Breast Biopsy: To assist in establishing a diagnosis of breast disease; in the presence of breast cancer, this test is also used to assist in evaluating prognosis and management of response to therapy.
PATIENT PREPARATION FOR BREAST BIOPSY
There are no activity restrictions unless by medical direction. Instruct the patient that to reduce the risk of aspiration related to nausea and vomiting, solid food and milk or milk products are restricted for at least 6 hr, and clear liquids are restricted for at least 2 hr prior to general anaesthesia, regional anaesthesia, or sedation/analgesia (monitored anaesthesia). The patient may be required to be NPO after midnight. Regarding the patient’s risk for bleeding, the patient should be instructed to avoid taking natural products and medications with known anticoagulants, antiplatelet, or thrombolytic properties or to reduce dosage, as ordered, prior to the procedure. Number of days to withhold medication is dependent on the type of anticoagulant. Note the last time and dose of medication taken. Patients on beta-blockers before the surgical procedure should be instructed to take their medication as ordered during the perioperative period. Protocols may vary among facilities.
NORMAL FINDINGS OF BREAST BIOPSY
(Method: Macroscopic and microscopic examination of tissue for biopsy; cytochemical or immunohistochemical for estrogen and progesterone receptors Ki67, PCNA, P53; flow cytometry for DNA ploidy and S-phase fraction; immunohistochemical or FISH for Her-2/neu) Fluorescence in situ hybridization (FISH) is a cytogenic technique that uses fluorescent labelled DNA probes to detect specific chromosome abnormalities. Favorable findings:
• Biopsy: No abnormal cells or tissue.
• DNA ploidy: Majority diploid cell population.
• SPF: Low fraction of replicating cells in total cell population.
• Her-2/neu, Ki67, PCNA, and P53: Negative to low percentage of stained cells.
• Estrogen and progesterone receptors: High percentage of stained cells.
CRITICAL FINDINGS AND POTENTIAL INTERVENTIONS OF BREAST BIOPSY
• Assessment of clear margins after tissue excision
• Classification or grading of tumour
• Identification of malignancy
Timely notification to the requesting healthcare provider (HCP) of any critical findings and related symptoms is a role expectation of the professional nurse. A listing of these findings varies among facilities.
OVERVIEW OF BREAST BIOPSY
(Study type: Tissue and cell microscopy, breast tissue or cells; related body system: Immune and Reproductive systems.) Label the appropriate specimen containers with the corresponding patient demographics, initials of the person collecting the specimen, date and time of collection, and site location, especially right or left breast. Breast cancer is the most common newly diagnosed cancer in American women. It is the second leading cause of cancer-related death. Biopsy is the excision of a sample of tissue that can be analysed microscopically to determine cell morphology and the presence of tissue abnormalities. Fine-needle and open biopsies of the breast have become more commonly ordered in recent years as the increasing emphasis on early detection of breast cancer has become stronger. Breast biopsies are used to assist in the identification and prognosis of breast cancer. A number of tests can be performed on breast tissue to assist in identification and management of breast cancer. Estrogen and progesterone receptor assays (ER and PR) are used to identify patients with a type of breast cancer that may be more responsive than other types of tumours to estrogen deprivation (antiestrogen) therapy or removal of the ovaries. Patients with these types of tumours generally have a better prognosis. DNA ploidy testing by flow cytometry may also be performed on suspicious tissue. Cancer is the unchecked proliferation of tumour cells that contain abnormal amounts of DNA.
