Introduction: Acute lymphoblastic leukemia (ALL) is the cancer with the highest incidence in childhood and adolescence, and pharmacotherapy is the primary form of treatment. Objective and methods: A systematic review of the efficacy and safety of polyethylene glycol (PEG)-asparaginase in acute lymphoblastic leukemia therapy in children and adolescents was conducted to compare it with native Escherichia coli L-asparaginase. PubMed, Web of Science, Science Direct, Cochrane Library, Scopus, LILACS (Latin American and Caribbean Health Sciences Literature) and EMBASE databases were selected. The following outcomes were analyzed: complete remission of the disease, event-free survival, overall survival, anti-asparaginase antibody level, hypersensitivity reactions, asparaginase and asparagine serum levels, number of postdiagnosis events, and overall mortality. Five randomized controlled trials were included. Analysis of the quality of evidence and risk of bias was performed using the Cochrane recommendation tool and the GRADE system. Results: The assessment results suggest that the level of certainty on the technology addressed is relatively weak from a methodological point of view. Evidence is insufficient to assess the effects on health outcomes because of the limited number and power of studies and important flaws in their design or conduct in classifying PEG-asparaginase as a superior drug or not, in the pharmacotherapy of ALL in children and adolescents. PEG-asparaginase can be used as a substitute for native E. coli L-asparaginase, demonstrating similar efficacy and safety. Conclusion: The study may help decision-makers in the public health system to offer a more in-depth judgment on the therapeutic alternatives used to treat this neoplasm in children and adolescents.
Esta revisión sistemática y meta-análisis se comparó la eficacia y la toxicidad de la dexametasona (DEX) versus prednisona (PRED) para la terapia de inducción en la leucemia linfoblástica aguda infantil (LLA). Se realizaron búsquedas en bases de datos biomédicas literatura y actas de congresos de ensayos controlados aleatorios que compararon la ejecución directa y PRED durante la terapia de inducción para la LLA infantil. Un total de ocho estudios fueron elegibles para su inclusión en este meta-análisis. DEX, en comparación con los eventos PRED, reducido (es decir, muerte por cualquier causa, la leucemia refractaria o en recaída o segundo tumor maligno; riesgo relativo (RR) 0,80, IC del 95% intervalo de confianza (IC), 0,68 a 0.94) y el sistema nervioso central recaída (RR 0,53, IC 95%, 0.44-0.65), pero no alteró recaída de médula ósea (RR 0,90, IC 95%, 0,69 a 1,18) o la mortalidad total (RR 0.91, IC 95%, 0,76-1,09). Los pacientes que recibieron DEX tenían un mayor riesgo de mortalidad durante la inducción (RR 2,31, IC 95%, 1.46-3.66), neuropsiquiátricos eventos adversos (RR 4,55, IC 95%, 2.45 a 8.46) y miopatía (RR 7,05, IC 95% , 3,00 a 16,58). No hubo diferencia estadísticamente significativa en el riesgo de osteonecrosis, sepsis, infección por hongos, la diabetes o pancreatitis. DEX en la terapia de inducción para los niños con LLA es más eficaz que PRED. Sin embargo, DEX también se asocia con mayor toxicidad, y en la actualidad no está claro si a corto plazo la superioridad de DEX también dará lugar a una mejor supervivencia en general.
Introduction: Acute lymphoblastic leukemia (ALL) is the cancer with the highest incidence in childhood and adolescence, and pharmacotherapy is the primary form of treatment. Objective and methods: A systematic review of the efficacy and safety of polyethylene glycol (PEG)-asparaginase in acute lymphoblastic leukemia therapy in children and adolescents was conducted to compare it with native Escherichia coli L-asparaginase. PubMed, Web of Science, Science Direct, Cochrane Library, Scopus, LILACS (Latin American and Caribbean Health Sciences Literature) and EMBASE databases were selected. The following outcomes were analyzed: complete remission of the disease, event-free survival, overall survival, anti-asparaginase antibody level, hypersensitivity reactions, asparaginase and asparagine serum levels, number of postdiagnosis events, and overall mortality. Five randomized controlled trials were included. Analysis of the quality of evidence and risk of bias was performed using the Cochrane recommendation tool and the GRADE system. Results: The assessment results suggest that the level of certainty on the technology addressed is relatively weak from a methodological point of view. Evidence is insufficient to assess the effects on health outcomes because of the limited number and power of studies and important flaws in their design or conduct in classifying PEG-asparaginase as a superior drug or not, in the pharmacotherapy of ALL in children and adolescents. PEG-asparaginase can be used as a substitute for native E. coli L-asparaginase, demonstrating similar efficacy and safety. Conclusion: The study may help decision-makers in the public health system to offer a more in-depth judgment on the therapeutic alternatives used to treat this neoplasm in children and adolescents.
