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

Yiming Chen, Hagop Kantarjian, Zeev Estrov, Stefan Faderl, Farhad Ravandi, Kristy Rey, Jorge Cortes, Gautam Borthakur

Research output: Contribution to journalArticle

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 languageEnglish (US)
Pages (from-to)341-344
Number of pages4
JournalClinical Lymphoma, Myeloma and Leukemia
Volume12
Issue number5
DOIs
StatePublished - Oct 1 2012
Externally publishedYes

Fingerprint

Chromosomes, Human, Pair 5
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Chromosome Aberrations
Cytogenetics
lenalidomide
Disease Progression
Hospitalization
Fever
Blood Platelets
Clone Cells
Safety
Infection

Keywords

  • Clinical trial
  • Deletion 5q
  • Response

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

A phase II study of lenalidomide alone in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes with chromosome 5 abnormalities. / Chen, Yiming; Kantarjian, Hagop; Estrov, Zeev; Faderl, Stefan; Ravandi, Farhad; Rey, Kristy; Cortes, Jorge; Borthakur, Gautam.

In: Clinical Lymphoma, Myeloma and Leukemia, Vol. 12, No. 5, 01.10.2012, p. 341-344.

Research output: Contribution to journalArticle

Chen, Yiming ; Kantarjian, Hagop ; Estrov, Zeev ; Faderl, Stefan ; Ravandi, Farhad ; Rey, Kristy ; Cortes, Jorge ; Borthakur, Gautam. / A phase II study of lenalidomide alone in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes with chromosome 5 abnormalities. In: Clinical Lymphoma, Myeloma and Leukemia. 2012 ; Vol. 12, No. 5. pp. 341-344.
@article{e24a6a6103054559949c9d2cc2fde8e7,
title = "A phase II study of lenalidomide alone in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes with chromosome 5 abnormalities",
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.",
keywords = "Clinical trial, Deletion 5q, Response",
author = "Yiming Chen and Hagop Kantarjian and Zeev Estrov and Stefan Faderl and Farhad Ravandi and Kristy Rey and Jorge Cortes and Gautam Borthakur",
year = "2012",
month = "10",
day = "1",
doi = "10.1016/j.clml.2012.04.001",
language = "English (US)",
volume = "12",
pages = "341--344",
journal = "Clinical Lymphoma, Myeloma and Leukemia",
issn = "2152-2650",
publisher = "Cancer Media Group",
number = "5",

}

TY - JOUR

T1 - A phase II study of lenalidomide alone in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes with chromosome 5 abnormalities

AU - Chen, Yiming

AU - Kantarjian, Hagop

AU - Estrov, Zeev

AU - Faderl, Stefan

AU - Ravandi, Farhad

AU - Rey, Kristy

AU - Cortes, Jorge

AU - Borthakur, Gautam

PY - 2012/10/1

Y1 - 2012/10/1

N2 - 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.

AB - 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.

KW - Clinical trial

KW - Deletion 5q

KW - Response

UR - http://www.scopus.com/inward/record.url?scp=84867430397&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84867430397&partnerID=8YFLogxK

U2 - 10.1016/j.clml.2012.04.001

DO - 10.1016/j.clml.2012.04.001

M3 - Article

C2 - 22579233

AN - SCOPUS:84867430397

VL - 12

SP - 341

EP - 344

JO - Clinical Lymphoma, Myeloma and Leukemia

JF - Clinical Lymphoma, Myeloma and Leukemia

SN - 2152-2650

IS - 5

ER -