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The estrogen receptor (ER) and progesterone receptor (PR) status and HER-2/neu status of the tumor should be determined at the time of initial biopsy Other studies such as proliferation indices may be performed These are performed on paraffin-fixed tissue by immunohistochemistry Receptor status is valuable not only in managing metastatic disease but also in helping select patients for adjuvant therapy It is critical to understand the biomarker status before initiating any adjuvant therapy because it may change after therapy The presence or absence of ER and PR is a critical element of breast cancer management Patients whose primary tumors are receptor-positive have a more favorable course than those whose tumors are receptor-negative Up to 60% of patients with metastatic breast cancer will respond to hormonal manipulation if their tumors are ER-positive Less than 5% of patients with metastatic, ER-negative tumors can be treated successfully in this fashion Adjuvant hormonal therapy, with or without chemotherapy, in receptor-positive tumors and adjuvant chemotherapy alone in receptor-negative tumors improve survival rates even in the absence of lymph node metastases Hormone receptors have no relationship to response to chemotherapy (see Adjuvant Therapy, below) PR status may be more sensitive than ER status in determining which patients are likely to respond to hormonal manipulation Up to 80% of patients with metastatic PR-positive tumors improve with hormonal manipulation In addition to ER status and PR status, the rate at which tumor divides and the differentiation of the cells (prolifer-
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Noninvasive cancer can occur within the ducts (DCIS) or lobules (lobular carcinoma in situ, LCIS) LCIS, although thought to be a premalignant lesion or a risk factor for breast cancer, in fact may behave like DCIS In a 2004 analysis of multiple NSABP studies, invasive lobular breast cancer not only developed in patients with LCIS but it developed in the same breast and indexed location as the original LCIS Although more research needs to be done in this area, the invasive potential of LCIS is being reconsidered DCIS tends to be unilateral and most often progresses to invasive cancer if untreated In approximately 40 60% of women who have DCIS treated with biopsy alone, invasive cancer develops within the same breast The treatment of intraductal lesions is controversial DCIS can be treated by wide excision with or without radiation therapy or with total mastectomy Conservative management is advised in patients with small lesions amenable to lumpectomy until further data are developed Although research is defining the malignant potential of LCIS, it can be managed with observation Patients unwilling to accept the increased risk of breast cancer may be offered surgical excision of the area in question or bilateral total mastectomy Currently, the accepted standard of care offers the alternative of chemoprevention, such as tamoxifen, which is effective in preventing invasive breast cancer in both LCIS and DCIS that has been completely excised Axillary metastases from in situ cancers
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altered during the course of the disease The doubling time of breast cancer cells ranges from several weeks in a rapidly growing lesion to years in slowly growing ones Assuming that the rate of doubling is constant and that the neoplasm originates in one cell, a carcinoma with a doubling time of 100 days may not reach clinically detectable size (1 cm) for about 8 years Rapidly growing cancers have a much shorter preclinical course and a greater tendency to metastasize by the time a breast mass is discovered The long preclinical growth phase and the tendency of breast cancers to metastasize have led clinicians to believe that most breast cancer is a systemic disease at the time of diagnosis Although it may be true that breast cancer cells are released from the tumor prior to diagnosis, variations in the host tumor relationship prohibit the growth of disseminated disease in many patients Clearly, not all breast cancer is systemic at the time of diagnosis For this reason, a pessimistic attitude concerning the management of breast cancer is unwarranted Most patients can be cured Controversy surrounds the timing of surgery with respect to the menstrual cycle Some suggest that operation during the time of unopposed estrogen adversely affects survival, but most studies support no such effect Several randomized trials are currently examining this question
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ative indices) are important In order to establish the rate of growth and differentiation, the amount and type of DNA is measured with flow cytometry Another key element in determining treatment and prognosis is the amount of the HER-2/neu oncogene present in the cancer HER-2/neu overexpression is scored using a numerical system: 1+ is not an overexpressor, 2+ is borderline, and 3+ is an overexpressor In the case of 2+ expression, fluorescence in situ hybridization (FISH) is recommended to more accurately assess HER-2/neu amplification and provide better prognostic information While individually these biomarkers provide insight to appropriate adjuvant therapy, when combined they provide a great deal of information regarding risk of recurrence A new test, Oncotype DX, combines 21 genetic markers, including ER, PR, and HER-2/neu expression in a tumor specimen The researchers were able to categorize risk of recurrence into three groups: high risk, intermediate risk, and low risk In addition, the test is able to identify that the high-risk group was more likely to benefit from chemotherapy in addition to tamoxifen while the low risk group did not This type of test is quite helpful when the survival advantage of therapy is difficult to determine but is only appropriate for ER-positive node-negative tumors Its applicability is limited by its experience and lack of prospective corroboration Another promising biomarker being studied is vascular endothelial growth factor (VEGF), a protein that stimulates the growth of blood vessels Elevated levels of VEGF may be a marker for a tumor that is more aggressive since it has the ability to develop blood vessels and grow While researchers look for more specific markers to determine the presence of breast cancer, these markers also provide insight to targeted methods of treatment Other markers being evaluated are p53, nm23, DNA 5c exceeding rate (DNA 5cER), G-actin, urokinase-type plasminogen activator (u-PA), and its type-1 inhibitor (PAI-1)
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Luadido J et al HER2 testing: a review of detection methodologies and their clinical performance Expert Rev Mol Diagn 2007 Jan;7(1):53 64 [PMID: 17187484] Paik S et al A multigene assay to predict recurrence of tamoxifen treated, node-negative breast cancer N Eng J Med 2004 Dec 30;351(27):2817 26 [PMID: 15591335] Winston JS et al HER-2/neu evaluation in breast cancer are we there yet Am J Clin Pathol 2004 Jun;121 Suppl:S33 49 [PMID: 15298149]
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