Background: Acute myeloid leukaemia (AML) in the elderly is not strong enough to tolerate aggressive chemotherapy. We conducted the present study to compare the efficacy and safety of low-dose cytarabine (LDAC) with best supportive care (BSC) in Egyptian patients.
Method: A prospective randomized study included 60 eligible patients aged over 60 years with newly diagnosed AML. They were randomized to receive LDAC or BSC. The overall survival (OS) was the primary endpoint, while the secondary endpoint was to compare the quality of life in the form of a length of hospital stays (LOHS), mode and frequency of admission in the two studied groups.
Results: Herein, 30 patients received LDAC and 30 patients received BSC. The mean survival time was 7.5 months in the BSC group compared with 10.2 months in the LDAC group. Even though the median OS was 8.4 months in the BSC group, it did not reach in the LDAC group; HR= 2.047, CI 95% (0.541-7.743) (P=0.2). There was a statistically significant association with LDAC and the frequency of hospital admission through the emergency department (ED) due to neutropenic fever and prolonged LOHS (P<0.001, P<0.002, and P<0.001, respectively). Meanwhile, the admission through the outpatient clinic (OPC) and for transfusion support were statistically insignificant in the two groups (P< 0.12 and P< 0.6, respectively).
Conclusion: Despite, there were no OS statistically significant benefits of the use of LDAC over BSC in our patients, poor quality of life in the form of frequent admission through the ED, more incidence of neutropenic fever, and prolonged LOHS were reported more to patients received LDAC.