Vosaroxin in combination with decitabine in newly diagnosed older patients with acute myeloid leukemia or high-risk MDS.

Vosaroxin in combination with decitabine in newly diagnosed older patients with acute myeloid leukemia or high-risk MDS. Haematologica. 2017 Jul 20;: Authors: Daver N, Kantarjian H, Garcia-Manero G, Jabbour E, Borthakur G, Brandt M, Pierce S, Vaughan K, Ning J, Nogueras González GM, Patel K, Jorgensen J, Pemmaraju N, Kadia T, Konopleva M, Andreeff M, DiNardo C, Cortes J, Ward R, Craig A, Ravandi F Abstract Vosaroxin is an anti-cancer quinolone derived DNA topoisomerase II inhibitor. We investigated vosaroxin with decitabine in patients ≥ 60 years of age with newly diagnosed acute myeloid leukemia (AML) (n=58) or myelodysplastic syndrome (MDS) (≥ 10% blasts) (n=7) in a phase 2 non-randomized trial. The initial 22 patients received vosaroxin 90 mg/m2 on Days 1 and 4 with decitabine 20 mg/m2 Days 1-5 every 4-6 weeks for up to 7 cycles. Due to high incidence of mucositis the subsequent 43 patients received vosaroxin 70 mg/m2 Days 1 and 4. Sixty-five patients with median age 69 years (range 60-78), secondary AML/MDS (22%), adverse karyotype (35%), TP53 mutation (20%) are evaluable. The overall response rate (ORR) was 74% including complete remission (CR) in 31 (48%), complete remission with incomplete platelet recovery (CRp) in 11 (17%), and complete remission with incomplete count recovery (CRi) in 6 (9%). The median number of cycles to response was 1 (1-4). The median duration of response was 9.9 months (0.5-32.0). The ORR among ad...
Source: Haematologica - Category: Hematology Authors: Tags: Haematologica Source Type: research