Patients With Newly Diagnosed DCIS Breast Cancer May Not Need Their Core Needle Biopsy Tested for Hormone Receptors Interview with:

Pedram Argani, M.D. Professor of Pathology and Principal consultant of the Breast Pathology Service Johns Hopkins Medicine

Dr. Pedram Argani

Pedram Argani, M.D.
Professor of Pathology and
Principal consultant of the Breast Pathology Service
Johns Hopkins Medicine What is the background for this study? What are the main findings?

Response: Most pathology laboratories, at the request if clinicians, automatically (reflexively) test needle core biopsies containing ductal carcinoma in situ (DCIS) for estrogen receptor (ER) and progesterone receptor (PR). The logic for testing DCIS for these hormone receptors is that, for patients who have pure DCIS that is ER positive after surgical excision, treatment with estrogen blockers like Tamoxifen can decrease the recurrence of DCIS by a small amount, though overall survival (which is excellent) is not impacted.

However, there are several factors which suggest that this reflex testing unnecessarily increases costs.
• First, the ER/PR results on core needle biopsy do not impact the next step in therapy; namely, surgical excision.
• Second, a subset of excisions performed for DCIS diagnosed on core needle biopsy will harbor invasive breast carcinoma, which would than need to be retested for ER/PR.
• Third, because ER and PR labeling is often variable in DCIS, negative results for ER/PR in a small core biopsy specimen should logically be repeated in a surgical excision specimen with larger amounts of DICS to be sure that the result is truly negative.
• Fourth, many patients with pure DCIS which is ER/PR positive after surgical excision will decline hormone therapy, so any ER/PR testing of their DCIS is unnecessary.
• Fifth, PR status in DCIS has no independent value.

We reviewed the Johns Hopkins experience with reflex ER/PR testing of DCIS on core needle biopsies over 2 years. We found that reflex core needle biopsy specimen testing unnecessarily increased costs by approximately $140.00 per patient. We found that ER/PR testing in the excision impacted management in only approximately one third of cases, creating an unnecessary increased cost of approximately $440.00 per patient. Extrapolating the increased cost of reflex ER/PR testing of DCIS to the 60,000 new cases of DCIS in the United States each year, reflex core needle biopsy ER/PR testing unnecessarily increased costs by approximately 35 million dollars. What should readers take away from your report?

Response: Patients with newly diagnosed DCIS on core needle biopsy do not need to have their core needle biopsy tested for ER/PR. This produces unnecessary costs for the patient. Testing can be performed after the surgical excision in a more cost effective fashion without impacting patient care. Pathologists can always go back to the core needle biopsy specimen at a later date and perform ER testing if it is necessary. What recommendations do you have for future research as a result of this study?

Response: Automatic (reflex) immunohistochemical or molecular testing of cancer specimens in a variety of organ systems (colon, lung, etc.) has the potential to result in duplicate testing of specimens in different hospitals, as well as testing that has no impact upon patient care, both of which unnecessarily increase patient costs without improving patient care. A review of reflex testing practices for other cancers should considered as means to help control increased medical costs. Thank you for your contribution to the community.


Reflex Estrogen Receptor (ER) and Progesterone Receptor (PR) Analysis of Ductal Carcinoma In Situ (DCIS) in Breast Needle Core Biopsy Specimens: An Unnecessary Exercise That Costs the United States $35 Million/ yr
VandenBussche, Christopher J. MD, PhD; Cimino-Mathews, Ashley MD; Park, Ben Ho MD, PhD; Emens, Leisha A. MD, PhD; Tsangaris, Theodore N. MD; Argani, Pedram MD
American Journal of Surgical Pathology:
August 2016 – Volume 40 – Issue 8 – p 1090–1099
doi: 10.1097/PAS.0000000000000674

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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