Efficacy of fluoroquinolone prophylaxis during induction phase in children with acute lymphoblastic leukemia: a systematic review and meta-analysis.
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UNLABELLED: The role of infection prevention with fluoroquinolone prophylaxis specifically, during induction chemotherapy in pediatric acute lymphoblastic leukemia (ALL), remains unclear. Therefore, we conducted a systematic review and meta-analysis to assess its efficacy. PubMed, Scopus, and Cochrane databases were systematically searched for randomized controlled trials and observational studies. The main outcome was febrile neutropenia (FN) 26 and secondary outcomes were bloodstream infection (BSI), Clostridioides difficile infection (CDI) and all-cause mortality (ACM). A random-effects meta-analysis was conducted. We included 7 studies with 991 patients; 439 (44.3%) used fluoroquinolone prophylaxis, of whom 255 used levofloxacin and 184 used ciprofloxacin. The B-cell immunophenotype was the most frequent. Fluoroquinolone prophylaxis reduced the risk of FN (46.1% vs 64.9%; OR 0.44; 95% CI 0.33-0.59; I2 = 0%). Fluoroquinolone prophylaxis also significantly reduced the risk of BSI (OR 0.50; 95% CI 0.32-0.81; I2 = 0%). Risks of CDI (OR 0.43; 95% CI 0.00-42.30; I2 = 39.6%) and ACM (OR 1.04; 95% CI 0.20-5.38; I2 = 54.3%) were not significantly altered. CONCLUSIONS: Fluoroquinolone prophylaxis during induction chemotherapy for pediatric ALL significantly reduces FN and BSI without increasing C. difficile risk. While overall mortality is unchanged, reducing infectious morbidity may enhance treatment tolerance. WHAT IS KNOWN: • Febrile neutropenia and bloodstream infections are major causes of treatment-related morbidity and mortality during induction chemotherapy in pediatric acute lymphoblastic leukemia and fluoroquinolone prophylaxis has shown inconsistent results across studies. • Prior evidence suggests potential reduction in infectious complications, but is limited by heterogeneous populations and lack of analyses specific for induction phase. WHAT IS NEW: • This systematic review and meta-analysis focused specifically on the induction phase of pediatric acute lymphoblastic leukemia and demonstrates that fluoroquinolone prophylaxis significantly reduces febrile neutropenia and bloodstream infections with consistent effect across study designs. • The study provides pooled estimate from an specific phase showing no clear increase in Clostridioides difficile infection, demonstrating the risk-benefit profile of fluoroquinolone prophylaxis.