Prognostic Factors and Real-World Outcomes in Adolescents and Young Adults (AYA) With Philadelphia-Negative Acute Lymphoblastic Leukemia (ALL) Treated With the AYA-15 Protocol: A Retrospective Cohort Study From a Tertiary Care Referral Center in the Middle East.
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BACKGROUND: Adolescents and young adults (AYA) with Philadelphia-negative acute lymphoblastic leukemia (ALL) represent a distinct population with variable outcomes. This study assessed the real-world efficacy and safety of the AYA-15 protocol in this group. PATIENTS AND METHODS: A retrospective cohort of 149 AYA patients (median age: 18 years) treated with the AYA-15 protocol at a tertiary care center in the middle east was analyzed. Baseline characteristics, measurable residual disease (MRD) kinetics, toxicity profiles, and survival outcomes were examined. Multivariate Cox regression was performed to identify adverse prognostic factors. RESULTS: Among the 149 patients, 74% had B-cell ALL and 10% had central nervous system (CNS) involvement. Day 28 MRD negativity was achieved in 76% of patients, increasing to 88% post-consolidation. The 5-year overall survival (OS), disease-free survival (DFS), and event-free survival (EFS) rates were 79%, 68%, and 59%, respectively. The most common grade ≥3 toxicities included febrile neutropenia, infections, hepatotoxicity, and hypersensitivity reactions to PEG-asparaginase. Multivariable analysis identified CNS involvement, post-consolidation MRD positivity, and elevated BMI as independent predictors of inferior outcomes. CONCLUSION: The AYA-15 protocol demonstrated favorable survival and MRD response rates in a real-world cohort of Philadelphia-negative AYA ALL patients. Certain baseline and treatment-related factors were associated with poorer outcomes, highlighting the importance of individualized risk stratification.