PB1752 REAL WORLD COMPARISON OF THE TWO HYPOMETHYLATING AGENTS IN ELDERLY ACUTE MYELOID LEUKEMIA PATIENTS‐ SINGLE INSTITUTION EXPERIENCE FROM INDIA
Authors: C. R  , BABU G. , L. K C  , ABRAHAM JACOB L. , L. D  , S.B. M C  , L. K N  , R. A H  , R. L K  , Koppaka D. , Asati V. , Patidar R. 
Published: June 2019

Background:

Outlook of elderly AML patients is poor. Azacytidine & decitabine are used interchangeably in elderly AML patients. No randomized comparisons are available to guide clinical practice.

Aims:

The primary objective was to compare overall survival (OS) in patients who received decitabine or azacytidine. Secondary objectives were to compare response rates and adverse events (AEs). Event for OS was death due to any cause. Patients were censored on the date of the last contact or lost to follow up.

Methods:

In this retrospective study, 66 AML patients >60 years treated with Azacytidine(AZA) (100 mg/m2/day, D1‐ D7) and decitabine(DEC) (20 mg/m2/day (D1‐D5) every 28 days between 2013‐2018 were analysed. Patients were categorized into different risk groups according to MRC criteria. Treatment was continued till relapse, progressive disease and lack of clinical benefit. Remission status was assessed after four cycles. Progressive disease was defined as blast counts increased more than 50% over baseline or development of the new extramedullary disease. Stable disease was defined as, not meeting criteria for any other treatment response. Transfusion independence (TI) was defined as no requirement of RBC/Platelet transfusion for consecutive eight weeks. Patients received best supportive care post progression/relapse.

Results:

34 patients received azacytidine and 32 patients received decitabine. The median age was 66 years in both the group. A total number of 206 AZA cycles and 148 cycles of DEC were administered, with a median of 6 cycles (1‐24) in AZA and 4 (1‐21) in DEC group. Overall response rate was 35.4% and 28% (AZA vs DEC, p = 0.88).Complete response was 25.8% vs 16% (AZA vs DEC, P = 0.44). Patients in AZA group achieved higher TI (54.8% vs 28%, p = 0.04). Median survival was 8.7 months vs 5.5 months (AZA vs DEC, P = 0.04, HR = 0.55).Patients achieving stable disease with azacytidine had better survival 8.7 months vs 4.4 months (HR = 0.06, p = 0.01). No survival difference was observed in those having response (12.8 vs 9.8 months HR –0.6, p = 0.46) and achieving TI (11.7 month vs 9.8 p = 0.57). Azacytidine resulted in longer survival in poor risk cytogenetics patients (5.8 vs 3.3 months HR = 0.58, p = 0.03). In multivariate analysis treatment with azacytidine (HR‐0.40, p = 0.005), performance status (HR‐2.25, p = 0.01) and poor risk cytogenetics (HR‐2.4, p = 0.01) were predictive of survival, age (p = 0.3) and blasts (p = 0.07) were not. There was no difference in the hematological (neutropenia p = 0.5 thrombocytopenia p = 0.2) and infectious complications (Febrile neutropenia p = 0.1) or hospital admission rate (RR‐ 0.98, p = 0.9) between the groups.

Summary/Conclusion:

Azacytidine and decitabine resulted comparable overall survival in elderly AML patients achieving response and TI. All though we have limited patients in both the groups azacytidine particularly in poor risk patients and achieving stable disease. Larger randomized trials are required for better decision making.