Phase Ib trial of lenalidomide as post-remission therapy for older adults with acute myeloid leukemia: Safety and longitudinal assessment of geriatric functional domains

被引:2
作者
Woods, Justin D. [1 ]
Zeidner, Joshua F. [1 ,2 ]
Van Deventer, Hendrik W. [1 ,2 ]
Jamieson, Katarzyna [1 ,2 ]
Matson, Melissa [2 ,3 ]
Zhang, Jack [2 ]
Pulley, William [2 ]
Brenizer, Tucker [2 ]
Muss, Hyman [1 ,2 ]
Nyrop, Kirsten A. [1 ,2 ]
Vohra, Sanah N. [2 ,5 ]
Deal, Allison M. [2 ]
Ivanova, Anastasia [2 ,4 ]
Foster, Matthew C. [1 ,2 ]
机构
[1] Univ N Carolina, Sch Med, Dept Med, Chapel Hill, NC 27599 USA
[2] Univ N Carolina, Lineberger Comprehens Canc Ctr, Chapel Hill, NC 27599 USA
[3] Univ N Carolina, Sch Med, Dept Pediat, Chapel Hill, NC 27599 USA
[4] Univ N Carolina, Gillings Sch Global Publ Hlth, Dept Biostat, Chapel Hill, NC 27599 USA
[5] Univ N Carolina, Gillings Sch Global Publ Hlth, Dept Epidemiol, Chapel Hill, NC 27599 USA
关键词
Geriatric assessment; Acute myeloid leukemia; Lenalidomide; HIGH-DOSE LENALIDOMIDE; QUALITY-OF-LIFE; CHEMOTHERAPY; SURVIVAL; AZACITIDINE; RELIABILITY; INDUCTION; TOXICITY;
D O I
10.1016/j.jgo.2021.11.015
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background and Objectives: Novel, non-cytotoxic agents are driving a paradigm shift for treatment of older adults with acute myeloid leukemia (AML). Older patients who initially receive intensive cytotoxic induction may choose to not proceed with cytotoxic consolidation therapy. Lenalidomide is an orally-administered immunomodulatory small molecule with activity in AML and a favorable safety profile in older adults with active leukemia. We conducted a phase Ib study of lenalidomide as post-remission therapy in older adults and assessed its impact on geriatric functional domains.Materials and Methods: Participants were patients with AML over age 60 years who had undergone induction therapy and were poor candidates for cytotoxic consolidation. Lenalidomide was administered for 28 days in three dose cohorts. A Bayesian dose-escalation method determined cohort assignment and maximum tolerated dose (MTD). Geriatric assessment (GA) was performed before and after the cycle of lenalidomide.Results: Nineteen patients with median age 68 were treated with at least one 28-day course of lenalidomide. Dose-limiting toxicities were observed in three participants at 25 mg, zero participants at 35 mg, and one participant at 50 mg. MTD was 35 mg. Median relapse-free survival was 4.3 months. GA was completed before and after treatment in fifteen patients, demonstrating improved cognitive function and no changes in physical, psychological, or social function after lenalidomide.Conclusion: Lenalidomide can be safely administered to older adults with AML with preservation of functional domains important to older patients. Serial GA can be performed in a novel drug study as a tool to characterize treatment tolerability. (c) 2022 Elsevier Ltd. All rights reserved.
引用
收藏
页码:499 / 504
页数:6
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