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Stereotactic Breast Biopsy: Indications and Results: Page 3 of 3

Stereotactic Breast Biopsy: Indications and Results: Page 3 of 3

Complications

In reported large series of stereotactic core biopsy, major complications have been rare. Parker et al[23] followed 3,765 women and found major complications in only 6 (0.2%). Among these patients, there were three hematomas requiring surgical drainage and three infections treated with drainage and/or antibiotics. Of note, no cases of needle-track seeding occurred.

Hann et al[24] found that when clinically significant bleeding develops after stereotactic core biopsy, it is invariably evident while the patient is at the facility performing the biopsy.

Minor complications are not unusual after stereotactic core biopsy. Of 100 women interviewed after stereotactic biopsy, 33 said that they experienced pain following the procedure, in some cases lasting up to 2 weeks, and 15 required analgesics.[25] In 28 women, noticeable bruising was reported. The most common side effect was the inability to return to normal activity after the procedure because of emotional stress. This occurred in more than half of the women.

Other authors have also cited a high rate of minor complications among their patients undergoing stereotactic core biopsy. Hardy et al[26] reported that patients undergoing these procedures were more concerned with the results than with the procedure itself. Jackman et al[27] noted that 69% of their patients experienced post-biopsy pain.

A few unusual complications have also been reported. In one case, a 14-gauge core biopsy done under sonographic guidance in a nursing mother produced a milk fistula, which healed during a 2-week weaning period.[28] In another instance, a large hematoma developed in a woman with factor XI deficiency, obscuring a small carcinoma diagnosed by stereotactic biopsy and making it impossible to localize the cancer for definitive surgical treatment.[29] After 3 months, the hematoma had resolved sufficiently to allow for treatment.

Diagnostic Limitations of Stereotactic Biopsy

The accuracy of stereotactic core biopsy in patient care depends on appropriate tissue sampling, histologic analysis, and correlation of histopathology with imaging findings. A limited number of studies have been published in which histologic findings at stereotactic core biopsy were correlated with those at surgical biopsy. These studies are listed in Table 1.[30-33] Accuracy in these series is approximately 90%. In any individual practice, this percentage will be influenced by the experience of the physician performing the biopsy, the type of lesion undergoing biopsy,[34] and the patient population.[35] Accuracy appears to be comparable with prone table and add-on units.[36]

In a series of 230 lesions biopsied with guidance from an add-on device, in which five cores of each lesion were obtained and results were correlated immediately with surgical biopsy findings, stereotactic core biopsy diagnosis was accurate in 98% of masses, 100% of masses with calcifications, 100% of focal asymmetries, and 86% of architectural distortions.[36] Of those lesions seen only as calcifications, 91% were accurately diagnosed. In this series, the overall accuracy of stereotactic biopsy was 97%.

Discordance of Biopsy Results and Imaging Patterns

These results of stereotactic core biopsy are comparable to the 96% to 98% accuracy rate of needle-localized breast biopsies. However, the total stereotactic biopsy procedure does not end with tissue sampling. The appropriateness of the histologic diagnosis should be determined by correlating it with the imaging pattern. If the histology does not correlate with the imaging pattern, it should be assumed that the lesion in question was not sampled at the time of stereotactic core biopsy and that a repeat biopsy needs to be performed.

In a study of 3,765 percutaneous large-core breast biopsies performed with either stereotactic or sonographic guidance, 5 (0.1%) were found to be malignant at 6-month follow-up examination.[23] In this series, 925 carcinomas were diagnosed. Of these cancers, 910 were detected at the time of stereotactic core biopsy, 10 were diagnosed at a surgical biopsy immediately after stereotactic biopsy, and the remaining 5 were found at the 6-month follow-up mammogram. The study’s criteria for immediate surgical biopsy after stereotactic core biopsy were not clearly stated.

In another series of 314 consecutive stereotactic core biopsies, 22 (7%) were found to have carcinoma at surgical biopsy done shortly after stereotactic biopsy that failed to diagnose carcinoma.[35] Of these cases, 15 were surgically biopsied because of a stereotactic core biopsy diagnosis of ductal atypia, and 7 were rebiopsied because of discordance between the stereotactic biopsy histologic diagnosis and the imaging pattern.

