Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.

Detalhes bibliográficos
Autor(a) principal: Marina Xavier Teixeira
Data de Publicação: 2022
Tipo de documento: Dissertação
Idioma: por
Título da fonte: Repositório Institucional da UFMG
Texto Completo: http://hdl.handle.net/1843/51284
Resumo: Multiple myeloma (MM) is a hematologic malignancy of plasma cells and presents variable signs and symptoms. The treatment is recommended for symptomatic patients in order to control the disease, promote remission, and increase survival and quality of life. However, discontinuation of treatment regimens often occurs due to several factors, such as ineffectiveness of treatment, problems in access to drugs, and the occurrence of adverse events. The aim of the study is to evaluate the discontinuation of antineoplastic treatment of MM patients initiating treatment. This is a historical cohort study conducted in onco-hematology outpatient clinics from 2009 to 2020. Study endpoints were first-line treatment discontinuation defined as transient discontinuation for termination of first-line and receipt of second-line treatment and permanent discontinuation for discontinuation of first-line antineoplastic therapy regimen in which patients did not receive subsequent lines of treatment within the study period. Selected exposure variables comprised sociodemographic, clinical, and pharmacotherapy variables. Data were collected from medical records and laboratory tests. Absolute and relative frequencies, measures of central tendency and dispersion of the study variables were calculated. The cumulative incidence of transient discontinuation, with a 95% confidence interval (CI), was estimated by nonparametric analysis of competitive risks in the presence of competitive events (reasons for permanent discontinuation - response to treatment, stable disease, limiting events, deaths, and discontinuations with no recorded reason - censoring). Transient discontinuation was compared according to exposure variables using Gray's test, considering a significance level of 5%. A total of 260 patients were selected for the study. Approximately half of the participants were younger than 65 years of age (mean 63.3 years; standard deviation - SD=11.9), 50.7% were female, 56.2% were linked to the private institution, and 27.3% and 72.7% started treatment in the periods 2009-2014 and 2015-2020, respectively. Thalidomide-based treatment regimens accounted for 47.7%, bortezomib-based 40.3%, thalidomide + bortezomib-based 6.2%, and other therapeutic regimens 5.8%. Polypharmacy use was identified for 68.5% of participants and 97.3% had comorbidities. The mean treatment time in first-line treatment was 7.4 months (SD=4.9). Of the participants, 125 (48%) experienced transient discontinuation and 135 patients (52%) experienced permanent discontinuation of first-line treatment. The main reason for transient discontinuation was the occurrence of a limiting event with AEs predominating, while achieving a response to treatment was the main reason for permanent discontinuation. The cumulative incidence of transient discontinuation was significantly different between the 2009-2014 and 2015-2020 treatment initiation periods (p<0.0001). Prevention and management of discontinuation for modifiable reasons should contribute to better MM treatment outcomes.
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spelling Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.First-line treatment discontinuation in patients with multiple myeloma: historical cohort.Mieloma múltiploDescontinuação de tratamentoResposta ao tratamentoEventos adversosCoorte históricaMultiple myeloma (MM) is a hematologic malignancy of plasma cells and presents variable signs and symptoms. The treatment is recommended for symptomatic patients in order to control the disease, promote remission, and increase survival and quality of life. However, discontinuation of treatment regimens often occurs due to several factors, such as ineffectiveness of treatment, problems in access to drugs, and the occurrence of adverse events. The