FIRES study: Filgrastim - retrospective investigation of effectiveness and safety in a health institution in Colombia
Estudio FIRES: Filgrastim - investigación retrospectiva de efectividad y seguridad en una institución de salud en Colombia
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Chemotherapy (QT) as a form of treatment of neoplasms causes neutropenia, febrile neutropenia, and myelosuppression, which favors the development of infections, sepsis, death, and a lower immune response. Colony-stimulating factors are a therapeutic alternative, which improves survival and immune response in patients with neoplasms. Methods: an observational retrospective analytical study was conducted in patients with neoplasms who attended a specialized health institution between 2017 and 2019 in the city of Bogota and treated with Filgrastim, who presented febrile neutropenia, addressing the clinical response and safety in terms of neutrophil increase. Results: the sample was comprised of 133 patients, it was found that the patients had more complications due to Non-Hodgkin's Lymphoma with 44.4% (n=59), followed by Leukemia 36.1% (n=48) and other tumors 12% (n=16). Of which 29% (n=38) were classified as stage 4, 12% (n=16) as stage 3 and 9% (n=12) as stage 2 of their neoplastic pathology. The group of patients treated with Filgrastim presented an increase in the neutrophil count after the start of treatment (p=0.04). Conclusions: febrile neutropenia occurs at any age, being more frequent in the sixth decade of life. Filgrastim proved to be an effective and safe drug, as part of the therapeutic intervention in patients with an oncologic diagnosis under QT schemes, representing an improvement of neutrophil count.
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Foote M. The Importance of Planned Dose of Chemotherapy on Time: Do We Need to Change Our Clinical Practice? Oncologist [Internet]. 1998;3(5):365-368. PMID: 10388127. Disponible en: https://pubmed.ncbi.nlm.nih.gov/10388127/
Sobrevilla Calvo PJ, Sobrevilla Moreno N, Ochoa Carrillo FJ, (2016). Neutropenia inducida por quimioterapia: el punto de vista del oncólogo. Gaceta Mexicana de Oncología [Internet]. 2016;16(6):344-349. Disponible en: https://10.1016/j.gamo.2016.08.006
Rastogi S, Kalaiselvan V, Ali S, Ahmad A, Guru SA, Sarwat M. Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis. Biology (Basel) [Internet]. 2021;10(10):1069. Disponible en: https://10.3390/biology10101069
U.S. Department of Health and Human Services NI, of Health NCI. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. 2009.
Rivera-Salgado D, Valverde-Muñoz K, Ávila-Agüero ML. Neutropenia febril en niños con cáncer: manejo en el servicio de emergencias. Revista Chilena de Infectología [Internet]. 2018;35(1):62–71. Disponible en: https://10.4067/s0716-10182018000100062
De Naurois J, Novitzky-Basso I, Gill MJ et al. Management of febrile neutropenia: ESMO Clinical Practice Guidelines. Ann Oncol [Internet]. 2010;21:252-6. Disponible en: https://10.1093/annonc/mdw325.
Culakova E, Thota R, Poniewierski MS, Kuderer NM, Wogu AF, Dale DC, Crawford J, Lyman GH. Patterns of chemotherapy-associated toxicity and supportive care in US oncology practice: a nationwide prospective cohort study. Cancer Medicine [Internet]. 2014;3(2), 434–444. Disponible en: https://10.1002/cam4.200
Jones SE, Savin MA, Holmes FA, O'Shaughnessy JA, Blum JL, Vukelja S, McIntyre KJ, Pippen JE, Bordelon JH, Kirby R, Sandbach J, Hyman WJ, Khandelwal P, Negron AG, Richards DA, Anthony SP, Mennel RG, Boehm KA, Meyer WG, Asmar L. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol [Internet]. 2006 Dec 1;24(34):5381-7. Disponible en: https://10.1200/JCO.2006.06.5391. Erratum in: J Clin Oncol. 2007 May 1;25(13):1819. PMID: 17135639.
Catalán, M., Álvarez, M. P., Sádaba, J., & Honorato J. Filgrastim: Factor estimulante de colonias de granulocitos. Rev Med Univ Navarra [Internet]. 1993;33-8. Disponible en: https://pubmed.ncbi.nlm.nih.gov/14735721/
PL. T. Principles of biologic Therapy. En: Loprinzi CL, comp. ASCO-SEP, Medical Oncology Self-Evaluation Program. Third. PL. T, editor. Alexandria: Springer Healthcare; 2013. 71-89 p. Disponible en: https://education.asco.org/product-details/asco-sep-6th-edition-self-evaluation
Sobrevilla-Calvo P, Castañeda-Soto N, Bustamante-Olivera E, Molina-Pérez A, Revilla-Beltri J. Evaluación de la seguridad y eficacia de Filgrastim en el manejo de la neutropenia febril posquimioterapia o radioterapia, en pacientes onco-hematológicos: Reporte de experiencia clínica. Gac Mex Oncol [Internet]. 2009;8(2):69-74. Disponible en: https://www.elsevier.es/es-revista-gaceta-mexicana-oncologia-305-articulo-evaluacion-seguridad-eficacia-Filgrastim-el-X1665920109501812.
