NEWS

Report Examines Management of Suspicious Breast Lesions

Laura Newman

The optimal work-up and diagnosis for suspicious breast lesions remains a highly contentious area of debate, especially with the proliferation of new imaging studies, potential risk factors, and shifting pathological schemes.

Yet well-designed reviews of the best available studies on these dimensions do not guide clinical strategy. Instead, these rigorous reviews prove most useful in flagging methodological weaknesses and setting the stage for establishing new research priorities.

Such was the case with an evidence report sponsored by the U.S. Agency for Healthcare Research and Quality to examine controversial areas in evaluating breast lumps and suspicious mammography findings. Investigators had hoped the report would help better stratify symptomatic individuals by risks and derive a more precise diagnostic algorithm.

Inconsistent Reporting

The report’s authors found that lack of standardized reporting of clinical research and clinical trials makes it difficult to pinpoint new ways to tailor patient management following an abnormal mammogram.

Cindy Levine, M.D., the report’s principal investigator and associate medical director of MetaWorks Inc., the evidence-based practice center that produced the report, said that this is perhaps the biggest hurdle in enhancing breast cancer risk models. Imaging studies offer a case in point. "We have this wonderful [Breast Imaging Reporting Data System] to grade mammograms," she said. "It would be great if everyone used it, but they do not."

Inconsistent study design also makes it difficult to compile results. "Some papers counted the number of patients, others counted the number of lesions, making it hard to go back and forth and pull the data together," said Levine.

The group had hoped to find information on how to incorporate risk factors, particularly age, menstrual status, pregnancy history, and family history, into treatment algorithms following abnormal mammograms or clinical exams. "Age was the only risk factor consistently associated with symptoms and cancer diagnosis," said Levine, who is also a clinical instructor in medicine at Tufts University School of Medicine in Boston, Mass.

But coinvestigator Katrina Armstrong, M.D., assistant professor of medicine at the University of Pennsylvania and a senior fellow of the Leonard Davis Institute of Health Economics, Philadelphia, suggested that this is because the traditional paradigm in managing suspicious lesions was to proceed straight to biopsy no matter what the risk factors.

"The most important thing the evidence report can offer is highlight the future of breast care, which will rely on individualizing care, providing more patient-centered care, and quality of care," she said. "Right now, we need to move to doing studies using these risk factors."

Specific Pathological Findings

The report clarified treatment protocols for several specific types of breast lesions. For atypical ductal hyperplasia, the report stated that a full excisional biopsy is necessary after diagnosis. The evidence report revealed that approximately 42% of atypical ductal hyperplasia diagnoses were changed after performing a full excisional biopsy, with most changes to ductal carcinoma in situ or invasive cancer. Thus, a stereotactic core biopsy does not spare a woman from undergoing an open surgical biopsy. (Stereotactic core biopsy has been touted as less invasive and thus resulting in less lymphedema.) "The evidence backs going directly to a full excisional biopsy," Levine said.

Data on the use of tamoxifen among women with LCIS or atypical hyperplasia were limited to one trial, which showed a marked decrease in subsequent cancer. Based on these "admittedly limited" data, Levine said that evidence points to the promise of tamoxifen in lowering risk of subsequent breast cancer.

Sentinel Node Biopsy

Sentinel node biopsy, a technique that has rapidly been disseminated ahead of the randomized controlled trials, has emerged as a less invasive technique than full axillary lymph node dissection, resulting in far less lymphedema, according to its proponents. The report’s authors examined the indications for performing a sentinel node biopsy, but Levine pointed out that the literature lacked long-term data and that the procedure involves a learning curve.

Even so, Levine acknowledged that "the technique looks promising." The assessment revealed that approximately one-third of sentinel lymph nodes tested positive for metastatic disease, thus mandating full axillary lymph node dissection to assess the extent of spread. On the other hand, although two-thirds of patients could be spared the invasive axillary dissection, 2% to 3% would get a false negative result.

In reviewing costs associated with these different management strategies, the assessment also came up short. Only six of 109 studies addressed cost. The data were "too disparate to draw any conclusions about the actual costs of various interventions and/or the long-term cost savings resulting from their use," said Levine.

Applying the Report

Kaiser Permanente of Northern California nominated these topics for review.

Susan Kutner, M.D., chair of Kaiser Permanente’s Breast Cancer Task Force and a Kaiser Northern California breast surgeon, said that even though Kaiser would like to develop some kind of patient management algorithm that incorporates these dimensions, finding that they "couldn’t substantiate with enough evidence how to proceed is still very helpful."

At Kaiser, every abnormal mammogram and at-risk diagnosis is tracked. "We are inching up" in figuring out how to incorporate new treatments and diagnoses, Kutner said. "There is an incredible amount of input" we are grappling with and women are bombarded with, she added.

While the evidence report did not lead to developing a new guideline, "it put people on alert," said Kutner. "It offers a baseline and an opportunity for us to develop tracking systems and reevaluate emerging dimensions."



             
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