Xavier G Thomas1, Christopher Arthur2, Jacques Delaunay3, Mark Jones4, Erhan Berrak4, Hagop M Kantarjian5. 1. Department of Haematology, Lyon-Sud Hospital, Lyon, France. Electronic address: xavier.thomas@chu-lyon.fr. 2. Department of Haematology, Royal North Shore Hospital, St Leonards, New South Wales, Australia. 3. Department of Haematology, Nantes University Hospital, Nantes, France. 4. Department of Oncology, Eisai Inc, Woodcliff Lake, NJ. 5. Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX.
Abstract
BACKGROUND: In a multicenter, randomized, open-label phase III study, patients ≥ 65 years with newly diagnosed AML receiveddecitabine 20 mg/m(2) once daily for 5 days every 4 weeks (n = 242) or treatment choice (supportive care or cytarabine 20 mg/m(2) once daily for 10 days every 4 weeks; n = 243). Decitabine use demonstrated greater response rates (P = .001) and OS data favored decitabine. PATIENTS AND METHODS: In a post hoc sensitivity analysis of mature data of patients in the intent-to-treat population (N = 485), OS at 3, 6, 12, 18, and 24 months after randomization was estimated for each arm using Kaplan-Meier methods. Age, cytogenetic risk, and Eastern Cooperative Oncology Group performance status were used as stratification factors in the Cox regression model to estimate the hazard ratio. RESULTS: A survival advantage was seen with decitabine at each cutoff time point; hazard ratios for OS for decitabine vs. treatment choice were 0.83, 0.71, 0.83, 0.80, and 0.79 at 3, 6, 12, 18, and 24 months, respectively. A trend toward improved OS with decitabine was observed at fixed time points over 2 years. CONCLUSION:Decitabine should be considered as a treatment option for older patients with AML and poor prognostic risk factors.
RCT Entities:
BACKGROUND: In a multicenter, randomized, open-label phase III study, patients ≥ 65 years with newly diagnosed AML received decitabine 20 mg/m(2) once daily for 5 days every 4 weeks (n = 242) or treatment choice (supportive care or cytarabine 20 mg/m(2) once daily for 10 days every 4 weeks; n = 243). Decitabine use demonstrated greater response rates (P = .001) and OS data favored decitabine. PATIENTS AND METHODS: In a post hoc sensitivity analysis of mature data of patients in the intent-to-treat population (N = 485), OS at 3, 6, 12, 18, and 24 months after randomization was estimated for each arm using Kaplan-Meier methods. Age, cytogenetic risk, and Eastern Cooperative Oncology Group performance status were used as stratification factors in the Cox regression model to estimate the hazard ratio. RESULTS: A survival advantage was seen with decitabine at each cutoff time point; hazard ratios for OS for decitabine vs. treatment choice were 0.83, 0.71, 0.83, 0.80, and 0.79 at 3, 6, 12, 18, and 24 months, respectively. A trend toward improved OS with decitabine was observed at fixed time points over 2 years. CONCLUSION:Decitabine should be considered as a treatment option for older patients with AML and poor prognostic risk factors.