Treatment-Related Toxicity Profile in Children with Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma during Induction Chemotherapy: Prospective Insights from a South Indian Cohort

Abstract There is limited data on treatment-related toxicity and mortality in children with acute lymphoblastic leukemia (ALL) in resource-limited settings, which is important for anticipation and better prophylactic care. This study aims to determine the proportion of children with ALL/T- lymphoblastic lymphoma (T-LL) developing treatment-related toxicity during induction chemotherapy, to study the proportion of mortality, the cumulative duration and frequency of treatment delays, and frequency of treatment protocol modifications. It was a prospective cohort study where all consecutive children aged between 1 month and 15 years with ALL/T-LL were included. They were followed up during induction chemotherapy and toxicities were recorded, graded as per the Common Terminology Criteria for Adverse Events grading, and analyzed. One-hundred and one children with median age of 6 years (interquartile range: 3, 11) were enrolled. A total of 696 toxicities were recorded among 101 children, of which 418 (60.06%) were of grades 3 and above, which were studied. Number of grades 3, 4, and 5 toxicities were 236 (33.91%), 176 (25.29%), and 5 (0.72%), respectively; of which 73.2% were hematological and 26.8% were nonhematological. Sixty-five treatment breaks were observed in 51 children (50.49%), with majority (34%) occurring in week 3. Protocol modification was observed in 10 (9.9%) due to toxicities and 9 (8.9%) required intensive care admission. Our induction mortality rate was 8.9%, of which infection-related mortality was observed in 4.9%. A statistically significant association was observed between risk group and toxicities of grade ≥ 3, with the nonstandard risk group exhibiting 3.21 times higher odds of experiencing these toxicities compared with the standard risk group. The results obtained from our study showed the prevalence and profile of treatment-related toxicities, with hematological toxicities being the most prevalent and infections and treatment delays being major concerns. High-risk disease was associated with increased toxicity, reinforcing the importance of proactive management strategies.