aim of the study is to evaluate the discontinuation of antineoplastic treatment of MM patients initiating treatment. This is a historical cohort study conducted in onco-hematology outpatient clinics from 2009 to 2020. Study endpoints were first-line treatment discontinuation defined as transient discontinuation for termination of first-line and receipt of second-line treatment and permanent discontinuation for discontinuation of first-line antineoplastic therapy regimen in which patients did not receive subsequent lines of treatment within the study period. Selected exposure variables comprised sociodemographic, clinical, and pharmacotherapy variables. Data were collected from medical records and laboratory tests. Absolute and relative frequencies, measures of central tendency and dispersion of the study variables were calculated. The cumulative incidence of transient discontinuation, with a 95% confidence interval (CI), was estimated by nonparametric analysis of competitive risks in the presence of competitive events (reasons for permanent discontinuation - response to treatment, stable disease, limiting events, deaths, and discontinuations with no recorded reason - censoring). Transient discontinuation was compared according to exposure variables using Gray's test, considering a significance level of 5%. A total of 260 patients were selected for the study. Approximately half of the participants were younger than 65 years of age (mean 63.3 years; standard deviation - SD=11.9), 50.7% were female, 56.2% were linked to the private institution, and 27.3% and 72.7% started treatment in the periods 2009-2014 and 2015-2020, respectively. Thalidomide-based treatment regimens accounted for 47.7%, bortezomib-based 40.3%, thalidomide + bortezomib-based 6.2%, and other therapeutic regimens 5.8%. Polypharmacy use was identified for 68.5% of participants and 97.3% had comorbidities. The mean treatment time in first-line treatment was 7.4 months (SD=4.9). Of the participants, 125 (48%) experienced transient discontinuation and 135 patients (52%) experienced permanent discontinuation of first-line treatment. The main reason for transient discontinuation was the occurrence of a limiting event with AEs predominating, while achieving a response to treatment was the main reason for permanent discontinuation. The cumulative incidence of transient discontinuation was significantly different between the 2009-2014 and 2015-2020 treatment initiation periods (p<0.0001). Prevention and management of discontinuation for modifiable reasons should contribute to better MM treatment outcomes.O mieloma múltiplo (MM) é uma doença hematológica maligna de células plasmáticas e apresenta sinais e sintomas variáveis. O tratamento é recomendado para os pacientes sintomáticos, com o objetivo de controlar a doença, promover a remissão e aumentar a sobrevida e a qualidade de vida. Entretanto, descontinuações dos esquemas terapêuticos acontecem frequentemente devido a vários fatores, como inefetividade do tratamento, problemas no acesso aos medicamentos e ocorrência de eventos adversos. O objetivo do estudo é avaliar a descontinuação do tratamento antineoplásico de pacientes com MM em início de tratamento. Trata-se de um estudo de coorte histórica conduzida em ambulatórios de onco-hematologia no período de 2009 a 2020. Os desfechos do estudo foram a descontinuação da primeira linha de tratamento definida como descontinuação transitória para o término da primeira linha e recebimento da segunda linha de tratamento e descontinuação permanente para interrupção do esquema de terapia antineoplásica de primeira linha em que os pacientes não receberam linhas de tratamento subsequentes no período do estudo. Variáveis de exposição selecionadas compreenderam variáveis sociodemográficas, clínicas e farmacoterapêuticas. Os dados foram coletados a partir de prontuários e exames laboratoriais. Realizou-se cálculo de frequências absolutas e relativas, medidas de tendência central e de dispersão das variáveis do estudo. A incidência acumulada da descontinuação transitória, com intervalo