Need for Core Needle Biopsy in Breast Cancer Questioned

Core needle biopsy hormone receptor testing was deemed to be unnecessary and wasteful, according to a study published in the American Journal of Surgical Pathology.

Thousands of women each year receive a core needle biopsy to test for cancer. Pathologists determine if the extracted tissue contains cancer, and if so, they classify it as invasive or noninvasive.

In the current study, researchers solely focused on individuals who were newly diagnosed with the noninvasive cancer ductal carcinoma in situ (DCIS). Researchers reviewed the pathology and medical record of 58 patients at The Johns Hopkins Hospital.

Those who were included had core needle biopsies that showed DCIS and follow-up excision within a 2-year period beginning in January 2011.

“Two-thirds of our DCIS study patients did not receive therapy, even after excision confirmed their hormone-receptor positive DCIS status,” said senior study author Pedram Argani, MD. “So analyzing their needle biopsies or surgical excisions for receptors would have clearly been unnecessary for them.”

The rationale for performing the test is that patients with hormone receptor-positive DCIS after excision can take relatively nontoxic medications, such as tamoxifen, to block the receptors and prevent DCIS recurrence. Although hormone-blocking therapy for receptor-positive DCIS can modestly lower the chance of tumor recurrence, prior studies have shown that the therapy ultimately had no effect on a patient’s survival.

Furthermore, medications like tamoxifen carry harsh side effects. Researchers provided several reasons why a core biopsy showing DCIS should not automatically be tested for hormone receptors.

First, regardless of the core biopsy hormone receptor testing results, the standard of care in the United States after needle biopsy for DCIS is that the breast tissue that remains in the suspect area be excised by lumpectomy or mastectomy, meaning that the core biopsy hormone receptor results have no effect on the therapy.

Furthermore, “almost 20% of the time, the excision reveals that the noninvasive DCIS that the core needle biopsy caught is actually accompanied by invasive breast cancer,” Argani said. “So you have to receptor-test the invasive cancer that the core biopsy missed. That means the testing of the core biopsy with DCIS was useless.”

Lastly, about 80% of the time, the surgical excision contains DCIS alone, and the core biopsy results are negative. In these instances, physicians recommend retesting the DCIS in the surgically excised specimen because hormone receptor expression can be heterogeneous, and a small biopsy may miss a positive area.

“If you apply our local results nationally, these unnecessary initial hormone receptor tests currently come with an annual price tag of around $35 million,” Argani said. “Our results indicate that’s an expense without any justification. If these tests were routinely eliminated, the savings would be substantial.”

The National Cancer Institute reports that approximately 1 woman gets a DCIS diagnosis for every 4 women diagnosed with invasive breast cancer. Last January, The Johns Hopkins Hospital ended the practice of routinely conducting core needle biopsy hormone receptor testing, which cost $140 per patient during the study.

“Extrapolating that to the roughly 60,000 US patients diagnosed with DCIS yearly puts the cost at about $8.5 million,” Argani said. “The unnecessary cost of automatically testing DCIS in excisions when the information is not used is $26.5 million, which adds up to $35 million dollars per year in the US.”