This experience reinforces the need for correlating the histologic results with the presumed diagnosis made on the basis of imaging findings. If a BI-RADS category 5 lesion (high probability of malignancy) is discovered before stereotactic core biopsy and the biopsy results show a benign lesion, the need for a repeat biopsy, either a stereotactic core or surgical biopsy, should be strongly considered. In one series, 47% of lesions in which stereotactic core biopsy results and imaging diagnosis were discordant were found to be malignant on repeat biopsy.[35]

Diagnosing Carcinoma Coexisting With Benign Disease

In some lesions, carcinoma and benign entities can coexist. These coexistent lesions are commonly found when larger volumes of tissue are removed at surgical biopsy. However, because of the smaller volume of tissue obtained at stereotactic core biopsy, only the benign part of the lesion may be excised. When these high-risk histopathologies are removed, surgical biopsy should be routinely performed to assess for the possibility of coexistent carcinoma. The most common of these entities is atypical ductal hyperplasia or ductal atypia. Radial scars should also routinely be considered for surgical excision.

In other cases, a pathologist may require a larger volume of tissue than that obtained at stereotactic core biopsy to make a definitive diagnosis. Most commonly, this occurs in patients with fibroepithelial lesions, in whom it may be difficult to differentiate a fibroadenoma from a phyllodes tumor.

Atypical Ductal Hyperplasia or Ductal Carcinoma?--The coexistence of atypical ductal hyperplasia and ductal carcinoma, especially ductal carcinoma in situ (DCIS), has been explained on the basis that these lesions arise from a central focus that can develop into atypical ductal hyperplasia or one of the many subtypes of DCIS. In one study of 100 consecutive cases of pure DCIS, it was found that atypical ductal hyperplasia was also present in 17 cases.[37] It is therefore not surprising to find DCIS present when atypical ductal hyperplasia is diagnosed.

In one series, 25 consecutive women diagnosed with atypical ductal hyperplasia at stereotactic biopsy were recommended for surgical excision of the biopsy site.[38] Surgical results were reported in 21 of these women, and carcinoma was found in 11 (52%) cases, of which 8 (73%) were pure DCIS and the remaining 3 (27%) were invasive ductal carcinoma.

In another study, 9 (50%) of 18 lesions diagnosed as atypical ductal hyperplasia at stereotactic core biopsy were found to contain carcinoma, which was DCIS in 6 cases and DCIS with invasive ductal carcinoma in the remaining 3 cases.[27] Of 30 women with atypical ductal hyperplasia at stereotactic biopsy reported by yet another group, 15 (50%) were found to have ductal carcinoma at surgical excision.[35]

Because of these data, lesions found to be atypical ductal hyperplasia at stereotactic core biopsy should be surgically excised. When stereotactic biopsy was performed using a 14-gauge gun-needle combination, about 50% of these reexcisions upgraded the lesion to ductal carcinoma, usually DCIS.

Because larger volumes of tissue are removed with vacuum-suction biopsy needles, carcinoma may be missed less frequently when it coexists with atypical ductal hyperplasia. Jackman and colleagues[21] found stereotactic core biopsy using a 14-gauge gun-needle combination missed carcinoma in 26 (48%) of 54 lesions diagnosed as atypical ductal hyperplasia. Using a vacuum-suction biopsy probe, this was reduced to 13 (18%) of 74 lesions.

This reduction in the underestimation of lesions with vacuum-suction biopsy was due to the acquisition of a larger number of cores, 10 per lesion, and a greater volume of tissue in each core, resulting in better sampling of the area. The use of vacuum-suction biopsy will decrease the number of cases of coexistent atypia/carcinoma in which only atypical ductal hyperplasia is diagnosed. However, in those women in whom this diagnosis is made at stereotactic core biopsy, surgical biopsy of the site remains necessary.

Understaging Lesions With DCIS/Invasive Cancer--Limited tissue sampling can also result in understaging of lesions in which DCIS and invasive carcinoma coexist. Because some lesions are largely DCIS but also have sites within the tumor that harbor invasive carcinoma, not sampling the entire lesion can result in failure to diagnose the invasive component.[39] This, in turn, can cause one to fail to appreciate the need for possible axillary dissection during the surgical procedure.[40] Consequently, the patient may need to undergo additional surgery when the diagnosis of invasion is made following histologic assessment of the surgical specimen.

One series has reported that 19% (8/43) of lesions diagnosed as DCIS at large-core needle biopsy had areas of invasion at surgical excision.[27] In another series of 12 cases diagnosed as DCIS at stereotactic core biopsy, 3 (25%) were found to have invasive ductal carcinoma also present within the lesion at surgery.

