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Tratamento do cancro da mama metastático em doentes com recetores hormonais positivos e HER negativo
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Introdução: O tratamento inicial do cancro da mama metastático (CMM) com recetores hormonais positivos (RH+) e recetores tipo 2 negativos do fator de crescimento epidérmico (HER2-), inclui a utilização dos inibidores das cinases dependentes das ciclinas 4 e 6 (iCDK4/6) [palbociclib (PC), abemaciclib (AC) e ribociclib (RC)], que demonstraram segurança e eficácia nos respetivos ensaios clínicos, quando associados à hormonoterapia (HT). A aprovação regulamentar de novas terapêuticas foca-se no risco-benefício, baseado em critérios de eficácia e segurança. Evidencia-se um interesse crescente na utilização de dados de vida real, como parte do processo de desenvolvimento de medicamentos, utilizados para complementar os resultados obtidos nos ensaios clínicos. Este estudo pretende caracterizar os padrões de utilização dos iCDK4/6 + inibidores da aromatase (IA) nesses doentes, analisando os eventos adversos ocorridos.
Métodos: Estudo descritivo, observacional, retrospetivo e unicêntrico que incluiu doentes com CMM com RH+ e HER2-, submetidos à terapêutica com iCDK4/6 + IA, seguidos no Serviço de Oncologia do Hospital São Francisco Xavier (HSFX), entre 2017 e 2022.
Resultados: Consideraram-se três grupos de doentes: (1) IA e PC; (2) IA e AC; (3) IA e RC. O primeiro grupo continha 10 doentes do sexo feminino. Destes, 70% descontinuaram o tratamento. Os eventos adversos (EA) mais frequentes foram a anemia (70%) e astenia (60%). No segundo grupo, composto por 11 doentes, apenas um do sexo masculino, sete doentes (63,6%) descontinuaram o tratamento. Os EA maioritários foram a diarreia (100%) e aumento da creatinina/anemia (63,6%). No último grupo, constituído por 3 doentes do sexo feminino, apenas um descontinuou o tratamento. Como EA mais frequentes destacam-se a ostealgia, infeção, neutropenia e astenia (66,7%). A população em estudo apresentou-se mais heterogénea, ocorreu uma caracterização pormenorizada da amostra, tendo o perfil de segurança sido favorável.
Conclusão: A avaliação da utilização de iCDK4/6 + IA, permitiu caracterizar a amostra de doentes tratados, o perfil de EA, a duração da terapêutica e o motivo de descontinuação em contexto de vida real. O aumento do número de doentes incluídos e do tempo de seguimento permitirá a comparação com os resultados obtidos em ambiente de ensaio clínico.
Background: The initial treatment of hormone receptor-positive (RH+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC) includes the use of cyclin-dependent kinases 4 and 6 inhibitors (iCDK4/6) [(palbociclib (PC), abemaciclib (AC) and ribociclib (RC)], which demonstrated safety and efficacy in their respective clinical trials, when combined with hormone therapy (HT). Regulatory approval of new therapies focuses on risk-benefit, based on efficacy and safety criteria. There is a growing interest in the use of real-life data, as part of the drug development process, used to complement the results obtained in clinical trials. This study aims to characterize the uses’ patterns of iCDK4/6 + aromatase inhibitors (AI) in these patients, analyzing the adverse events that occurred. Methods: Descriptive, observational, retrospective and unicentric study, which included MBC patients with HR+ and HER2-, undergoing therapy with iCDK4/6 + AI, followed up at the Oncology Service of Hospital São Francisco Xavier (HSFX), between 2017 and 2022. Results: Three groups of patients were considered: (1) AI and PC; (2) AI and AC; (3) AI and RC. The first group contained 10 female patients. Of these, 70% discontinued treatment. The most frequent adverse events (AE) were anemia (70%) and asthenia (60%). In the second group, composed by 11 patients, only one male, seven patients (63.6%) discontinued treatment. The major AEs were diarrhea (100%) and increased creatinine/anemia (63.6%). In the last group, formed by 3 female patients, only one discontinued treatment. As the most frequent AEs were ostealgia, infection, neutropenia and asthenia (66.7%). The studied population was more heterogeneous, there was a detailed characterization of the sample and the safety profile was favorable. Conclusion: The evaluation of the use of iCDK4/6 + AI allowed to characterize the sample of treated patients, the AE profile, the duration of therapy and the reason for discontinuation in a real-life context. The increase in the number of patients included and the follow-up time will allow the comparison with the results obtained in a clinical trial environment.
Background: The initial treatment of hormone receptor-positive (RH+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC) includes the use of cyclin-dependent kinases 4 and 6 inhibitors (iCDK4/6) [(palbociclib (PC), abemaciclib (AC) and ribociclib (RC)], which demonstrated safety and efficacy in their respective clinical trials, when combined with hormone therapy (HT). Regulatory approval of new therapies focuses on risk-benefit, based on efficacy and safety criteria. There is a growing interest in the use of real-life data, as part of the drug development process, used to complement the results obtained in clinical trials. This study aims to characterize the uses’ patterns of iCDK4/6 + aromatase inhibitors (AI) in these patients, analyzing the adverse events that occurred. Methods: Descriptive, observational, retrospective and unicentric study, which included MBC patients with HR+ and HER2-, undergoing therapy with iCDK4/6 + AI, followed up at the Oncology Service of Hospital São Francisco Xavier (HSFX), between 2017 and 2022. Results: Three groups of patients were considered: (1) AI and PC; (2) AI and AC; (3) AI and RC. The first group contained 10 female patients. Of these, 70% discontinued treatment. The most frequent adverse events (AE) were anemia (70%) and asthenia (60%). In the second group, composed by 11 patients, only one male, seven patients (63.6%) discontinued treatment. The major AEs were diarrhea (100%) and increased creatinine/anemia (63.6%). In the last group, formed by 3 female patients, only one discontinued treatment. As the most frequent AEs were ostealgia, infection, neutropenia and asthenia (66.7%). The studied population was more heterogeneous, there was a detailed characterization of the sample and the safety profile was favorable. Conclusion: The evaluation of the use of iCDK4/6 + AI allowed to characterize the sample of treated patients, the AE profile, the duration of therapy and the reason for discontinuation in a real-life context. The increase in the number of patients included and the follow-up time will allow the comparison with the results obtained in a clinical trial environment.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2022, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Cancro da mama metastático Inibidores da aromatase Inibidores das cinases dependentes das ciclinas 4 e 6 Mundo real Segurança Mestrado integrado - 2022