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Core needle biopsy and frozen section. Myths and reality.

In each case of suspicious breast lesion, confirmation of the malignancy with a biopsy is necessary before deciding about the final treatment method. For several decades, open surgical biopsy was the method of choice for diagnosing cancer. The term "open surgical biopsy" means surgical removal of the tumor and histological examination of the specimen. In most cases, the histological examination was carried out during surgery (frozen section) and, if a malignancy was diagnosed, the surgeon moved on to completing theprocedure with a mastectomy and removal of the axillary lymph nodes.

Over the last decades there have been tremendous developments in both understanding the biological behavior of cancer and in treating it.  Regular screening can lead to the detection of very small tumors or even precancerous lesions (carcinoma in situ). Selective surgical techniques have been developed (lumpectomy, sentinel lymph node biopsy, oncoplastic surgery, simultaneous reconstruction in cases of mastectomy). The value of pre-operative or neoadjuvant systemic treatment (chemotherapy, immunotherapy, hormone therapy) has been scientifically confirmed for many groups of patients (locally advanced inoperable tumors, inflammatory cancer, triple-negative tumors, HER-2 positive tumors and others). Last, the obligation of the doctor to fully inform the patient, who now has a say in treatment decisions, has been made clear.

Given all these developments, pre-operative diagnosis by means of a percutaneous biopsy with a needle (fine or core needle) is now a necessary diagnostic procedure instead of an unnecessary luxury.

                                                                              

The advantages from obtaining a pre-operative diagnosis by means of a needle biopsy are numerous:

  • Selection of patients who will benefit more from getting pre-operative treatment (triple-negative tumors, HER-2 positive tumors, shrinking of tumor to avoid a mastectomy).
     
  • Identification of patients with an increased possibility of presenting with multicentric disease (lobular cancer) in order to evaluate them further.
     
  • Better planning of and preparation for the surgical procedure (planning of the oncoplastic technique, performance of a lymphoscintigraphy before surgery to biopsy the sentinel lymph node).
     
  • Completion of surgical treatment in one step.
     
  • Reduction of the time of surgery through avoidance of the time-consuming frozen section.
     
  • Fully informing the patient on the diagnosis and the recommended therapy. The patient is informed about the diagnosis before surgery, not after. She is given information on the treatment options, she has a say in treatment decisions and time to discuss and opt for simultaneous reconstruction in case of a mastectomy. As a result she feels calmer and more secure.
     
  • Dramatic decrease of unnecessary surgeries (open surgical biopsies for benign conditions which ultimately do not need surgical treatment).

On the contrary, diagnosis with a frozen section has numerous disadvantages:

  • The diagnosis is performed during surgery and decisions are made with the patient "asleep" and insufficiently informed. This increases the patient's insecurity and stress.
     
  • The time of surgery is prolonged, since the surgeon has to wait for the results of the histological examination.
     
  • Possible false negative results in some cases (papillary carcinoma, low-grade ductal carcinoma in situ).
     
  • Preparation of the patient with a lymphoscintigraphy (administration of a radioactive drug) and exposure to radiation for a hypothetically malignant, unconfirmed lesion.

Additionally, given that the material used in frozen section cannot be used in permanent histopathological sections, this method may in some cases be considered malpractice with possibly catastrophic results:

  • For microcalcifications. It may destroy some material and result in missing some small invasive lesion (cancer) inside a carcinoma in situ (precancerous lesion). Also, even if it detects this small lesion, the material will be unsuitable for permanent processing and recovering valuable information that is necessary for further treatment (immunohistochemical examination).
     
  • For cancers smaller than 1 cm.  It may destroy material which is valuable for further processing (immunohistochemical examination, testing with Oncotype DX).

Unfortunately, even nowadays there are several unfounded rumors and hypothetical risks around percutaneous needle biopsy:

  • Can a needle biopsy turn a benign lesion to a malignant one? No. There is no medical report or study that suggests or confirms this. A malignant tumor is malignant from the beginning or starts as a precancerous lesion that evolves into an invasive tumor; no needle biopsy can hinder or accelerate its evolution.
     
  • Can a needle biopsy delay cancer diagnosis and treatment due to a false negative result? No. Each breast lesion is evaluated according to a triple assessment method (clinical finding, imaging-based finding, biopsy result). A negative needle biopsy with a suspicious clinical or imaging-based finding does not rule out malignancy. In this case, the biopsy is repeated or an open surgical biopsy is performed.
     
  • Can a needle biopsy cause the cancer to spread? No. There have been many clinical trials which showed that in some cases (e.g. mucinous carcinoma) cancer cells are implanted along the needle tract, but this has no clinical effect. So, the possibility of a local relapse is the same with or without a needle biopsy.

More and more advanced systems of percutaneous needle biopsy are developed in the modern world. The European Society of Breast Cancer Specialists (EUSOMA) specifies that every breast surgeon must ensure pre-operative diagnosis for at least 95% of the cancer cases they undertake to treat. It also discourages the use of frozen section for tumors smaller than 1 cm and for cases of microcalcification.



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Photo Gallery
Syringe attached to a special device for a fine needle aspiration (FNA) biopsy
Palpating-guided fine needle aspiration (FNA) biopsy
Ultrasound-guided fine needle aspiration (FNA) biopsy
Fixation of the fine needle aspiration (FNA) biopsy material on a special glass plate
Core needle biopsy device
Palpating-guided core needle biopsy
Ultrasound-guided core needle biopsy
Fixation of the sections collected using a core needle biopsy in formalin solution
Vacuum-assisted core needle biopsy device for collection of multiple tissue blocks
Mammography-guided (stereotactic) core needle biopsy
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