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Outcome of the Modified St. Jude Total XV Protocol in Turkish Children with Newly Diagnosed Acute Lymphoblastic
Hülya Yılmaz1, Selin Aytaç2, Barış Kuşkonmaz2
1Hacettepe University Faculty of Medicine, Department of Pediatrics, Ankara, Türkiye
Insights
This study assessed Turkish children with acute lymphoblastic leukemia (ALL) treated with a modified protocol. High-dose methylprednisolone (HDMP) showed promising event-free survival (EFS) and overall survival (OS) rates.
Area of Science:
- Pediatric Oncology
- Hematology
- Clinical Trial Research
Background:
- Acute lymphoblastic leukemia (ALL) is a significant pediatric cancer.
- Optimizing treatment protocols is crucial for improving outcomes in childhood ALL.
- The St. Jude Total XV Protocol is a recognized treatment regimen for ALL.
Purpose of the Study:
- To evaluate prognostic factors and outcomes in Turkish children with newly diagnosed ALL.
- To assess the efficacy of a modified St. Jude Total XV Protocol incorporating high-dose methylprednisolone (HDMP).
- To determine the impact of HDMP on early response and survival rates in pediatric ALL.
Main Methods:
- A cohort of 183 newly diagnosed ALL patients (aged 1-18 years) received the Modified St. Jude Total XV Protocol.
- HDMP was administered at 10 mg/kg/day or 20 mg/kg/day for 7 days prior to induction, followed by a tapering schedule.
- Absolute blast count (ABC) and minimal residual disease (MRD) were assessed at key time points; follow-up extended to July 2019.
Main Results:
- The 5-year event-free survival (EFS) was 85.6% and overall survival (OS) was 89.2%.
- An 88% rate of good steroid response (ABC < 1000/mm3 on day 7) was observed, with 97% achieving complete remission post-induction.
- EFS and OS correlated with initial leukocyte count, age (10-18 years), CD20 positivity, and gram-negative infections.
Conclusions:
- The Modified St. Jude Total XV Protocol with HDMP demonstrates significant early response and promising EFS/OS rates in childhood ALL.
- Short-term HDMP, preferably at 10 mg/kg/day for 7 days, can be initiated at induction onset.
- Early and substantial response to HDMP is highlighted as a key factor in treatment success.
Objective:
The prognostic factors and outcomes of Turkish children with newly diagnosed acute lymphoblastic leukemia (ALL), treated with the Modified St. Jude Total XV Protocol, which was adjusted by adding high-dose methylprednisolone (HDMP) before induction in the original protocol, were assessed in this study.
Materials And Methods:
The Modified St. Jude Total XV Protocol was administered to 183 newly diagnosed ALL patients, aged 1-18 years, between 1 January 2008 and 30 January 2016. HDMP was applied at doses of either 10 mg/kg/day (Group A) or 20 mg/kg/day (Group B) for 7 days before induction and then tapered over the next 7 days to 5 or 10 mg/kg/day, and continued at 2 mg/kg/day for 2 weeks during the induction phase. Absolute blast count (ABC) in peripheral blood and minimal residual disease (MRD) in bone marrow were assessed at the end of the initial 7-day HDMP treatment. MRD in the bone marrow was evaluated on day 15 and at the end of the induction period. The follow-up for these patients ended on 15 July 2019.
Results:
The 5-year event-free (EFS) and overall survival (OS) rates for all patients were 85.6±2.6% and 89.2±2.3%, respectively. The rate of good response to steroids (defined as ABC in peripheral blood of less than 1000/mm3 on day 7) was 88% and 97% of children achieved complete remission after induction. The survival rate and infection frequency did not show statistically significant differences between Group A and B. EFS and OS correlated with initial leukocyte count, age of 10-18 years at diagnosis, CD20 positivity at diagnosis, and gram-negative bacterial infection during remission induction.
Conclusion:
The remarkable response rates on days 7 and 15, along with the promising EFS and OS results in childhood ALL patients treated with the Modified St. Jude Total XV Protocol, highlight the early and substantial response effect of HDMP. At the onset of induction, short-term HDMP can be initiated, preferably at 10 mg/kg/day for the first 7 days, to minimize potential side effects.
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