Decitabine As First Line Treatment in Acute Myeloid Leukemia of the Elderly: Real-Life Experience from a Single Center

Background: Acute myeloid leukemia, a disease common in the elderly, remains a therapeutic challenge for the hematologist. Patients are compromised and have comorbidities that make the treatment-related toxicities, difficult to manage; the net effect is treatment discontinuation. Therefore, hypomethylating agents present a reasonable and manageable therapeutic approach; our study provides information on the real-world data of such an approach in a cohort of patients.

Patients and methods: A total of 44 patients were enrolled in the present study. They were referred to our hospital between January 2016 and March 2018. These patients were suffering from AML and they received decitabine as first line treatment (if they were not eligible for intensive chemotherapy) or as salvage treatment. The primary objective was to evaluate the efficacy and safety of decitabine in real life setting. The drug was administered at a dose of 20 mg/m² body surface area by intravenous infusion over 1 hour, repeated daily for 5 consecutive days.

Results: All patients received treatment with decitabine. The median age at diagnosis was 71.8 years ranging from 48 to 83 years old. The mean decitabine cycles were 2.6. Out of the 44 patients only 25% received ≥ 4 cycles of the drug while 20 patients received only 1 decitabine course. The Overall Response Rate (ORR=CR+PR) was 13.7%. CR was achieved in 1/44 patient (2.3 %). PR was achieved in 5/44 patients (11.4%) while SD was observed in 8/44 patients (18.2%). For the patient achieved CR, the duration of response was 9 months, while the median duration of response in the group of patients with PR and SD was 7 months and 4.5 months respectively. All patients experienced adverse events with hematological toxicity being the most common, following by infections. Thrombocytopenia was the most common among hematological toxicity (82.5%), while anemia and neutropenia were recorded in 45% and 55% of the cases respectively. The main cause of treatment discontinuation was the progression of the disease. The mean survival time was 6.8 months. Results from univariate Cox regression analysis for survival showed a significant association with comorbidities and number of cycles of decitabine. When multiple Cox regression analysis in a stepwise method was conducted it was found that patients with comorbidities had 2.5x greater hazard as compared to those without comorbidities. Additionally, patients treated with more than one cycles of decitabine had 71% lower hazard as compared to those treated with only one cycle.

Conclusion: These data from a single center experience provide information about the efficacy and safety profile of decitabine in real life setting. Although the number of the patients is low, however our analysis confirms the acceptable use of decitabine in AML as first line or as salvage treatment especially in compromised patients. Decitabine is a well-tolerated drug with adverse events consistent with the safety profile of the drug and it appears as a reasonable treatment for patients with comorbidities such as the elderly or for the heavily treated.