The higher the grade of tumour cells, the more likely abnormal DNA will be detected. The ploidy (number of chromosome sets in the nucleus) is an indication of the speed of cell replication and tumour growth. Cells synthesize DNA in the S phase of mitosis. S-phase fraction(SPF) is an indicator of the number of cells undergoing replication. Normal tissue has a higher percentage of resting diploid cells, or cells containing two chromosomes. Aneuploid cells contain multiple chromosomes. Genes on the chromosomes are coded to produce specific proteins. Ki67 and proliferating cell nuclear antigen (PCNA) are examples of proteins that can be measured to indicate the degree of cell proliferation in biopsied tissue. Overexpression of a protein called human epidermal growth factor receptor 2 (HER-2/neu oncoprotein) is helpful in establishing histological evidence of metastatic breast cancer. Metastatic breast cancer patients with high levels of HER-2/neu oncoprotein have a poor prognosis. They have rapid tumour progression, an increased rate of recurrence, poor response to standard therapies, and a lower survival rate. Herceptin (trastuzumab) is indicated for the treatment of HER-2/neu overexpression. P53 is a suppressor protein that normally prevents cells with abnormal DNA from multiplying. Mutations in the P53 gene cause the loss of P53 functionality; the checkpoint is lost, and cancerous cells are allowed to proliferate.
Knowledge of genetics assists in identifying those who may benefit from additional education, risk assessment, and counselling. Genetics is the study and identification of genes, genetic mutations, and inheritance. For example, genetics provides some insight into the likelihood of inheriting a condition associated with a type of cancer such as breast cancer. Genomic studies evaluate the interaction of groups of genes. The combined activity or combined expression of groups of genes allows assumptions or predictions to be made. As an example, genomic studies measure the levels of activity in multiple genes to predict how they influence the development and growth of a tumour. Further information regarding inheritance of genes can be found in the study titled “Genetic Testing.” Presently, there are four genomic tests for breast cancer: Oncotype DX, MammaPrint, Mammostrat, and Prosigna Breast Cancer Prognostic Gene Signature Assay
• Oncotype DX measures the activity of 21 genes that influence the likelihood that breast cancer will develop and, if so, how well it will respond to chemotherapy (early-stage invasive) or radiation treatments (ductal cancer in situ [DCIS]). Candidates include patients who have been diagnosed with early-stage breast cancer, recently diagnosed with estrogen receptor–positive breast cancer, recently diagnosed with DCIS, or scheduled to have a lumpectomy to remove the ductal cancer in situ. Test results from this assay have been robustly validated in research studies. The assay is included in the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) treatment guidelines for early-stage breast cancer. Use of the test for DCIS is growing, but it has not yet been included in the NCCN or ASCO treatment guidelines.
• MammaPrint measures the activity of 70 genes. Candidates include patients who have been diagnosed with stage I or stage II cancer—whether estrogen receptor-positive or negative—that is invasive, smaller than 5 cm, or present in three or fewer lymph nodes.
• Mammostrat measures the activity of five genes. Candidates include patients who have been diagnosed with stage I or stage II cancer. It is not widely used to make treatment decisions.
• Prosigna measures the activity of 58 genes. Candidates are limited to postmenopausal patients who have been diagnosed with
- a. Stage I or stage II breast cancer that is lymph node-negative
- b. Stage II breast cancer with one to three positive nodes
- c. Breast cancer and are hormone receptor-positive
- d. Breast cancer that is invasive
- e. Breast cancer and have been treated with surgery and hormone therapy.
It is not widely used to make treatment decisions.
Fluid from breast cysts or nipple discharge may be collected by aspiration and examined microscopically for benign or cancerous findings. Mammography should be performed before aspiration of cyst fluid because of the potential interference to the mammogram from bleeding. Potential complications of fluid aspiration include infection, pneumothorax, and hematoma.
Sentinel lymph node biopsy (SLNB) may be considered to assist in the diagnosis of breast cancer. A sentinel lymph node (SLN) is the first lymph node to be infiltrated by cancer cells from the primary tumour, usually in the axilla or armpit area. To identify an SLN, the surgeon injects one or more tracers (such as technetium-99m and isosulfan blue dye) near the tumour, then uses a handheld gamma detector to locate the nodes emitting radioactivity or visually inspects the nearby nodes for any that are stained blue from the dye. Once the SLN is located, a small incision is made and the node is removed. The suspicious tissue is checked microscopically for the presence of cancer cells by a pathologist. Positive SLN samples may warrant immediate removal of additional lymph nodes or removal during a follow-up procedure. SLNB is used to assist in staging cancers, to estimate the risk of metastasis to other parts of the body, and in the case of negative SLN testing to avoid the unnecessary removal of nearby lymph nodes. Adverse effects of lymph node surgery include lymphedema, pain, and increased risk of infection in the affected area.
