Long-term Outcome of Children with Acute Lymphoblastic Leukemia Treated with IC-BFM2002 Regimen

Background: Changes in pediatric chemotherapy regimens over the last three decades have introduced a variety of protocols to increase the survival of patients with acute lymphoblastic leukemia (ALL). Intercontinental Berlin-Frankfort-Munich (IC-BFM) 2002 is one of the protocols widely used in countries that could not perform minimal residual disease by polymerase chain reaction (MRD PCR) method. Evaluation the results of these regimens is very effective in improving their quality.

Materials and Methods: Children with newly diagnosed ALL in Ali Asghar Children's Hospital were randomly divided into two groups. Patients in both groups underwent chemotherapy according to IC-BFM 2002 protocol. Patients were divided into two groups based on the type of reinduction regimen, so that patients in-group A received protocol II and patients in-group B received protocol III as a reinduction regimen. Then demographic information and patient outcome were statistically analyzed with SPSS 23.

Results: Sixty-three patients were included in the study. There were 32 patients in-group A (18 boys and 14 girls) and 31 patients in-group B (11 boys and 20 girls). The number of high-risk patients was higher in-group A, but this difference was not statistically significant. The recurrence rate in-group B patients was about seven times higher than the recurrence rate in group A patients, and this difference was statistically significant. In-group A, no patients had an early relapse, while about half of the recurrences in-group B occurred as early relapse and the rest as late relapse. CNS recurrence occurred in only two patients. 5-yr EFS of all enrolled patients was 88.90 ± 8.00% (95% CI). This rate for group A and B was 96.90 ± 6.20% (95% CI) and 80.60 ± 14.20% (95% CI), respectively (P=0.022).

Conclusion: It seems that IC-BFM 2002 protocol is an appropriate treatment regimen with acceptable results for children with ALL in developing countries, a workable protocol with significant consequences. Protocol II seems to be suitable for reinduction and increasing the Methotrexate dose may not be necessary for non-high-risk groups.