Management of BI-RADS Category 5 Lesions: Usefulness of Fine-Needle Aspiration
Gal-Gombos EC, Esserman LE, Welsberry S, Recine MA and Poppifi RJ, Jr.

OBJECTIVE:

The usage of fine-needle aspiration (FNA) for accurate diagnosis of a breast mass is declining when compared with core-needle biopsy. We analyzed the utility of FNA as a quick and cost effective method in a special group of patients who had mammographic lesions characterized as highly suggestive of malignancy (BI-RADS category 5).

MATERIALS AND METHODS:

Thirty-eight patients underwent ultrasound guided fine needle aspiration of the breast for 40 masses ranging in size from 0.6 to 4.1 cm. All the masses were highly suggestive of malignancy on mammography (BI-RADS category 5) and sonography. Nineteen of the masses were palpable. The smears were evaluated for signs of malignancy. We reviewed FNA-s and the corresponding histology of the breast masses.

RESULTS:

The FNA findings were reviewed and compared to the surgical biopsy findings and in all the cases the FNA was diagnostic. In our group of patients both the specificity and sensitivity of FNA-s was 100%.

CONCLUSION:

FNA is an accurate and efficient diagnostic tool. FNA can be the best diagnostic choice in patients with BI-RADS category 5 lesions, with tumor status suggesting no need for pre-surgery neoadjuvant therapy: 1) elderly, immobile or non-compliant patients, who cannot rescheduled for an other day for core biopsy 2) patients with coagulopathy or other contraindication for large core needle biopsy.

Our objective was to assess the potential clinical role for preoperative FNA in the diagnostic evaluation of mammographically and or clinically highly suspicious BI-RADS category 5 breast lesions. The usage of fine needle aspiration for the diagnosis of a breast mass is declining when compared with core needle biopsy. The reason is the easy use of core biopsy, which is generally reproducible and provides a definitive diagnosis in the majority of the cases. Another reason is that FNA does not provide histological material, only cells. Carcinomas are ideal lesions for cytopathologic examination since they are usually very cellular.

The American College of Radiology has developed the Breast Imaging Reporting and Data System = BI-RADS, which is intended to standardize the terminology, assessment of the findings and recommendation of action to be taken. On the basis of the level of suspicion the mammographically detected lesions can be placed into one of 4 categories (Category 1. means negative mammogram):

A Category 5 lesion has a high positive predictive value (PPV) for carcinoma (reported as 81-97 per cent). The features with the highest positive predictive value--spiculated margins, irregular shape, linear morphology, and segmental or linear distribution--warrant designation of a lesion as category 5.

A consecutive series of patients who presented with BI-RADS 5, underwent ultrasound guided FNA from September to December 1999. The patient population consisted of 38 women with 40 masses, mean age 70, and range 33 - 91 years.

The 38 patients underwent ultrasound guided fine needle aspiration of the breast for 40 masses ranging in size from 0.6 Ð 4.1 cm in greatest dimension.

The patients first underwent diagnostic mammogram and ultrasound and were found to have BI-RADS category 5 lesions by at least two mammographers. Only sonographically detectable lesions were included in this study. FNA was performed by the standard technique. A high degree of accuracy can be achieved with ultrasound guidance during the procedure. The tip and long axis of the needle can be visualized with real time sonography. Additional confirmation can be obtained by noting the texture of the lesion upon entering it. Nineteen of the patients had a palpable mass. The smears were evaluated for signs of malignancy. FNA-s and the corresponding histology of the breast masses were reviewed.

By using FNA we diagnosed 39 of 39 carcinomas and the diagnosis for the one benign lesion: fat necrosis was also suspected. The results were proven by histology. In addition, FNA was able to demonstrate squamous cells in a case of squamous cell carcinoma, mucin production in two cases of mucinous carcinoma and indicated suspicion of lobular morphology in one case of carcinoma.

The FNA findings were reviewed and compared to surgical biopsy findings and in all cases the FNA was diagnostic. In our group of patients both PPV and sensitivity of FNA was 100%.

Figure 1. Infiltrating carcinoma, duct cell type. An 86-year-old patient after left lower inner quadrant lumpectomy presents for routine follow up.

1A. Right craniocaudal mammography shows an irregular mass in the lateral aspect of the left breast.
1B. Ultrasound demonstrates the 0.6cm mass.
1C. FNA shows highly cellular smears with carcinoma cells (Giemsa x100).

Figure 2. Squamous cell carcinoma. A 47-year-old patient presented for screening mammography.

2A. Left mediolateral mammography shows a BI-RADS 5 irregular mass.
2B. Sonography at the time of FNA. Irregular, hypodense mass with the 18-gauge needle inside.
2C. FNA shows clusters and individual cells with abundant cytoplasm and pink-orange keratinized squamous cells in the background (PAP x200).
2D. Histopathology of the surgical excision showing the well-differentiated squamous cell carcinoma (H and E x100).

FIGURE 1A	FIGURE 1B
	FIGURE 1C

FIGURE 2A	FIGURE 2B
FIGURE 2C	FIGURE 2D

The wide use of core biopsies in the USA has led to a decrease in the use of FNA for diagnostic purposes. In addition, many surgeons donÕt trust FNA for an accurate and definitive diagnosis. Our results support our hypothesis that if there is a clinically and mammographically highly suspicious BI-RADS 5 lesion and ultrasound guided FNA is positive, no further biopsy is needed prior to surgery. If the FNA is non-conclusive, with the above-mentioned clinical setting, another procedure like core biopsy or surgical excision can be added. The highest reported false negative rate for FNA have occurred with the relatively paucicellular tubular and mucinous carcinomas. Other types of infiltrating carcinomas are generally very cellular and ideal for FNA diagnosis.

Figure 3. FNA shows a highly cellular smear with 3 dimensional clusters of carcinoma cells (Giemsa x100). Histopathology (not shown) proved infiltrating carcinoma, duct cell type.

Figure 4. FNA shows single carcinoma cells in the background of mucin in a case of mucin-producing breast carcinoma (Giemsa x100).

There are a few lesions that can mimic carcinoma on mammography and sonography, the most frequent is fat necrosis.

Figure 5. The diagnosis of fat necrosis (the only benign lesion) in the presented series was suspected clinically because the 33 year-old patient had a previous history of augmentation mammoplasty and the lesion was superficial.

5A. FNA shows multinucleated cells and pigment-laden macrophages and a few atypical cells (Giemsa x400).

5B. Excisional biopsy proved the suspected fat necrosis (H and E x10).

FNA has the advantage of simplicity and shorter procedure time and is therefore more cost effective than the other alternatives. We suggest using core biopsy instead of FNA BI-RADS 5 lesions before neo-adjuvant chemotherapy because a clip to locate the lesions can be put at the same time as the biopsy procedure.

FNA is an accurate and efficient diagnostic tool. It can be the best diagnostic choice in certain patients with BI-RAD 5 lesions with tumor status suggesting no need for pre-surgery neo-adjuvant chemotherapy such as:

FIGURE 3	FIGURE 4
FIGURE 5A	FIGURE 5B

Elderly, immobile or non-compliant patients who cannot be easily rescheduled for another day for a core biopsy or Patients with coagulopathy or other contraindication for large core needle biopsy.

In addition ultrasound guided FNA can be done the same time as diagnostic ultrasound, eliminating the need for a time consuming and expensive second procedure.

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