Análise de sobrevida em farmacoterapia
Conceitos, aplicações e desafios para a equipe multidisciplinar de saúde
Resumen
Devido aos recentes avanços no tratamento sistêmico do câncer, um número progressivamente maior de medicamentos, tanto na forma de monofármacos quanto de combinações, juntamente com o lançamento de várias estratégias terapêuticas, tem sido produzido nos últimos 20 anos. Aliado a isso, também é crescente o número de estudos avaliando o impacto na sobrevida e os dados obtidos acabam ficando disponíveis para uso clínico nas diversas linhas de tratamento da doença avançada. No entanto, ainda há grande controvérsia sobre quais desfechos utilizados em ensaios clínicos melhor representam o benefício associado à intervenção terapêutica de interesse e quais profissionais seriam necessários para monitorar e avaliar esses desfechos. Uma vez selecionado, o endpoint clínico aplicado pode resultar na possibilidade de integrar na prática clínica as informações obtidas em estudos de utilização de medicamentos. Este trabalho tem como objetivo conceituar as principais metodologias de análise de sobrevivência aplicadas à farmacoterapia do câncer e em estudos de utilização de medicamentos, mostrar quais são os desafios encontrados na oncologia e propor uma perfeita interação entre os participantes da equipe multidisciplinar de saúde (EMS) na condução destes estudos.
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https://sphweb.bumc.bu.edu/otlt/mph-modules/bs/bs704_survival/BS704_Survival5.html
Blagoev KB, Wilkerson J, Fojo T. Hazard ratios in cancer clinical trials--a primer. Nat Rev Clin Oncol. 2012 Jan 31;9(3):178-83. doi: 10.1038/nrclinonc.2011.217
Booth, C. M. and Eisenhauer, E. A. Progression-Free Survival: Meaningful or Simply Measurable? Journal of Clinical Oncology, v. 30, n. 10, p. 1030-1033, 2012. doi: 10.1200/JCO.2011.38.7571.
Collet JP. Limite des essais cliniques [Limitations of clinical trials]. Rev Prat. 2000 Apr 15;50(8):833-7. French. PMID: 10874859.
Damuzzo V, Agnoletto L, Leonardi L, Chiumente M, Mengato D and Messori A (2019). Analysis of Survival Curves: Statistical Methods Accounting for the Presence of Long-Term Survivors. Front. Oncol. 9:453. doi: 10.3389/fonc.2019.00453
Delgado A, Guddati AK. Clinical endpoints in oncology - a primer. Am J Cancer Res. 2021 Apr 15;11(4):1121-1131. PMID: 33948349
EUROPEAN MEDICINES AGENCY – EMA. Guideline on the evaluation of anticancer medicinal products in man. London: 2012. URL: https://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500137128.pdf. Accessed on May, 02, 2023
Fiteni F; Westeel, V.; Pivot, X. et al. Endpoints in cancer clinical trials. Journal of Visceral Surgery, v. 151 (1), p. 17-22, 2014. doi: 10.1016/j.jviscsurg.2013.10.001
FOOD AND DRUG ADMINISTRATION – FDA. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Maryland: 2007. URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-endpoints-approval-cancer-drugs-and-biologic. Accessed on May, 02, 2023.
Gajra A, Zemla TJ, Jatoi A, Feliciano JL, Wong ML, Chen H, Maggiore R, McMurray RP, Hurria A, Muss HB, Cohen HJ, Lafky J, Edelman MJ, Lilenbaum R, Le-Rademacher JG. Time-to-Treatment-Failure and Related Outcomes Among 1000+ Advanced Non-Small Cell Lung Cancer Patients: Comparisons Between Older Versus Younger Patients (Alliance A151711). J Thorac Oncol. 2018 Jul;13(7):996-1003. doi: 10.1016/j.jtho.2018.03.020.
Machado, K; Katz, A; Buyse, M; Saad, E.D. Sobrevida Global e Outros Desfechos Clínicos em Câncer de Mama : Situação Atual e Controvérsias. Rev Assoc Med Bras 2010; 56(5): 493-516. doi.org/10.1590/S0104-42302010000500008
Matulonis, UA; Oza, AM; Ho, TW; Ledermann, JA. Intermediate clinical endpoints: A bridge between progression-free survival and overall survival in ovarian cancer trials. Cancer, V 121, Issue 11, 2015. Pages 1737-1746. doi.org/10.1002/cncr.29082
Sachin Date. Introduction to Survival Analysis – Concepts, Techniques and Regression models Using Python and Lifelines. URL: timeseriesreasoning.com/contents/survival-analysis/. Accessed in May, 05, 2023.
Miot HA. Análise de sobrevivência em estudos clínicos e experimentais. J Vasc Bras. 2017 Oct-Dec;16(4):267-269. Portuguese. doi: 10.1590/1677-5449.001604
Wilson, M. K.; Karakasis, K.; Oza, A. M. Outcomes and endpoints in trials of cancer treatment: the past, present and future, The Lancet, v. 16, p. e31-e42, 2015. doi: 10.1016/S1470-2045(14)70375-4.
Pazdur R. Endpoints for assessing drug activity in clinical trials. The Oncologist. 2008;13(suppl 2):19–21. doi: 10.1634/theoncologist.13-S2-19.
Sherrill B, Amonkar M, Wu Y, Hirst C, Stein S, Walker M, Cuzick J. Relationship between effects on time-to-disease progression and overall survival in studies of metastatic breast cancer. Br J Cancer. 2008 Nov 18;99(10):1572-8. doi: 10.1038/sj.bjc.6604759.
Saad ED, Squifflet P, Burzykowski T, et al. Disease-free survival as a surrogate for overall survival in patients with HER2-positive, early breast cancer in trials of adjuvant trastuzumab for up to 1 year: a systematic review and meta-analysis. Lancet Oncol. 2019;20:361-370. doi.org/10.1016/S1470-2045(18)30750-2
Yin J, LaPlant B, Uy GL, Marcucci G, Blum W, Larson RA, Stone RM, Mandrekar SJ. Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614). Blood Adv. 2019 Jun 11;3(11):1714-1721. doi: 10.1182/bloodadvances.2018026112.
Zhuang, Sen H. MD, PhD; Xiu, Liang PhD; Elsayed, Yusri A. MD, PhD. Overall Survival: A Gold Standard in Search of a Surrogate: The Value of Progression-Free Survival and Time to Progression as End Points of Drug Efficacy. The Cancer Journal 15(5):p 395-400, September 2009. DOI: 10.1097/PPO.0b013e3181be231d
Arias. E. Life time for total population: USA 2003. The National Vital Statistics Reports. Vol 54, N. 14, April, 19. 2006.
URL: https://www.cdc.gov/nchs/data/nvsr/nvsr54/nvsr54_14.pdf
LaMorte, WW. Comparing Survival Curves. Boston University School of Public Health. 2016.
https://sphweb.bumc.bu.edu/otlt/mph-modules/bs/bs704_survival/BS704_Survival5.html
Publicado
2023-11-26
Cómo citar
Soeiro Pantoja, W. M. (2023). Análise de sobrevida em farmacoterapia: Conceitos, aplicações e desafios para a equipe multidisciplinar de saúde. Revista Brasileira De Saúde Militar, 2(2), 78-89. Recuperado a partir de https://ebrevistas.eb.mil.br/HCE/article/view/11944
Sección
Artigo de Revisão
