Why Should We Avoid Excisional Biopsy of Breast Lump? ASOMA Guide for Managing a Discrete Breast Lump 

Introduction

Breast cancer is the most common cancer of the human race. In developing countries, women present with advanced stage of disease [1, 2].

A discrete mass is the most common presentation of breast cancer. The current guidelines recommend clinical breast examination followed by imaging and image-guided biopsy. According to a report that included 160 studies, women were 15 times more likely to have their cancer treated with a single surgical procedure if they underwent image-guided biopsy rather than excision biopsy [3].

Current Management

The current guideline for a breast lump is the triple assessment with thorough clinical evaluation including history and detailed physical examination followed by appropriate imaging. Diagnostic imaging includes ultrasound evaluation of the whole breast including major milk ducts, the lesion and axillary nodes, mammography of both breasts (for women with age > 30–35 years), followed by image-guided pathological examination by large core needle biopsy. The triple assessment achieves a diagnostic accuracy of 99 to 100%. Pathological examination includes the tissue histology and the immunohistochemistry including the estrogen receptor (ER) expression, progesterone receptor (PR) expression, and human epidermal growth factor receptor 2 (HER2). Ki67 is a proliferation rate indicator which can indicate therapy response and the biology of the tumor [4]. These markers help in prognostication and appropriate adjuvant therapy.

Core Needle Biopsy

The core needle biopsy of breast lesions is carried out with 14-gauge spring-loaded large core biopsy gun under image guidance from the solid part of the lesion avoiding any area of cystic degeneration and adjoining blood vessels lest a hematoma should form. Five or more cores of tissues should be taken [3]. This is the current standard of care for histopathological diagnosis and the most certain way to exclude cancer. It is associated with slightly greater discomfort as compared to fine-needle aspiration cytology (FNAC) and has higher cost. However, it provides histological architecture to better classify subtypes of cancer, immunohistochemical evaluation of receptors, and mitotic index. Moreover, it avoids repeated procedures. The presence of invasion can only be ascertained by histological evaluation of tissue obtained by core biopsy. The sensitivity of core needle biopsy is 84–88% and the specificity is 98–99% [5].

The concept of minimal access approach and de-escalation has percolated every sphere of medicine. Imbued with this minimal invasive intervention, minimally invasive breast biopsy (MIBB) has been introduced since the early 1990s. MIBB includes core needle and fine-needle aspiration (FNA). Several studies have confirmed the diagnostic accuracy of MIBB in diagnosing both benign and malignant lesions of the breast. MIBBs confer many advantages as compared to open excisional biopsies. Patients undergoing MIBB suffer less morbidity and are less likely to undergo unnecessary surgery. Moreover, patients after MIBB are more likely to have negative margins after lumpectomy and are more likely to undergo only one surgery. MIBB has been considered as the “standard of care” by many consensus guidelines since 2001. It has been suggested that rates of MIBB utilization should exceed 90% and open excisional biopsy should be rarely used. Some studies report that patients in rural areas, even in the USA, receive more of open biopsies as compared to core needle biopsy [6].

There is an increasing trend among oncologists to treat more and more breast cancers with primary systemic therapy (PST)/neoadjuvant therapy (NAT) based on the biological aggressiveness of the lesion. Thus, lesions > 5 mm, HER-2 rich or TNBC, younger patients, node positive, and high Ki67 index are all being offered primary systemic therapy, rather than upfront surgery. Hence, it is utmost essential to provide all the markers of tumor biology prior to any therapy.

Many patients achieve pathological complete remission (pCR) following PST/NAT. A large body of evidence demonstrates that pCR achievers enjoy happy, healthy, recurrence-free life compared to non-pCR achievers. Therefore, we must give the lady the opportunity to achieve pCR [7].

Some surgeons perform palpation-guided biopsy. The lump is steady with thumb and finger and the core biopsy needle is passed with a small nick in the skin. This facilitates quick processing of the tissue and faster reporting with definite diagnosis if image-guided biopsy facility is not readily available.

Why Image-Guided Biopsy?

A malignant tumor comprises a heterogenous population of cancer cells, along with necrotic areas. The surrounding tissue undergoes desmoplastic reaction and tumor-induced angiogenesis. The fibrotic tissue produced due to desmoplasia renders the mass “hard” and gives a false sense of a diameter greater than the “actual tumor.” If a palpation-guided core needle biopsy is performed, it is possible that the necrotic areas or surrounding thickened normal tissue may be sampled giving a “false negative or inconclusive” report subjecting the patient to a repeat biopsy causing pain, bruising, and a delay in the diagnosis. If a malignant lesion presents with a complex cyst (cyst with solid component), one may only aspirate the cyst during the blind core biopsy procedure and give a false-negative report. Once the cyst is aspirated, the solid component disappears within the breast tissue, thus making the diagnosis further difficult. Accidental puncture of adjacent blood vessels may cause hematoma at the lesion site which results in not only severe pain and discomfort but also over-staging as the overall diameter of the lesion increases.

