medigraphic.com
ISSN 1561-2996 (Electronic)
ISSN 0864-0289 (Print)

2021, Number 3

<< Back Next >>

Rev Cubana Hematol Inmunol Hemoter 2021; 37 (3)

Adverse drug events during the induction treatment of acute lymphoblastic leukemia in children

Gil AM, Year AIB, González OA

Language: Spanish
References: 36
Page: 1-19
PDF size: 576.62 Kb.


ABSTRACT

Introduction: During the induction treatment of acute lymphoid leukemia in children, adverse drug reactions are not always identified.
Aims: Describe the demographic and clinical characteristics of children with acute lymphoid leukemia who receive induction treatment at the Institute of Hematology and Immunology between 2012-2017. Characterize adverse events that occur during induction treatment. Describe adverse drug reactions during induction.
Methods: Observational, descriptive, cross-sectional study of case series in pharmacovigilance, used active pharmacovigilance. Variables: sex, age, prognosis group, week of treatment, type of adverse event, organ system affected, severity and imputability. The information was obtained from the national register of the ALLIC-BFM 2009 protocol and the medical records.
Results: 69 children were included, 55.1% belonged to the male sex, 56.5% were between one and six years old. 52.2% (36 children) belonged to the intermediate prognosis group. 471 events were recorded. 50.5% occurred in the first week of treatment. The most frequent: anemia (17.8%), neutropenia (16.1%) and thrombocytopenia (15.9%). The most affected organ systems: hemolinfopoietic (57.5%) and gastrointestinal (15.7%). According to the severity, 72.4% were moderate and 27.4% severe.
Conclusions: The whole presented adverse events, hematological alterations and reported events for drugs included in chemotherapy predominated. Adverse reactions classified as possible were identified, moderate and severe predominated.


REFERENCES

  1. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Clinical safety data management: definitions and standards for expedited reporting.E2A. 1994. [acceso 29/10/2020]. [aprox. 12 p.]. Disponible en https://database.ich.org/sites/default/files/E2A_Guideline.pdf

  2. Hunger SP, Mullighan CG. Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2015;373:1541-52. DOI: https://10.1056/NEJMra1400972

  3. Oskarsson T, Söderhäll S, Arvidson S, Forestier E, LethFrandsen T, Hellebostad M, et al. Treatment-related mortality in relapsed childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2018 Apr; 65:e26909. DOI: https://10.1002/pbc.26909

  4. Inaba H. Current therapeutic approaches in pediatric acute lymphoblastic leukemia. HematolMéx. 2018 April-June;19(2):91-9.

  5. Lassaletta Atienza A. Leucemias. Leucemia linfoblástica aguda. Pediatr Integral.2016;(6): 380-9.

  6. González Otero A, Menéndez Veitía A, Machín García S, Svarch E, Campo Díaz M, Fernández Nodarse R, et al. Resultados del tratamiento de la Leucemia Linfoide Aguda del niño en Cuba. Revista Cubana de Hematol, Inmunol y Hemoter. 2014;30(1):36-46.

  7. The WHO Adverse Reaction Terminology- WHO-ART. [Acceso 20 de marzo 2020]. [aprox. 9 p. ]. Disponible en: http://www.pharmadhoc.com/uploads/3/2/7/4/3274790/who-art_2005.pdf

  8. Karch F, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther 1977; 21: 247-54.

  9. Machín García S, González Otero A, Querol Betancourt N, Escalona Vives Y, García Caraballoso MB, Fernández Nodarse R et al. Caracterización y expectativa de vida de las leucemias en edad pediátrica en Cuba. 2006-2015. Rev Cubana Hematol Inmunol Hemoter [Internet]. 2018 [acceso 05/04/2020]; 33(S1): [aprox. 0 p.]. Disponible en: http://revhematologia.sld.cu/index.php/hih/article/view/673

  10. Villalba Toquica CP, Martínez Silva PA, Acero H. Caracterización clínico-epidemiológica de los pacientes pediátricos con leucemias agudas en la Clínica Universitaria Colombia. Serie de casos 2011-2014. Pediatría. 2016 enero-marzo; 49(1):17-22.