There are a number of risk factor tools that can be used to estimate an individuals’s risk of breast cancer. The tools cannot determine whether a person will get breast cancer. The tools are based on the average risk for a group of women with similar risk factors; the original tools were based on data from women of European ethnicity. Generally, an HCP will consider the number of risk factors a person has and how much each factor contributes to increasing the risk for breast cancer (e.g., a BRCA1 gene mutation contributes a significant amount of risk). The Gail model, commonly used by HCPs, calculates a woman’s short-term risk (within the next 5 years) and long-term risk (within her lifetime, up to age 90) of developing breast cancer. It is based on seven key risk factors.
1. Current age
2. Age at first menstrual period
3. Age at the first birth of a child (or a woman who has not given birth)
4. Family history of breast cancer (mother, sister, daughter)
5. Number of past breast biopsies
6. Number of breast biopsies showing atypical hyperplasia
Women with a 5-year risk of 1.67% or greater are classified as high risk, which is the U.S. Food and Drug Administration’s guideline for taking a drug such as tamoxifen or raloxifene to reduce the risk of developing breast cancer. Other commonly used tools include the Claus model and the Tyrer-Cuzick model.
INDICATIONS OF BREAST BIOPSY
• Evidence of breast lesion by palpation, mammography, or ultrasound.
• Identify patients with breast or other types of cancer that may respond to hormone or antihormone therapy.
• Monitor responsiveness to hormone or antihormone therapy.
• Observable breast changes such as peau d’orange skin, scaly skin of the areola, drainage from the nipple, or ulceration of the skin.
INTERFERING FACTORS OF BREAST BIOPSY
Patients with bleeding disorders (related to the potential for prolonged bleeding from the biopsy site)
Factors that may alter the results of the study
• Massive tumour necrosis or tumours with low cellular composition falsely decrease results.
• Antiestrogen preparations (e.g., tamoxifen) ingested 2 mo before tissue sampling will affect test results [ER and PR]).
• Pretesting preservation of the tissue is method and test dependent. The testing laboratory should be consulted for proper instructions prior to the biopsy procedure. Failure to transport specimen to the laboratory immediately can result in degradation of tissue. Prompt and proper specimen processing, storage, and analysis are important to achieve accurate results.
POTENTIAL MEDICAL DIAGNOSIS:
CLINICAL SIGNIFICANCE OF RESULTS
Positive findings in
• Hormonal therapy (ER and PR)
• Receptor-positive tumours (ER and PR)
NURSING IMPLICATIONS OF BREAST BIOPSY
➧ Inform the patient this procedure can assist in evaluating breast health.
➧ Explain that prior to the procedure, laboratory testing may be required to determine the possibility of bleeding risk (coagulation testing) or to assess for impaired kidney function (creatinine level and estimated glomerular filtration rate) if use of iodinated contrast medium is anticipated.
➧ Pregnancy may be a contraindication to procedures involving some types of anaesthesia. Explain to the female patient that she will be asked the date of her last menstrual period. Pregnancy testing may be performed to determine the possibility of pregnancy before the biopsy is performed.
