TY - JOUR
T1 - Phase 2 study of lenalidomide maintenance for patients with high-risk acute myeloid leukemia in remission
AU - Abou Dalle, Iman
AU - Kantarjian, Hagop M.
AU - Ravandi, Farhad
AU - Daver, Naval
AU - Wang, Xuemei
AU - Jabbour, Elias
AU - Estrov, Zeev
AU - DiNardo, Courtney D.
AU - Pemmaraju, Naveen
AU - Ferrajoli, Alessandra
AU - Jain, Nitin
AU - Wang, Sa A.
AU - Jammal, Nadya
AU - Borthakur, Gautam
AU - Naqvi, Kiran
AU - Pelletier, Sarah
AU - Pierce, Sherry
AU - Andreeff, Michael
AU - Garcia-Manero, Guillermo
AU - Cortes, Jorge E.
AU - Kadia, Tapan M.
N1 - Publisher Copyright:
© 2020 American Cancer Society
PY - 2021/6/1
Y1 - 2021/6/1
N2 - Background: New drug combinations have led to significant improvements in remission rates for patients with acute myeloid leukemia (AML). However, many patients with high-risk AML who respond to their initial treatment and are not candidates for allogeneic stem cell transplantation (ASCT) will eventually relapse with poor outcomes. Methods: In this phase 2 trial, the efficacy of lenalidomide maintenance was evaluated in patients with high-risk AML who had achieved their first or second remission after induction chemotherapy and at least 1 consolidation cycle and who were not candidates for immediate ASCT. Lenalidomide was given orally at 10 to 20 mg daily on days 1 to 28 of a 28-day cycle for up to 24 cycles. Results: A total of 28 patients were enrolled in this study with a median age of 61 years (range, 24-87 years). The median number of cycles was 8 (range, 1-24 cycles). Ten patients (36%) completed 24 months of maintenance treatment. With a median follow-up of 22.5 months (range, 2.6-55 months), 12 patients (43%) relapsed after a median of 3 months (range, 0.7-23 months). The median duration of remission for all patients was 18.7 months (range, 0.7-55.1 months). The 2-year overall survival and relapse-free survival rates from the time of enrollment were 63% and 50%, respectively. Overall, lenalidomide was well tolerated; serious adverse events of grade 3 or 4, including rash (n = 5), thrombocytopenia (n = 4), neutropenia (n = 4), and fatigue (n = 2), were observed in 13 patients (46%). Conclusions: Lenalidomide is a safe and feasible maintenance strategy in patients with high-risk AML who are not candidates for ASCT, and it has beneficial effects for patients with negative measurable residual disease.
AB - Background: New drug combinations have led to significant improvements in remission rates for patients with acute myeloid leukemia (AML). However, many patients with high-risk AML who respond to their initial treatment and are not candidates for allogeneic stem cell transplantation (ASCT) will eventually relapse with poor outcomes. Methods: In this phase 2 trial, the efficacy of lenalidomide maintenance was evaluated in patients with high-risk AML who had achieved their first or second remission after induction chemotherapy and at least 1 consolidation cycle and who were not candidates for immediate ASCT. Lenalidomide was given orally at 10 to 20 mg daily on days 1 to 28 of a 28-day cycle for up to 24 cycles. Results: A total of 28 patients were enrolled in this study with a median age of 61 years (range, 24-87 years). The median number of cycles was 8 (range, 1-24 cycles). Ten patients (36%) completed 24 months of maintenance treatment. With a median follow-up of 22.5 months (range, 2.6-55 months), 12 patients (43%) relapsed after a median of 3 months (range, 0.7-23 months). The median duration of remission for all patients was 18.7 months (range, 0.7-55.1 months). The 2-year overall survival and relapse-free survival rates from the time of enrollment were 63% and 50%, respectively. Overall, lenalidomide was well tolerated; serious adverse events of grade 3 or 4, including rash (n = 5), thrombocytopenia (n = 4), neutropenia (n = 4), and fatigue (n = 2), were observed in 13 patients (46%). Conclusions: Lenalidomide is a safe and feasible maintenance strategy in patients with high-risk AML who are not candidates for ASCT, and it has beneficial effects for patients with negative measurable residual disease.
KW - acute myeloid leukemia (AML)
KW - immunomodulation
KW - lenalidomide
KW - maintenance
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U2 - 10.1002/cncr.33409
DO - 10.1002/cncr.33409
M3 - Article
C2 - 33449377
AN - SCOPUS:85105315724
SN - 0008-543X
VL - 127
SP - 1894
EP - 1900
JO - Cancer
JF - Cancer
IS - 11
ER -