  11. Stary J, Zimmermann M, Campbell M, Castillo L, Dibar E, Donska S. Intensive Chemotherapy for Childhood Acute Lymphoblastic Leukemia: Results of the Randomized Intercontinental Trial ALL IC-BFM 2002. J ClinOncol. 2013; 32:174-84. DOI: https://10.1200/JCO.2013.48.6522

  12. González Otero A, Arencibia Núñez A, Machín García S, Menéndez Veitía A, Gutiérrez Díaz A, Nordet Carrera I, et al. Protocolo ALLIC-BFM 2002 en el Instituto de Hematología e Inmunología: experiencia de 10 años. Rev Cubana HematolInmunolHemoter. 2016 ene-mar; 32(1):70-85.

  13. Jin MW, Xu SM, An Q, Wang P. A review of risk factors for childhood leukemia. Eur Rev Med Pharmacol Sci. 2016;20:3760-4.

  14. Pieters R, Groot-Kruseman H, Van der Velden V, Fiocco M, Van den Berg H, de Bont E, et al. Successful Therapy Reduction and Intensification for Childhood Acute Lymphoblastic Leukemia Based on Minimal Residual Disease Monitoring: Study ALL10 from the Dutch Childhood Oncology Group. J Clin Oncol. 2016;34:2591-601. DOI: https://10.1200/JCO.2015.64.6364

  15. CananÖzdemir Z, DüzenliKar Y, BozkurtTurhan A, Bör O. Assessment of Hematological Toxicity in Children with Acute Lymphoblastic Leukemia, Receiving Treatment with ALL IC-BFM 2009 Protocol. OALib J. 2017 Jan;4(8):1-13. DOI: https://10.4236/oalib.1103807

  16. Ferreiro J, García LJ, Barceló R, Rubio I. Quimioterapia: efectos secundarios. Gac Med Bilbao. 2003;100:69-74.

  17. Molinés Honrubia A. Leucemias linfoblásticas agudas infantiles. Evolución histórica y perspectivas futuras. BSCP Can Ped. 2001;25(2):279-90.

  18. Ludwig H, Van Belle S, Barrett-Lee P, Birgegård G, Bokemeyer C, Gascón P, et al. The European Cancer Anemia Survey (ECAS): A large, multinational, prospective survey defining the prevalence, incidence, and treatment of anemia in cancer patients. Eur J Cancer. 2004 Oct; 40(15):2293-306. DOI: https://10.1016/j.ejca.2004.06.019

  19. Schmiegelow K, Müller K, Mogensen SS, Mogensen PR, Wolthers BO, Stoltze UK. Non-infectious chemotherapy-associated acute toxicities during childhood acute lymphoblastic leukemia therapy. F1000Res. 2017 Apr 7; 6:444. DOI: https://10.12688/f1000research.10768.1

  20. CananÖzdemir Z, DüzenliKar Y, BozkurtTurhan A, Bör O. Assessment of Hematological Toxicity in Children with Acute Lymphoblastic Leukemia, Receiving Treatment with ALLIC-BFM 2009 Protocol. OALib J. 2017; 4(8):1-13. DOI: https://10.4236/oalib.1103807

  21. Buendía Bravo S, González Haba Peña E, García Sánchez R, Arrabal Durán P, Sánchez Fresneda MN, Sanjurjo Sáez M. Análisis descriptivo de los motivos que originan visitas a urgencias en pacientes oncológicos: toxicidad postquimioterapia. Farm Hosp. 2015;39(6):333-337. DOI: https://10.7399/fh.2015.39.6.8728

  22. Díaz-Morales K, Reyes-Arvizu J, Morgado-Nájera K, Everardo-Domínguez D. Síntomas en niños con cáncer y estrategias de cuidado familiar. Rev Cuid. 2019 ene-abr;10(1):e597. DOI: https://10.15649/cuidarte. v10i1.597

