A phase 2 study of high-dose lenalidomide as initial therapy for older patients with acute myeloid leukemia
Open accessAbstract
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-line therapy for older AML patients. In this phase 2 study, patients 60 years of age or older with untreated AML received high-dose (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.
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In patients with R/R AML, the combination of high-dose lenalidomide (50 mg daily) with mitoxantrone, etoposide and cytarabine resulted in a CR or CR with incomplete haematological recovery rate of 41%, which is considerably higher than expected with MEC alone (17-28%) based on data from historical cohorts.
“In patients with R/R AML, the combination of high-dose lenalidomide (50 mg daily) with mitoxantrone, etoposide and cytarabine (MEC) resulted in a CR or CR with incomplete haematological recovery (CR/CRi) rate of 41%104, which is considerably higher than expected with MEC alone (17–28%) based on data from historical cohorts105,106.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [104]
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Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide
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- Authors
- Fehniger, T. A., Uy, G. L., Trinkaus, K., Nelson, A. D., Demland, J., Abboud, C. N., Cashen, A. F., Stockerl-Goldstein, K. E., Westervelt, P., DiPersio, J. F., & Vij, R.
- Affiliations
- Washington University in St. Louis (US)
- ORCID
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 2011-02-10
- Volume
- 117
- Issue
- 6
- Pages
- 1828-1833
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- PMC
- PMC3318598
- OpenAlex
- W2087607698
- Cited by
- 107
- References
- 33
- Citations by year
- 2025: 1 · 2024: 3 · 2023: 4 · 2022: 2 · 2021: 7 · 2020: 3 · 2019: 3 · 2018: 10 · 2017: 7 · 2016: 10 · 2015: 5 · 2014: 6 · 2013: 12 · 2012: 18
- FWCI
- 9.21
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Blood (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Society of Clinical Oncology
- National Cancer Institute (K23CA140707)
- National Center for Research Resources (UL1RR024992)
- Topics
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinoids in leukemia and cellular processes
- Keywords
- lenalidomide, acute myeloid leukemia, elderly patients, initial treatment, complete remission, cytogenetic risk, adverse events, thrombocytopenia, neutropenia
- MeSH terms
- Lenalidomide, Age Factors, Aged, Aged, 80 and over, Antineoplastic Agents, Blood Cell Count, Female, Humans, Male, Middle Aged, Prognosis, Prospective Studies, Remission Induction, Thalidomide, Time Factors, Leukemia, Myeloid, Acute, Treatment Outcome, Disease-Free Survival, Cytogenetic Analysis, Kaplan-Meier Estimate
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