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Real world data regarding management of positive hormone receptors - HER-2 negative early breast cancer with high risk of relapse, previously to adjuvant Abemaciclib use : a retrospective study in a certified breast unit
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Introdução: Cancro de mama precoce com recetores hormonais positivos, HER-2 negativo de alto risco, tem uma elevada probabilidade de desenvolver recidivas locoregionais ou à distância, e potencialmente morte. Novas moléculas têm sido adicionadas aos tratamentos tradicionais nesta população. O estudo MonarchE demonstrou que a adição de abemaciclib à terapia hormonal adjuvante aumenta a sobrevivência livre de doença invasiva (IDFS), quando comparado com terapia hormonal apenas. Embora eficaz, o abemaciclib é muito caro e tem toxicidade associada, sendo necessários métodos alternativos para melhorar a sobrevivência dos doentes. Objetivo: Este estudo retrospetivo com dados do mundo real procurou demonstrar os benefícios do tratamento de doentes numa unidade de mama certificada pela Sociedade Europeia de Especialistas em Cancro de Mama (EUSOMA), de acordo com as recomendações internacionais. Métodos: Doentes operados entre 10/11/2011 e 31/12/2022, respeitando os critérios de inclusão e exclusão do estudo MonarchE, foram incluídos neste estudo. O seguimento dos doentes terminou em 31/05/2023. A IDFS e a sobrevivência livre de recidiva à distância (DRFS) foram calculadas e colocadas em perspetiva com os resultados do estudo MonarchE. O cumprimento dos indicadores de qualidade foi calculado de acordo com as recomendações da EUSOMA, assim como o tempo decorrido entre o diagnóstico e o primeiro tratamento, e entre tratamentos. Resultados: A IDFS e a DRFS na nossa população foram semelhantes ao braço com abemaciclib e significativamente melhores do que o braço de controlo do MonarchE. Todos os requisitos da EUSOMA e os tempos recomendados foram cumpridos. Conclusão: A sobrevivência dos doentes pode ser melhorada otimizando os cuidados de saúde durante todo o percurso do doente, evitando escalar tratamentos e seus custos e toxicidade associados. A certificação de Unidades de Mama por sociedades internacionais é uma metodologia estandardizada e validada, para garantir a mais elevada qualidade dos cuidados prestados em cancro da mama.
Introduction: High risk HR-positive/HER-2 negative early breast cancers have a high probability of developing loco regional or distant metastasis, potentially resulting in death. New molecules are being introduced in addition to traditional treatments for this population. The MonarchE study demonstrated that abemaciclib addition to adjuvant hormone therapy increases invasive disease-free survival (IDFS), when compared with hormone therapy only. Although effective, abemaciclib is very expensive and has associated toxicity, so alternate methods to improve patient survival are required. Objective: This real-world retrospective study aimed to demonstrate the benefits of treating breast cancer patients in an EUSOMA certified breast unit, in accordance with international guidelines. Methods: Patients operated between November 10th, 2011, and December 31st, 2022, and fulfilling the MonarchE inclusion and exclusion criteria, were included in this study. Patient follow-up ended on May 31st, 2023. IDFS and DRFS (distant relapse free survival) were calculated and put into perspective with MonarchE study arms outcomes. Breast unit quality indicators fulfillment was calculated according to EUSOMA guidelines, and timings from diagnosis to first treatment, and between treatments were also evaluated. Results: In our patient population, IDFS and DRFS were similar to MonarchE’s abemaciclib arm and significantly better than its control arm. All EUSOMA requirements and recommended timings were fulfilled. Conclusion: Patients’ survival can be improved based on optimizing quality of healthcare during the entire patients’ pathway, avoiding escalating treatments and their associated cost and toxicity. Breast Unit certification by international societies is a standardized and validated methodology to ensure the highest quality of breast cancer care.
Introduction: High risk HR-positive/HER-2 negative early breast cancers have a high probability of developing loco regional or distant metastasis, potentially resulting in death. New molecules are being introduced in addition to traditional treatments for this population. The MonarchE study demonstrated that abemaciclib addition to adjuvant hormone therapy increases invasive disease-free survival (IDFS), when compared with hormone therapy only. Although effective, abemaciclib is very expensive and has associated toxicity, so alternate methods to improve patient survival are required. Objective: This real-world retrospective study aimed to demonstrate the benefits of treating breast cancer patients in an EUSOMA certified breast unit, in accordance with international guidelines. Methods: Patients operated between November 10th, 2011, and December 31st, 2022, and fulfilling the MonarchE inclusion and exclusion criteria, were included in this study. Patient follow-up ended on May 31st, 2023. IDFS and DRFS (distant relapse free survival) were calculated and put into perspective with MonarchE study arms outcomes. Breast unit quality indicators fulfillment was calculated according to EUSOMA guidelines, and timings from diagnosis to first treatment, and between treatments were also evaluated. Results: In our patient population, IDFS and DRFS were similar to MonarchE’s abemaciclib arm and significantly better than its control arm. All EUSOMA requirements and recommended timings were fulfilled. Conclusion: Patients’ survival can be improved based on optimizing quality of healthcare during the entire patients’ pathway, avoiding escalating treatments and their associated cost and toxicity. Breast Unit certification by international societies is a standardized and validated methodology to ensure the highest quality of breast cancer care.
Descrição
Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2023
Palavras-chave
Cancro de mama precoce RH positivos HER-2 negativo Sobrevivência Unidades de mama certificadas Abemaciclib Oncologia