Outcome of Childhood and Adolescents and Young Adults ALL Treated with ALL IC-BFM 2009 Protocol-A Single-Center Experience in India.

ALL is a biologically heterogeneous disease. Risk and response adapted therapy improved the survival of childhood ALL above 90%. Early response parameters independently predicted the survival and relapse. This study was a single-center, prospective, randomized study conducted in AIIMS Rishikesh from April 2021 to February 2023. The objectives were to assess the efficacy and toxicity of two steroid groups in Induction and overall survival of patients treated with ALL IC-BFM 2009 protocol. The study enrolled 75 ALL patients in the age group of 1-24 years. Forty-one patients received dexamethasone and thirty-four patients received prednisolone. Of evaluable patients, 83% completed induction therapy. Of enrolled patients, 86% achieved good steroid response, 73% had day 15 BM M1 and 38% had day 15 BM MRD below 0.1%. Complete remission was achieved in 97% of participants with 77% MRD below 0.01%. There was no statistically significant difference in efficacy between the two groups. There was a significantly higher incidence of neutropenia in the Dexa group compared to the Pred group [Dexa- 97%, Pred- 60%; p < 0.001]. The incidence of Induction mortality in the study was 12% [Dexa-14.6%; Pred-8.8%] (p 0.449). There was no statistically significant difference in other toxicities between the groups. The overall survival and event-free survival were 74.24% (dexa- 76.3%; pred-71.4%) and 65.3% [dexa- 70.7%, Pred- 58.8%] respectively. The subgroup analysis demonstrated an overall survival of 80% for SR, 84% for IR & 64% for HR groups. The overall incidence of relapse was 6.4%. Prospective studies are needed from LMIC to correlate combined day 15 and post-induction MRD.