  23. Cihan MK, Karabulut HG, Kutlay NY, Ruhi HI, Tükün A, Olcay L. Association Between N363S and BclI Polymorphisms of the Glucocorticoid Receptor Gene (NR3C1) and Glucocorticoid Side Effects During Childhood Acute Lymphoblastic Leukemia Treatment. Turk J Hematol. 2017;34:151-58. DOI: https://10.4274/tjh.2016.0253

  24. Fuentes L, Flores M, Iglesias A, Luzuriaga A, Rendón N, Ordoñez R, et al. Características de la leucemia linfoblástica aguda y neutropenia febril en niños y adolescentes atendidos en un hospital de Guayaquil, Ecuador. Rev Peru Med Exp Salud Pública. 2018;35(2):272-8. DOI: https://10.17843/rpmesp.2018.352.2862

  25. Li SD, Chen YB, Li ZG, Wu RH, Qin MQ, Zhou X, et al. Infections During Induction Therapy of Protocol CCLG-2008 in Childhood Acute Lymphoblastic Leukemia: A Single-center Experience with 256 Cases in China. Chinese Med J. 2015; 128 (4):472-6. DOI: https://10.4103/0366-6999.151085

  26. Inaba H, Pei D, Wolf J, Howard SC, Hayden RT, Go M. Infection-related complications during treatment for childhood acute lymphoblastic leukemia. Ann Oncol. 2017;28: 386-92. DOI: https://10.1093/annonc/mdw557

  27. León Barrios YR, Céspedes Quevedo MC, Vinent Céspedes AM. Neutropenia inducida por citostáticos en oncología. MEDISAN. 2017; 21(11):3163-71.

  28. Mendo Alcolea N, Cala Calviño L, Leyva Miranda T, Álvarez Escalante L, Traba Delis N. Reacciones adversas medicamentosas en pacientes con cáncer atendidos en el Hospital Oncológico Docente "Conrado Benítez". MEDISAN. 2017 Nov; 21(11):3145.

  29. Palomo-Colli MA, Soltero-Becerril DC, Juárez Villegas LE, Cicero-Oneto C, Gaytán-Morales JF, Castorena-Villa I, et al. Mucositis oral en niños con cáncer y su relación con limitación de actividades. Gac Mex Oncol. 2018; 17:87-92 DOI: https://10.24875/j.gamo.M18000137

  30. Juárez-López MLA, Solano-Silva MN, Fragoso-Ríos R, Murrieta-Pruneda F. Oral diseases in children with acute lymphoblastic leukemia with chemotherapy treatment. Rev Med Inst Mex Seguro Soc. 2018 Mar-Apr; 56(2):132-5.

  31. Schmiegelow K, Müller K, Mogensen SS, Mogensen PR, Wolthers BO, Stoltze UK. Non-infectious chemotherapy-associated acute toxicities during childhood acute lymphoblastic leukemia therapy. F1000Res. 2017 Apr 7;6:444. DOI: https://10.12688/f1000research.10768.1

  32. Alfonso I, Alonso C, Alonso L, Calvo DM, Cires M, Cruz MA, et al. Formulario Nacional de Medicamentos 4ta Ed. La Habana: Ciencias Médicas; 2014.

  33. Martindale Guía Completa de Consulta Farmacoterapéutica. 3a ed. España: Pharma Editores; 2008.

  34. Kim YJ, Jun YH, Kim YR, Park KG, Park YJ, Kang JY, et al. Risk factors for mortality in patients with Pseudomonas aeruginosa bacteremia; retrospective study of impact of combination antimicrobial therapy. BMC Infect Dis. 2014 Mar 24;14:161. DOI: https://10.1186/1471-2334-14-161

  35. Teachey DT, O'Connor D. How I treat newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in children. Blood. 2020 Jan 16;135(3):159-66. DOI: https://10.1182/blood.2019001557

  36. Maaz AUR, Badar T, Nassir IJ. High infection related mortality in pakistani children with acute lymphoblastic leukaemia during remission induction chemotherapy: review of data from a single institution. J Cancer Allied Spec. 2016;2(4):6.




2020     |     www.medigraphic.com