FLAG with Bortezomib in Children and Adolescents with Relapsed/Refractory Acute Myeloid Leukemia in a Resource-Limited Setting: A Single-Center Experience from India.
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OBJECTIVES: The present study aimed to evaluate the impact, challenges, and outcome by adding bortezomib to the FLAG (fludarabine, cytarabine, and filgrastim) regimen in these populations in a resource-constraint setting. MATERIALS AND METHODS: A prospective observational study was conducted at a tertiary cancer center in India from January 2022 to September 2024 involving patients diagnosed with relapsed/refractory acute myeloid leukemia (AML) receiving FLAG-bortezomib. Complete remission (CR) and associated toxicities were assessed. RESULTS: Out of 13 patients, 8 (61.53%) were males and 5 (38.46%) were females (range: 2-17 years). Sorafenib ( n = 1) and midostaurin ( n = 2) were given along with chemotherapy for children with FLT3 mutations. Myelosuppression was the most frequent toxicity, with all patients developing ≥ grade 3 pancytopenia. Five (38.46%) patients achieved CR after first cycle, two (15.39%) died during treatment, and six (46.15%) were with persistent leukemic activity. Median duration of neutrophil and platelet recovery was 22 (range: 6-65) and 24 (range: 5-70) days, respectively, in children who achieved CR. Median overall survival was 12 months. At the last follow-up, three (23.08%) patients are alive. CONCLUSION: FLAG-bortezomib regimen could help in pediatric and adolescent relapsed AML to achieve a remission comparable with other regimen in low- and middle-income countries, highlighting its potential.