Use of Oral Metformin Therapy for Therapy-Induced Hyperglycemia in Pediatric Patients With Acute Lymphoblastic Leukemia.
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BACKGROUND: Hyperglycemia during treatment for pediatric acute lymphoblastic leukemia (ALL) is often induced by corticosteroids and asparaginase. Although insulin remains the standard therapy, oral metformin presents a promising alternative due to its ease of use, lower risk of hypoglycemia, and noninvasive route of administration-factors that can significantly enhance patient comfort and quality of life. OBJECTIVE: To evaluate the efficacy and safety of oral metformin in managing therapy-induced hyperglycemia (TIH) in children with ALL. MATERIALS AND METHODS: An ambispective analysis was conducted over 6 years (September 2018-August 2024) in pediatric ALL patients who developed hyperglycemia during induction or re-induction. We assessed the effectiveness of metformin in controlling hyperglycemia and the need for insulin in cases of suboptimal response. RESULTS: Out of 281 ALL patients, 54 (19.2%) developed TIH, with a median age of 12 years (range 5-16). Most cases (57.4%, n = 31) occurred in the preadolescent/adolescent group. Pre-B ALL accounted for 85.2% (n = 46), and T-ALL for 14.8% (n = 8). A WBC count >20 × 109/L was noted in 44.4% (n = 24). BMI was normal in 63% (n = 34), whereas 22.2% (n = 12) were overweight. Extremes of BMI (underweight/obese) were seen in 7.4% (n = 4) each. Most cases occurred during induction (49 patients), with 17 experiencing recurrence during re-induction. Hyperglycemia typically appeared within a week of initiating steroids. The mean baseline glucose was 240 mg/dL (range: 201-338 mg/dL), which declined to 137 mg/dL at Day 7 (range: 110-174 mg/dL), with a mean reduction from baseline of 103 mg/dL. Metformin (up to 1500 mg/day) successfully controlled blood glucose in 36 induction-phase patients (73.4%, 95% CI 59.7-83.8), whereas 13 (26.5%) required insulin. During re-induction, seven patients needed dual therapy. Insulin was added for glucose >300 mg/dL, signs of ketoacidosis, or poor response to metformin. In the TIH group, febrile neutropenia and culture-positive sepsis occurred in 42.6% (n = 23) and 24.1% (n = 13), respectively-higher than in non-hyperglycemic patients. All patients reverted to euglycemia after steroid tapering, with no long-term hypoglycemic therapy needed. Metformin was well-tolerated, with no adverse effects warranting discontinuation. Glycemic management did not interfere with leukemia remission or treatment completion. CONCLUSION: Oral metformin proved to be a safe and effective first-line option for managing TIH in pediatric ALL. Insulin therapy could be avoided in majority of the patients (73.4% in induction, 68.1% in re-induction), making this drug an attractive first-line option for children with treatment-induced non-severe hyperglycemia.