Treatment with a 5-day versus a 10-day schedule of decitabine in older patients with newly diagnosed acute myeloid leukaemia: a randomised phase 2 trial

Publication date: Available online 10 December 2018Source: The Lancet HaematologyAuthor(s): Nicholas J Short, Hagop M Kantarjian, Sanam Loghavi, Xuelin Huang, Wei Qiao, Gautam Borthakur, Tapan M Kadia, Naval Daver, Maro Ohanian, Courtney D Dinardo, Zeev Estrov, Rashmi Kanagal-Shamanna, Abhishek Maiti, Christopher B Benton, Prithviraj Bose, Yesid Alvarado, Elias Jabbour, Steven M Kornblau, Naveen Pemmaraju, Nitin JainSummaryBackgroundHypomethylating agents, such as decitabine, are the standard of care for older patients with newly diagnosed acute myeloid leukaemia. Single-arm studies have suggested that a 10-day schedule of decitabine cycles leads to better outcomes than the usual 5-day schedule. We compared the efficacy and safety of these two schedules.MethodsEligible patients were aged 60 years or older with acute myeloid leukaemia but unsuitable for intensive chemotherapy (or <60 years if unsuitable for intensive chemotherapy with an anthracycline plus cytarabine). The first 40 patients were allocated equally to the two treatment groups by computer-generated block randomisation (block size 40), after which a response-adaptive randomisation algorithm used all previous patients' treatment and response data to decide the allocation of each following patient favouring the group with superior response. Patients were assigned to receive 20 mg/m2 decitabine intravenously for 5 or 10 consecutive days as induction therapy, every 4–8 weeks for up to three cycles. Responding pa...
Source: The Lancet Haematology - Category: Hematology Source Type: research