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Master's Dissertation
DOI
https://doi.org/10.11606/D.5.2022.tde-15062022-092534
Document
Author
Full name
Marcelo Junqueira Atanazio
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2022
Supervisor
Committee
Rocha, Vanderson Geraldo (President)
Seguro, Fernanda Salles
Maiolino, Angelo
Martinez, Gracia Aparecida
Title in Portuguese
Transplante autólogo de células-tronco hematopoiéticas no paciente com idade maior ou igual a 60 anos com mieloma múltiplo: avaliaçao de mortalidade, morbidade e resposta
Keywords in Portuguese
Células-tronco hematopoéticas
Idoso
Mieloma múltiplo
Mortalidade
Toxicidade
Transplante autólogo
Abstract in Portuguese
INTRODUÇÃO: O transplante autólogo de células-tronco hematopoiéticas (TaCTH) é um dos pilares no tratamento do mieloma múltiplo (MM). Embora seu uso já esteja bem documentado em pacientes jovens, faltam dados em relação à sua segurança e eficiência em idosos. O objetivo do estudo foi descrever as toxicidades, a mortalidade relacionada ao transplante (MRT), a sobrevida global (SG) e a sobrevida livre de progressão (SLP) pós-TaCTH. MÉTODOS: Foram avaliados retrospectivamente pacientes que realizaram, entre janeiro de 2010 e dezembro de 2020, TaCTH como terapia de consolidação para MM cuja idade no dia do TaCTH era, pelo menos, 60 anos completos. O desfecho primário foi descrever a incidência e os fatores associados ao evento toxicidade grave no pósTaCTH. Toxicidade grave foi definida como qualquer um dos seguintes eventos: mucosite oral grau 3/4, insuficiência renal aguda grau 3/4 ou diarreia grau 3/4, necessidade de uso de droga vasoativa, intubação orotraqueal, internação em terapia intensiva ou óbito em até 60 dias do TaCTH. Os desfechos secundários foram: descrever a incidência de complicações do TaCTH, avaliar as causas de MRT (definidas com óbito por qualquer causa exceto progressão de doença em até 60 dias do TaCTH), determinar a SG e a SLP pós-TaCTH. RESULTADOS: Foram estudados 177 pacientes. A idade mediana no TaCTH foi 63 anos (variando entre 60-71 anos), 90 (50,9%) pacientes eram do sexo masculino. International Staging System foi III em 50 (31,5%) pacientes. A dose de melfalano usada no condicionamento foi de 140 mg/m2 em 43 (24,3%) pacientes. Mucosite oral e diarréia grau 3/4 foram observadas em 32 (19,5%) e 37 (23,0%) pacientes respectivamente. Toxicidade de alto grau ocorreu em 77 (44,8%) pacientes. Observou-se que os pacientes com Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 2 ou 3 (razão de chances [RC]: 3,07; intervalo de confiança de 95% [IC95%] 1,30 - 7,26) concentração de hemoglobina ao TaCTH abaixo de 12 g/dl (RC 3,22; IC95% 1,53 - 6,75) concentração de albumina ao TaCTH abaixo de 3,5 g/dl (RC 3,96; IC95% 1,36 - 11,57) e que a realização de infusão de células-tronco a fresco (RC 5,48; IC95% 1,67 - 17,97) apresentaram maior chance exibir o evento toxicidade grave. A MRT foi 6,2% (11 pacientes faleceram). Dos 11 pacientes que apresentaram MRT cinco faleceram de infecção bacteriana documentada (um faleceu por celulite facial e quatro por infecção de corrente sanguínea relacionada a cateter). Pacientes com ECOG-PS 2 ou 3 (RC 4,43; IC95% 1,10 - 17,85) e com concentração de creatinina ao TaCTH acima de 2,0 mg/dl (RC 12,53; IC95% 2,33 - 67,57) apresentavam maior chance de MRT. Idade cronológica e dose de melfalano no condicionamento não foram associadas a toxicidade grave nem à MRT nas análises multivariadas. As SLP e SG medianas foram, respectivamente 23,6 e 92,2 meses. CONCLUSÕES: Os principais fatores implicados na morbimortalidade do TaCTH não são diretamente relacionados ao procedimento em si, mas, sim, ao performance status e às comorbidades dos pacientes. Apesar da alta MRT observada a SLP e SG pós-TaCTH foram semelhantes aos resultados da literatura. Os dados do presente estudo mostram que o TaCTH é uma opção terapêutica factível em doentes selecionados com idade maior ou igual a 60 anos
