Core needle biopsy ER, PR receptor testing unnecessary in DCIS patients

Routine testing for estrogen and progesterone (ER/PR) receptors in tissue taken from patients with ductal carcinoma in situ (DCIS) on first needle biopsy is unnecessary, according to results from researchers from Johns Hopkins University, Baltimore, MD, who published their study in the current issue of The American Journal of Surgical Pathology.

In fact, based on their results, routine core needle biopsy hormone receptor testing has ceased at Johns Hopkins Hospital since January 2016.

"If you apply our local results nationally, these unnecessary initial hormone receptor tests currently come with an annual price tag of around $35 million," said senior author Pedram Argani, MD, professor of pathology and oncology, Johns Hopkins University School of Medicine, and director of the Breast Pathology Service at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

"Our results indicate that's an expense without any justification. If these tests were routinely eliminated, the savings would be substantial," he added.

Over 2 years, Dr. Argani and colleagues reviewed results from 58 core needle biopsies with corresponding surgical excision specimens that showed pure DCIS. In all, 8.6% (n=4) were benign, 75.9% (n=44) pure DCIS, and 15.5% (n=9) DCIS with invasive mammary carcinoma. Repeated ER/PR testing was required in 9 cases with invasive mammary carcinoma in the specimen, and 4 with pure DCIS that were ER/PR negative, causing an increased cost of $8148.92 ($140/patient for 58 patients in study).

The current standard of care after needle biopsy in DCIS patients is surgical excision of the remaining breast tissue in the suspected area, regardless of core biopsy hormone receptor test results.

In line with this, researchers found that patient management was impacted by ER/PR test results in only 16 of 49 cases with pure DCIS after surgical excision, which resulted in $20,685.72 in unnecessary ER/PR testing costs ($357/patient in study). Further, in the 16 cases for whom ER/PR results did impact patient management, PR testing could have been omitted, and saved $5014.72 ($86.46/patient).

"Two-thirds of our DCIS study patients did not receive hormone therapy, even after excision confirmed their hormone-receptor positive DCIS status. So analyzing their needle biopsies or surgical excisions for receptors would have clearly been unnecessary for them," noted Dr. Argani.

Thus, they estimated that unnecessary early receptor analysis cost about $140 per patient for preparing a trustworthy stained slide and for the pathologist's study of it.

"Extrapolating that to the roughly 60,000 US patients diagnosed with DCIS yearly puts the cost at about $8.5 million," said Dr. Argani. "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 per year in the US."

Based on these findings, the researchers recommended that ER/PR should not be automatic in core needle biopsy or surgical excision specimens containing DCIS, and that ER alone be used in surgical excision specimens only when hormone therapy is considered after medical oncology consultation.

This study was funded by the Johns Hopkins University School of Medicine.