Real-World Outcomes of FLAG-Ida Regimen in 1079 Adult Patients With First Relapsed/Refractory AML: A PETHEMA Study

Area of Science:

• Hematology
• Oncology
• Clinical Trials

Background:

• Relapsed/refractory acute myeloid leukemia (R/R AML) presents a significant therapeutic challenge.
• Salvage chemotherapy regimens are crucial for patients who do not respond to initial treatments or relapse.
• Evaluating real-world outcomes of salvage therapies like FLAG-Ida is essential for clinical practice.

Purpose of the Study:

• To assess the effectiveness of FLAG-Ida salvage therapy in a large cohort of R/R AML patients.
• To validate the prognostic accuracy of the SALFLAGE score in this patient population.
• To analyze trends in treatment outcomes over time.

Main Methods:

• Retrospective analysis of 1079 adult R/R AML patients treated with FLAG-Ida across 112 institutions from 1998-2024.
• Inclusion of patients with primary refractory disease and first relapse.
• Evaluation of complete remission composite (CRc), overall survival (OS), and prognostic factors using the SALFLAGE score.

Main Results:

• A CRc rate of 56.8% was achieved, with 35.2% of patients proceeding to allogeneic transplantation.
• Median OS was 10.2 months, with a 5-year OS rate of 21.6%.
• Prior transplantation and longer relapse-free intervals predicted better OS, while high-risk cytogenetics, FLT3-ITD mutations, and age ≥ 60 predicted worse OS. The SALFLAGE score showed moderate discrimination (C-index 0.67).

Conclusions:

• FLAG-Ida is confirmed as a reference salvage regimen for fit R/R AML patients.
• The SALFLAGE score is validated as a useful prognostic tool in this setting.
• Treatment outcomes, including 30-day mortality and OS, have shown improvement over different time periods.