Study Finds More Selective Ordering of Breast Biomarker Tests Could Save Millions in Health-Care Dollars
A review of medical records for almost 200 patients with breast cancer suggests that more selective use of biomarker testing for such patients has the potential to save millions of dollars in health-care spending without compromising care, according to Johns Hopkins researchers.
Specifically, waiting to perform these tests until a patient has a full excisional biopsy, instead of reflexively testing for them on initial core biopsies, could save as much as $117 million annually, according to a report on the study published by VandenBussche et al in The American Journal of Surgical Pathology.
Common Practice
Pathologists traditionally have tested for the biomarkers estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) on breast cancers in excisional biopsy specimens to help guide drug treatment.
Over the past 10 years, however, there’s been a shift toward testing of core biopsies for these markers, says senior study author Pedram Argani, MD, Director of the Breast Pathology Service at Johns Hopkins Hospital and Professor of Pathology and Oncology at Johns Hopkins University School of Medicine. “The main reason is that some of these patients may receive neoadjuvant chemotherapy instead of adjuvant chemotherapy, and if they receive neoadjuvant chemotherapy, knowing the markers beforehand is important.”
However, some experts question the routine use of core biopsy marker testing. Many patients do not receive neoadjuvant chemotherapy, as many of the tumors detected today are too small to be eligible for the therapy. For patients who do not receive neoadjuvant chemotherapy, a negative biomarker test on their smaller core biopsy may not reflect the results in the larger excision specimen, because biomarkers may appear in some parts of the tumor but not in others, Dr. Argani said. “That means pathologists generally have to repeat a biomarker test that is negative in the core biopsy on the excision specimen.”
Study Findings
To investigate whether smarter, less routine use of small sample marker testing would make sense clinically and financially, researchers, led by Christopher J. VandenBussche, MD, PhD, Assistant Professor of Pathology at Johns Hopkins University School of Medicine, studied records for 197 patients with breast cancer at Johns Hopkins who had so-called reflex biomarker testing done after small sample core needle biopsy. Among those patients, just 27 (13.6%) received chemotherapy before surgery, and 8 (4%) showed no residual cancer during excisional biopsy. In those cases, researchers noted, biomarker testing on the core biopsy was necessary.
However, none of the remaining 162 patients received chemotherapy before surgery, and that treatment was considered only in a minority of those patients. Five patients (3%) were seen by a radiation oncologist and medical oncologist before surgery, whereas six (4%) were seen only by a medical oncologist. Forty-four patients (26%) visited only a radiation oncologist before surgery, but these visits were largely for decisions about local therapy, such as lumpectomy vs mastectomy, not chemotherapy.
On repeat testing after excisional biopsy, researchers noted that 3 of the 18 cancers (17%) that were estrogen receptor–negative in core biopsy samples were now found to be positive on excision, and 1 of the 24 (4%) cancers that were progesteron receptor–negative in core biopsy samples was now positive on excision. On repeat HER2 testing, 1 of the 42 cancers (2.4%) that were HER2-negative in the core biopsy was positive on excision.
Enormous Savings
Analyzing costs and benefits, the researchers found that if all negative core biopsy tests had been repeated, the increased costs would potentially have been more than $100,000, or about $500 per patient. The researchers estimated that if these costs were applied to the 230,000 new breast cancer cases diagnosed in the United States each year, they would total as much as $117 million annually.
“We suggest that clinical breast cancer teams consider stopping the practice of reflex testing of core needle biopsies, because the results typically do not guide the next step in therapy,” Dr. Argani said. “A more logical, cost-effective approach would be to perform such testing only if chemotherapy before surgery is a serious consideration for that individual patient.”
There are other cancers, such as colon and lung cancers, for which testing is done for different genetic markers that guide treatment, Dr. Argani added, “and when you do it reflexively on all specimens, you often end up repeating your tests on different specimens from the same patient and driving up costs for no reason.” Treating clinicians using these tests may not realize the costs, he says, because the tests are done reflexively without a specific order for that patient, and the bill comes not from the treating clinician, but from the hospital pathology department.
“It’s our hope that people will look at this and start thinking about how to change policies,” Dr. Argani said. “It would be smart for most, if not all, medical centers to consider limiting their breast core biopsy biomarker testing to cases in which chemotherapy before surgery is a serious clinical consideration.”
Dr. Argani is the corresponding author of The American Journal of Surgical Pathology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
