Approach to THE Patient With a Breast Mass Part 1

More than half of the patients who present to a breast clinic have the chief complaint of a breast mass.1 The identification of a breast mass causes a great deal of anxiety in women, although the majority of breast masses are benign. The most important task of the physician who is evaluating a breast mass is to exclude the presence of malignancy. Once malignancy is ruled out, the physician must provide an accurate diagnosis, suitable treatment, and reassurance to the patient.

Assessment of Normal Organ Function

The normal breast is a mixture of epithelial (glandular) elements, stromal tissue, and fat. This heterogeneity is responsible for the lumpiness that is characteristic of normal breasts, particularly in premenopausal women. The upper outer quadrant and the inframammary ridge are usually the most nodular areas of the normal breast. In women older than 40 years, small pealike nodules can often be felt beneath the areola. These nodules represent dilated ducts and are of no clinical concern. Most normal areas of nodularity can be readily identified by their presence in both breasts.

In premenopausal women, the normal hormonal fluctuations of the menstrual cycle often result in changes in breast nodularity that may be mistaken for disease processes. The progesterone surge at ovulation results in mammary duct differentiation and alveolar epithelial cell differentiation into secretory cells. Clinically, this translates to a greater degree of nodularity in the upper outer quadrants of the breasts and may also result in breast tenderness or discomfort. Cyclical nodular-ity generally decreases after the onset of menses, which is the rationale for the recommendation that a patient perform breast self-examination in the week after her period, when the breasts are the least nodular. These cyclical changes in breast nodulari-ty are often erroneously termed fibrocystic disease, but they are in fact a component of normal physiology.2 After menopause with its concomitant withdrawal of estradiol and progesterone, the epithelial elements of the breast atrophy, making the breasts softer, less nodular, and easier to examine.


History and Physical Examination of the Patient with a Breast Mass

The key to evaluating the patient who presents with a breast mass is to determine whether a dominant mass is present and to define the level of suspicion for malignancy associated with the mass, should one be detected. These determinations are initially made on the basis of a careful history and physical examination and will direct the approach to diagnosis and management for each patient.

HISTORY

The initial step in obtaining the pertinent history is to characterize the mass by determining the mass’s duration, fluctuation with the menstrual cycle, associated tenderness, and whether it has changed in size since the patient first identified it. The patient should be asked whether she has a history of breast problems, including cyst aspirations and biopsies. A menstrual history is important, including the date of the last period, any recent menstrual irregularities, use of oral contraceptives or hormone replacement therapy, and recent changes in hormone preparation.

An assessment of the patient’s level of risk for breast cancer is appropriate [see Table 1], although the characteristics of the breast mass rather than the patient’s level of risk for cancer should be the primary determinant of the appropriate workup. The characteristics of the breast mass take precedence over the assessment of cancer risk because the majority of women with breast cancer lack identifiable risk factors.3 When eliciting a family history, it is important to obtain information on both maternal and paternal relatives, because breast cancer on either side of the family is associated with an increased level of risk.

Physical examination

Physical examination is important to confirm the presence of a mass. Often, a mass identified by a patient or a primary care physician is actually an area of normal glandular nodularity or normal breast tissue and underlying structures. In a study of 605 women younger than 40 years, Morrow and colleagues reported that referral by a primary care provider to a surgeon for the evaluation of a breast lump led to confirmation of the presence of a dominant mass in 29% of women, whereas patient-detected masses were confirmed by the surgeon in 36% (a difference that was not statistically significant).4

Examination should be carried out with the patient in both an upright sitting position and a supine position. The breasts should be evaluated for symmetry with the arms relaxed and with the arms raised over the head. The presence of skin or nipple retraction, edema, or erythema should be noted. In many women, the breasts are not precisely the same size, and in some women, there may be a significant difference in size. If a size discrepancy is noted, the patient should be questioned regarding its duration. Similarly, many women have bifid or chronically inverted nipples, the latter of which occur particularly after lactation; however, bifid nipples or chronically inverted nipples are of no concern, even if the chronically inverted nipples are present in a patient who has never lactated.

Table 1 Factors Used for Assessment of Breast Cancer Risk

Patient age

Number of relatives with

Patient race

breast and/or ovarian cancer

Age at menarche

Relationship to patient

Age at first live birth

Age at diagnosis

Age at menopause

Number of previous breast biopsies

History of postmeno-pausal hormone

Pathologic findings at biopsy

replacement therapy

Palpation of both breasts, as well as the axilla, should follow. The axilla should be examined with the patient seated and the ipsilateral arm supported to relax the pectoral muscle. Small palpable nodes are not uncommon in slender women, and any palpable nodes must be assessed for worrisome characteristics such as fixation, large size, or hardness.

