair 5
• Female
• Humans
• Lenalidomide
• Leukemia, Myeloid, Acute (drug therapy, genetics)
• Male
• Middle Aged
• Myelodysplastic Syndromes (drug therapy, genetics)
• Recurrence
• Risk Factors
• Thalidomide (adverse effects, analogs & derivatives, therapeutic use)
• Treatment Outcome