Limiting hormone receptor testing of diagnostic core biopisies containing ductal carcinoma in situ (DCIS) could save up to $35 million in associated health care costs every year in the United States.

The results of a cost analysis conducted by researchers at Johns Hopkins University were so striking that the hospital has now eliminated reflex testing of core needle biopsies for DCIS, Christopher J. VandenBussche, MD, and his colleagues wrote in the American Journal of Surgical Pathology (2016;40:1090-9).

“We suggest that reflex [hormone receptor] testing of core needle biopsy specimens harboring DCIS should not be performed, as the results do not guide the next step in therapy,” wrote Dr. VandenBussche of Johns Hopkins University, Baltimore. “On the basis of this study, we have convinced our clinicians and no longer reflexively perform estrogen- and progesterone-receptor [ER/PR] testing on core needle biopsy specimens with DCIS at Hopkins and encourage other institutions to follow suit.”

Conducting expensive hormone receptor testing of these biopsy samples before surgery doesn’t make clinical or financial sense, for several reasons, the team said:

• Hormone receptor status at biopsy has no effect on the next treatment step, as DCIS patients always progress first to surgical excision, not neoadjuvant hormone therapy.

• Surgery sometimes reveals extensive breast cancer in patents with pure DCIS, and these cancers will always need ER/PR testing, rendering irrelevant biopsy testing.

• Because ER and PR labeling are often heterogeneous in DCIS, negative results for ER/PR on small core needle biopsy specimens would have to be repeated anyway on surgical excision specimens with larger amounts of DCIS, to be sure that the result is truly negative.

• Hormone therapy for DCIS does decrease recurrence, but it doesn’t impact survival – and it does carry significant adverse effects. Therefore, many women refuse hormone therapy if they do have ER/PR-positive tumors.

• The independent role of PR status in DCIS is unproven, so testing for it is not supported by clinical evidence.

To examine the costs associated with reflexive ER/PR testing, the investigators reviewed 58 core needle biopsies of pure DCIS followed by surgical excision. None of the patients had neoadjuvant hormone therapy. Of the 58 tumors, 76% were pure DCIS, and 16% were DCIS with invasive breast cancer. Most of the DCIS (47) tumors were ER+/PR+; 6 were ER-/PR-; and 5 were ER+/PR-.

The team reviewed the records of 49 patients who underwent surgical excision and ended up with a diagnosis of pure DCIS. These included 46 ER-positive cases, and 3 that were ER-negative in both biopsy and excision.

The findings suggested that ER/PR results from either the biopsy and the surgical excision samples were relevant to therapy in only a portion of these patients.

“We found that the ER/PR results after surgical excision impacted therapy in at most only 16 of 49 cases (33%),” they said. These included the 3 ER-/PR-negative cases, which would, in any case, not have triggered hormone therapy; 10 patients who chose hormone therapy despite a Hopkins oncologist’s neutral recommendation; 1 of 2 who took hormone therapy on a Hopkins oncologist’s recommendation; and 2 of 3 who took it after seeing a non-Hopkins oncologist.

“In contrast,” the authors wrote, “in 33 of the cases (67%), the ER/PR result of the DCIS after surgical excision did not impact therapy.” All of these were ER-positive cases, including 4 patients who opted for bilateral mastectomies (no subsequent role for neoadjuvant therapy), 8 who declined to meet with an oncologist, 1 for whom hormone therapy was contraindicated, 8 (of 8) who declined hormone therapy when their Hopkins oncologist did not recommend it, 10 (of 20) who declined hormone therapy when their Hopkins oncologist was neutral about its risk/benefit ratio, 1 (of 2) who declined hormone therapy when the Hopkins oncologist recommended it, and the 1 patient (of 3) who declined hormone therapy after visiting a non-Hopkins oncologist.

After reviewing the costs associated with these cases, “we found that ER testing … costing $20,685.72 ($357 per patient) had been performed unnecessarily,” the investigators said. In addition, if the PR testing – which has never been proven clinically important in DCIS – had been eliminated, there would have been an additional $86.46 savings per patient, a total savings of $5,014.

“Extrapolating the increased cost of $583 per DCIS diagnosis on core needle biopsy to 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increases costs by approximately $35 million,” the authors said. “We recommend that ER/PR not be reflexively ordered on core needle biopsy specimens or surgical excision specimens containing DCIS, but instead that ER alone be performed on surgical excision specimens only when hormone therapy is a serious consideration after medical oncology consultation.”

The group noted that this total reflects the total amount billed, not typical reimbursement. “Regardless,” they said, “the cost of this testing is staggering.”

The authors did not mention the study’s funding source. They had no relevant financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @Alz_Gal

Clinical value of costly ER/PR testing of ductal carcinoma biopsies questioned