Unnecessary Testing in Breast Cancer Surveillance

Alexander M. Castellino, PhD

December 22, 2014

The American Society of Clinical Oncology (ASCO) guidelines discourage tumor-marker assessment for the surveillance in patients with early-stage breast cancer.

However, a study published online October 20 in the Journal of Clinical Oncology reports that tumor markers for the breast "are frequently used among women with early-stage disease and are associated with an increase in both diagnostic procedures and total cost of care."

"Despite longstanding recommendations against routine use of tumor mark for surveillance of patients with early-stage breast cancer, our analysis of SEER–Medicare records for women age 65 or older finds that testing persists," write Scott D. Ramsey, MD, PhD, from the Fred Hutchison Cancer Research Center in Seattle, and colleagues.

In an accompanying editorial, Cynthia Owusu, MD, and Lyndsay Harris, MD, both from Case Western Reserve University in Cleveland, note that "these findings represent an underestimation of the scope of tumor-marker testing within the oncology community as the study population was limited to women 65 years and older."

"I am disappointed, but not surprised," said Lowell E. Schnipper, MD, chief of hematology/oncology at the Beth Israel Deaconess Medical Center in Boston, and chair of the ASCO Value in Cancer Care Task Force.

It would be great if we understood what drives physician behavior, he added. He said from his own experience, he believes that ordering unnecessary tests is multifactorial. Physicians need to feel they are on top of the case, but patients are terrified and want to be sure they do not have cancer all over, Dr Schnipper told Medscape Medical News.

ASCO Recommendation Against Tumor Markers

Dr Schnipper was involved in the development of ASCO's 2012 list of the top five practices in oncology that must stop (J Clin Oncol. 2012;30:1715-1724), which was part of the Choosing Wisely campaign, an initiative led by the American Board of Internal Medicine Foundation to encourage conversations between physicians and patients about the overuse or misuse of medical tests.

On that list is the following recommendation: Do not perform surveillance testing (biomarkers) or imaging (PET, CT, and radionuclide bone scans) for asymptomatic patients who have been treated for breast cancer with curative intent.

"For breast cancer that has been treated with curative intent, several studies have shown there is no benefit from routine imaging or serial measurement of serum tumor markers in asymptomatic patients. False-positive tests can lead to harm through unnecessary invasive procedures, overtreatment, and misdiagnosis," Dr Schnipper and his colleagues write.

Population-Based SEER–Medicaid Study

In their study, Dr Ramsey's team used the Surveillance, Epidemiology, and End Results (SEER)–Medicare database to identify 39,650 women diagnosed with breast cancer from 2001 and 2007 who were followed for at least 2 years. This enabled the researchers to exclude women whose disease recurred, they explain.

The Healthcare Common Procedure Coding System for tumor-marker testing — in particular codes for CEA and CA 15-3/CA-27.29 — was used.

Reimbursements for claims filed from 3 months before diagnosis to 2 years after were used to calculate the cost of care.

In the 2 years after diagnosis, 16,653 patients (42%) underwent at least one tumor-marker test (average, 5.7 tests per person).

Patients who were younger were more likely to be tested, as were Hispanic patients, those with stage II or III disease, and those being treated by community physicians in rural settings.

Tumor-marker testing increased during the study period, from 38% in 2001 to 46% in 2007. Specifically, the number of CA 15-3/CA27.29 tests increased from 2.6 to 3.9 per person.

Patients who underwent tumor-marker testing were more likely to receive chemotherapy than those who did not (24% vs 11%), and were more likely to undergo advanced imaging (62% vs 47%).

Tumor-marker testing was associated with an increase in the cost of care. In months 3 to 12 after diagnosis, costs were 35% higher in tested than in untested patients; in months 13 to 24, they were 28% higher.

Overall, the cost of care was 29% higher in tested than in untested patients. For women with stage I disease, costs were 24% higher with testing.

"Why Are We Still Doing Useless Tests?"

In their editorial, Drs Owusu and Harris point out that the ASCO guidelines issued in 1996, 1997, 2006, and 2007 do not recommend or support the use of these serum markers for screening, diagnosis, staging, or surveillance for detecting recurrence. And they note that the National Cancer Comprehensive Network (NCCN) does not recommend the use of breast cancer markers for routine surveillance after primary treatment.

Because the study population involved women diagnosed only up to 2007, the researchers might not have captured the impact of the 2007 ASCO update, Drs Owusu and Harris acknowledge.

However, they ask, Why are these tests still being done for surveillance in early-stage breast cancer?

The overuse of surveillance testing is associated with older providers, lower provider self-efficacy, international medical graduates, and the view of perceptive providers that "survivorship care may be conflicting or ambiguous," Drs Owusu and Harris report.

It does not help that most of tests ordered for disease recurrence are approved by the US Food and Drug Administration (FDA) for clinical use — an apparent conflict with ASCO and NCCN recommendations. The FDA "clearance of tests has thus far not required evidence of clinical utility, unlike the ASCO and NCCN guidelines," the editorialists write.

They suggest that the overuse indicates a lack of familiarity with the guidelines, and recommend a targeted education campaign that emphasizes not just the lack of benefit, but also the significant harm associated with unnecessary testing.

"Indeed, there is significant morbidity associated with unnecessary tumor-marker testing in the early-stage setting including the distress and ongoing anxiety of the patient with a positive tumor marker in the setting of negative metastatic work-up and excessive testing resulting from this finding," Drs Owusu and Harris write.

They also suggest that "payers and CMS should ensure that these tests are not reimbursed to discourage their use."

"Finally, a direct-to-consumer education approach may be helpful, as patients must bear now the burden of cost, particularly in older patients who can least afford it," they add.

Several of the study authors report ties with industry. Dr Owusu and Dr Harris have disclosed no relevant financial relationships.

J Clin Oncol. October 20, 2014. Abstract, Editorial

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