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Publication
Caracterização da utilização de nivolumab ao abrigo de Programa de Acesso Precoce em doentes com carcinoma do pulmão de não pequenas células
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Authors
Abstract(s)
Contexto: O nivolumab demonstrou eficácia e segurança em ensaios clínicos para o tratamento do carcinoma do pulmão de não pequenas células (CPNPC), existindo, no entanto, poucos dados sobre a sua utilização na prática clínica. Com este estudo pretende-se caracterizar a utilização de nivolumab ao abrigo de programa de acesso precoce (PAP) num Hospital Português e comparar os resultados obtidos com dados publicados recentemente.
Métodos: Estudo descritivo, observacional retrospetivo que incluiu todos os doentes com CPNPC que iniciaram terapêutica com nivolumab ao abrigo de PAP. A segurança foi avaliada através da determinação da frequência e gravidade de potenciais reações adversas e a efetividade através da determinação da sobrevivência global, sobrevivência livre de progressão, sobrevivência livre de eventos e tempo de sobrevivência pós-terapêutica. Os dados foram recolhidos entre 28/03/2017 e 21/06/2017 a partir dos registos clínicos.
Resultados: Dos 8 doentes incluídos, a maioria era do sexo masculino (6 doentes) com idade mediana de 65,5 anos. Todos apresentavam adenocarcinoma, com predominância para o estádio IV (62,5%) à data do diagnóstico. Na maioria dos doentes (62,5%) o nivolumab foi insittuído como terapêutica de 2ª linha. O tempo mediano desde o diagnóstico até ao início da terapêutica foi 15,1 meses. A duração média do tratamento foi 5,3 meses. 7 doentes tiveram potenciais reações adversas ao nivolumab, mas apenas 1 teve de suspender a terapêutica. A sobrevivência global mediana foi de 9,0 meses. A sobrevivência livre de progressão mediana foi de 8,4 meses. A sobrevivência livre de eventos mediana foi de 7,0 meses. O tempo de sobrevivência pós-terapêutica mediano foi 3,0 meses.
Conclusão: Encontrou-se uma elevada proporção de doentes com potenciais reações adversas que justifica uma monitorização intensiva futura. A sobrevivência global mediana foi inferior e a sobrevivência livre de progressão mediana e a sobrevivência livre de eventos mediana foram superiores às observadas nos estudos consultados.
Background: Nivolumab has shown efficacy and safety in clinical trials for non-small cell lung cancer (NSCLC) treatment, but there are few data on its use in the clinical practice. This study will characterize the use of nivolumab in a named patient program in a Portuguese Hospital and compare the obtained results with recently published data. Methods: Descriptive, observational, retrospective study that included all NSCLC patients that were approved for the named patient program and commenced therapy with nivolumab. Nivolumab’s safety was assessed based on the frequency and severity of potential treatment-related adverse events and its effectiveness was measured by overall survival, progression-free survival, event-free survival and post-therapy survival time. Data was collected from clinical records between 28/03/2017 and 21/06/2017. Results: Of the 8 patients included in the study, most were male (6 patients) with a median age of 65.5 years. All patients had adenocarcinoma and the stage at diagnosis for most (62.5%) of them was IV. When starting therapy with nivolumab all patients had stage IV disease. In most patients (62.5%) nivolumab was given as second-line therapy. Median time from diagnosis until the start of treatment was 15.1 months. Average treatment duration was 5.3 months. 7 patients had potential treatment-related adverse events, but only 1 had to discontinue treatment. Median overall survival was 9.0 months. Median progression-free survival was 8.4 months. Median event-free survival was 7.0 months. Post-therapy survival time was 3.0 months. Conclusion: The percentage of patients with potential treatment-related adverse events was high, justifying the need of further monitoring. The median overall survival was lower and the median progression-free survival and median event-free survival obtained were higher than the ones obtained in the consulted studies.
Background: Nivolumab has shown efficacy and safety in clinical trials for non-small cell lung cancer (NSCLC) treatment, but there are few data on its use in the clinical practice. This study will characterize the use of nivolumab in a named patient program in a Portuguese Hospital and compare the obtained results with recently published data. Methods: Descriptive, observational, retrospective study that included all NSCLC patients that were approved for the named patient program and commenced therapy with nivolumab. Nivolumab’s safety was assessed based on the frequency and severity of potential treatment-related adverse events and its effectiveness was measured by overall survival, progression-free survival, event-free survival and post-therapy survival time. Data was collected from clinical records between 28/03/2017 and 21/06/2017. Results: Of the 8 patients included in the study, most were male (6 patients) with a median age of 65.5 years. All patients had adenocarcinoma and the stage at diagnosis for most (62.5%) of them was IV. When starting therapy with nivolumab all patients had stage IV disease. In most patients (62.5%) nivolumab was given as second-line therapy. Median time from diagnosis until the start of treatment was 15.1 months. Average treatment duration was 5.3 months. 7 patients had potential treatment-related adverse events, but only 1 had to discontinue treatment. Median overall survival was 9.0 months. Median progression-free survival was 8.4 months. Median event-free survival was 7.0 months. Post-therapy survival time was 3.0 months. Conclusion: The percentage of patients with potential treatment-related adverse events was high, justifying the need of further monitoring. The median overall survival was lower and the median progression-free survival and median event-free survival obtained were higher than the ones obtained in the consulted studies.
Description
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2017
Keywords
Carcinoma do pulmão de não pequenas células Nivolumab Programa de acesso precoce Segurança Efetividade Mestrado Integrado - 2017