de confiança (IC) de 95%, foi estimada por meio da análise não paramétrica de riscos competitivos na presença de eventos competitivos (motivos da descontinuação permanente - resposta ao tratamento, doença estável, eventos limitantes, óbitos e descontinuações sem registro do motivo - censura). A descontinuação transitória foi comparada de acordo com as variáveis de exposição por meio do teste de Gray, considerando o nível de significância de 5%. Um total de 260 pacientes foi selecionado para o estudo. Aproximadamente metade dos participantes tinha menos de 65 anos de idade (média 63,3 anos; desvio padrão - DP=11,9), 50,7% eram do sexo feminino, 56,2% eram vinculados à instituição privada e 27,3% e 72,7% iniciaram o tratamento nos períodos de 2009-2014 e 2015-2020, respectivamente. Os esquemas de tratamento baseados em talidomida corresponderam a 47,7%, baseados em bortezomibe 40,3%, baseados em talidomida + bortezomibe 6,2% e outros esquemas terapêuticos 5,8%. O uso de polifarmácia foi identificado para 68,5% dos participantes e 97,3% apresentavam comorbidades. A média do tempo de tratamento na primeira linha de tratamento foi de 7,4 meses (DP=4,9). Dos participantes, 125 (48%) apresentaram descontinuação transitória e 135 pacientes (52%) apresentaram descontinuação permanente da primeira linha de tratamento. O principal motivo de descontinuação transitória foi a ocorrência de evento limitante com predominância dos EAs, enquanto alcançar uma resposta ao tratamento foi o principal motivo da descontinuação permanente. A incidência acumulada da descontinuação transitória foi significativamente diferente entre os períodos de início de tratamento 2009-2014 e 2015-2020 (p<0,0001). A prevenção e manejo da descontinuação por motivos modificáveis devem contribuir para a obtenção de melhores desfechos do tratamento do MM.Universidade Federal de Minas GeraisBrasilFARMACIA - FACULDADE DE FARMACIAPrograma de Pós-Graduação em Medicamentos e Assistencia FarmaceuticaUFMGCristiane Aparecida Menezes de Páduahttps://buscatextual.cnpq.br/buscatextual/visualizacv.do?id=K4777370J9&tokenCaptchar=03AFY_a8Wh4v7F-448G8e3mJ4332ORs7jI-RQqAp6SkAajNscQxG7Mev6LzVw8ygyFtx71Njr1sF6NRlg5epuEuBdWjcehRhhV54kIEiDuidb5tuAWvIGRmEltTa9K3QbJvfhddnZ6dp8xIzUroCLr-nAPZEMTCyhY00j6Umns-BqvQj9F8geRcLrm2sGSwEs7Q55dhfabgPCzWNR2XCyzFeye5SlKklGHhlLrJiI1x6ixOEioYrFFJ1Fb0w2QTzVzURFmwCJAGnqZrl64WQEokGfO2rkinNntXpNX1hxDbb9d87aRr96htJFL_kMaQsrK6vQTqUA_w5EpXBm2RcFKk_-qRnoIDS7jT4h0kPSwTzASpxC79iMK6ysh19tT04VIU9c05hfc0VeqTHQGBIV0qF-6hNltkmdX19TnNdEOQNmc3k-xzLHTfTfT7t94zdzO9kZxFbunZLCzUbcpocWYssftOrrndi6okBaSPv_itZSdDofN2MuhFHKvyb03b2S-1jpH1qMLt6BfThCXaXHPR0RHjP3ikX4qlHyIa6hJ8bT-Y81ZfR40EqV1TlE2LowsljSWaixRbmWoKCcTAiW5hK2ax732GOQeFgAdriano Max Moreira ReisMariana Martins Gonzaga do NascimentoLaís Lessa Neiva PantuzzaMarina Xavier Teixeira2023-03-28T15:30:41Z2023-03-28T15:30:41Z2022-12-16info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/1843/512840000-0002-5309-9644porhttp://creativecommons.org/licenses/by-nc-nd/3.0/pt/info:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMG2023-03-28T15:30:41Zoai:repositorio.ufmg.br:1843/51284Repositório InstitucionalPUBhttps://repositorio.ufmg.br/oairepositorio@ufmg.bropendoar:2023-03-28T15:30:41Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false
dc.title.none.fl_str_mv Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.
First-line treatment discontinuation in patients with multiple myeloma: historical cohort.
title Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.
spellingShingle Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.
Marina Xavier Teixeira
Mieloma múltiplo
Descontinuação de tratamento
Resposta ao tratamento
Eventos adversos
Coorte histórica
title_short Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.
title_full Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.
title_fullStr Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.
title_full_unstemmed Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.
title_sort Descontinuação da primeira linha de tratamento de pacientes com mieloma múltiplo: coorte histórica.
