A post hoc sensitivity analysis of survival probabilities in a multinational phase III trial of decitabine in older patients with newly diagnosed acute myeloid leukemia.
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.


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.


CONCLUSIONS
Decitabine should be considered as a treatment option for older patients with AML and poor prognostic risk factors.
Department of Haematology, Lyon-Sud Hospital, Lyon, France. Electronic address: xavier.thomas@chu-lyon.fr.
Xavier G
XG
Thomas
Department of Haematology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
Christopher
C
Arthur
Department of Haematology, Nantes University Hospital, Nantes, France.
Jacques
J
Delaunay
Department of Oncology, Eisai Inc, Woodcliff Lake, NJ.
Mark
M
Jones
Department of Oncology, Eisai Inc, Woodcliff Lake, NJ.
Erhan
E
Berrak
Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX.
Hagop M
HM
Kantarjian
D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001374:Azacitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077209:Decitabine; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D000077209:Decitabine; D001374:Azacitidine
Age factors; Chemotherapy; Cytarabine; Dacogen; Treatment outcome