Dale DC, Crawford J, Klippel Z, Reiner M, Osslund T, Fan E, Morrow PK, Allcott K, Lyman GH. A systematic literature review of the efficacy, effectiveness, and safety of Filgrastim. Support Care Cancer [Internet]. 2018 Jan;26(1):7-20. doi: 10.1007/s00520-017-3854-x. Epub 2017 Sep 22. PMID: 28939926; PMCID: PMC5827957. Disponible en: https://10.1007/s00520-017-3854-x
Borelli G, Bódega E. Evaluación de la movilización de células progenitoras hematopoyéticas para trasplante autólogo en hemopatías malignas y tumores sólidos con Filgen JP (Filgrastim Clausen)* Experiencia de un centro (Hospital Maciel, Montevideo, Uruguay) Dr. Biomed. 2006, p. 206-213. Disponible en: https://www.academia.edu/17490502/Evaluaci%C3%B3n_de_la_movilizaci%C3%B3n_de_c%C3%A9lulas_progenitoras_hematopoy%C3%A9ticas_con_Filgen_JP_Filgrastim_Clausen_para_trasplante_aut%C3%B3logo_en_hemopat%C3%ADas_malignas_y_
Scott S. Identification of cancer patients at high risk of febrile neutropenia. Am J Health Syst Pharm [Internet]. 2002 Aug 1;59(15 Suppl 4):S16-9. Disponible en: https://10.1093/ajhp/59.suppl_4.S16.PMID:12166033.
Rivas Llamas JR. Neutropenia febril: el punto de vista del hematólogo. Gaceta Mexicana de Oncología [Internet]. 2016;15(4):212–221. Disponible en: https://10.1016/j.gamo.2016.07.005
Cortés de Miguel S, Calleja-Hernández MÁ, Menjón-Beltrán S, Vallejo-Rodríguez I. Granulocyte colony-stimulating factors as prophylaxis against febrile neutropenia. Support Care Cancer [Internet]. 2015 Feb;23(2):547-59. Disponible en: https://10.1007/s00520-014-2459-x. Epub 2014 Oct 7. PMID: 25284722.
Lyman GH, Dale DC, Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol [Internet]. 2003; 21:4524–4531. Disponible en: https://10.1200/JCO.2003.05.002.
Bongiovanni A, Recine F, Fausti V, Rossi B, Mercatali L, Liverani C, De Vita A, Gurrieri L, De Bonis S, Miserocchi G, Spadazzi C, Calpona S, Riva N, Cocchi C, Ibrahim T. Clinical role of Filgrastim in the management of patients at risk of prolonged severe neutropenia: An evidence-based review. Int J Clin Pract [Internet]. 2019 Nov;73(11):e13404. Disponible en: https://10.1111/ijcp.13404. Epub 2019 Sep 13. PMID: 31408256.
Edelsberg J, Weycker D, Bensink M, Bowers C, Lyman GH. Prophylaxis of febrile neutropenia with colony-stimulating factors: the first 25 years. Curr Med Res Opin [Internet]. 2020 Mar;36(3):483-495. Disponible en: https://10.1080/03007995.2019.1703665. Epub 2019 Dec 29. PMID: 31834830.
Yang BB, Kido A. Pharmacokinetics and pharmacodynamics of pegFilgrastim. Clin Pharmacokinet [Internet]. 2011 May;50(5):295-306. Disponible en: https://10.2165/11586040-000000000-00000. PMID: 21456630.
Silvestris N, Del Re M, Azzariti A, Maiello E, Lombardi L, Cinieri S, et al. Optimized granulocyte colony-stimulating factor prophylaxis in adult cancer patients: From biological principles to clinical guidelines. Expert Opin Ther Targets [Internet]. 2012;16(SUPPL.2):111-7. Disponible en: https://10.1517/14728222.2011.652089
Carrato A, Rodríguez L, Rodríguez Á. Consenso sobre el manejo de Factores de crecimiento. 2006. 108 p.
Lyman GH. Guidelines of the National Comprehensive Cancer Network on the use of myeloid growth factors with cancer chemotherapy: a review of the evidence. J Natl Compr Canc Netw [Internet]. 2005 Jul;3(4):557-71. Disponible en: https://10.6004/jnccn.2005.0031. PMID: 16038646.
Cornes P, Gascon P, Chan S, et al. Systematic Review and Meta-analysis of Short- versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia [la corrección publicada aparece en Adv Ther. 2018 Oct 29:]. Adv Ther [Internet]. 2018;35(11):1816-1829. Disponible en: https://10.1007/s12325-018-0798-6
Heil G, Hoelzer D, Sanz MA, Lechner K, Noens L, Szer J, Ganser A, Matcham J, Renwick J; International Acute Myeloid Leukemia Study Group. Long-term survival data from a phase 3 study of Filgrastim as an adjunct to chemotherapy in adults with de novo acute myeloid leukemia. Leukemia [Internet]. 2006 Mar;20(3):404-9. Disponible en: https://10.1038/sj.leu.2404090. PMID: 16424872.
Wang L, Baser O, Kutikova L, Page JH, Barron R. The impact of primary prophylaxis with granulocyte colony-stimulating factors on febrile neutropenia during chemotherapy: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer [Internet]. 2015 Nov;23(11):3131-40. Disponible en: https://10.1007/s00520-015-2686-9. Epub 2015 Mar 29. PMID: 25821144; PMCID: PMC4584106.