Summary
Our group recently showed that the (ASNase) formulation available in Brazil from 2017 to 2018 when used at the same dose and frequency as the formulation provided previously did not reach the activity considered therapeutic. Based on these, our goal was to assess the impact of these facts on the prognosis of children with ALL at different oncology centers. A multicentre retrospective observational study followed by a prospective follow‐up. Patients aged >1 and <18 years in first‐line treatment followed up at 10 referral centres, between 2014 and 2018 who received the formulation Leuginase® were identified (Group B). For each patient, the centre registered 2 patients who received ASNase in the presentation of Aginasa® exclusively (Group A). Data collection was registered using (Redcap®). A total of 419 patients were included; 282 in Group A and 137 in B. Group A had a 3‐year OS and EFS of 91·8% and 84·8% respectively, while Group B had a 3‐year OS of 83·8% (P = 0·003) and EFS of 76·1% (P = 0·008). There was an impact on 3‐year OS and EFS of children who received a formulation. This result highlights the importance of evaluating ASNase and monitoring its activity.
Background
Acute lymphoblastic leukemia (ALL) is the most common neoplasm in childhood. The probability of current overall survival (OS) is around 90% in developed countries. There are few studies that demonstrate the results in Brazil.
Aim
This work aims to analyze the results of children with ALL treated at a single institution in Rio de Janeiro.
Methods and results
Retrospective analysis survival study of a cohort of childhood ALL patients treated in Hemorio. Kaplan–Meier and log‐rank methods were used for the analysis of OS and events‐free survival (EFS) and the Cox proportional hazards regression model for multivariate analysis.
The probability of OS and EFS at 6 years was 52% and 45%. The probability of OS and EFS in 6 years for patients aged 10‐17 years was 31% and 28% and for the younger was 65% and 55%, respectively (p < .001). A probability of OS and EFS in 6 years for patients with more than 100 000 leukocytes/mm3 at diagnosis was 19% and 16% and those with less than 100 000 were 62% (p = .007) and 55% (p = .008). Those who received less than 10 doses of native Escherichia coli asparaginase had a probability of OS and EFS in 6 years of 27% and 21% and those who received at least 10 doses were 74% and 65% (p < .001).
Conclusions
The presence of a high number of adolescents and high‐risk patients, as well as many patients who discontinued the use of asparaginase or any substitute led to a lower probability of OS and EFS in our cohort.
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