➧ Explain that reducing health-care-associated infections is an important patient safety goal and a number of different safety practices will be implemented during their procedure. Advise the patient that hair in the area near the incision site may be clipped or shaved and the area cleaned with an antiseptic solution to cleanse bacteria from the skin in order to reduce the risk for infection. Note: The World Health Organization, Centers for Disease Control and Prevention, and Association of periOperative Registered Nurses recommend that hair not be removed at all unless it interferes with the incision site or other aspects of the procedure because hair removal by any means is associated with increased infection rates. When hair removal is necessary, facilities must use a protocol that is based on scientific literature or the endorsement of a professional organization. Clipping immediately before the procedure and in a location outside the procedure area is preferred to shaving with a razor. Shaving creates a break in skin integrity and provides a way for bacteria on the skin to enter the incision site.
➧ Review the procedure with the patient, address concerns about pain, and explain that there may be moments of discomfort or pain experienced when the IV line is inserted to allow infusion of fluids such as saline, anaesthetics, sedatives, medications used in the procedure, or emergency medications. Instruct the patient that prophylactic antibiotics may be administered before the procedure.
➧ Inform the patient that the biopsy is performed under sterile conditions by an HCP specializing in this procedure. The surgical procedure usually takes about 20 to 30 min to complete, and sutures may be necessary to close the site. A needle biopsy usually takes about 15 min to complete.
➧ Baseline vital signs will be recorded and monitored throughout the procedure. Protocols may vary among facilities.
➧ Explain that the patient will be monitored for complications related to the procedure (e.g., allergic reaction, etc.).
➧ Explain that once the study is completed, a pressure dressing is applied over the puncture site.
➧ Adhere to organizational policies and the Centers for Medicare and Medicaid Services (CMS) quality measures regarding administration of prophylactic antibiotics. Administer ordered prophylactic antibiotics 1 hr before incision and use antibiotics that are consistent with current guidelines specific to the procedure.
➧ After administration of general anaesthetic and surgical preparation are completed, an incision is made, suspicious area(s) are located, and tissue samples are collected.
➧ Direct the patient to take slow, deep breaths when the local anaesthetic is injected. Protect the site with sterile drapes. Instruct the patient to take a deep breath, exhale forcefully, and hold the breath while the biopsy needle is inserted and rotated to obtain a core of breast tissue. Once the needle is removed, the patient may breathe. Pressure is applied to the site for 3 to 5 min, then a sterile pressure dressing is applied.
➧ Place tissue samples in formalin solution. Label the specimen, indicating site location, and promptly transport the specimen to the laboratory for processing and analysis.
Potential Nursing Actions
Make sure a written and informed consent has been signed prior to the procedure and before administering any medications.
➧ Anticoagulants, aspirin, and other salicylates should be discontinued by medical direction for the appropriate number of days prior to a procedure in which bleeding is a potential complication.
AFTER THE STUDY: POTENTIAL NURSING ACTIONS OF BREAST BIOPSY
➧ Bleeding (related to a bleeding disorder or the effects of natural products and medications with known anticoagulant, antiplatelet, or thrombolytic properties) or seeding of the biopsy tract with tumour cells. Observe/assess the biopsy site for bleeding, inflammation, or hematoma formation. Instruct the patient in the care and assessment of the biopsy site and to report any fever, chills, redness, oedema, bleeding, or pain at the biopsy site.
➧ Do not allow the patient to eat or drink until the gag reflex returns due to aspiration risk.
➧ Monitor vital signs and neurological status every 15 min for 1 hr, then every 2 hr for 4 hr, and then as ordered by the HCP. Monitor temperature every 4 hr for 24 hr. Monitor intake and output at least every 8 hr. Compare with baseline values. Notify the HCP if the temperature is elevated. Discontinue prophylactic antibiotics within 24 hr after the conclusion of the procedure.
➧ Assess for nausea and pain. Administer antiemetic and analgesic medications as needed and as directed by the HCP. Administer antibiotic therapy if ordered and emphasize the importance of completing the entire course of antibiotic therapy, even if signs and symptoms disappear before completion of therapy.
➧ Assess the patient’s ability to swallow before allowing the patient to attempt liquids or solid foods. Instruct the patient to resume preoperative diet, as directed by the HCP.