TY - JOUR
T1 - A phase 2 study of high-dose lenalidomide as initial therapy for older patients with acute myeloid leukemia
AU - Fehniger, Todd A.
AU - Uy, Geoffrey L.
AU - Trinkaus, Kathryn
AU - Nelson, Alissa D.
AU - Demland, Jeffery
AU - Abboud, Camille N.
AU - Cashen, Amanda F.
AU - Stockerl-Goldstein, Keith E.
AU - Westervelt, Peter
AU - DiPersio, John F.
AU - Vij, Ravi
PY - 2011/2/10
Y1 - 2011/2/10
N2 - Older patients with acute myeloid leukemia (AML) have limited treatment options and a poor prognosis, thereby warranting novel therapeutic strategies. We evaluated the efficacy of lenalidomide as front-ine therapy for older ML patients. In this phase 2 study, patients 60 years of age or older with untreated AML received highdose (HD) lenalidomide at 50 mg daily for up to 2 28-day cycles. If patients achieved a complete remission (CR)/CR with incomplete blood count recovery (CRi) or did not progress after 2 cycles of HD lenalidomide, they received low-dose lenalidomide (10 mg daily) until disease progression, an unacceptable adverse event, or completion of 12 cycles. Thirty-three AML patients (median age, 71 years) were enrolled with intermediate (55%), unfavorable (39%), or unknown (6%) cytogenetic risk. Overall CR/CRi rate was 30%, and 53% in patients completing HD lenalidomide. The CR/CRi rate was significantly higher in patients presenting with a low (< 1000/μL) circulating blast count (50%, P = .01). The median time to CR/CRi was 30 days, and duration of CR/CRi was 10 months (range, 1- ≥ 17 months). The most common grades ≥ 3 toxicities were thrombocytopenia, anemia, infection, and neutropenia. HD lenalidomide has evidence of clinical activity as initial therapy for older AML patients, and further study of lenalidomide in AML and MDS is warranted. This study is registered at www.clinicaltrials.gov as #NCT00546897.
AB - Older patients with acute myeloid leukemia (AML) have limited treatment options and a poor prognosis, thereby warranting novel therapeutic strategies. We evaluated the efficacy of lenalidomide as front-ine therapy for older ML patients. In this phase 2 study, patients 60 years of age or older with untreated AML received highdose (HD) lenalidomide at 50 mg daily for up to 2 28-day cycles. If patients achieved a complete remission (CR)/CR with incomplete blood count recovery (CRi) or did not progress after 2 cycles of HD lenalidomide, they received low-dose lenalidomide (10 mg daily) until disease progression, an unacceptable adverse event, or completion of 12 cycles. Thirty-three AML patients (median age, 71 years) were enrolled with intermediate (55%), unfavorable (39%), or unknown (6%) cytogenetic risk. Overall CR/CRi rate was 30%, and 53% in patients completing HD lenalidomide. The CR/CRi rate was significantly higher in patients presenting with a low (< 1000/μL) circulating blast count (50%, P = .01). The median time to CR/CRi was 30 days, and duration of CR/CRi was 10 months (range, 1- ≥ 17 months). The most common grades ≥ 3 toxicities were thrombocytopenia, anemia, infection, and neutropenia. HD lenalidomide has evidence of clinical activity as initial therapy for older AML patients, and further study of lenalidomide in AML and MDS is warranted. This study is registered at www.clinicaltrials.gov as #NCT00546897.
UR - http://www.scopus.com/inward/record.url?scp=79951495012&partnerID=8YFLogxK
U2 - 10.1182/blood-2010-07-297143
DO - 10.1182/blood-2010-07-297143
M3 - Article
C2 - 21051557
AN - SCOPUS:79951495012
SN - 0006-4971
VL - 117
SP - 1828
EP - 1833
JO - Blood
JF - Blood
IS - 6
ER -