A simple change in how steroids are given could save the lives of children with leukemia in lower-income countries, according to a landmark clinical trial.
A major clinical trial in India has shown that giving steroids in short bursts rather than continuously halves the number of early treatment-related deaths in children with a common form of leukemia.
Key Findings
- Dramatic Reduction in Deaths: The "pulsed" schedule of steroids reduced early death rates from 3.5% to just 1.3%.
- No Loss of Effectiveness: The shorter steroid exposure did not compromise treatment. Remission rates were approximately 98% in both the pulsed and continuous groups, and long-term survival outcomes were similar.
- A Key Risk Factor Identified: Using anthracyclines (a type of chemotherapy) early in treatment was found to increase the risk of treatment-related deaths.
Trial Details
The study, called ICiCle‑ALL‑14, involved over 3,000 children across six major cancer centers in India. It is the first multicenter randomized pediatric oncology trial ever conducted in the country. Researchers compared the standard four-week continuous steroid course against a pulsed schedule given in weeks one, two, and four.
Context
Most early deaths from childhood leukemia are caused by severe infections, which are worsened by the prolonged immune suppression from continuous steroid use. This challenge is especially acute in low- and middle-income countries. While survival rates for childhood leukemia exceed 90% in wealthy nations, children in lower-income settings face a much higher risk of dying during the initial phase of treatment.
Key Statements
Professor Vaskar Saha (University of Manchester and Tata Medical Center, lead author and ICiCle founder): "The findings show that a simple change in steroid administration can save lives by reducing infection risk without compromising treatment."
Professor Venkatraman Radhakrishnan (Cancer Institute, WIA): "The study provides robust evidence that steroid scheduling is a modifiable determinant of induction mortality, with no detriment to response or survival."
Funding
The study was funded by:
- National Cancer Grid
- Indian Council of Medical Research
- DBT-Wellcome India Alliance
- Tata Consultancy Services
Participating Centers
- BR Ambedkar Rotary Cancer Hospital - AIIMS New Delhi
- Department of Pediatrics, PGIMER Chandigarh
- Department of Pediatrics, AIIMS New Delhi
- Department of Pediatric Oncology, Tata Memorial Hospital Mumbai
- Department of Paediatric Haematology and Oncology, Tata Medical Center Kolkata
- Department of Medical Oncology, Cancer Institute (WIA) Chennai