Views:0 Author:Site Editor Publish Time: 2021-09-08 Origin:Site
For hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, current treatment guidelines support continued endocrine therapy after first-line treatment progresses, including everolimus + exemestane combination therapy. According to the results of the BOLERO-2 study, after the progress of non-steroidal aromatase inhibitors, everolimus + exemestane compared with exemestane alone, the median of HR-positive and HER2-negative advanced breast cancer postmenopausal women The progression-free survival time was doubled (7.8 vs. 3.2 months), the risk of recurrence or death was reduced by 55% (hazard ratio: 0.45, 95% confidence interval: 0.38 to 0.54, P<0.0001), and the total median follow-up for 18 months The remission rate was 12.6% vs. 1.7% (95% confidence interval: 9.8-15.9%, 0.5-4.2%).
On October 30, 2018, the International Anti-Cancer Alliance "International Journal of Cancer" published a copy of the Frankfurt Hematology and Oncology Center, Munich Outpatient Cancer Treatment Center, Ravensburg Cancer Hospital, Bonn Gynecology Center, Heidelberg University Hospital, National Oncology Center, Kiel University Hospital, Hessian Eastern Medical Center, Erlangen Nuremberg University, Berlin University School of Medicine, Frankfurt Northwestern Hospital, Ulm University Hospital, Novartis Nuremberg, Tübingen University Hospital Phase IIIB 4EVER study The report evaluated the effectiveness, safety and quality of life of everolimus + exemestane for postmenopausal women with HR-positive and HER2-negative advanced breast cancer. Since this study has no limitation on the time of progression after non-steroidal aromatase inhibitors, previous advanced disease chemotherapy or previous exemestane treatment, compared with previous main studies, the evaluation of the patient population is larger, so it can reflect the truth more Clinical practice in the world.
This non-blinded single-group Phase IIIB 4EVER study was enrolled from 82 German centers from June 2012 to November 2013. Postmenopausal women who progressed during or after non-steroidal aromatase inhibitor treatment with HR-positive HER2-negative advanced breast cancer Among 299 patients, the clinical effectiveness of everolimus + exemestane for 281 patients and the safety of 299 patients were evaluated. The primary endpoint is the total response rate (percentage of patients with complete response + partial response) in the 24 weeks before treatment. Secondary endpoints include progression-free survival, overall survival, safety, and health-related quality of life.
As a result, the overall response rate was 8.9% (95% confidence interval: 5.8 to 12.9%), and the median progression-free survival time was 5.6 months (95% confidence interval: 5.4 to 6.0 months), both lower than the BOLERO-2 study , May be due to more advanced patients and more previous treatments. The most common grade 3/4 adverse events were stomatitis, deterioration of general health, dyspnea, and anemia. The incidences were 8.4%, 6.7%, 4.7%, and 4.3%, respectively.
Therefore, the results of the study show that these data confirm the clinical benefit and known safety of everolimus + exemestane for postmenopausal women with HR-positive and HER2-negative advanced breast cancer.