A randomized controlled trial was conducted at AIIMS New Delhi to assess the diagnostic accuracy of image-guided core breast biopsy versus a palpation-guided biopsy. In this trial, 52.8% patients needed a repeat biopsy because of inadequate samples or inconclusive report in the “palpation-guided group” [1].

In patients who show BIRADS 2 lesions on imaging like clear cyst, simple cyst, complicated cyst, or galactocele, there is no need to subject the patient for unnecessary biopsy. Thus, a pre-biopsy ultrasonography is mandatory.

Thus, ultrasound-guided biopsies and BCS have led to improved aesthetic outcome. MIBB allows an individualized therapy with greater use of neoadjuvant treatment combined with BCS which has led to more favorable aesthetic and oncological results, with reduced postoperative complications [8].

The European Breast Imaging Society in 2020 described “Percutaneous image-guided needle biopsy is essential in the management of suspicious breast lesions detected by screening or during the assessment of clinical abnormalities. It is a safe and cost-effective procedure allowing for an accurate diagnosis, pivotal for adequate decision making, including, when indicated, treatment planning” [9].

There is an increasing adoption of ultrasound-guided biopsy in many Asian and Middle Eastern countries. In a study from Dubai (UAE), US-CNB detected malignant lesions in 109 patients, with a total sensitivity and specificity for malignancy at 96.33% and 75.10%, respectively. The most frequent malignant tumor diagnosed with US-CNB was invasive ductal carcinoma. The most common benign masses detected were 38 (32.1%) fibroadenomas and fat necrosis. The positive and negative predictive values for US-CNB were 92.4% and 87.5%, respectively [10].

Excision Biopsy

Excision biopsy of a lesion is the removal of the tumor with the intent to remove it in its entirety. In the current scenario, it is no longer the standard of care for primary diagnosis of breast masses. The current indications for excision biopsy are when there is discordance between clinical and radiological findings with the core biopsy findings, even on repeat core biopsy. Excision is also indicated for core biopsy showing atypical lobular hyperplasia, atypical ductal hyperplasia, and lobular carcinoma in situ and in such cases is termed as therapeutic excision [11].

Few surgeons in the low- and middle-income societies have not adopted this sequential triple assessment approach and perform excision of the suspected tumor as an upfront diagnostic procedure.

Why Should We Avoid an Excision Biopsy?

Despite advancement in diagnostic methods, excision biopsies are performed far too commonly. Excision biopsy is performed mostly by surgeons who do not follow oncological principles. The biopsy specimen is taken without adequate margins, which invariably renders the specimen pathological margins to be positive in case the diagnosis is malignancy, causing additional hassles to the patient and surgeon for subsequent management [9, 12]. The excision biopsy specimen is most of the times not oriented by the operating surgeon necessitating complete re-excision of the entire cavity for even a single positive margin. Re-operation forces the surgeon to perform excessive removal of breast tissue and increased morbidity with disfigurement of the breast and increased risk of infection. Positive surgical margin after lumpectomy is an independent risk factor for “in breast tumor recurrence” (IBTR), poor disease-free survival, and overall survival. Positive surgical margins and IBTR have also been associated with increased systemic recurrence in several studies [6, 13].

As it is a relatively unplanned surgery with only a diagnostic mindset, the operating surgeon may even cut through the tumor (trans-tumoral resection) accidentally. The conventional teaching in oncology is that we should not be seeing the actual tumor while excising it. It is a sin in the realm of oncology to perform “trans-tumoral resection” for a potentially curable cancer. Performing the excision biopsy in this manner violates the very principles of oncology that is “wide excision with a margin of healthy tissue” to be included all around the tumor to prevent recurrence of the lesion. Moreover, the exact ascertainment of histological tumor dimensions becomes erroneous.

