The Translational and Integrative Oncology research group of the Biosanitary Research Institute of Granada (ibs.GRANADA), led by Isabel Blancas López-Barajas and Sergio Granados, has collaborated in carrying out an international clinical trial that has shown that the therapy endocrine, combined with a drug used in breast cancer called Abemaciclib, means a treatment with greater safety and better results perceived by patients in the treatment of high-risk breast cancer in its initial stages.
High-risk breast cancer that is estrogen receptor positive and Her-2 negative can be defined by different factors such as more advanced stages of presentation, higher rates of cell proliferation, or high degrees of cell differentiation.
This international study called MonarchE, in which researchers from ibs.GRANADA, the San Cecilio Clinical University Hospital and the University of Granada participate, is a phase 3 clinical trial in which almost six thousand patients from different countries have participated. In this study, a 27-month follow-up was carried out comparing patients with hormonal therapy with and without Abemaciclib, with the aim of observing the adverse effects of both lines of treatment.
Previous studies have already shown a clinically significant improvement in invasive disease-free survival with combination treatment of abemaciclib with hormone therapy in patients with high-risk, estrogen receptor-positive, Her-2-negative breast cancer, but this has not been demonstrated. exhaustively reported the assessment of treatments and outcomes for each study participant.
In addition, this analysis has contributed to more precisely establishing the safety of the use of adjuvant abemaciclib from data provided by nearly XNUMX trial patients, who received at least one dose of study treatment. For this, the incidence of adverse effects, their clinical management and their outcome were analyzed, as well as the quality of life perceived by the patients, taking into account the symptoms experienced and other variables such as the weight that these had in their lives. Adverse effects.
One of the most relevant conclusions of this study, in which ibs.GRANADA researchers have participated, is that in patients with high-risk breast cancer in its initial stage, with positive estrogen receptors and Her-2 negative, adjuvant treatment combining Abemaciclib and hormonal therapy have an acceptable safety profile and are well tolerated. The results obtained show that combining abemaciclib with endocrine therapy, despite the fact that it may cause an increase in the incidence of adverse effects, does not imply that patients suffer more clinical complications.
All this is also supported by the results where the subjective perception of the patient was evaluated, which is manifested in all age groups. Despite the fact that the adverse effects of this treatment were greater in the group that received abemaciclib, they were generally problems that were only detected in blood tests and lacked clinical significance (such as elevated transaminases or neutropenia). ), which could be reversed and managed using medication, reducing the abemaciclib dose, or temporarily stopping treatment.
About the research group
The "ae23 Translational and Integrative Oncology" research group at ibs.GRANADA, whose lead researchers are Isabel Blancas López-Barajas and Sergio Granada, has the main objective of facilitating the transition from basic research to clinical applications that benefit health and develop holistic and personalized treatment programs for the cancer patient. This translational medicine is aimed at providing the best and most advanced treatment based on the latest advances.
More information about the group at https://www.ibsgranada.es/grupos-de-investigacion/ae23-oncologia-traslacional-e-integrativa/
Bibliographic reference: Rugo HS, O'Shaughnessy J, Boyle F, Toi M, Broom R, Blancas I, Gumus M, Yamashita T, Im YH, Rastogi P, Zagouri F, Song C, Campone M, San Antonio B, Shahir A, Hulstijn M, Brown J, Zimmermann A, Wei R, Johnston SRD,
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