Abstract
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.
Original language | English (US) |
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Pages (from-to) | 341-344 |
Number of pages | 4 |
Journal | Clinical Lymphoma, Myeloma and Leukemia |
Volume | 12 |
Issue number | 5 |
DOIs | |
State | Published - Oct 2012 |
Externally published | Yes |
Keywords
- Clinical trial
- Deletion 5q
- Response
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research