Editor's Note: At the 2024 San Antonio Breast Cancer Symposium (SABCS), Dr. Icro Meattini from the University of Florence, Italy, presented significant findings from the EUROPA trial. This Phase III randomized controlled trial focused on women aged 70 and above with Stage I Luminal breast cancer. The study aimed to compare the effects of radiation therapy (RT) alone versus endocrine therapy (ET) alone on health-related quality of life (HRQoL) and ipsilateral breast tumor recurrence (IBTR). Oncology Frontier interviewed Dr. Icro Meattini to discuss the study design and future research directions.Oncology Frontier: How did you determine that women aged 70 and above with Stage I Luminal breast cancer would be the focus of the EUROPA trial? What specific needs or challenges do patients in this age group and disease type face in treatment decisions?
Dr. Icro Meattini: I am Icro Meattini from the University of Florence, Italy. The EUROPA trial is a Phase III clinical study specifically designed for patients aged 70 and above. This is a particularly unique group because their treatment often requires further optimization. Current guidelines generally recommend breast-conserving surgery for these patients. For those diagnosed with estrogen receptor-positive (Luminal-type) breast cancer, most typically receive endocrine therapy and often postoperative radiation therapy.
The EUROPA trial aimed to explore how using either endocrine therapy or radiation therapy alone as a single treatment strategy would impact patients’ health-related quality of life. It’s important to highlight that HRQoL was a novel primary endpoint in our research, emphasizing the growing focus on patient-centered outcomes in breast cancer treatment.
Oncology Frontier: In the planned interim analysis, the study found that patients receiving endocrine therapy (ET) experienced a significant decline in health-related quality of life (HRQoL) compared to those receiving radiation therapy (RT). How do you interpret this result? Was this outcome unexpected?
Dr. Icro Meattini:This interim analysis was conducted on the first 152 patients enrolled and randomized in this trial, which ultimately aims to recruit around 1,000 participants. We have already observed a significant finding: patients receiving endocrine therapy showed a notable decline in health-related quality of life compared to those who received only radiation therapy.
This result was not entirely unexpected. We believe that these relatively vulnerable patients might benefit more from receiving only one of the two treatment options. Radiation therapy, in this context, appears to offer a better outcome in maintaining or improving health-related quality of life.
Oncology Frontier: In the EUROPA trial, how did you balance treatment effectiveness with patient safety? Specifically, what safety concerns do you believe are particularly important for elderly patients?
Dr. Icro Meattini:This is another critical aspect of our study. In the EUROPA trial, we carefully balanced health-related quality of life (HRQoL) with ipsilateral breast tumor recurrence (IBTR). Our primary goal was to ensure that omitting either endocrine therapy or radiation therapy would not compromise local control. Therefore, local control was measured through IBTR, making it one of the two primary endpoints of the study.
Adverse events are undoubtedly a crucial factor for these patients, as they are directly linked to health-related quality of life. In fact, approximately 20% of patients receiving endocrine therapy experienced new adverse events during the trial. This could partly explain the observed decline in their health-related quality of life.
Oncology Frontier: Based on the current interim analysis results, what changes or trends do you foresee in treatment strategies for elderly breast cancer patients? How do you plan to further advance this study to gain a more comprehensive understanding of how different treatment approaches impact patients’ long-term quality of life?
Dr. Icro Meattini: Of course, the current findings are not sufficient to change clinical practice yet, as this is only a planned interim analysis. The next step is to complete the five-year follow-up for 1,000 patients to obtain comprehensive results. This process will take some time, but we are confident that it will provide patients with more treatment options.
Some patients may be suitable for receiving both endocrine therapy and radiation therapy, while more vulnerable patients could, after thorough consultation, opt for either endocrine therapy alone or radiation therapy—whichever approach is more beneficial for improving their quality of life.
Oncology Frontier: Do you also plan to explore other factors or biomarkers that may impact patient prognosis?
Dr. Icro Meattini: Absolutely. While we anticipate that the local recurrence rate will be very low, we are still committed to identifying potential biomarkers associated with patient recurrence. However, this will be pursued as a sub-study and will require a clearer understanding of the final event rates before we can delve deeper into this area.
Dr. Icro Meattini Director of the Breast Unit and Breast Cancer Multidisciplinary Team (MDT) University Hospital of Florence, ItalyBottom of Form