Breast palpation should be performed with the patient both in the upright position and in the supine position. In the supine position, the ipsilateral arm should be placed behind the head to spread the breast tissue across the chest wall. The pads, rather than the tips, of the first three fingers should be used for palpation, and pinching of the breast tissue between the fingers should be avoided. The goal of the examination is to determine if a dominant mass is present. Dominant masses are distinguished from nodular breast tissue by having three dimensions and a texture different from the adjacent normal breast. If a mass is identified, it should be measured with a ruler, the consistency should be noted (e.g., soft, rubbery, firm, hard), and the characteristics of its margins described (e.g., well circumscribed, poorly defined) [see Table 2]. Fixation of the mass within the breast or to the chest wall should also be noted. If there is uncertainty whether a finding represents a true dominant mass, comparison with the mirror-image location in the opposite breast is often helpful.

Once the examination is complete, regardless of whether a mass is identified, the patient should be asked to indicate the area that concerns her. This ensures that the area of concern to the patient is not overlooked by the physician. At the conclusion of the examination, the patient can be categorized according to four possible assessments: (1) no abnormal finding is appreciated; (2) a prominent nodularity is present, but it does not have the characteristics of a dominant mass; (3) a dominant mass with clinically benign characteristics is present; and (4) a dominant mass suspicious for cancer is present. The appropriate imaging and diagnostic workup is specific to the outcome of the physical examination.

Evaluation of a Breast Mass

No Abnormality Detected by Physician

If no abnormality is detected during a clinical breast examination, even after careful examination of the area of concern, the patient should be reassured of the absence of worrisome findings. Women 40 years of age and older who have not had a mammogram within the past year should receive a mammo-gram to screen for nonpalpable abnormalities. In younger patients, no imaging should be recommended unless their level of risk for malignancy indicates screening as a prudent measure. To ensure that no worrisome finding was overlooked, a follow-up examination 2 to 3 months after the patient’s initial visit is appropriate for physicians who do not have extensive experience in evaluating breast masses. The follow-up visit is also a good time to review the woman’s age and cancer risk to determine the appropriate type and frequency of screening tests.

Modularity

It can sometimes be difficult to confidently differentiate a nodularity from a dominant mass. In women between 35 and 40 years of age, mammography is usually not helpful in making this determination. Morrow and colleagues reported that in 197 women who were referred for evaluation of a lump but whose physical examinations were considered by the surgeon to be normal or characterized only by glandular nodularity, only three had a mass identified on mammography that resulted in a breast biopsy, and all three were benign.4 More commonly, the imaging study led to a recommendation for a 6-month follow-up mammogram to monitor abnormalities that were classified as "probably benign" and were independent of the patient’s reason for presentation. None of the abnormalities monitored by follow-up mammograms proved to be carcinoma. Similarly, Harris and Jackson reported that no malignant lesions were identified in their study of 625 women younger than 35 years when mammography was used to examine lumpy breasts and suspected fibrocystic disease.5

Table 2 Physical Characteristics of Benign and Malignant Breast Masses

Characteristic

Benign

Malignant

Borders

Well circumscribed

Irregular

Texture

Firm or rubbery

Hard

Mobility

Mobile

Fixed to surrounding tissue

Skin changes

None

Dimpling, retraction

Nipple changes

None

Retraction, bloody discharge, scaling

Directed ultrasound of the area in question is the initial study recommended in young women when there is uncertainty regarding the presence of a dominant mass. If no suspicious findings are revealed on ultrasound, a short-interval follow-up examination in 1 to 2 months is appropriate.

In women older than 40 years, a diagnostic imaging workup should be performed when a dominant mass is identified on physical examination. The mammogram should include placement of a skin marker over the area of interest and extra views of the indicated area, if these are determined to be appropriate by the radiologist. If no abnormality is seen on mammography, a directed ultrasound study should be performed to exclude the presence of mammographically occult carcinoma. If these imaging studies reveal no evidence of a breast mass, then a short-interval follow-up examination constitutes appropriate management.

Attempts at needle aspiration to reassure both the patient and her physician that no worrisome abnormalities are present are not usually helpful in the absence of a dominant mass. Normal breast tissue is significantly less cellular than dominant masses; thus, the rate of nondiagnostic aspirates is significantly higher in cases in which no discrete abnormality is detected than in cases in which a dominant mass is present.4,6 An aspirate with insufficient material for diagnosis is generally considered an indication for surgical biopsy; therefore, the use of fine-needle aspiration (FNA) for vague areas of nodularity may lead to unnecessary biopsies.

In patients with nodularity on physical examination and a negative imaging workup, a follow-up examination should be performed in 1 to 3 months to ensure the stability and benign nature of the nodularity. If the finding persists, another examination after 6 months is appropriate to ensure that a discrete mass is not evolving [see Dominant Masses with Clinically Benign Features, below].

Dominant Masses With Clinically Benign Features

Imaging Evaluation

In the woman whose physical examination detected a dominant mass with benign clinical features, the initial step in evaluation is to determine whether the mass is cystic or solid. Cysts cannot be reliably diagnosed by physical examination alone, and thus, ultrasound or aspiration of fluid and subsequent resolution of the mass are required for diagnosis [see Figure 1].

Ultrasound In women younger than 35 years, ultrasound is often the only diagnostic study needed for the evaluation of a clinically benign breast mass. Mammography is recommended only if the mass is considered suspicious for malignancy, because cancer is rare in this group and mammograms are usually inconclusive because of breast density. Women older than 35 years who present with a breast mass should be evaluated by mammography and ultrasound.

