Phase 2 study of lenalidomide maintenance for patients with high‐risk acute myeloid leukemia in remission. Issue 11 (15th January 2021)

• Record Type: Journal Article
• Authors: Abou Dalle, Iman; Kantarjian, Hagop M.; Ravandi, Farhad; Daver, Naval; Wang, Xuemei; Jabbour, Elias; Estrov, Zeev; DiNardo, Courtney D.; Pemmaraju, Naveen; Ferrajoli, Alessandra; Jain, Nitin; Wang, Sa A.; Jammal, Nadya; Borthakur, Gautam; Naqvi, Kiran; Pelletier, Sarah; Pierce, Sherry; Andreeff, Michael; Garcia‐Manero, Guillermo; Cortes, Jorge E.; Kadia, Tapan M.
• Is Part Of: Cancer. Volume 127:Issue 11(2021)
• Page Start: 1894
• Page End: 1900
• Publication Date: 2021-01-15
• Subjects: acute myeloid leukemia (AML) -- immunomodulation -- lenalidomide -- maintenance; Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.33409
• Languages: English
• ISSNs: 0008-543X

Abstract

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. Abstract : Lenalidomide maintenance in patients with high‐risk acute myeloid leukemia results in a 2‐year overall survival rate of 63%. The beneficial effect is most profound in patients with negative minimal residual disease and in those without a history of prior myeloid or nonmyeloid neoplasms.