October is breast cancer awareness month: the annual, international health campaign to increase awareness and raise funds for research into the prevention, diagnosis, treatment, and cure for this disease. Pink is the given color, and we will see it around us this month as a reminder of the effect this disease has had around the world. My son and his football teammates will wear bright pink socks to all their games this month. Many of their opponents will be wearing pink socks too. Football moms will be a focus of at least one game. Susan G. Komen® has used the color pink since its inception in 1982. The organization estimates that there will be 287,850 new cases of invasive breast cancer and 43,250 breast cancer deaths among women this year. For men, the organization estimates 2,710 new cases of invasive breast cancer and 530 deaths this year. Breast cancer survival depends on both the diagnosis and treatment.
The clinical laboratory plays a significant role in both the diagnosis and treatment of breast cancer patients, and according to the Centers for Disease Control and Prevention, laboratories are responsible for approximately 70% of the decisions made during the course of a patient’s care. If a follow-up mammogram, ultrasound, or MRI indicates further testing is needed, a biopsy is next. When a sample of tumor is sent to the laboratory following a patient biopsy, a pathologist examines thin slices of the tumor under a microscope to determine exactly what type and stage of cancer a patient might have. Following this evaluation, a pathologist determines the diagnosis, and ultimately the course of treatment for a patient.
The two most common lab tests performed are the hormone receptor test and the HER2 test. The HER2 test looks for whether cancer cells have too many copies of the HER2 gene or a higher-than-normal level of the HER2 protein. The formal name of the HER2 gene is the human epidermal growth factor receptor 2, and it makes HER2 proteins. HER2 tells cells when to grow and when to stop growing. HER2 proteins are found on the surface of breast cells, and they’re involved in normal cell growth but can become “overexpressed.” Historically, cancers with higher-than-normal levels of HER2 were called “HER2-positive.” Cancers with normal HER2 levels were called “HER2-negative.” For years, any score lower than three was considered HER2-negative. Thankfully, due to more detailed testing, there’s a name for HER2 levels between 1–2: HER2-low. Patients diagnosed in the new HER2-low category are now eligible for a new targeted treatment that increases survival. On pages 40–41, Dr. Jim Richter describes HER2-low research and its treatment options. Of note, in August of this year, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer, which is the first approved therapy targeted to patients with the HER2-low breast cancer.
70% of decisions based on laboratory results is a considerable portion! So, lastly, I’d like to point readers to page 51. We are now accepting applications for our 2023 Lab of the Year, which celebrates medical laboratories that demonstrate their extraordinary commitment to quality patient care. Submission requirements are at:
https://cdn.mlo-online.com/files/base/ebm/mlo/document/2022/09/LOY2023.6319f98769e44.pdf.
I welcome your comments, questions, and opinions — please send them to me at [email protected].
