Of four surgical procedures for breast cancer that have been determined to be of low value because they yield no meaningful clinical benefit, two continue to be utilized; in fact, the use of two of these procedures has increased in the United States, new research shows.
“This is the first study to [evaluate] all four of the low-value breast cancer procedures at the same time and try to draw some conclusions on practice patterns across facilities,” said senior author Lesly A. Dossett, MD, MPH, Center for Health Outcomes and Policy, the University of Michigan, Ann Arbor, Michigan.
The two low-value procedures that have increased in use are contralateral prophylactic mastectomy for average-risk women with unilateral cancer and sentinel lymph node biopsy for clinically node-negative women aged 70 years and older with hormone receptor–positive (HR+) cancer.
“This suggests that formal efforts to reduce low-value care through dissemination of guidelines, education of patients or providers, or alignment of incentives will be necessary to achieve full deimplementation,” she told Medscape Medical News.
The team emphasizes that the providing of services that have no clinically meaningful benefit is a national epidemic, costing the United States more than $100 billion dollars annually.
These trends are notable and likely reflect a broad range of factors, commented Katharine Yao, MD, chief of the Division of Surgical Oncology at the NorthShore University HealthSystem, Evanston, Illinois.
“I think the better message here is not so much that facilities are doing too many low-value procedures but more that these procedures are still being performed, and the trends show increased rates over the years ― why is that?”
“Perhaps there are other factors here we need to explore: why do these procedures persist and why, despite the Choosing Wisely campaign, they continue to increase?” she told Medscape Medical News. “Maybe there is something we can learn here about patient and physician preferences that perhaps we should be paying more attention to.”
The study was published on February 3 in JAMA Sugery.
For the analysis, Dossett and her colleagues evaluated surgical data from the National Cancer Database. They examined data from more than 1500 surgical facilities and from surgeries involving 920,256 women in the United States who were diagnosed with breast cancer between 2004 and 2016.
The team focused on four procedures that have been determined to be of low value by Choosing Wisely, a campaign of the American Board of Internal Medicine Foundation, on the basis of recommendations of the American College of Surgeons, the Society for Surgical Oncology (SSO), and the American Society for Breast Surgeons.
The results show that for two of the four low-value procedures, use declined significantly over the study period. These two procedures were axillary lymph node dissection for limited nodal disease for patients undergoing lumpectomy and radiotherapy, and lumpectomy reexcision for patients whose surgical margins were close but were negative for invasive cancer.
Axillary lymph node dissection declined from 63% in 2004 to 14% in 2016. The steepest reduction was seen soon after data from the Z0011 study were published in 2010. The rates for this procedure halved in the following year, from 62% in 2010 to 31% in 2011 (P < .001).
Likewise, reoperation rates after lumpectomy dropped from 19% in 2004 to 15% in 2016. The sharpest decline, from 18% in 2013 to 16% in 2014, corresponded to the publishing of the SSO/ASTRO consensus statement, which designated a negative margin as having “no tumor on ink.”
Two of the four low-value procedures increased in use during the study period.
Rates of contralateral prophylactic mastectomy increased nearly 2.5-fold among women with unilateral breast cancer undergoing mastectomy, from 11% in 2004 to 26% in 2016, despite SSO guidelines issued in 2007 recommending that the procedure not be used for women at average risk.
In addition, rates of sentinel lymph node biopsy among women aged 70 years and older with clinically node-negative HR+ breast cancer increased from 78% in 2004 to 87% in 2012. There was no significant decline in the use of this procedure even after the CALGB 9343 trial, from the Cancer and Leukemia Group B, showed no survival benefit in 2013.
Patterns at Hospitals Vary
The study authors also examined hospital factors, which can heavily influence choice of procedure.
These results showed that the greatest reductions of the low-value breast cancer procedures occurred at academic research programs and high-volume surgical facilities. Elsewhere, the rates varied widely.
Interfacility rates of axillary lymph node dissection ranged from 7% to 47%; lumpectomy reoperation rates ranged from 3% to 62%; contralateral prophylactic mastectomy rates ranged from 9% to 67%; and sentinel lymph node biopsy rates ranged from 25% to 97%.
Being an outlier for use of one procedure did not necessarily translate to nonconformity for others. Factors such as a hospital’s volume of breast cancer cases or the type of facility did not appear to influence rates of axillary lymph node dissection or lumpectomy reoperation.
However, the rates of contralateral prophylactic mastectomy were significantly higher in high-volume centers and integrated network cancer programs compared with community cancer programs (23% vs 2%; P < .001).
Dossett said the lack of consistency was somewhat unexpected.
“We expected we would find some facilities were constantly good or bad at deimplementation or that there would be stronger associations between certain facility characteristics and performance,” she said. “That really wasn’t the case, and most facilities had mixed performance.”
Evidence May or May Not Influence Trends
The authors speculate on why the low-value designation is in some cases being ignored.
The evidence regarding the risk for lymphedema related to axillary lymph node dissection procedure appears to have helped reduce its use, they note.
However, surgeons have been much less convinced of benefits in omitting sentinel lymph node biopsy, either because they are unfamiliar with the recommendations to avoid the procedure or they may feel the procedure adds only minimal time and risk to a patient’s operation, the authors explain.
Patients may be convinced to opt to omit sentinel lymph node biopsy if they are properly counseled regarding the risks and benefits of the procedure, Dossett commented.
Yao added that for elderly patients, age can play an important role in sentinel node biopsy.
“Patients’ life expectancy has increased over the years, and node status may impact adjuvant therapy decisions for these patients, even chemotherapy decisions,” she said.
Pressure to continue to perform contralateral prophylactic mastectomy is believed to be significantly patient-driven, Dossett noted.
“I ultimately think the best way to reduce contralateral prophylactic mastectomy is to encourage women with small cancers to undergo breast-conserving surgery, ie, lumpectomy, instead of mastectomy,” she explained.
“Once the decision for mastectomy is made, there is often a great deal of momentum towards a contralateral prophylactic mastectomy,” she said.
She agreed that “contralateral prophylactic mastectomy is a personal preference that many surgeons are willing to do for their patients,” Yao explained.
“Although no survival benefit has been demonstrated for this procedure, patients find many other benefits that have nothing to do with survival.”
The authors and Yao have disclosed no relevant financial relationships.
JAMA Surgery. Published online February 3, 2021. Abstract
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