Intensive Versus Non-Intensive Therapy in Older Patients with Acute Myeloid Leukemia: A Real-World Experience.

Background and Objectives: The optimal treatment strategy for older patients with acute myeloid leukemia (AML) remains uncertain because treatment selection is influenced by age, comorbidity, functional status, and disease biology. This study explored real-world outcomes with intensive and non-intensive treatment strategies. Materials and Methods: We retrospectively analyzed 69 patients aged ≥ 65 years diagnosed with AML between 2012 and 2022 at a tertiary center. Treatment intensity was defined by regimen. Baseline demographic, clinical, and laboratory parameters were recorded. Progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan-Meier method and compared using log-rank tests. Results: A total of 69 patients were included, with a median age of 71 years. Intensive and non-intensive therapies were administered in 24.2% and 75.8% of treated patients, respectively. The median PFS was 6.7 months, and the median OS was 7.8 months. One- and two-year OS rates were 29% and 9.2%, respectively. No significant differences in PFS or OS were observed between treatment intensity groups. Among response-evaluable patients, complete remission/complete remission with incomplete hematologic recovery (CR/CRi) was achieved in 58.0% of intensively treated patients and 43.3% of those receiving hypomethylating agent (HMA)-based therapy. Among the evaluated baseline variables, only Eastern Cooperative Oncology Group (ECOG) performance status was significantly associated with overall survival. Patients with an ECOG performance status ≥ 2 had significantly shorter OS than those with ECOG <2 (median OS: 4.85 vs. 8.60 months, p = 0.009). Conclusions: In this real-world cohort of older patients with AML, no statistically significant differences in PFS or OS were observed between intensive and non-intensive treatment strategies. Although CR/CRi rates were numerically higher with intensive therapy, disease progression remained frequent among patients who achieved a response. ECOG performance status was significantly associated with overall survival, highlighting the relevance of functional status in individualized treatment selection. These findings should not be interpreted as evidence of therapeutic equivalence.