Title in English
Autologous stem cell transplantation in patients aged at least 60 years with multiple myeloma: evaluation of mortality, morbidity and response
Keywords in English
Aged
Autologous transplantation
Hematopoietic stem cells
Mortality
Multiple myeloma
Toxicity
Abstract in English
INTRODUCTION: Autologous stem cell transplantation (ASCT) is one of the pillars of multiple myeloma (MM) treatment. Although ASCT is widely performed in young patients, there is not enough data regarding its safety and efficiency in elderly. The objectives of this study were to describe ASCT toxicities, transplant related mortality (TRM), post ASCT overall survival (OS) and progression free survival (PFS). METHODS: Records from patients aged at least 60 years that underwent ASCT as consolidation therapy for MM between January 2010 and December 2020 were retrospective evaluated. The primary outcome was to describe the incidence and factors associated with the post ASCT event high-grade toxicity. High-grade toxicity was defined as any of the following events: grade 3/4 oral mucositis, grade 3/4 acute renal failure, grade 3/4 diarrhea, need for vasoactive drugs, mechanical ventilation, intensive care unit admission or death within 60 days of ASCT. Secondary outcomes were: describe ASCT complications, evaluate TRM causes (defined as death within 60 days of ASCT), determinate post ASCT PFS and OS. RESULTS: One hundred seventy seven patients were studied. Median ASCT age was 63 years (range 60-71 years), 90 (50.9%) patients were male. International Staging System was III in 50 (31.5%) patients. ASCT Melphalan dose was 140 mg/m2 in 43 (24.3%) patients. Grade 3/4 oral mucositis and diarrhea were observed in 32 (19.5%) and 37 (23.0%) patients respectively. High-grade toxicity was seen in 77 (44.8%) patients. We observed that patients with Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) 2 or 3 (odds ratio [OR]: 3.07 95% confidence interval [95%CI] 1.30 - 7.28), hemoglobin concentration at ASCT than 12 g/dl (OR 3.22; 95%CI 1.53 - 6.75), albumin concentration at ASCT lower than 3.5 g/dl (OR 3.96; 95%CI 1.36 - 11.57) and infusion of non cryopreserved stem cells (OR 5.48; 95%CI 1.67 - 17.97) had a higher chance of presenting the event high-grade toxicity. TRM was 6.2% (11 patients died). Of the 11 patients who had TRM, five died from a documented bacterial infection (one died from facial cellulitis and four from catheter-related bloodstream infection). Patients with ECOG-PS 2 or 3 (OR 4.43; 95CI% 1.10 - 17.85) and creatinine concentration at ASCT above 2.0 mg/dl (OR 12.53; 95%CI 2.33 - 67.57) had a higher chance of TRM. Chronological age and conditioning melphalan dose were not associated with high-grade toxicity or TRM in multivariate analysis. PFS and OS were respectively 23.6 and 92.2 months. CONCLUSIONS: The main factors involved in ASCT morbimortality were not directly related to the procedure itself, but were rather related to patient´s performance status and comorbidities. Despite the high TRM, post xvi ASCT PFS and OS were similar to the results in the literature. Data from the present study show that ASCT is a feasible therapeutic option in selected patients aged 60 years or over
 
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Publishing Date
2022-06-23
 
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