Ultrasound, unlike mammography, has the capacity to differentiate solid masses from cystic masses. Simple cysts are seen on ultrasound as round or oval with sharply defined margins and posterior acoustic enhancement—that is, the tissue deep to the cyst appears brighter than other breast tissue found at the same level—and without any internal echoes. If a cyst is seen to have a solid component on ultrasound, further workup is warranted.

Aspiration Complex cysts are defined as those with sep-tations or internal echoes and are traditionally managed by aspiration. However, in a study of 308 complex cysts, the incidence of malignancy was only 0.3%, suggesting that many complex cysts can be managed adequately by short-term fol-low-up.7

Biopsy Cystic lesions with thick and indistinct walls, thick septations, or any solid component should be biopsied, because some of these masses are malignant. In a study by Berg and colleagues, 18 out of 79 lesions with these characteristics proved to be malignant.8

It has been suggested that patients with a palpable breast mass exhibiting normal mammographic and ultrasound findings do not require tissue diagnosis9; however, evidence suggests that malignant masses may not be detected by mammog-raphy and ultrasonography. Edeiken reported that 22% of 499 women with a palpable breast cancer had a false negative mammogram,10 and the majority of false negatives were observed in women younger than 50 years (a finding attributed primarily to the prevalence of breast density in young women). Ultrasound is an extremely operator-dependent technique. Although Dennis and colleagues9 reported that ultrasound has a high sensitivity for the diagnosis of cancer, it is not clear that these results can be generalized to a variety of practice settings.

A patient with a palpable solid mass should be referred to a surgeon for a tissue diagnosis regardless of whether the mass is visualized by imaging studies. Solid masses may be diagnosed with FNA cytology, core-needle biopsy, or excisional biopsy [see Figure 1].

Triple Diagnosis Test

The triple diagnosis test uses a combination of physical examination, imaging studies, and FNA cytology as an alternative to surgical excision to establish that a breast mass is benign. The triple test is considered to identify the mass as benign if the physical examination, mammogram, and FNA all indicate a benign process. If the lesion cannot be visualized on mammogram or if the FNA contains insufficient cells for diagnosis, the triple test cannot be confirmatory for a benign lesion. In a study of 191 patients who had confirmatory surgical biopsy, Steinberg and colleagues reported that the triple test had a sensitivity of 95.5% and a specificity of 100%." Vetto and colleagues reported that the triple diagnosis test is accurate and results in a substantial reduction in the need for surgical excisional biopsies of benign lesions.12 In their study of 46 breast lesions identified in 43 patients, the triple test produced concordant results in 21 lesions.12 Twelve triple tests gave concordant benign results, and biopsy was confirmatory in all of these cases (negative predictive value of 100%). In nine cases, there were concordant malignant results, and final pathology on all of these confirmed malignancy (positive predictive value of 100%). There were 25 discordant triple test results (54%): in nine of these cases, the final pathology was benign, and the remaining 16 demonstrated malignancy (positive predictive value of 64%).

Management of a solid breast mass. The most important facet of the evaluation and management of a new breast mass is the exclusion of a diagnosis of breast cancer. First, the presence of a mass must be confirmed. Next, the mass is classified as either solid or cystic [see Figure 2]. A solid mass requires either cytologic or histologic sampling to exclude the presence of malignancy. Referral to a breast specialist is indicated at any point at which the diagnosis or choice of management is in doubt.

Figure 1 Management of a solid breast mass. The most important facet of the evaluation and management of a new breast mass is the exclusion of a diagnosis of breast cancer. First, the presence of a mass must be confirmed. Next, the mass is classified as either solid or cystic [see Figure 2]. A solid mass requires either cytologic or histologic sampling to exclude the presence of malignancy. Referral to a breast specialist is indicated at any point at which the diagnosis or choice of management is in doubt.

No single mode of evaluation used in the triple test is as accurate as the combination of the three.12 Bicker and colleagues reported that only seven of 2,184 (0.32%) patients assessed as having benign disease by the triple test were subsequently found to have carcinoma, with five of the seven cancers diagnosed within the first year of observation.13 Overall, FNA has been shown to be quite accurate in the evaluation of benign breast masses [see Table 3].11,12,14-16 FNA cytology alone has a sensitivity ranging from 65% to 98% and a specificity of 34% to 100%. In a review of 29 studies, the likelihood of identifying malignant cytology in patients with breast cancer ranged from 35% to 92%.17 Lower sensitivity is associated with smaller tumors and younger patient age; sensitivity is quite high when FNA is performed by trained personnel and interpreted by an experienced cytologist.18

Following a benign, concordant triple diagnosis test, an identified mass must be monitored for growth by serial examination and imaging studies, which are generally recommended to be performed every 6 months for 2 years, until stability is documented. Growth of the lesion should prompt surgical excision. Patients opting for observation should be counseled about the small possibility of a delay in the diagnosis of cancer. Particular caution should be used when taking a wait-and-see approach in women 50 years of age or older, because in this group benign breast masses are infrequent and carcinoma is more common.

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