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Effective Treatment of Ph-Negative Acute Lymphoblastic Leukemia for Uninsured Hispanic Adolescents and Young Adults with a Low-Cost Outpatient Regimen

Introduction Pediatric inspired regimens can achieve good outcomes in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) by delivering intense non-myelosuppressive chemotherapy and are considered standard. Experience with the implementation of these regimens outside of acade...

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Bibliographic Details
Published in:Blood 2021-11, Vol.138 (Supplement 1), p.4102-4102
Main Authors: Gomez-De Leon, Andres, Varela-Constantino, Ana, Colunga-Pedraza, Perla R.R., Sánchez-Arteaga, Alexia, García-Zárate, Valeria, Méndez-Ramírez, Nereida, Fuentes-Chávez, Eli de Jesús, González López, Elías Eugenio, Gomez-Almaguer, David
Format: Article
Language:English
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Summary:Introduction Pediatric inspired regimens can achieve good outcomes in adolescents and young adults (AYAs) with acute lymphoblastic leukemia (ALL) by delivering intense non-myelosuppressive chemotherapy and are considered standard. Experience with the implementation of these regimens outside of academic centers in high-income countries is limited. Furthermore, Mexican patients (with “hispanic ethnicity”) have increased risk for relapse and treatment related complications. Objectives Primary objective: to determine 2-year overall survival (OS) and event-free survival (EFS). Secondary objectives: to determine the impacts of treatment abandonment and measurable residual disease (MRD) on outcomes, and to compare treatment costs with a widely used standard regimen in the United States. Patients and Methods Consecutive patients 16-45 years diagnosed with Ph-negative B-cell acute lymphoblastic leukemia after 2016 were included. The salient features of our modified-BFM regimen include the use mitoxantrone, E. coli L-asparaginase, without systemic cytarabine or high dose methotrexate designed to be delivered entirely in an outpatient basis for maximum affordability (Table 1), given that we treat an uninsured population that must cover their own treatment costs out of pocket. Genetic risk assessment was limited to BCR/ABL. Thereafter, relapse risk assessment was based exclusively on “next generation” flow cytometry measurable residual disease (MRD) after consolidation, with a planned allogeneic transplant for MRD-positive patients (≥0.001%). Treatment abandonment was defined as a missed ≥14-day period during intensive treatment or ≥1 month during maintenance. Statistical analysis was performed as intent-to-treat. Lastly, drugs included in our protocol were compared to those of CALGB 10403 with current local pricing in USD. Results Ninety-one AYAs have been treated, 47 women and 44 men, with a median age of 21 years (range, 15-45), mostly with a good functional capacity and no comorbidities (ECOG≤2: 92.1%; HCT-Ci 0-1: 97.8%); 43.8% of patients had ≥30x10 9/L white blood cells at diagnosis and 31.7% had grade ≥1 obesity. Notable grade ≥3 adverse events during induction were infections/neutropenic fever (35.6%),hepatotoxicity (11%) and thrombosis/bleeding (8.1%) with 44.3% eventually requiring hospitalization. Induction related mortality was 11%. Only n=3 were refractory to induction and the remainder assessed achieved complete remission (n=63; 95.5%) with a median foll
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2021-152768