New Drug Reduces Breast Cancer Recurrence by 25%, First in 20 Years
Based on research findings at ESMO 202, adding abemaciclib to hormonal therapy decreases the risk of recurrence of cancer by 25 percent in patients who have HR+ or high-risk early hormone receptor-positive HER2- or human epidermal growth factor receptor 2 negative or HER2 breast cancer.
According to Professor Stephen Johnston, the study's lead author, this is the first time in over two decades that there's advancement in the adjuvant treatment of this form of breast cancer.
Johnston, who is from London-based Royal Marsden Hospital NHS Foundation Trust, also explained that HR+ breast cancer is the most typical form of the said cancer type, affecting 70 percent of patients, with most of them being diagnosed with early disease.
A lot of these patients, he added, can be cured with presently available treatments such as surgery, radiotherapy, chemotherapy, and hormone treatment.
The professor also said that about 20 percent have a high-risk illness and will develop recurrence either locally in the breast or in any part of the body over the first decade of treatment.
Once the new standard of care for patients gets approved for high-risk HR+ HER2- early breast cancer, it will be recommended to add two more years of abemaciclib to endocrine therapy.
High-Risk Early Breast Cancer
According to Professor Johnston, the said patients who have high-risk early breast cancer present an amount of resistance to hormone therapy, deteriorating early despite everything currently being given to them.
CDK4/6 inhibitors like abemaciclib have changed the way doctors treat metastatic breast cancer for the past few years, overcoming primary endocrine resistance, not to mention enhancing survival.
It was said to be an obvious approach to find out if adding abemaciclib to hormone treatment in individuals who have high-risk breast cancer could lessen the risk of recurrence of their cancer.
Meanwhile, the international phase 3 monarchE research comprised more than 5,600 patients who have HR+ HER- early breast cancer with clinical or pathological risk factors putting them at risk for deterioration.
Upon completion of their primary treatment, the patients were randomized on an open-label basis to receive 150 mg of abemaciclib, two times every day for two years, plus endocrine treatment, or just an endocrine treatment.
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25% Decrease in Recurring Cancer
The lead author reported they found a 25 percent reduction in cancer recurrence with the first two years when abemaciclib was added to hormone treatment than to just hormone treatment.
During this period, the study showed that 11.3 percent of patients under the control group category had their cancer relapse compared to 7.8 percent of those in the abemaciclib group, a total 3.5 percent difference.
Most of the reductions took place in areas of distant metastases, particularly to liver and bone. According to the University of Milan's Medical Oncology, Associate Professor Giuseppe Curigliano, this is a pioneering study to present that adding an abemaciclib to endocrine therapy substantially improves invasive disease-free survival in the adjuvant setting.
Curigliano, the ESMO Guidelines Committee chair, also said that this study is a vital trial, and the results will change practice.
Once this new standard of care for patients gets approved for high-risk HR+ HER2- early breast cancer, it will be to add two more years of abemaciclib to endocrine therapy.
Tissue and Plasma Samples Collected
Curigliano proposed it would have been interesting to have involved genetic signature in evaluating patients at high risk, on top of the number of positive lymph nodes, tumor size, histologic grade, and Ki-67.
Additionally, Johnston said, plasma and tissue samples had been collected from all participants for translational studies that will involve looking at genomic signatures and reaction to abemaciclib.
The safety data are essential, especially the number of patients given the abemaciclib treatment who had needed to discontinue or required reductions of dose because of the side effects.
A total of 463 patients stopped their use of abemaciclib because of adverse incidents, most typically, diarrhea, 306 of these participants continued with endocrine treatment.
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Sep 20, 2020 10:49 PM EDT