author Marina Xavier Teixeira
author_facet Marina Xavier Teixeira
author_role author
dc.contributor.none.fl_str_mv Cristiane Aparecida Menezes de Pádua
https://buscatextual.cnpq.br/buscatextual/visualizacv.do?id=K4777370J9&tokenCaptchar=03AFY_a8Wh4v7F-448G8e3mJ4332ORs7jI-RQqAp6SkAajNscQxG7Mev6LzVw8ygyFtx71Njr1sF6NRlg5epuEuBdWjcehRhhV54kIEiDuidb5tuAWvIGRmEltTa9K3QbJvfhddnZ6dp8xIzUroCLr-nAPZEMTCyhY00j6Umns-BqvQj9F8geRcLrm2sGSwEs7Q55dhfabgPCzWNR2XCyzFeye5SlKklGHhlLrJiI1x6ixOEioYrFFJ1Fb0w2QTzVzURFmwCJAGnqZrl64WQEokGfO2rkinNntXpNX1hxDbb9d87aRr96htJFL_kMaQsrK6vQTqUA_w5EpXBm2RcFKk_-qRnoIDS7jT4h0kPSwTzASpxC79iMK6ysh19tT04VIU9c05hfc0VeqTHQGBIV0qF-6hNltkmdX19TnNdEOQNmc3k-xzLHTfTfT7t94zdzO9kZxFbunZLCzUbcpocWYssftOrrndi6okBaSPv_itZSdDofN2MuhFHKvyb03b2S-1jpH1qMLt6BfThCXaXHPR0RHjP3ikX4qlHyIa6hJ8bT-Y81ZfR40EqV1TlE2LowsljSWaixRbmWoKCcTAiW5hK2ax732GOQeFg
Adriano Max Moreira Reis
Mariana Martins Gonzaga do Nascimento
Laís Lessa Neiva Pantuzza
dc.contributor.author.fl_str_mv Marina Xavier Teixeira
dc.subject.por.fl_str_mv Mieloma múltiplo
Descontinuação de tratamento
Resposta ao tratamento
Eventos adversos
Coorte histórica
topic Mieloma múltiplo
Descontinuação de tratamento
Resposta ao tratamento
Eventos adversos
Coorte histórica
description Multiple myeloma (MM) is a hematologic malignancy of plasma cells and presents variable signs and symptoms. The treatment is recommended for symptomatic patients in order to control the disease, promote remission, and increase survival and quality of life. However, discontinuation of treatment regimens often occurs due to several factors, such as ineffectiveness of treatment, problems in access to drugs, and the occurrence of adverse events. The aim of the study is to evaluate the discontinuation of antineoplastic treatment of MM patients initiating treatment. This is a historical cohort study conducted in onco-hematology outpatient clinics from 2009 to 2020. Study endpoints were first-line treatment discontinuation defined as transient discontinuation for termination of first-line and receipt of second-line treatment and permanent discontinuation for discontinuation of first-line antineoplastic therapy regimen in which patients did not receive subsequent lines of treatment within the study period. Selected exposure variables comprised sociodemographic, clinical, and pharmacotherapy variables. Data were collected from medical records and laboratory tests. Absolute and relative frequencies, measures of central tendency and dispersion of the study variables were calculated. The cumulative incidence of transient discontinuation, with a 95% confidence interval (CI), was estimated by nonparametric analysis of competitive risks in the presence of competitive events (reasons for permanent discontinuation - response to treatment, stable disease, limiting events, deaths, and discontinuations with no recorded reason - censoring). Transient discontinuation was compared according to exposure variables using Gray's test, considering a significance level of 5%. A total of 260 patients were selected for the study. Approximately half of the participants were younger than 65 years of age (mean 63.3 years; standard deviation - SD=11.9), 50.7% were female, 56.2% were linked to the private institution, and 27.3% and 72.7% started treatment in the periods 2009-2014 and 2015-2020, respectively. Thalidomide-based treatment regimens accounted for 47.7%, bortezomib-based 40.3%, thalidomide + bortezomib-based 6.2%, and other therapeutic regimens 5.8%. Polypharmacy use was identified for 68.5% of participants and 97.3% had comorbidities. The mean treatment time in first-line treatment was 7.4 months (SD=4.9). Of the participants, 125 (48%) experienced transient discontinuation and 135 patients (52%) experienced permanent discontinuation of first-line treatment. The main reason for transient discontinuation was the occurrence of a limiting event with AEs predominating, while achieving a response to treatment was the main reason for permanent discontinuation. The cumulative incidence of transient discontinuation was significantly different between the 2009-2014 and 2015-2020 treatment initiation periods (p<0.0001). Prevention and management of discontinuation for modifiable reasons should contribute to better MM treatment outcomes.
publishDate 2022
dc.date.none.fl_str_mv 2022-12-16
2023-03-28T15:30:41Z
2023-03-28T15:30:41Z
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dc.publisher.none.fl_str_mv Universidade Federal de Minas Gerais
Brasil
FARMACIA - FACULDADE DE FARMACIA
Programa de Pós-Graduação em Medicamentos e Assistencia Farmaceutica
UFMG
publisher.none.fl_str_mv Universidade Federal de Minas Gerais
Brasil
FARMACIA - FACULDADE DE FARMACIA
Programa de Pós-Graduação em Medicamentos e Assistencia Farmaceutica
UFMG
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFMG
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reponame_str Repositório Institucional da UFMG
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repository.name.fl_str_mv Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)
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