Because of this experience, a stereotactic core biopsy diagnosis of DCIS needs to be confirmed by surgical histopathology. Although the presence of DCIS within the lesion is invariably confirmed, areas of invasion may be discovered in about 20% of cases. If axillary dissection is required for adequate treatment, planning of the complete surgical treatment may not be possible based on stereotactic core biopsy results.

Significance of Lobular
Carcinoma in Situ

Special note should be made of the stereotactic core biopsy diagnosis of lobular carcinoma in situ (LCIS). Because LCIS has no specific mammographic findings and is an incidental diagnosis made at the time of excision of another lesion, it should not be accepted as consistent with the imaging findings that mandated breast biopsy.[41] If LCIS is the diagnosis made at stereotactic core biopsy, it should be assumed that the lesion in question was missed and a repeat biopsy is necessary.

Other Potential Problems

Specimens obtained at stereotactic core biopsy should be sent for paraffin sectioning, not frozen-tissue analysis. The diminished quality of cytologic detail in frozen-section analysis increases the possibility of overdiagnosing invasive carcinoma due to the mingling of proliferative epithelium and stroma in such lesions as sclerosing adenosis and radial scar.[42]

Stereotactic core biopsy also results in the displacement of epithelial fragments beyond the main tumor mass in a considerable percentage of patients. Youngson et al[43] found that this occurred in 28% (12/43) of cases examined at surgical pathology obtained after stereotactic core biopsy had been performed to establish a preoperative diagnosis. Epithelial displacement is also seen following needling procedures, including anesthesia injection, suturing, needle localization, and fine-needle aspiration biopsy. Pathologists should be careful not to interpret these foci of displaced epithelium as sites of invasive carcinoma.

The issue of whether displacement of tumor at the time of needling has any clinical significance is difficult to assess. However, in a study by Berg and Robbins[44] that assessed the long-term outcome of women with palpable, stage-matched breast cancers, 15-year survival did not differ between women diagnosed with or without aspiration biopsy.

Accreditation of Biopsy Facilities

The full potential of stereotactic core biopsy to improve the quality of care available to women and to decrease the cost of breast cancer diagnosis will only be realized if facilities with appropriately trained staff make this procedure available to the community.[45] As with the delivery of mammography services in the United States, it is expected that stereotactic core biopsy may be regulated by the FDA under the Mammography Quality Assurance Act, which establishes federal control of all breast procedures done with x-ray imaging.

An accreditation program for stereotactic breast biopsy has been established by the American College of Radiology and joined by the American College of Surgeons.[46] This program sets criteria for the training, experience, and continuing medical education of physicians, technicians, and physicists involved in the performance of stereotactic core biopsy and equipment maintenance. Other components of the program include standards for radiation exposure, quality-control procedures, and evaluation of practice outcomes data.

Summary

Stereotactic core biopsy makes it possible to diagnose many mammographically evident breast lesions with greater speed, less cosmetic deformity, and less expense than traditional surgical biopsy. Performance of stereotactic core biopsy in any individual case may be limited by equipment availability, breast size, and coexisting medical conditions. Small lesions can be accurately targeted, but caution should be exercised before fully removing these lesions unless a localizing clip can be placed or an adjacent landmark identifies the site.

Major complications of stereotactic biopsy, including hemorrhage and infection, are rare, occurring in well below 1% of cases. Minor complications of ecchymosis, pain, and anxiety are common.

The accuracy of stereotactic core biopsy diagnosis is high, but biopsy results must be interpreted in light of the probable imaging diagnosis. A benign histopathology for a very suspicious imaging pattern suggests that the lesion targeted for biopsy may have been missed and that a repeat biopsy may be needed.

Because of the histologic heterogeneity of some lesions, sampling with stereotactic core biopsy may only remove areas from the less aggressive components of the lesion. A stereotactic core biopsy diagnosis of atypical ductal hyperplasia raises the possibility of coexistent carcinoma, usually DCIS, and should prompt surgical excision of the lesion. A radial scar should be managed in the same fashion. Other, less common histologies may also require surgical excision in order to establish a definitive diagnosis.

Diagnosis of DCIS by stereotactic core biopsy may also represent understaging of the lesion, as areas of invasion will be found at surgical excision in some of these cases. Therefore, it may not be possible to plan for axillary lymph node dissection preoperatively in some of these women.

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