SOHO 2021: Adding Azacitidine to FLAG Chemotherapy in AML
Posted: Wednesday, September 15, 2021
Mansour Alfayez, MD, of King Fahad Medical City, Riyadh, Saudi Arabia, and colleagues analyzed the efficacy and safety of using azacitidine in combination with FLAG chemotherapy—fludarabine and high-dose cytarabine with granulocyte colony-stimulating factor (G-CSF—to treat patients with resistant acute myeloid leukemia (AML). Presented during the 2021 Society of Hematologic Oncology (SOHO) Annual Meeting, their results suggest that although this combination therapy seems safe, it does not appear to offer a benefit regarding survival or response rate (Abstract AML-149).
This phase II study enrolled 21 patients with relapsed or refractory AML who had preserved organ function and an Eastern Cooperative Oncology Group performance status of 2. Participants were administered azacitidine plus FLAG chemotherapy in the salvage setting. Azacitidine was given for 5 days prior to the administration of the standard agents.
Patients received a median of one prior treatment, and nine individuals were refractory to the most recent therapy; most patients experienced a relapse less than 6 months after their previous treatment before enrolling in this study. The complete response or complete response with incomplete blood cell count recovery rate was 53%, and five of nine patients with refractory disease achieved this. Measurable residual disease negativity was reached by 8 of 11 patients who achieved a complete response or a complete response with incomplete blood cell count recovery, whereas 8 patients received a subsequent stem cell transplant.
A total of five patients who achieved a complete response or a complete response with incomplete blood cell count recovery remained alive at the last follow-up. The relapse-free survival was 4.7 months, and the overall survival was 4.1 months. Although the combination was tolerated, the most common adverse event was bone marrow suppression, of which all patients experienced. Additionally, 30-day mortality was recorded in two patients, both related to infection and septic shock with the failure of multiple organs.
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