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 - Funding Information:
Iman Abou Dalle reports personal fees from Novartis, Amgen, Jansen, and AbbVie outside the submitted work. Hagop M. Kantarjian reports grants and other from AbbVie, Amgen, Daiichi-Sankyo, Novartis, and Pfizer; grants from Ascentage, Bristol-Myers Squibb, Immunogen, Jazz, and Sanofi; and other from Actinium, Adaptive Biotechnologies, Aptitude Health, BioAscend, Delta Fly, Janssen Global, Oxford Biomedical, and Takeda during the conduct of the study. Farhad Ravandi reports grants and personal fees from Bristol-Myers Squibb and personal fees from Celgene outside the submitted work. Courtney D. DiNardo reports grants and personal fees from AbbVie, Agios, Novartis, Immune-Onc, Daiichi Sankyo, and Celgene/Bristol-Myers Squibb; personal fees from Notable Labs, MedImmune, Takeda, and Foghorn; and grants from Calithera outside the submitted work. Naveen Pemmaraju reports personal fees from Pacylex Pharmaceuticals, Incyte, LFB Biotechnologies, Roche Diagnostics, and Blueprint Medicines; grants and other from Affymetrix; grants from the SagerStrong Foundation; personal fees and other from Novartis; personal fees, nonfinancial support, and other from Stemline Therapeutics and AbbVie; personal fees and nonfinancial support from Celgene, Mustang Bio, and DAVA Oncology; and other from Samus Therapeutics, Cellectis, Daiichi Sankyo, and Plexxikon outside the submitted work. Nitin Jain reports grants and personal fees from Pharmacyclics, AbbVie, Genentech, AstraZeneca, Verastem, Adaptive Biotechnologies, Servier, and Precision BioSciences; personal fees from Janssen; grants from Bristol-Myers Squibb, Pfizer, Incyte, ADC Therapeutics, and Cellectis outside the submitted work. Guillermo Garcia-Manero reports consultancy for Bristol-Myers Squibb, Astex, and Helsinn and grants from Bristol-Myers Squibb, Astex, Helsinn, Amphivena, Novartis, AbbVie, Onconova, H3 Biomedicine, and Merck outside the submitted work. Jorge E. Cortes reports grants from Bristol-Myers Squibb and grants and personal fees from Novartis, Pfizer, Takeda, Biopath Holdings, and Jazz outside the submitted work. Tapan M. Kadia reports grants from Celgene and Bristol-Myers Squibb during the conduct of the study; personal fees from Agios and Daiichi outside the submitted work; grants from Amgen, AstraZeneca, Astellas, Cellenkos, Incyte, and Ascentage outside the submitted work; and grants and personal fees from Pfizer, AbbVie, Genentech, and Jazz outside the submitted work. The other authors made no disclosures. This study was funded by Celgene. The University of Texas MD Anderson Cancer Center is supported by the National Institutes of Health (grant P30 CA016672).
Funding Information:
This study was funded by Celgene. The University of Texas MD Anderson Cancer Center is supported by the National Institutes of Health (grant P30 CA016672).
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 -