After an excision biopsy, on obtaining diagnosis of a cancer, the surgeon takes the patient back to the operation theater and tries to excise the tumor bed. This not only is psychologically stressful for the patient but also exposes them to the additional anesthetic and surgical complications. The re-excision can never be performed correctly because the original tumor bed has now been distorted due to collection of seroma or hematoma or is collapsed by suturing the tissues of the wall of the cavity. The tumor cells on the wall of the tumor bed or cavity may lead to regrowth under the influence of many growth factors and cause local and systemic recurrence. Moreover, poorly planned incisions may pose difficulty in achieving cosmesis during the definitive surgery.

Failure to localize the tumor bed appropriately may also interfere with adequate administration of radiotherapy boost to the tumor bed [8].

The current guideline for breast cancer and some other tumors is to administer pre-operative primary systematic therapy or neoadjuvant therapy in the form of cytotoxic drugs or hormone therapy to downsize the tumor and achieve pathological complete remission. Ladies achieving a pathological complete remission (PCR) enjoy a longer, disease-free, happy, healthy life compared to those without PCR [14, 15]. An excision biopsy deprives the patient of the putative benefits of PCR.

It is thus of paramount importance to avoid excision biopsy of any suspected tumor [14].

What to Do in Non-ideal Situations in Low- and Middle-Income Societies?

In certain institutions, non-availability of core biopsy needle or lack of easy accessibility to ultrasound machine may pose a hindrance to the management of patients. In such situations, it is best to refer the patient earliest to an institute where such diagnostic provisions are available. With rising incidence of breast cancer burden, it is recommended to equip the center with ideal core biopsy set-up.

What to Do in Compelling Situations Where Facilities for Image-Guided Biopsy Does Not Exist?

Biopsy

If biopsy cannot be performed with image guidance, it is recommended that the doctor performing the core biopsy must review the image of the lump carefully before taking cores. The direction of the needle must be planned accordingly and only the solid parts must be targeted and the blood vessels avoided.

In situations where excision biopsy could not be avoided for diagnosis, the surgeon must remember certain considerations. The incision made on the breast must be as close to the tumor as possible and should be so oriented that it may be encompassed in the mastectomy incision if deemed necessary at a later date. The incisions in upper quadrant of the breast must be circumareolar or peri-areolar while those in lower quadrants should be radial for best cosmetic outcome. Periareolar incisions leave almost an inconspicuous scar. These incisions may help avoid disfiguration of breast and ugly scar if repeat surgery of breast is needed (Fig. 1). Excision biopsy done in such rare situations is usually in suspected cases of cancer. In such cases, it is advisable to clear wider margins of 1 cm all around the lesion. If the lump seems too close to the skin, an island of skin directly above it should also be removed. After removal of the specimen, a cavity wash with distilled water or povidone iodine must be given. The titanium liga-clips in the four walls of the cavity and the floor must be applied to facilitate radiotherapy boost. The specimen should be appropriately marked and oriented by placing marking sutures (usually by silk), long for lateral and short for superior orientation, and a suture loop on the anterior side (Fig. 2). This guides the pathologist and surgeon in orienting the specimen, in case of positive margin(s), requiring re-excision. The patient must be kept in follow-up with careful evaluation of histopathological report and guidance for further adjuvant therapy.

Fig. 1.

A, B Wrongly placed ugly scar of excision biopsy compelling the surgeon to modify the mastectomy incision. C Incisions must not cross the anterior axillary fold (dotted red line), as it severs the afferent lymphatics from upper arm increasing the risk of lymphedema. The green tick-mark shows correct area of axillary incisions

Fig. 2.

The above figure shows excision biopsy specimen marking. A SS—short superiorly and LL—long laterally by a silk 1.0 suture and B an anteriorly placed “loop” to identify the anterior side for histopathological analysis (Anterior loop)

Impalpable Breast Lesions

These lesions are very difficult to diagnose. When imaging shows suspicious lesions like cluster/linear micro-calcifications, architectural distortion, and border irregularity, it should arouse suspicion of cancer. These lesions can be better managed at a higher center where a dedicated breast radiologist and facilities for stereotactic vacuum-assisted biopsy are available and wire-guided localization with excision can be performed.

Ulcerated Lesions

In advanced breast cancer with involvement of skin in the form of ulceration, incision biopsy from the edge of the tumor must be taken along with adjacent skin (in order to demonstrate the infiltration of normal tissue by the tumor cells).

Conclusion

Every patient presenting with a breast lump should be evaluated by triple assessment. Image-guided biopsy is the key to primary histopathological diagnosis of a lump. It has many advantages over a diagnostic excision in planning an oncologically correct resection and cosmetically appealing scar. It also helps avoid re-surgery and further morbidity to the patient.

Declarations

Conflict of Interest

The authors declare no competing interests.