Phase 2 study of lenalidomide maintenance for patients with high-risk acute myeloid leukemia in remission.

Abstract

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.

• Authors: Iman Abou Dalle, Hagop M Kantarjian, Farhad Ravandi, Naval Daver, Xuemei Wang, Elias Jabbour, Zeev Estrov, Courtney D DiNardo, Naveen Pemmaraju, Alessandra Ferrajoli, Nitin Jain, Sa A Wang, Nadya Jammal, Gautam Borthakur, Kiran Naqvi, Sarah Pelletier, Sherry Pierce, Michael Andreeff, Guillermo Garcia-Manero, Jorge E Cortes, Tapan M Kadia
• Journal: Cancer (Cancer) Vol. 127 Issue 11 Pg. 1894-1900 (06 01 2021) ISSN: 1097-0142 [Electronic] United States
• PMID: 33449377 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 American Cancer Society.

Chemical References

• Angiogenesis Inhibitors
• Lenalidomide

Topics

• Adult
• Aged
• Aged, 80 and over
• Angiogenesis Inhibitors (therapeutic use)
• Hematopoietic Stem Cell Transplantation
• Humans
• Lenalidomide (therapeutic use)
• Leukemia, Myeloid, Acute (drug therapy)
• Maintenance Chemotherapy
• Middle Aged
• Remission Induction
• Risk Assessment
• Young Adult