Efficacy and safety of oral magnesium supplementation in reducing febrile neutropenia episodes in children with solid tu
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ORIGINAL ARTICLE
Efficacy and safety of oral magnesium supplementation in reducing febrile neutropenia episodes in children with solid tumors treated with cisplatin‑based chemotherapy: randomized clinical trial Osvaldo D. Castelán‑Martínez1 · Miguel A. Palomo‑Colli2 · Victoria E. Barrios‑López2,3 · Karla M. Silva‑Jivaja1 · Luis E. Juárez‑Villegas2 · Gilberto Castañeda‑Hernández3 · Martha A. Sánchez‑Rodríguez4 Received: 12 May 2020 / Accepted: 24 September 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Purpose Hypomagnesemia has been associated with febrile neutropenia (FN) in pediatric patients receiving cisplatin-based chemotherapy (CDDPBC). The primary aim was to determine whether oral magnesium supplementation reduces FN episodes in pediatric patients with solid tumors treated with CDDPBC. Method This randomized clinical trial, with open-label, single-center, parallel group and superiority design was conducted in Hospital Infantil de Mexico Federico Gomez at Mexico City. Children ≥ 9 years with solid tumors that were to receive a CDDPBC cycle were invited to participate. Each chemotherapy cycle with CDDPBC was randomly assigned to receive oral magnesium supplementation (250 mg/day) or not receive magnesium supplementation (control group). Efficacy was determined by relative risks (RR) with 95% confidence intervals (95% CI) as well as with numbers needed to treat (NNT). Active surveillance was conducted to assess safety in both groups. Analyses were carried out by intention to treat. ClinicalTrials.gov number NCT03449693. Results One hundred and one chemotherapy cycles with CDDPBC were analyzed (50 in the magnesium supplement arm and 51 in control group). Baseline clinical characteristics were similar comparing both groups. Oral magnesium supplementation reduces FN episodes compared to control group [RR 0.53, (95% CI 0.32–0.89), NNT = 4]. In the supplemented group, patients had fewer episodes of septic shock secondary to FN [RR 0.43, (95% CI 0.02–0.94), NNT = 6] and FN appeared on average 5 days later (p = 0.031). Hypomagnesemia episodes and adverse events were similar across both groups. Conclusion Oral supplementation with magnesium reduces FN episodes neutropenia in pediatric patients with solid tumors treated with CDDPBC. Keywords Children · Cisplatin · Febrile neutropenia · Magnesium · Septic shock · Solid tumors
Introduction * Osvaldo D. Castelán‑Martínez [email protected] 1
Clinical Pharmacology Laboratory, UMIEZ, Facultad de Estudios Superiores Zaragoza, UNAM, Batalla 5 de mayo s/n esquina Fuerte de Loreto, Col. Ejército de Oriente, Iztapalapa, CP 09230 Mexico City, Mexico
2
Onco‑Hematology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico
3
Pharmacology Department, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico
4
Research Uniton Gerontology, Facultad de Estudios Superiores Zaragoza, UNAM, Mexico City, Mexico
Febrile neutropenia (FN) is a common and potentially lifethrea
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