Maintenance therapy with decitabine in younger adults with acute myeloid leukemia in first remission: a phase 2 Cancer and Leukemia Group B Study (CALGB 10503)

• Published in: Leukemia Vol. 31; no. 1; pp. 34 - 39
• Main Authors: Blum, W, Sanford, B L, Klisovic, R, DeAngelo, D J, Uy, G, Powell, B L, Stock, W, Baer, M R, Kolitz, J E, Wang, E S, Hoke, E, Mrózek, K, Kohlschmidt, J, Bloomfield, C D, Geyer, S, Marcucci, G, Stone, R M, Larson, R A
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01-01-2017; Nature Publishing Group
• Subjects: 5-aza-2'-deoxycytidine; 692/308/153; 692/308/2779/109/1941; 692/699/67/1990/283/1897; 692/700/565/1436; Acute myelocytic leukemia; Acute myeloid leukemia; Adolescent; Adult; Adults; Azacitidine - administration & dosage; Azacitidine - analogs & derivatives; Cancer; Cancer Research; Cancer therapies; Chemotherapy; Clinical trials; Consolidation; Critical Care Medicine; Cytotoxicity; Decitabine; Disease-Free Survival; Dosage and administration; Drug therapy; Female; Genetic aspects; Health aspects; Hematology; Humans; Intensive; Internal Medicine; Leukemia; Leukemia, Myeloid, Acute - drug therapy; Leukemia, Myeloid, Acute - mortality; Maintenance; Maintenance Chemotherapy - methods; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; original-article; Patients; Remission; Remission (Medicine); Remission Induction; Stem cell transplantation; Stem cells; Survival Rate; Transplantation; Young Adult; Young adults; United States > US; Ohio
• ISSN: 0887-6924; 1476-5551
• DOI: 10.1038/leu.2016.252

In this prospective phase 2 clinical trial conducted by Cancer and Leukemia Group B (CALGB, now the Alliance), we studied decitabine as maintenance therapy for younger adults with acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive induction and consolidation. Given that decitabine is clinically active in AML and with hypomethylating activity distinct from cytotoxic chemotherapy, we hypothesized that 1 year of maintenance therapy would improve disease-free survival (DFS) for AML patients <60 years, who did not receive allogeneic stem cell transplantation in CR1. After blood count recovery from final consolidation, patients received decitabine at 20 mg/m
2
intravenously daily for 4–5 days, every 6 weeks for eight cycles. One hundred and thirty-four patients received decitabine and 85 (63%) had favorable risk AML. The median number of cycles received was 7 (range: 1–8) and the primary reason for discontinuation was relapse. DFS at 1 year and 3 years was 79% and 54%, respectively. These results are similar to the outcomes in the historical control comprising similar patients treated on recent CALGB trials. Thus, maintenance with decitabine provided no benefit overall. Standard use of decitabine maintenance in younger AML patients in CR1 is not warranted. This trial was registered at
www.clinicaltrials.gov
as NCT00416598.