Breast cancer is the most common malignancy among women in the world with approximately 552,000 related deaths each year. This disease is heterogeneous with distinct histological and molecular subtypes which make prognosis and diagnosis of breast cancer challenging, particularly, on deciding on the best treatment regimen. Moreover, breast cancer staging is one of the most important factors in determining prognosis and treatment options, with the majority of patients present with early stages (stages I, IIA, IIB, and IIIA).
However, advances in genomic and transcriptomic techniques allowed more accurate breast cancer classifications. A multi-gene assay is a genetic analysis of the tumor itself and provides the treating oncologist with details on what is driving a cancer’s growth and what treatment the tumor may best respond to. These assays can give early stage breast cancer patients a clear and reliable prognosis of whether adjuvant therapy is actually necessary for their recovery or not. Currently, the major commercialized, FDA approved, and available multi-gene assays in the west as well as in the Middle East are: MammaPrint, Prosigna, Oncotype DX and Endopredict.
Multi-gene assays can assess the risk of recurrence in early stage breast cancer patients. Several studies had reported that multi-gene assay’s results had changed the recommendations of the treating oncologist on the adjuvant treatment, and many patients skipped chemotherapy to be treated with hormonal therapy alone. Interestingly, the data on the impact of the multi-gene assays results on adjuvant treatment managements in the Middle East region, particularly in Lebanon, is still unavailable.
The primary objective of this study is to examine the number and rate of requests of the main available multi-gene profiling tests (Oncotype DX, Prosigna, Endopredict and others) applied for early stage breast cancer patients at the American University of Beirut Medical Center. Furthermore, this study will show how these tests have an impact on the treatment recommendations of the treating oncologist about whether there is a need for chemotherapy or not. Moreover, we will check the practice changes imposed by the use of these tests and emphasize also on the cost, ease of access and the implications of these tests in the absence of clinical trials platform at AUBMC.
All patients diagnosed with early-stage breast cancer at the American University of Beirut Medical Center, and who underwent multi-gene assay test (Oncotype DX, Prosigna, Endopredict, etc.) are involved. Recruitment of eligible patients will begin in February of 2016, and is expected to be completed in 1 year time. After obtaining IRB approval, every involved oncologist will provide the number of treated patients and their identification data. Following that, our research team will have access to the patient’s data records, with the cooperation and supervision of the primary care oncologist in charge throughout the process of data collection. Moreover, we will document the treating oncologist treatment recommendations prior to knowing the genomic test results, and how these results changed his adjuvant treatment management between hormonal therapy alone vs chemotherapy followed by hormonal therapy.
After obtaining IRB approval, oncologists at AUBMC will provide the number of patients who underwent multi-gene assay testing and their identification data. Following that, our research team will have access to the patient’s data records, with the cooperation and supervision of the primary care oncologist in charge throughout the process of data collection. Moreover, we will document the treating oncologist treatment recommendations prior to knowing the genomic test results, and how these results changed his adjuvant treatment management between chemotherapy followed by hormonal treatment vs hormonal treatment alone.
Baseline demographics and pathological data of each patient will be collected from the treating oncologist and the medical records.
this study is prospective, a consent form is required. The primary care
physician introduces the study to the patient. The research team will then
discuss the study in detail and obtain the informed consent from breast cancer
patients who agree to participate. The letter of consent will state that the
study is voluntary and confidential and that all results will be kept in a
locked cabinet in the office of the PI.
All adult patients (≥18 years old) diagnosed with an early-stage, estrogen and/or progesterone receptor-positive, node-negative or positive breast cancer treated with surgical intervention, who underwent multi-gene assay test (Oncotype DX, Prosigna, Endopredict, and others) to decide on adjuvant treatment plan are included.
This study will only include patients who agree to participate in the study and signed the consent form.
Patients below the age of 18 are excluded.
All other breast cancer patients not fitting inclusion criteria.